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Abstract Background Despite the availability of evidence-based treatments for anorexia nervosa (AN), remission rates are moderate, and mortality is high. Olanzapine is used as adjunct therapy for AN in case of insufficient response to first-line treatments, even though the evidence is limited. Its effect on eating disorder (ED) psychopathology, its efficacy and tolerability, and its acceptability and adherence rate are unclear. Methods We assessed the feasibility of a future definitive trial on olanzapine in young people with AN in an open-label, one-armed feasibility study that aimed to include 55 patients with AN or atypical AN aged 12–24 who gained

Introduction Breast cancer is the most common cancer among women worldwide. While increasing numbers of women are living beyond breast cancer, treatment-related body image concerns are common and associated with adverse consequences. Nonetheless, rigorously evaluated and effective body image interventions are lacking among this group. Accepting your Body after Cancer (ABC) has indicated promise in relation to inperson delivery. However, online delivery may increase accessibility and facilitate sustainability of the intervention. Therefore, we aim to establish the feasibility of conducting a fully powered randomised controlled trial to evaluate online delivery of ABC.Methods and analysis 120 women who have received treatment for breast cancer and are experiencing body image concerns will be randomised equally to either the ABC or standard care control group. All participants in both conditions will receive a body image booklet for people who have had cancer. ABC participants will also take part in a weekly seven-session, group-based cognitive behavioural therapy intervention, delivered online by a psychologist and cancer support specialist. Outcome measures will be completed at baseline and 9 weeks, 20 weeks and 32 weeks post baseline. Quantitative data on recruitment, retention, ABC attendance and questionnaire completion rates will be analysed using descriptive statistics. Qualitative data will also be collected to better understand the feasibility and acceptability of the research process and intervention, with data analysed using ‘codebook’ thematic analysis.Ethics and dissemination The study has received ethical approval from the Newcastle North Tyneside Research Ethics Committee (ref: 24/NE/0092). The findings will be disseminated to academic and health professionals via a peer-reviewed publication and presentations at relevant conferences. Results will also be disseminated to participants, national cancer organisations and the general public via accessible reports, online presentations and different communication channels.Trial registration number ClinicalTrials.gov NCT06412341; ISRCTN ISRCTN88199566; IRAS 327507; REC reference 24/NE/0092; funder reference NIHR205415.

BackgroundA smartphone app, Parent Positive, was developed to help parents manage their children’s conduct and emotional problems during the COVID-19 pandemic. A randomized controlled trial, Supporting Parents and Kids Through Lockdown Experiences (SPARKLE), found Parent Positive to be effective in reducing children’s emotional problems. However, app effectiveness may be influenced by a range of child, family, socioeconomic, and pandemic-related factors. ObjectiveThis study examined whether baseline factors related to the child, family, and socioeconomic status, as well as pandemic-related disruption circumstances, moderated Parent Positive’s effects on child conduct and emotional problems at 1- and 2-month follow-up. MethodsThis study was a secondary exploratory analysis of SPARKLE data. The data set included 646 children (4-10 years of age) with parents randomized to either Parent Positive (n=320) or follow-up as usual (n=326). Candidate baseline moderators included child age, gender, attention-deficit/hyperactivity disorder symptoms, parental psychological distress, family conflict, household income, employment status, household overcrowding, and pandemic-related disruption risk (ie, homeschooling, lockdown status, and isolation status). Child conduct and emotional problem outcomes measured at 1- (T2) and 2-months (T3) post randomization were analyzed using linear mixed-effects analysis of covariance models adjusting for baseline (T1) measure of outcome and including intervention and intervention by time point interaction terms allowing for different effects at the 2 time points. Moderation of intervention effects by baseline factors was assessed by replacing the intervention by time interaction terms with intervention by time point by baseline moderator interaction terms. ResultsChild gender was a significant moderator of the Parent Positive versus follow-up as usual effect on emotional problems (B=0.72, 95% CI 0.12-1.33; P=.02). Specifically, the effect of Parent Positive was close to significant (T2: B=–0.41, 95% CI –0.82 to 0.0004; P=.05) or significant (T3: B=–0.76, 95% CI –1.22 to –0.30; P

Abstract Background The Brief Educational Workshops in Secondary Schools Trial (BESST) is an England-wide school-based cluster randomised controlled trial assessing the clinical and cost-effectiveness of an open-access psychological workshop programme (DISCOVER) for 16–18-year-olds. This baseline paper describes the self-referral and other recruitment processes used in this study and the baseline characteristics of the enrolled schools and participants. Method We enrolled 900 participants from 57 Secondary schools across England from 4th October 2021 to 10th November 2022. Schools were randomised to receive either the DISCOVER day-long Stress workshop or treatment as usual which included signposting information. Participants will be followed up for 6 months with outcome data collection at baseline, 3-month, and 6-month post randomisation. Results Schools were recruited from a geographically and ethnically diverse sample across England. To reduce stigma, students were invited to self-refer into the study if they wanted help for stress. Their mean age was 17.2 (SD = 0.6), 641 (71%) were female and 411 (45.6%) were from ethnic minority groups. The general wellbeing of our sample measured using the Mood and Feelings Questionnaire (MFQ) found 314 (35%) of students exhibited symptoms of depression at baseline. Eighty percent of students reported low wellbeing on the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) suggesting that although the overall sample mean is below the cut-off for depression, the self-referral approach used in this study supports distressed students in coming forward. Conclusion The BESST study will continue to follow up participants to collect outcome data and results will be analysed once all the data have been collected. Trial registration ISRCTN registry ISRCTN90912799. Registered on 28 May 2020.

Abstract Background The National Health Service in England pledged >£365 million to improve access to mental healthcare services via Community Perinatal Mental Health Teams (CPMHTs) and reduce the rate of perinatal relapse in women with severe mental illness. This study aimed to explore changes in service use patterns following the implementation of CPMHTs in pregnant women with a history of specialist mental healthcare in England, and conduct a cost-analysis on these changes. Methods This study used a longitudinal cohort design based on existing routine administrative data. The study population was all women residing in England with an onset of pregnancy on or after 1st April 2016 and who gave birth on or before 31st March 2018 with pre-existing mental illness (N = 70,323). Resource use and costs were compared before and after the implementation of CPMHTs. The economic perspective was limited to secondary mental health services, and the time horizon was the perinatal period (from the start of pregnancy to 1-year post-birth, ~ 21 months). Results The percentage of women using community mental healthcare services over the perinatal period was higher for areas with CPMHTs (30.96%, n=9,653) compared to areas without CPMHTs (24.72%, n=9,615). The overall percentage of women using acute care services (inpatient and crisis resolution teams) over the perinatal period was lower for areas with CPMHTs (4.94%, n=1,540 vs. 5.58%, n=2,171), comprising reduced crisis resolution team contacts (4.41%, n=1,375 vs. 5.23%, n=2,035) but increased psychiatric admissions (1.43%, n=445 vs. 1.13%, n=441). Total mental healthcare costs over the perinatal period were significantly higher for areas with CPMHTs (fully adjusted incremental cost £111, 95% CI £29 to £192, p-value 0.008). Conclusions Following implementation of CPMHTs, the percentage of women using acute care decreased while the percentage of women using community care increased. However, the greater use of inpatient admissions alongside greater use of community care resulted in a significantly higher mean cost of secondary mental health service use for women in the CPMHT group compared with no CPMHT. Increased costs must be considered with caution as no data was available on relevant outcomes such as quality of life or satisfaction with services.

Background Depression and anxiety are increasingly prevalent in adolescents. The Brief Educational Workshops in Secondary Schools Trial investigated the effectiveness of a brief self-referral stress workshop programme for sixth-form students aged 16–18 years old.Objective This study conducted a secondary analysis on the outcomes of participants with elevated depressive symptoms at baseline.Methods This is an England-wide, multicentre, cluster randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of a brief cognitive–behavioural therapy workshop (DISCOVER) compared with treatment-as-usual (TAU) (1:1). The primary outcome was depression symptoms (Mood and Feelings Questionnaire (MFQ)) at 6-month follow-up, using the intention-to-treat (ITT) population and analysed with a multilevel linear regression estimating a between-group adjusted mean difference (aMD). Cost-effectiveness, taking a National Health Service (NHS) and personal social services perspective, was explored using quality-adjusted life years (QALYs).Findings Between 4 October 2021 and 10 November 2022, 900 adolescents at 57 schools were enrolled. 314 students were identified as having elevated symptoms of depression at baseline (>27 on MFQ). In this prespecified subgroup, the DISCOVER arm included 142 participants and TAU included 172. ITT analysis included 298 participants. Primary analysis at 6 months found aMD to be −3.88 (95% CI −6.48, –1.29; Cohen’s d=−0.52; p=0.003), with a similar reduction at 3 months (aMD=−4.00; 95% CI −6.58, –1.42; Cohen’s d=0.53; p=0.002), indicating a moderate, clinically meaningful effect in the DISCOVER arm. We found an incremental cost-effectiveness ratio of £5255 per QALY, with a probability of DISCOVER being cost-effective at between 89% and 95% compared with TAU.Conclusions and clinical implications DISCOVER is clinically effective and cost-effective in those with elevated depressive symptoms. This intervention could be used as an early school-based intervention by the NHS.Trial registration number ISRCTN90912799.

Abstract Background Over 3000 young people under the age of 18 are admitted to Tier 4 Child and Adolescent Mental Health Services (CAMHS) inpatient units across the UK each year. The average length of hospital stay for young people across all psychiatric units in the UK is 120 days. Research is needed to identify the most effective and efficient ways to care for young people (YP) with psychiatric emergencies. This study aims to evaluate the clinical effectiveness and cost-effectiveness of intensive community care service (ICCS) compared to treatment as usual (TAU) for young people with psychiatric emergencies. Methods This is a multicentre two-arm randomized controlled trial (RCT) with an internal pilot phase. Young people aged 12 to < 18 considered for admission at participating NHS organizations across the UK will be randomized 1:1 to either TAU or ICCS. The primary outcome is the time to return to or start education, employment, or training (EET) at 6 months post-randomization. Secondary outcomes will include evaluations of mental health and overall well-being and patient satisfaction. Service use and costs and cost-effectiveness will also be explored. Intention-to-treat analysis will be adopted. The trial is expected to be completed within 42 months, with an internal pilot phase in the first 12 months to assess the recruitment feasibility. A process evaluation using visual semi-structured interviews will be conducted with 42 young people and 42 healthcare workers. Discussion This trial is the first well-powered randomized controlled trial evaluating the clinical and cost-effectiveness of ICCS compared to TAU for young people with psychiatric emergencies in Great Britain. Trial registration ISRCTN ISRCTN42999542, Registration on April 29, 2020

Abstract Background Perinatal depression affects an estimated 1 in 5 women in North America during the perinatal period, with annualized lifetime costs estimated at $20.6 billion CAD in Canada and over $45.9 billion USD in the US. Access to psychological treatments remains limited for most perinatal women suffering from depression and anxiety. Some barriers to effective care can be addressed through task-sharing to non-specialist providers and through telemedicine platforms. The cost-effectiveness of these strategies compared to traditional specialist and in-person models remains unknown. This protocol describes an economic evaluation of non-specialist providers and telemedicine, in comparison to specialist providers and in-person sessions within the ongoing Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) trial. Methods The economic evaluation will be undertaken alongside the SUMMIT trial. SUMMIT is a pragmatic, randomized, non-inferiority trial across five North American study sites (N = 1,226) of the comparable effectiveness of two types of providers (specialist vs. non-specialist) and delivery modes (telemedicine vs. in-person) of a behavioural activation treatment for perinatal depressive and anxiety symptoms. The primary economic evaluation will be a cost-utility analysis. The outcome will be the incremental cost-effectiveness ratio, which will be expressed as the additional cost required to achieve an additional quality-adjusted life-year, as assessed by the EuroQol 5-Dimension 5-Level instrument. A secondary cost-effectiveness analysis will use participants’ depressive symptom scores. A micro-costing analysis will be conducted to estimate the resources/costs required to implement and sustain the interventions; healthcare resource utilization will be captured via self-report. Data will be pooled and analysed using uniform price and utility weights to determine cost-utility across all trial sites. Secondary country-specific cost-utility and cost-effectiveness analyses will also be completed. Sensitivity analyses will be conducted, and cost-effectiveness acceptability-curves will be generated, in all instances. Discussion Results of this study are expected to inform key decisions related to dissemination and scale up of evidence-based psychological interventions in Canada, the US, and possibly worldwide. There is potential impact on real-world practice by informing decision makers of the long-term savings to the larger healthcare setting in services to support perinatal women with common mental health conditions.

IntroductionThe Pathway for Eating disorders and Autism developed from Clinical Experience (PEACE pathway) is a clinical pathway of adapted treatment for individuals with eating disorders and autism in the UK. This study aims to investigate multidisciplinary clinicians’ views of the strengths and challenges of PEACE pathway adaptations, while identifying areas where further improvement is needed.MethodSemi-structured interviews were conducted with 16 clinicians who worked on the PEACE pathway. Themes relevant to the benefits, challenges and areas of improvement were identified, and a thematic map was produced.ResultsPEACE Pathway brought clinical benefits such as improved understanding of patients’ perspective, improved flexibility and individualisation in clinicians’ approach, increased patient engagement, and provision of resources that are helpful to all patients with or without autism. Benefits to the service included increase in autism awareness, clinicians’ confidence, and team collaboration. Challenges were also identified, including difficulties in incorporating autism adaptations into existing treatment protocol, implementing PEACE at different levels of care, staff schedule conflicts, and increased pressure to meet patients’ needs. Overall, there is a need for systemic improvement in aftercare and community support for autism, more suitable autism screening tool, and more structured guidelines for making adaptations.Conclusions and implicationsPEACE Pathway has brought clinical and service benefits, while also bringing practical challenges rooted in the difficulty in distinguishing between autism and eating disorder in comorbid population. Future areas of improvement are highlighted for PEACE resources as well as in the national support system for autistic individuals.

Abstract Background A one-off sensory wellbeing workshop has been developed to help patients with eating disorders (ED) manage sensory sensitivities. The aim of this study was to evaluate and compare the outcomes of the workshop in online versus face-to-face (F2F) formats among a sample of patients with ED. Methods Cumulative link models were applied to the outcome measures (awareness of sensory wellbeing, awareness of strategies to enhance sensory wellbeing, and confidence in managing sensory wellbeing) to test the differences between online and F2F workshops. Participants’ ratings of usefulness of the workshop were also compared between online and F2F workshops. Results A total of 14 workshops (4 online and 10 F2F) were run from 2020 to 2023. All participants reported significant and substantial improvements in all outcome measures. There was no significant difference in outcomes between online and F2F workshops. The majority of patients rated the workshops as useful. Conclusions Both online and face-to-face formats of the sensory workshop led to improvement in sensory wellbeing management for patients with ED. Future studies are warranted to test the impact of the workshop on ED treatment outcomes.

Summary: Background: Adolescence represents a distinctive phase of development, and variables linked to this developmental period could affect the efficiency of prevention and treatment for depression and anxiety, as well as the long-term prognosis. The objectives of this study were to investigate the long-term effectiveness of psychosocial interventions for adolescents on depression and anxiety symptoms and to assess the influence of different intervention parameters on the long-term effects. Methods: In this systematic review and meta-analysis, we searched five databases (Cochrane Library, Embase, Medline, PsychInfo, Web of Science) and trial registers for relevant papers published between database inception and Aug 11, 2022, with no restrictions on the language or region in which the study was conducted. An updated search was performed on Oct 3, 2023. Randomised controlled trials of psychosocial interventions targeting specifically adolescents were included if they assessed outcomes at 1-year post-intervention or more. The risk of bias in the results was assessed using the Cochrane RoB 2.0. Between-study heterogeneity was estimated using the I2 statistic. The primary outcome was depression and studies were pooled using a standardised mean difference, with associated 95% confidence interval, p-value and I2. The study protocol was pre-registered on PROSPERO (CRD42022348668). Findings: 57 reports (n = 46,678 participants) were included in the review. Psychosocial interventions led to small reductions in depressive symptoms, with standardised mean difference (SMD) at 1-year of −0.08 (95% CI: −0.20 to −0.03, p = 0.002, I2 = 72%), 18-months SMD = −0.12, 95% CI: −0.22 to −0.01, p = 0.03, I2 = 63%) and 2-years SMD = −0.12 (95% CI: −0.20 to −0.03, p = 0.01, I2 = 68%). Sub-group analyses indicated that targeted interventions produced stronger effects, particularly when delivered by trained mental health professionals (K = 18, SMD = −0.24, 95% CI: −0.38 to −0.10, p = 0.001, I2 = 60%). No effects were detected for anxiety at any assessment. Interpretation: Psychosocial interventions specifically targeting adolescents were shown to have small but positive effects on depression symptoms but not anxiety symptoms, which were sustained up to 2 years. These findings highlight the potential population-level preventive effects if such psychosocial interventions become widely implemented in accessible settings, such as schools. Future trials should include a longer term-follow-up at least at 12 months, in order to determine whether the intervention effects improve, stay the same or wear off over time. Funding: UKRI Medical Research Council.

Abstract Background Children referred for attention-deficit/hyperactivity disorder (ADHD) often present with a broader pattern of conduct problems including oppositionality and defiance. This combination can be extremely stressful to parents, lower parents’ self-esteem and negatively impact family life. The National Institute for Health and Care Excellence (NICE) recommends that families receive support as soon as possible after their referral. However, as clinical services are overstretched, and traditional in-person parenting intervention programmes are expensive, families often must wait times a long time prior to receiving this vital input. To address this, we have created a digital parenting programme called STEPS. It is delivered as a mobile phone app providing a set of tools and resources that can be easily accessed at parents’ convenience. This study aims to evaluate the clinical and cost-effectiveness of STEPS in supporting parents of children with high levels of hyperactivity/impulsivity, inattention and conduct problems, who are waiting to be assessed by specialist children’s clinical services. Methods Online Parent Training for The Initial Management of ADHD referrals (OPTIMA) is a two-arm superiority parallel randomised controlled trial with an internal pilot study. We aim to recruit 352 parents and their children, who have been accepted onto a waitlist in Child and Adolescent Mental Health Services or similar child health services. Parents who consent will be randomised 1:1 to either the STEPS or wait-as-usual (WAU) group. The trial will be conducted remotely (online and telephone) with measures taken at baseline and 3, 6, 9 and 12 months post-randomisation. The primary objective is to evaluate whether STEPS reduces the severity of children’s oppositional and defiant behaviour, as rated by parents, measured at 3 months post-randomisation compared to WAU. Discussion Digital solutions, such as mobile phone apps, have potential for delivering psychological support for parents of children with clinical-level needs in a timely and inexpensive manner. This trial will provide data on the clinical and cost-effectiveness of the STEPS app, which could support the implementation of this scalable parenting intervention programme into standard clinical care and, ultimately, improve the outcomes for families of children referred to specialist child and adolescent health services. Trial registration ISRCTN 16523503. Prospectively registered on 18 November 2021. https://www.isrctn.com/ISRCTN16523503

Background Acamprosate is an effective and cost-effective medication for alcohol relapse prevention but poor adherence can limit its full benefit. Effective interventions to support adherence to acamprosate are therefore needed. Objectives To determine the effectiveness of Medication Management, with and without Contingency Management, compared to Standard Support alone in enhancing adherence to acamprosate and the impact of adherence to acamprosate on abstinence and reduced alcohol consumption. Design Multicentre, three-arm, parallel-group, randomised controlled clinical trial. Setting Specialist alcohol treatment services in five regions of England (South East London, Central and North West London, Wessex, Yorkshire and Humber and West Midlands). Participants Adults (aged 18 years or more), an International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, diagnosis of alcohol dependence, abstinent from alcohol at baseline assessment, in receipt of a prescription for acamprosate. Interventions (1) Standard Support, (2) Standard Support with adjunctive Medication Management provided by pharmacists via a clinical contact centre (12 sessions over 6 months), (3) Standard Support with adjunctive Medication Management plus Contingency Management that consisted of vouchers (up to £120) to reinforce participation in Medication Management. Consenting participants were randomised in a 2 : 1 : 1 ratio to one of the three groups using a stratified random permuted block method using a remote system. Participants and researchers were not blind to treatment allocation. Main outcome measures Primary outcome: self-reported percentage of medication taken in the previous 28 days at 6 months post randomisation. Economic outcome: EuroQol-5 Dimensions, a five-level version, used to calculate quality-adjusted life-years, with costs estimated using the Adult Service Use Schedule. Results Of the 1459 potential participants approached, 1019 (70%) were assessed and 739 (73 consented to participate in the study, 372 (50%) were allocated to Standard Support, 182 (25%) to Standard Support with Medication Management and 185 (25%) to Standard Support and Medication Management with Contingency Management. Data were available for 518 (70%) of participants at 6-month follow-up, 255 (68.5%) allocated to Standard Support, 122 (67.0%) to Standard Support and Medication Management and 141 (76.2%) to Standard Support and Medication Management with Contingency Management. The mean difference of per cent adherence to acamprosate was higher for those who received Standard Support and Medication Management with Contingency Management (10.6%, 95% confidence interval 19.6% to 1.6%) compared to Standard Support alone, at the primary end point (6-month follow-up). There was no significant difference in per cent days adherent when comparing Standard Support and Medication Management with Standard Support alone 3.1% (95% confidence interval 12.8% to −6.5%) or comparing Standard Support and Medication Management with Standard Support and Medication Management with Contingency Management 7.9% (95% confidence interval 18.7% to −2.8%). The primary economic analysis at 6 months found that Standard Support and Medication Management with Contingency Management was cost-effective compared to Standard Support alone, achieving small gains in quality-adjusted life-years at a lower cost per participant. Cost-effectiveness was not observed for adjunctive Medication Management compared to Standard Support alone. There were no serious adverse events related to the trial interventions reported. Limitations The trial’s primary outcome measure changed substantially due to data collection difficulties and therefore relied on a measure of self-reported adherence. A lower than anticipated follow-up rate at 12 months may have lowered the statistical power to detect differences in the secondary analyses, although the primary analysis was not impacted. Conclusions Medication Management enhanced with Contingency Management is beneficial to patients for supporting them to take acamprosate. Future work Given our findings in relation to Contingency Management enhancing Medication Management adherence, future trials should be developed to explore its effectiveness and cost-effectiveness with other alcohol interventions where there is evidence of poor adherence. Trial registration This trial is registered as ISRCTN17083622 https://doi.org/10.1186/ISRCTN17083622. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 22. See the NIHR Journals Library website for further project information. Plain language summary What is the problem? Many people who are trying to stop drinking alcohol can find it difficult to remain alcohol free. There is a medication called acamprosate (Campral) that can reduce cravings thereby increasing the likelihood of abstinence. However, some people have trouble taking the right amount of acamprosate tablets needed every day at the right time, preferably at mealtimes. This means the medication is not as effective. We have tested some new ways to help support people taking acamprosate. What did we do? We tested three different strategies to find the best way to support people taking acamprosate. We recruited 739 people aged 18 and over who were receiving alcohol treatment to stop drinking and were taking acamprosate. We randomly allocated these people to three groups. The first was Standard Support, the usual support people receive when taking acamprosate. The second group received Standard Support plus Medication Management. This consisted of 12 telephone calls over 6 months with a trained pharmacist to discuss the importance of taking the right amount of the medication, how the medication works and strategies to help people take the medication correctly. The third group received Standard Support, Medication Management and Contingency Management. This involved giving people shopping vouchers for participating with Medication Management calls. The maximum value of vouchers per person was £120. What did we find out? People who were in the group receiving Medication Management and Contingency Management took a greater number of acamprosate tablets. We also found that Medication Management plus Contingency Management was more cost-effective; there were greater gains in health with a smaller cost per person compared to Standard Support alone. This shows that there is likely to be a benefit to patients of Medication Management plus Contingency Management for supporting people taking acamprosate. Scientific summary Background Alcohol is a significant risk factor for morbidity and mortality. In the UK there has been an increase in harm related to alcohol while also a reduction in funding to public health budgets, including alcohol services. While some individuals do successfully complete alcohol treatment, the majority will undergo frequent episodes of relapse. Providing effective treatment can reduce relapse rates and associated harms thus having a positive impact on cost-effectiveness. The National Institute for Health and Care Excellence (NICE) recommends acamprosate in combination with psychological intervention as a first-line treatment for relapse prevention in alcohol dependence, however, acamprosate adherence poses a problem for its effectiveness in clinical practice. The reasons for non-adherence are complex and often due to multiple influences. Currently there is insufficient evidence as to which forms of intervention are effective in increasing adherence. Psychosocial interventions to support medication adherence have the potential to promote positive beliefs about medication and any concerns. Medication Management (MM) is a psychosocial intervention which aims to improve medication and treatment adherence by providing education, support, and practical advice about drinking behaviour and medication. There has also been an increasing focus on extending the role of the community pharmacist and the delivery of MM to improve medication adherence compliments this expanding role. Engagement in psychological interventions and retention in treatment is often poor in alcohol dependence but there is evidence that Contingency Management (CM) improves engagement and retention in substance use disorder treatment. There is currently limited evidence of its effectiveness within alcohol treatment but if shown to be effective it has the potential to also be adopted within the NHS and community pharmacies. Objectives Our aim was to evaluate the effectiveness and cost-effectiveness of adjunctive MM with and without CM in improving adherence to acamprosate for relapse prevention in alcohol dependence. To conduct a definitive three-arm, randomised controlled trial (RCT) of the effectiveness of MM with and without CM compared to Standard Support (SS) alone in enhancing adherence to acamprosate in alcohol dependence relapse prevention. To estimate the cost-effectiveness of MM with and without CM compared to SS alone in enhancing adherence to acamprosate in alcohol dependence relapse prevention. To assess the impact of adherence to acamprosate for alcohol dependence relapse prevention on abstinence and reduced alcohol consumption. Methods Trial design This was a three-arm, parallel-group, pragmatic RCT, which began with an internal pilot phase to demonstrate recruitment, randomisation and interventions could be implemented as planned. Eligibility and recruitment Participants presenting to alcohol services in one of the trial sites (London, Southampton, Birmingham, Yorkshire and Humber) who met the trial inclusion criteria were recruited via service staff. Participants Inclusion criteria were: (1) adults, aged 18 years and over; (2) an International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, diagnosis of alcohol dependence; (3) abstinent from alcohol at baseline assessment; (4) in receipt of a prescription of acamprosate; and (5) willing and able to provide informed consent. Exclusion criteria were: (1) a diagnosis of a severe physical/mental illness likely to preclude active participation in treatment or follow-up, (2) unable to understand verbal English at a level necessary to engage in the intervention and follow-up and (3) concurrent dependence on an illicit substance (other than cannabis). Randomisation and interventions Participants were randomised in a 2 : 1 : 1 ratio to SS, SS + MM or SS + MM + CM using a stratified random permuted block method using a remote system. Participants and researchers were not blind to treatment allocation. SS typically comprised of monthly dispensing of prescribed acamprosate, monthly monitoring of the service user for 3 months by the specialist alcohol service, and then returned to the care of their GP for monthly monitoring in accordance with NICE guidelines and current clinical NHS clinical practice. SS + MM participants followed the same care pathway as those in SS, with the addition of MM delivered by a central telephone support service by trained pharmacists. MM was delivered once a week for the first 6 weeks, reducing to once a fortnight for the following 6 weeks, and then monthly for 3 months. SS + MM + CM participants followed the same care pathway as those in the SS + MM arm but with the addition of CM. Incentives in the form of vouchers were provided to reinforce attendance at MM sessions, up to a total of £120. Outcomes The primary outcome measure was the self-reported per cent of medication taken as prescribed during the 6-month target phase of prescribing, post randomisation. Data collection Data were collected at baseline, 2, 4, 6 and 12 months. Following an amendment, the 12-month follow-up was removed to maximise participant recruitment, and the recruitment period was extended without extending the trial end date. Data that had been collected at the 12-month follow-up were still included in the trial analysis plan. The primary outcome was collected at the 6-month follow-up. Sample size The sample size aimed to detect a clinically important effect size difference of 0.3, about 13% difference in per cent adherence. In order to make the study cost-efficient, we proposed to allocate twice as many to the SS group than to the SS + MM and SS + MM + CM groups. With power at 80%, alpha of 0.05 and a two-sided test, this required 524 to be followed up at the primary end point, 262 in the SS group and 131 in each of the other groups. We anticipated a loss to follow-up at month 6 of 30% and inflated the required sample at baseline to 748 to account for this. Sample sizes were calculated using Stata 12 (StataCorp LP, College Station, TX, USA). Statistical methods The primary analysis was an analysis by treatment allocated (ATA) and was based on all available data for participants who were randomised, irrespective of whether they complied with their allocation or not. The primary analysis was based on the ATA. Secondary analyses examined treatment effects under different scenarios for compliance with allocation/treatment: complier average causal effects (CACE). Two scenarios of compliance were defined in this trial. The first compliance for those in the SS + MM and SS + MM + CM group was defined as adhering to at least 50% of the MM calls. In the second, the threshold was increased to 100%. Both scenarios are modelled in the analysis. We considered missing data as being missing at random (MAR) or missing not at random (MNAR). We conducted a multiple imputation to address MAR and a sensitivity analysis to address MNAR. Fractional regression was conducted to model the relationship between pre-randomisation factors and per cent adherence to acamprosate and per cent days abstinent from alcohol at month 6. Interaction terms with treatment allocation were included in the model and a significance level of 0.1 was used as a threshold to determine which variables were maintained in the final model reported. Baseline variables included initially in the model include age, gender, marital status, ethnicity, employment status, number of children, age of first drink, weekly and daily drinking, frequency and quantity of alcohol consumption, severity of alcohol dependence, alcohol urges and alcohol-related problems. This analysis was augmented with an additional analysis for the SS + MM and SS + MM + CM groups where the same dependent variable was assessed with the same independent variables with the addition of therapeutic alliance. Method of economic evaluation The primary economic analysis was a cost-utility analysis where outcomes were expressed as quality-adjusted life-years (QALYs), as recommended by NICE. A secondary analysis explored cost-effectiveness in terms of the primary clinical outcome which was adherence to relapse prevention medication. The primary economic perspective was the NHS and personal social services (NHS/PSS) perspective preferred by NICE. The primary time horizon of the economic analyses using both QALYs and relapse medication adherence was the 6-month follow-up, consistent with the primary clinical analysis. A secondary analysis was carried out at the 12-month follow-up using QALYs. The primary economic outcome was QALYs calculated using the EuroQol-5 Dimensions, a five-level version measure of health-related quality-of-life scores at baseline, 6- and 12-month follow-ups. The primary economic analysis was composed of two separate comparisons: (1) SS + MM + CM versus SS alone; and (2) SS + MM versus SS alone, both at 6 months post randomisation, and assessed cost-effectiveness in terms of cost per QALY using the EuroQol-5 Dimensions measure of quality of life. Two secondary economic evaluations were carried out, a cost-utility analysis at 12 months post randomisation and a cost-effectiveness analysis using adherence to relapse medication which was the primary clinical outcome. Cost-effectiveness was explored using incremental cost-effectiveness ratios (difference in mean cost divided by difference in mean effect) and cost-effectiveness acceptability curves (CEACs), which show the probability that SS + MM + CM or SS + MM are cost-effective compared to SS alone for different levels of willingness to pay for improvements in outcome. Sensitivity analyses were carried out to test the impact of varying methods and assumptions on the relative cost-effectiveness of the interventions being compared. We planned three sensitivity analyses: (1) a broader analytical perspective to include the cost of crime (which was not completed as no crimes were reported), (2) a complete case analysis for comparison with the results that used multiple imputation for missing data and (3) a cost-utility analysis using QALYs calculated from EuroQol-5 Dimensions, three-level version tariffs. Results A total of 1459 potential participants were approached of whom 1019 (70%) were assessed. Of these 739 (73%) were eligible and consented to participate in the study. Allocation was in the ratio of 2 : 1 : 1, 372 (50%) were allocated to SS, 182 (25%) to SS + MM and 185 (25%) to SS + MM + CM. At the primary end point, 6 months post randomisation, 518 (70%) were successfully followed up with 255 (68.5%) allocated to SS, 122 (67.0%) to SS + MM and 141 (76.2%) to SS + MM + CM. There were no serious adverse events related to the trial interventions reported. The mean difference in per cent adherence to acamprosate at month 6 between those allocated to SS and SS + MM + CM versus SS was 10.6% [95% confidence interval (CI) 19.6% to 1.6%]; this difference was statistically significant. When the SS + MM group was compared to SS alone, the SS + MM group had a lower per cent days adherent than the SS group, mean difference 3.1% (95% CI 12.8% to −6.5%); this was not significant. A similar non-significant finding was seen when we compared the SS + MM and SS + MM + CM groups, mean difference 7.9% (95% CI 18.7% to −2.8%). Our secondary analysis included per cent days abstinent from alcohol at month 6. The ATA found differences favouring both intervention groups over SS alone but neither of these was significant. When a CACE analysis was conducted using scenario 2, both intervention groups had a significantly greater per cent days abstinent than SS alone. This analysis also highlighted the relationship between adherence to acamprosate and better outcomes, something additionally highlighted by a significant correlation between adherence to acamprosate and increased per cent days abstinent at month 6. CACE analysis: Under scenario 1, 50% adherence, the mean difference in per cent adherence increases from 10.6% (95% CI 19.6 to 1.62) to 12.4% (95% CI 17.8% to 7.1%) in the SS + MM + CM versus SS comparison, indicating that at 50% compliance those allocated to SS + MM + CM have a mean of 12.44% more adherence to acamprosate at month 6 than those allocated to SS alone. When comparing the SS + MM versus the SS group, a previous non-significant difference 3.14% (95% CI 12.8% to −6.5%) becomes a significant difference of 13.2% (25.4–1.15%). Under scenario 2, the differences are larger in magnitude, the SS + MM + CM group having 22.2% (95% CI 29.7% to 14.7%) more adherent days than the SS group alone. At the same time, the magnitude of difference is larger for the SS + MM versus SS comparison 31.8% (95–60.5% vs. 3.10%), although this comparison is based on a small number of participants, 20, and should be interpreted with caution. For SS + MM + CM versus SS, the primary economic analysis at 6-month follow-up using QALYs, the secondary economic analysis at 6-month follow-up using medication adherence and the economic modelling over a 20-year time horizon using QALYs all found SS + MM + CM to dominate SS (better outcomes at lower cost). At 12-month follow-up, although SS + MM + CM was not dominant, it generated more QALYs at an additional cost that was below the NICE cost per QALY threshold. CEACs also showed there was a higher probability of SS + MM + CM being cost-effective compared to SS alone in all analyses and at all time points. For SS + MM versus SS, at 6- and 12-month follow-up and when modelled over 20 years, SS + MM achieved better outcomes at higher cost compared to SS. In terms of cost-effectiveness, SS + MM was not found to be cost-effective at 6-month follow-up but had a higher probability of being cost-effective compared to SS at both the 12-month follow-up (using the higher £30,000 per QALY NICE threshold) and when modelled over 20 years (over the full £20,000–30,0000 cost per QALY threshold). Conclusions When comparing SS + MM + CM versus SS alone, we observed a significantly higher per cent adherence to acamprosate in the SS + MM + CM group, and the differences were of the magnitude that would indicate a clinically important difference. Differences were also observed when comparing SS + MM versus SS and SS + MM + CM versus SS + MM, but these were not significant. We explored how robust these findings were to assumptions about the nature of any missing data and we explored a missing data imputation model to explore the impact of data that may be MAR and a sensitivity analysis to explore data that may not be MAR. Neither of these analyses found any significant deviation from the analysis based on observed values, we can be confident that our findings from the ATA analysis are robust. To explore the effect of compliance to MM we conducted a CACE analysis using two scenarios of compliance, 50% and 100%. In both scenarios, we found greater benefits associated with SS + MM + CM and SS + MM versus SS alone and these benefits were significant and clinically important. There were several limitations to the current trial that should be taken into consideration. The trial’s primary outcome measure changed substantially due to data collection difficulties and therefore relied on a measure of self-reported adherence. A lower than anticipated follow-up rate at 12 months may have lowered the statistical power to detect differences in the secondary analyses, although the primary analysis was not impacted. The results of the primary economic analysis at the 6-month follow-up point suggest that MM was only cost-effective when supported by incentives to encourage support session uptake. This finding was heavily influenced by lower total costs in the SS + MM + CM group as a result of lower use of residential rehabilitation facilities compared to both SS + MM and SS alone, which may be related to the significantly higher medication adherence seen in the CM group. Over the medium (12 months) and longer term (20 years), SS + MM + CM remained cost-effective compared to SS and there was a higher probability of SS + MM being cost-effective compared to SS. These results support the addition of MM to SS for alcohol dependence, with or without CM. However, the economic benefit was stronger when CM was included. Trial registration This trial is registered as ISRCTN17083622 https://doi.org/10.1186/ISRCTN17083622. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 27, No. 22. See the NIHR Journals Library website for further project information.

BackgroundThe Structured E-Parenting Support (STEPS) app provides support for parents of children with elevated hyperactivity, impulsivity, inattention, and conduct problems who are awaiting clinical assessment. STEPS will be evaluated in a randomized controlled trial (RCT) within the Online Parent Training for the Initial Management of ADHD Referrals (OPTIMA) research program in the United Kingdom. Phase 1 of the OPTIMA tested the feasibility of participants’ recruitment and the app’s usability. ObjectiveThis study aimed to adapt a digital routine clinical monitoring system, myHealthE, for research purposes to facilitate waitlist recruitment; test using remote methods to screen and identify participants quickly and systematically; pilot the acceptability of the recruitment and assessment protocol; and explore the usability of STEPS. MethodsmyHealthE was adapted to screen patients’ data. Parents’ and clinicians’ feedback on myHealthE was collected, and information governance reviews were conducted in clinical services planning to host the RCT. Potential participants for the observational feasibility study were identified from new referrals using myHealthE and non-myHealthE methods. Descriptive statistics were used to summarize the demographic and outcome variables. We estimated whether the recruitment rate would meet the planned RCT sample size requirement (n=352). In addition to the feasibility study participants, another group of parents was recruited to assess the STEPS usability. They completed the adapted System Usability Scale and responded to open-ended questions about the app, which were coded using the Enlight quality construct template. ResultsOverall, 124 potential participants were identified as eligible: 121 (97.6%) via myHealthE and 3 (2.4%) via non-myHealthE methods. In total, 107 parents were contacted, and 48 (44.9%) consented and were asked if, hypothetically, they would be willing to participate in the OPTIMA RCT. Of the 28 feasibility study participants who provided demographic data, 21 (75%) identified as White. Their children had an average age of 8.4 (SD 1.7) years and 65% (31/48) were male. During the primary recruitment period (June to July 2021) when 45 participants had consented, 38 (84%) participants agreed hypothetically to take part in the RCT (rate of 19/mo, 95% CI 13.5-26.1), meeting the stop-go criterion of 18 participants per month to proceed with the RCT. All parents were satisfied or very satisfied with the study procedures. Parents (n=12) recruited to assess STEPS’ usability described it as easy to navigate and use and as having an attractive combination of colors and visual design. They described the content as useful, pitched at the right level, and sensitively presented. Suggested improvements included adding captions to videos or making the recorded reflections editable. ConclusionsRemote recruitment and study procedures for testing a parenting intervention app are feasible and acceptable for parents. The parents felt that STEPS was a useful and easy-to-use digital parenting support tool. International Registered Report Identifier (IRRID)RR2-10.1186/s40814-021-00959-0

Abstract Anxiety and depression are increasingly prevalent in adolescents, often causing daily distress and negative long-term outcomes. Despite the significant and growing burden, less than 25% of those with probable diagnosis of anxiety and depression are receiving help in England. Significant barriers to help-seeking exist in this population, with a scarcity of easily accessible, effective, and cost-effective interventions tailored specially for this age group. One intervention that has been shown to be feasible to deliver and with the promise of reducing stress in this age group is a school-based stress workshop programme for 16–18-year-olds (herein called DISCOVER). The next step is to rigorously assess the effectiveness, and cost-effectiveness, of the DISCOVER intervention in a fully powered cluster randomised controlled trial (cRCT). If found to be clinically and cost-effective, DISCOVER could be scaled up as a service model UK-wide and have a meaningful impact on the mental health of adolescents across the country. Trial registration: ISRCTN registry ISRCTN90912799. Registered with ISRCTN 28 May 2020.

Abstract Background Associations between the COVID-19 pandemic and hospitalizations have not been studied Iran. This study aimed to examine the impact of the COVID-19 pandemic on hospital admissions for nine categories of disease in seven public hospitals in Kermsnahah city, the capital of Kermsnahah province, in the west of Iran. Methods Data on monthly hospitalization rates (number of hospitalizations per 100,000 population) were collected for nine categories of disease for a period of 40 months (23 months before and 17 months after the COVID-19 outbreak in Iran) from the health information systems of all seven public hospitals in Kermanshah city. Categories of disease included those related to pregnancy, childbirth and the puerperium period, neoplasms, diseases of the digestive, respiratory, circulatory, genitourinary and nervous systems, mental and behavioural disorders, and infectious and parasitic diseases. Population data were extracted from the Statistics Centre of Iran. An interrupted time series analysis with segmented regression was used to examine the impact of COVID-19 on hospital admissions. Findings Average monthly hospitalization rates fell for all nine categories of disease included in the study after the onset of the pandemic, with overall rates of 85.5 per 100,000 population in the period before the COVID-19 outbreak and 50.4 per 100,000 population after the outbreak began. The relative reduction in hospitalizations for the nine diseases was 56.4%. Regression analysis of monthly data indicated a sharp decrease in hospitalisations during the first month after the COVID-19 outbreak, which was statistically significant for all diseases (p

BackgroundChildren’s conduct and emotional problems increased during the COVID-19 pandemic. ObjectiveWe tested whether a smartphone parenting support app, Parent Positive, developed specifically for this purpose, reversed these effects in a cost-effective way. Parent Positive includes 3 zones. Parenting Boosters (zone 1) provided content adapted from standard face-to-face parent training programs to tackle 8 specific challenges identified by parents and parenting experts as particularly relevant for parents during the pandemic. The Parenting Exchange (zone 2) was a parent-to-parent and parent-to-expert communication forum. Parenting Resources (zone 3) provided access to existing high-quality web-based resources on a range of additional topics of value to parents (eg, neurodevelopmental problems, diet, and sleep). MethodsSupporting Parents And Kids Through Lockdown Experiences (SPARKLE), a randomized controlled trial, was embedded in the UK-wide COVID-19: Supporting Parents, Adolescents and Children during Epidemics (Co-SPACE) longitudinal study on families’ mental health during the pandemic. Parents of children aged 4 to 10 years were randomized 1:1 to Parent Positive or follow-up as usual (FAU) between May 19, 2021, and July 26, 2021. Parent Positive provided advice on common parenting challenges and evidence-based web-based resources and facilitated parent-to-parent and expert-to-parent support. Child conduct and emotional problems and family well-being were measured before randomization (T1) and at 1 (T2) and 2 (T3) months after randomization. Service use, costs, and adverse events were measured, along with app use and satisfaction. The primary outcome was T2 parent-reported child conduct problems, which were analyzed using linear mixed regression models. ResultsA total of 320 participants were randomized to Parent Positive, and 326 were randomized to FAU. The primary outcome analysis included 79.3% (512/646) of the participants (dropout: 84/320, 26% on Parent Positive and 50/326, 15% on FAU). There were no statistically significant intervention effects on conduct problems at either T2 (standardized effect=−0.01) or T3 (secondary outcome; standardized effect=−0.09) and no moderation by baseline conduct problems. Significant intervention-related reductions in emotional problems were observed at T2 and T3 (secondary outcomes; standardized effect=−0.13 in both cases). Parent Positive, relative to FAU, was associated with more parental worries at T3 (standardized effect=0.14). Few intervention-attributable adverse events were reported. Parent Positive was cost-effective once 4 outliers with extremely high health care costs were excluded. ConclusionsParent Positive reduced child emotional problems and was cost-effective compared with FAU once outliers were removed. Although small when considered against targeted therapeutic interventions, the size of these effects was in line with trials of nontargeted universal mental health interventions. This highlights the public health potential of Parent Positive if implemented at the community level. Nevertheless, caution is required before making such an interpretation, and the findings need to be replicated in large-scale, whole-community studies. Trial RegistrationClinicalTrials.gov NCT04786080; https://clinicaltrials.gov/ct2/show/NCT04786080

Abstract Given well‐established links between socio‐economic adversity and mental health, it is unsurprising that young people's mental health is deteriorating amidst economic crises. The World Health Organisation (WHO) recognises mental health as “crucial to personal, community, and socio‐economic development” and outlines goals to reshape environments such as schools to protect mental health. Schools offer an ideal setting to promote wellbeing and prevent mental ill‐health during a key developmental window. We describe how social inequalities present a challenge to designing school‐based interventions for prevention and promotion for mental health and wellbeing, and suggest priorities to aid and evaluate their effectiveness.

Abstract Background Although the effectiveness of screening tools for detecting depression in pregnancy has been investigated, there is limited evidence on the cost-effectiveness. This is vital in providing full information to decision makers. This study aimed to explore the cost-effectiveness of different screening tools to identify depression in early pregnancy compared to no screening. Methods A decision tree was developed to model the identification and treatment pathways of depression from the first antenatal appointment to 3-months postpartum using the Whooley questions, the Edinburgh Postnatal Depression Scale (EPDS) and the Whooley questions followed by the EPDS, compared to no screening. The economic evaluation took an NHS and Personal Social Services perspective. Model parameters were taken from a combination of sources including a cross-sectional survey investigating the diagnostic accuracy of screening tools, and other published literature. Cost-effectiveness was assessed in terms of the incremental cost per quality adjusted life years (QALYs). Cost-effectiveness planes and cost-effectiveness acceptability curves were produced using a net-benefit approach based on Monte Carlo simulations of cost-outcome data. Results In a 4-way comparison, the Whooley, EPDS and Whooley followed by the EPDS each had a similar probability of being cost-effective at around 30% for willingness to pay values from £20,000–30,000 per QALY compared to around 20% for the no screen option. Conclusions All three screening approaches tested had a higher probability of being cost-effective than the no-screen option. In the absence of a clear cost-effectiveness advantage for any one of the three screening options, the choice between the screening approaches could be made on other grounds, such as clinical burden of the screening options. Limitations include data availability and short time horizon, thus further research is needed. Clinical trials registration N/A

Abstract Background Anorexia nervosa (AN) is a serious and disabling mental disorder with a high disease burden. In a proportion of cases, intensive hospital-based treatments, i.e. inpatient or day patient treatment, are required, with day patient treatment often being used as a ‘step-down’ treatment after a period of inpatient treatment. Demand for such treatment approaches has seen a sharp rise. Despite this, the relative merits of these approaches for patients, their families, and the NHS and wider society are relatively unknown. This paper describes the rationale for, and protocol of, a two-arm multi-centre open-label parallel group non-inferiority randomised controlled trial, evaluating the effectiveness and cost-effectiveness of these two intensive treatments for adults with severe AN: inpatient treatment as usual and a stepped care day patient approach (the combination of day patient treatment with the option of initial inpatient treatment for medical stabilisation). The main aim of this trial is to establish whether, in adults with severe AN, a stepped care day patient approach is non-inferior to inpatient treatment as usual in relation to improving body mass index (BMI) at 12 months post-randomisation. Methods 386 patients with a Diagnostic and Statistical Manual 5th edition diagnosis of severe AN or related disorder, with a BMI of ≤16 kg/m2 and in need of intensive treatment will be randomly allocated to either inpatient treatment as usual or a stepped care day patient approach. Patients in both groups will receive treatment until they reach a healthy weight or get as close to this point as possible. Assessments will be conducted at baseline (prior to randomisation), and at 6 and 12 months post-randomisation, with additional monthly symptom monitoring. The primary outcome will be BMI at the 12-month post-randomisation assessment. Other outcomes will include psychosocial adjustment; treatment motivation, expectations and experiences; cost-effectiveness; and carer burden. Discussion The results of this study will provide a rigorous evaluation of two intensive treatment approaches which will inform future national and international treatment guidelines and service provision. Trial registration ISRCTN ISRCTN10166784 . Registered 28 February 2020. ISRCTN is a primary registry of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) network and includes all items from the WHO Trial Registration Data Set.

Abstract Background People with psychosis have high rates of trauma, with a post-traumatic stress disorder (PTSD) prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pilot studies have shown that trauma-focused (TF) psychological therapies can be safe and effective in such individuals. This trial, the largest to date, will evaluate the clinical effectiveness of a TF therapy integrated with cognitive behaviour therapy for psychosis (TF-CBTp) on post-traumatic stress symptoms in people with psychosis. The secondary aims are to compare groups on cost-effectiveness; ascertain whether TF-CBTp impacts on a range of other meaningful outcomes; determine whether therapy effects endure; and determine acceptability of the therapy in participants and therapists. Methods Rater-blind, parallel arm, pragmatic randomised controlled trial comparing TF-CBTp + treatment as usual (TAU) to TAU only. Adults (N = 300) with distressing post-traumatic stress and psychosis symptoms from five mental health Trusts (60 per site) will be randomised to the two groups. Therapy will be manualised, lasting 9 months (m) with trained therapists. We will assess PTSD symptom severity (primary outcome); percentage who show loss of PTSD diagnosis and clinically significant change; psychosis symptoms; emotional well-being; substance use; suicidal ideation; psychological recovery; social functioning; health-related quality of life; service use, a total of four times: before randomisation; 4 m (mid-therapy); 9 m (end of therapy; primary end point); 24 m (15 m after end of therapy) post-randomisation. Four 3-monthly phone calls will be made between 9 m and 24 m assessment points, to collect service use over the previous 3 months. Therapy acceptability will be assessed through qualitative interviews with participants (N = 35) and therapists (N = 5–10). An internal pilot will ensure integrity of trial recruitment and outcome data, as well as therapy protocol safety and adherence. Data will be analysed following intention-to-treat principles using generalised linear mixed models and reported according to Consolidated Standards of Reporting Trials-Social and Psychological Interventions Statement. Discussion The proposed intervention has the potential to provide significant patient benefit in terms of reductions in distressing symptoms of post-traumatic stress, psychosis, and emotional problems; enable clinicians to implement trauma-focused therapy confidently in this population; and be cost-effective compared to TAU through reduced service use. Trial registration ISRCTN93382525 (03/08/20)

Abstract Background Individuals with autism spectrum disorder (ASD) are more likely to use healthcare than their counterparts without disabilities, which imposes high medical costs to families and health systems. This study aimed to investigate healthcare costs and its determinants among individuals with ASD. Methods In this systematic review, we searched online databases (Web of Science, Medline through PubMed and Scopus) for observational and experimental studies that included data on service use and costs associated with ASD and published between January 2000 and May 2021. Exclusion criteria included non-English language articles, duplicates, abstracts, qualitative studies, gray literature, and non-original papers (e.g., letters to editors, editorials, reviews, etc.). Results Our searches yielded 4015 articles screened according to PRISMA guidelines. Of 4015 studies identified, 37 articles from 10 countries were eligible for final inclusion. Therapeutic interventions, outpatient visits and medications constituted the largest proportion of direct medical expenditure on individuals with ASD. Included studies suggest lack of health insurance, having associated morbidities, more severe symptoms, younger age groups and lower socioeconomic status (SES) are associated with higher medical expenditure in individuals with ASD. Conclusions This systematic review identified a range of factors, including lower SES and lack of health insurance, which are associated with higher healthcare costs in people with ASD. Our study supports the formulation of policy options to reduce financial risks in families of individuals with ASD in countries which do not have a tax-based or universal health coverage system.

Abstract Background In the UK, children with high levels of hyperactivity, impulsivity and inattention referred to clinical services with possible attention-deficit/hyperactivity disorder (ADHD) often wait a long time for specialist diagnostic assessment. Parent training (PT) has the potential to support parents during this difficult period, especially regarding the management of challenging and disruptive behaviours that often accompany ADHD. However, traditional face-to-face PT is costly and difficult to organise in a timely way. We have created a low-cost, easily accessible PT programme delivered via a phone app, Structured E-Parenting Support (STEPS), to address this problem. The overall OPTIMA programme will evaluate the efficacy and cost-effectiveness of STEPS as a way of helping parents manage their children behaviour while on the waitlist. To ensure the timely and efficient evaluation of STEPS in OPTIMA, we have worked with children’s health services to implement a remote strategy for recruitment, screening and assessment of recently referred families. Part of this strategy is incorporated into routine clinical practice and part is OPTIMA specific. Here, we present the protocol for Phase 1 of OPTIMA—a study of the feasibility of this remote strategy, as a basis for a large-scale STEPS randomised controlled trial (RCT). Methods This is a single arm observational feasibility study. Participants will be parents of up to 100 children aged 5-11 years with high levels of hyperactivity/impulsivity, inattention and challenging behaviour who are waiting for assessment in one of five UK child and adolescent mental health or behavioural services. Recruitment, consenting and data collection will occur remotely. The primary outcome will be the rate at which the families, who meet inclusion criteria, agree in principle to take part in a full STEPS RCT. Secondary outcomes include acceptability of remote consenting and online data collection procedures; the feasibility of collecting teacher data remotely within the required timeframe, and technical difficulties with completing online questionnaires. All parents in the study will receive access to STEPS. Discussion Establishing the feasibility of our remote recruitment, consenting and assessment strategy is a pre-requisite for the full trial of OPTIMA. It can also provide a model for future trials conducted remotely.

Abstract Background The needs of children in care are a government priority, yet the evidence base for effective interventions to support the emotional wellbeing of children in care is lacking. Research suggests that supporting the carer-child relationship, by promoting the carer’s reflective parenting, may be an effective approach to improving the wellbeing of these children. Methods The study comprises a definitive, superiority, two-armed, parallel, pragmatic, randomised controlled trial, with embedded process evaluation and economic evaluation, and an internal pilot, to evaluate the effectiveness, and cost-effectiveness, of the Reflective Fostering Programme. Randomisation is at the individual level using a 1:1 allocation ratio. The study is being conducted in local authority sites across England, and is targeted at foster carers (including kinship carers) looking after children aged 4 to 13. Consenting participants are randomly allocated to the Reflective Fostering Programme (intervention arm) in addition to usual support or usual support alone (control arm). The primary outcome is behavioural and emotional wellbeing of the child 12 months post-baseline, and secondary outcomes include the following: foster carer’s level of stress, quality of life, reflective capacity, compassion fatigue and burnout, placement stability, the quality of the child-carer relationship, child’s capacity for emotional regulation, and achievement of personalised goals set by the carer. Discussion A feasibility study has indicated effectiveness of the Programme in improving the child-carer relationship and emotional and behavioural wellbeing of children in care. This study will test the effectiveness and cost-effectiveness of implementing the Reflective Fostering Programme as an additional aid to the support already available to local authority foster carers. Trial registration ISRCTN 70832140 .

IntroductionPrevious research has explored the overlapping presentation between autism and eating disorders (ED). This study aims to summarize the clinical challenges associated with co-occurring autism and anorexia nervosa (AN) based on clinicians' case notes and minutes from case discussions, to understand how to better support people with the comorbidity.MethodThematic analysis was conducted on de-identified notes on 20 cases with AN and autistic characteristics and minutes from case discussions. Themes relevant to clinical challenges in supporting those with the comorbidity were identified, and a thematic map was produced to visually represent the results.ResultsThe key challenges faced by clinicians when treating patients with AN and autism included: communication difficulties, maintaining boundaries, autism screening, presence of other comorbidities, sensory difficulties, atypical presentation of eating difficulties, cognitive rigidity, and emotional difficulties. Adaptations to resolve some of these difficulties included exposure-based food experiments, keeping a record of patients' self-reported communication preferences, individual-level modification of communication style, and providing tools for patients to identify emotions.Conclusions and implicationsFurther exploration to establish the effectiveness of the adaptations is warranted. Furthermore, tools for differentiating between ED, autism and other comorbidities are needed to help clinicians clarify the cause of a presenting symptom, and help them to best support and maintain boundaries with patients.

Plain English summary Specialist eating disorders services may improve outcomes and reduce hospitalisations for children and adolescents with anorexia nervosa. Reductions in hospitalisation could save money for the NHS and are better for young people because hospitalisation disrupts their home life, social life and education. This study evaluated outcomes and costs of specialist eating disorders services compared to general child and adolescent mental health services (CAMHS) for children and adolescents with anorexia nervosa. Children and adolescents were identified by contacting child and adolescent psychiatrists in the UK and Ireland and asking them to report any new cases of anorexia nervosa. These psychiatrists identified 298 young people aged 8 to 17 with an anorexia nervosa diagnosis for the first time. The psychiatrists provided information on the health services these young people used and how they were doing when they were first diagnosed and 6 months and 1 year later. Children and adolescents in specialist services were more severely ill than those in CAMHS when they were first diagnosed. Despite this, care for the young people in specialist services cost about the same as for those diagnosed in CAMHS, and their outcomes after 1 year were similar. This work showed that specialist services may be better value for money than CAMHS.

Abstract Background MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme, compared with normal social and emotional learning (SEL) school provision to enhance mental health, social-emotional-behavioural functioning and well-being in adolescence. The original trial protocol was published in Trials (accessible at https://doi.org/10.1186/s13063-017-1917-4 ). This included recruitment in two cohorts, enabling the learning from the smaller first cohort to be incorporated in the second cohort. Here we describe final amendments to the study protocol and discuss their underlying rationale. Methods Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited was increased based on what we learned in the first cohort; (3) some changes were made to the secondary outcome measures to improve their validity and ability to measure constructs of interest and to reduce the burden on school staff; and (4) the current Coronavirus Disease 2019 (SARS-CoV-2 or COVID-19) pandemic both influences and makes it difficult to interpret the 2-year follow-up primary endpoint results, so we changed our primary endpoint to 1-year follow-up. Discussion These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures. Furthermore, the change in the primary endpoint will give a more reliable answer to our primary question because it was collected prior to the COVID-19 pandemic in both cohort 1 and cohort 2. Nevertheless, the longer 2-year follow-up data will still be acquired, although this time-point will be now framed as a second major investigation to answer some new important questions presented by the combination of the pandemic and our study design. Trial registration International Standard Randomised Controlled Trials ISRCTN86619085 . Registered on 3 June 2016.

Background Preventing mental health problems in early adolescence is a priority. School-based mindfulness training (SBMT) is an approach with mixed evidence.Objectives To explore for whom SBMT does/does not work and what influences outcomes.Methods The My Resilience in Adolescence was a parallel-group, cluster randomised controlled trial (K=84 secondary schools; n=8376 students, age: 11–13) recruiting schools that provided standard social–emotional learning. Schools were randomised 1:1 to continue this provision (control/teaching as usual (TAU)), and/or to offer SBMT (‘.b’ (intervention)). Risk of depression, social–emotional–behavioural functioning and well-being were measured at baseline, preintervention, post intervention and 1 year follow-up. Hypothesised moderators, implementation factors and mediators were analysed using mixed effects linear regressions, instrumental variable methods and path analysis.Findings SBMT versus TAU resulted in worse scores on risk of depression and well-being in students at risk of mental health problems both at post intervention and 1-year follow-up, but differences were small and not clinically relevant. Higher dose and reach were associated with worse social–emotional–behavioural functioning at postintervention. No implementation factors were associated with outcomes at 1-year follow-up. Pregains−postgains in mindfulness skills and executive function predicted better outcomes at 1-year follow-up, but the SBMT was unsuccessful to teach these skills with clinical relevance.SBMT as delivered in this trial is not indicated as a universal intervention. Moreover, it may be contraindicated for students with existing/emerging mental health symptoms.Clinical implications Universal SBMT is not recommended in this format in early adolescence. Future research should explore social−emotional learning programmes adapted to the unique needs of young people.

Background: Looked-after children are at risk of suboptimal attachment patterns and reactive attachment disorder. However, access to interventions varies widely and there are no evidence-based interventions for this disorder. Objectives: (1) To adapt an existing video-feedback intervention to meet the specific needs of foster children in the UK with reactive attachment symptoms, (2) to conduct a case series to road-test the treatment manual and study procedures, (3) to conduct a scoping study of the key hurdles in a pilot trial and (4) to conduct a pilot randomised controlled trial of the adapted intervention to determine the feasibility of a future full-scale trial. Design: This was a mixed-methods study. The adapted treatment manual was developed with expert input and tested on a small case series. Qualitative interviews with key stakeholders were used in the scoping study in preparation for the trial and later with foster carers who received the new intervention. The final stage was a feasibility and pilot randomised controlled trial of the new intervention, compared with usual care. Researchers assessing the outcomes were blinded to group assignment. Setting: The study was set in outpatient child and adolescent mental health services and partner social services departments. Sites included urban and rural/semirural areas. Participants: Participants were foster carers with children aged ≤ 6 years presenting with difficulties in the domain of reactive attachment disorder. Key stakeholders included children’s services managers and mental health service practitioners in the scoping study. Foster carers who received the modified intervention participated in qualitative interviews. Intervention: The video-feedback intervention to promote positive parenting and sensitive discipline is an extensively evaluated and effective treatment approach. This intervention was modified (based on the adapted version for foster care in the Netherlands) to suit the needs of young children with reactive attachment symptoms in foster care in the UK and was delivered to improve the sensitive responding of foster carers, foster carer–child relationships and child outcomes. The modified intervention was delivered in-home by trained mental health professionals over a period of 4–6 months. Main outcome measure: The main outcome was reactive attachment symptom scores on the Disturbances of Attachment Interview. Results: A series of minor changes to the intervention programme were introduced, which focused on improving its suitability for the UK foster care context. Challenges in recruitment meant that, despite numerous modifications to the protocol and the inclusion of additional sites, only 30 families (target, n = 40) were recruited to the randomised controlled trial (15 allocated to each group). However, most other trial parameters were deemed feasible and acceptable, particularly the high levels of data and treatment completeness. All randomised families were available for baseline analyses, but two in the treatment arm were not available for post-treatment analyses. The revised intervention was positively received by practitioners and foster carers. Limitations: Only three-quarters of the target sample size was recruited. Furthermore, the sites’ own exclusion of potential participants and the low return rates of screening questionnaires raise the possibility of non-randomness of non-responses. Conclusion: A larger-scale trial may be feasible, but only if recruitment barriers can be overcome. Dedicated resources to support recruitment within local authorities and wider inclusion criteria are recommended. Central resourcing of intervention capacity to supplement NHS staff is also recommended. Trial registration: This trial is registered as ISRCTN18374094. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 35. See the NIHR Journals Library website for further project information.

Introduction At least one in four people treated by the primary care improving access to psychological therapies (IAPT) programme in England experiences distressing psychotic experiences (PE) in addition to common mental disorder (CMD). These individuals are less likely to achieve recovery. IAPT services do not routinely screen for nor offer specific treatments for CMD including PE. The Tailoring evidence-based psychological therapY for People with common mental disorder including Psychotic EXperiences study will evaluate the clinical and cost-effectiveness of an enhanced training for cognitive behavioural therapists that aims to address this clinical gap.Methods and analysis This is a multisite, stepped-wedge cluster randomised controlled trial. The setting will be IAPT services within three mental health trusts. The participants will be (1) 56–80 qualified IAPT cognitive behavioural therapists and (2) 600 service users who are triaged as appropriate for cognitive behavioural therapy in an IAPT service and have PE according to the Community Assessment of Psychic Experiences—Positive 15-items Scale. IAPT therapists will be grouped into eight study clusters subsequently randomised to the control-intervention sequence. We will obtain pseudonymous clinical outcome data from IAPT clinical records for eligible service users. We will invite service users to complete health economic measures at baseline, 3, 6, 9 and 12-month follow-up. The primary outcome will be the proportion of patients with common mental disorder psychotic experiences who have recovered by the end of treatment as measured by the official IAPT measure for recovery.Ethics and dissemination The study received the following approvals: South Central—Berkshire Research Ethics Committee on 28 April 2020 (REC reference 20/SC/0135) and Health Research Authority (HRA) on 23 June 2020. An amendment was approved by the Ethics Committee on 01 October 2020 and HRA on 27 October 2020. Results will be made available to patients and the public, the funders, stakeholders in the IAPT services and other researchers.Trial registration number ISRCTN93895792.

Background: It is unclear how best to identify and treat women with mental disorders in pregnancy and the year after birth (i.e. the perinatal period). Objectives: (1) To investigate how best to identify depression at antenatal booking [work package (WP) 1]. (2) To estimate the prevalence of mental disorders in early pregnancy (WP1). (3) To develop and examine the efficacy of a guided self-help intervention for mild to moderate antenatal depression delivered by psychological well-being practitioners (WP1). (4) To examine the psychometric properties of the perinatal VOICE (Views On Inpatient CarE) measure of service satisfaction (WP3). (5) To examine the clinical effectiveness and cost-effectiveness of services for women with acute severe postnatal mental disorders (WPs 1–3). (6) To investigate women’s and partners’/significant others’ experiences of different types of care (WP2). Design: Objectives 1 and 2 – a cross-sectional survey stratified by response to Whooley depression screening questions. Objective 3 – an exploratory randomised controlled trial. Objective 4 – an exploratory factor analysis, including test–retest reliability and validity assessed by association with the Client Satisfaction Questionnaire contemporaneous satisfaction scores. Objective 5 – an observational cohort study using propensity scores for the main analysis and instrumental variable analysis using geographical distance to mother and baby unit. Objective 6 – a qualitative study. Setting: English maternity services and generic and specialist mental health services for pregnant and postnatal women. Participants: Staff and users of mental health and maternity services. Interventions: Guided self-help, mother and baby units and generic care. Main outcome measures: The following measures were evaluated in WP1(i) – specificity, sensitivity, positive predictive value, likelihood ratio, acceptability and population prevalence estimates. The following measures were evaluated in WP1(ii) – participant recruitment rate, attrition and adverse events. The following measure was evaluated in WP2 – experiences of care. The following measures were evaluated in WP3 – psychometric indices for perinatal VOICE and the proportion of participants readmitted to acute care in the year after discharge. Results: WP1(i) – the population prevalence estimate was 11% (95% confidence interval 8% to 14%) for depression and 27% (95% confidence interval 22% to 32%) for any mental disorder in early pregnancy. The diagnostic accuracy of two depression screening questions was as follows: a weighted sensitivity of 0.41, a specificity of 0.95, a positive predictive value of 0.45, a negative predictive value of 0.93 and a likelihood ratio (positive) of 8.2. For the Edinburgh Postnatal Depression Scale, the diagnostic accuracy was as follows: a weighted sensitivity of 0.59, a specificity of 0.94, a positive predictive value of 0.52, a negative predictive value of 0.95 and a likelihood ratio (positive) of 9.8. Most women reported that asking about depression at the antenatal booking appointment was acceptable, although this was reported as being less acceptable for women with mental disorders and/or experiences of abuse. Cost-effectiveness analysis suggested that both the Whooley depression screening questions and the Edinburgh Postnatal Depression Scale were more cost-effective than with the Whooley depression screening questions followed by the Edinburgh Postnatal Depression Scale or no-screen option. WP1(ii) – 53 women with depression in pregnancy were randomised. Twenty-six women received modified guided self-help [with 18 (69%) women attending four or more sessions] and 27 women received usual care. Three women were lost to follow-up (follow-up for primary outcome: 92%). At 14 weeks post randomisation, women receiving guided self-help reported fewer depressive symptoms than women receiving usual care (adjusted effect size −0.64, 95% confidence interval −1.30 to 0.06). Costs and quality-adjusted life-years were similar, resulting in a 50% probability of guided self-help being cost-effective compared with usual care at National Institute for Health and Care Excellence cost per quality-adjusted life-year thresholds. The slow recruitment rate means that a future definitive larger trial is not feasible. WP2 – qualitative findings indicate that women valued clinicians with specialist perinatal expertise across all services, but for some women generic services were able to provide better continuity of care. Involvement of family members and care post discharge from acute services were perceived as poor across services, but there was also ambivalence among some women about increasing family involvement because of a complex range of factors. WP3(i) – for the perinatal VOICE, measures from exploratory factor analysis suggested that two factors gave an adequate fit (comparative fit index = 0.97). Items loading on these two dimensions were (1) those concerning aspects of the service relating to the care of the mother and (2) those relating to care of the baby. The factors were positively correlated (0.49; p

Abstract Background Mental health disorders in the context of long-term conditions in children and young people are currently overlooked and undertreated. Evidence-based psychological treatments for common childhood mental health disorders (anxiety, depression and disruptive behaviour disorders) have not been systematically evaluated in young people with epilepsy despite their high prevalence in this population. The aim of this multi-site randomised controlled trial is to determine the clinical and cost-effectiveness of adding a modular psychological intervention to usual care for the mental health disorders in comparison to assessment-enhanced usual care alone. Methods In total, 334 participants aged 3–18 years attending epilepsy services will be screened for mental health disorders with the Strengths and Difficulties Questionnaire (SDQ) and the diagnostic Development and Wellbeing Assessment (DAWBA). Those identified as having a mental health disorder and consenting to the trial will be randomised to either receive up to 22 sessions of the modular psychological intervention (MATCH-ADTC) delivered over the telephone over 6 months by non-mental health professionals in addition to usual care or to assessment-enhanced usual care alone. Outcomes will be measured at baseline, 6 months and 12 months post-randomisation. It is hypothesised that MATCH-ADTC plus usual care will be superior to assessment-enhanced usual care in improving emotional and behavioural symptoms. The primary outcome is the SDQ reported by parents at 6 months. Secondary outcomes include parent-reported mental health measures such as the Revised Children’s Anxiety and Depression Scale, quality of life measures such as the Paediatric Quality of Life Inventory and physical health measures such as the Hague Seizure Severity Scale. Outcome assessors will be blinded to group assignment. Qualitative process evaluations and a health economic evaluation will also be completed. Discussion This trial aims to determine whether a systematic and integrated approach to the identification and treatment of mental health disorders in children and young people with epilepsy is clinically and cost-effective. The findings will contribute to policies and practice with regard to addressing mental health needs in children and young people with other long-term conditions. Trial registration ISRCTN ISRCTN57823197 . Registered on 25 February 2019.

Abstract Background Depression has serious personal, family and economic consequences. It is estimated that it will cost £12.15 billion to the economy each year in England by 2026. Improving access to psychological therapies (IAPT) is the National Health Service talking therapies service in England for adults experiencing anxiety or depression. Over 1 million people are referred to IAPT every year, over half experiencing depression. Where symptoms of depression are mild to moderate, people are typically offered cognitive behavioural therapy (CBT) self-help (CBT-SH) supported by a psychological well-being practitioner. The problem is that over half of people who complete treatment for depression in IAPT remain depressed despite receiving National Institute of Health and Care Excellent recommended treatment. Furthermore, less than half of IAPT service users complete treatment. This study seeks to investigate the effectiveness of an alternative to CBT-SH. Mindfulness-based cognitive therapy (MBCT) differs from CBT in focus, approach and practice, and may be more effective with a higher number of treatment completions. Methods/design This is a definitive randomised controlled trial comparing supported MBCT self-help (MBCT-SH) with CBT-SH for adults experiencing mild to moderate depression being treated in IAPT services. We will recruit 410 participants experiencing mild to moderate depression from IAPT services and randomise these to receive either an MBCT-based self-help workbook or a CBT-based self-help workbook. Participants will be asked to complete their workbook within 16 weeks, with six support sessions with a psychological well-being practitioner. The primary outcome is depression symptom severity on treatment completion. Secondary outcomes are treatment completion rates and measures of generalized anxiety, well-being, functioning and mindfulness. An exploratory non-inferiority analysis will be conducted in the event the primary hypothesis is not supported. A semi-structured interview with participants will guide understanding of change processes. Discussion If the findings from this randomised controlled trial demonstrate that MBCT-SH is more effective than CBT-SH for adults experiencing depression, this will provide evidence for policy makers and lead to changes to clinical practice in IAPT services, leading to greater choice of self-help treatment options and better outcomes for service users. If the exploratory non-inferiority analysis is conducted and this indicates non-inferiority of MBCT-SH in comparison to CBT-SH this will also be of interest to policy makers when seeking to increase service user choice of self-help treatment options for depression. Trial registration Current Controlled Trial registration number: ISRCTN 13495752. Registered on 31 August 2017 ( www.isrctn.com/ISRCTN13495752 ).

Abstract Objectives The COVID-19 related lockdowns and distancing measures have presented families with unprecedented challenges. A UK-wide cohort study tracking changes in families’ mental health since early lockdown (Co-SPACE) found a significant rise in primary school-aged children’s behaviour problems and associated family-related stress. Three-quarters of parents in Co-SPACE also reported wanting extra support. In SPARKLE, we will examine whether providing Co-SPACE families with a smartphone application delivering information and parenting support, Parent Positive, can reverse the negative effects of the pandemic on children and parents. The efficacy on child and parent outcomes and cost-effectiveness of Parent Positive will be examined. We will also test whether the effects are moderated by pre-existing levels of child conduct problems and usage of Parent Positive. Exploratory analyses will examine whether other baseline characteristics or lockdown circumstances moderate the effects of Parent Positive. Trial design SPARKLE is a two-arm superiority parallel group randomised controlled trial embedded in an existing large UK-wide self-selected community cohort – Co-SPACE. Those who consent to SPARKLE will be randomised 1:1 to either Parent Positive or Follow-up As Usual (FAU). Participants Co-SPACE (a UK-wide longitudinal cohort study) parents aged ≥18 who have children aged 4-10 years will be eligible for SPARKLE. Intervention and comparator Parent Positive: is a digital public health intervention that can be delivered rapidly at scale to support parents in managing their children’s behaviour to reduce conduct problems and levels of family conflict, which were exacerbated during the first lockdown, and which may increase further in future months as families need to cope with continuous uncertainty and further disruption to their daily lives. Co-designed with parents and based on decades of parenting research, Parent Positive consists of three elements: (i) Parenting Boosters: where advice, delivered in the form of narrated animations, videos, graphics and text is provided to help parents with eight common parenting challenges; (ii) Parenting Exchange: a facilitated parent-to-parent communication and peer support platform and; (iii) Parent Resources: giving access to carefully selected high-quality, evidence-based online parenting resources. Follow-up as Usual: FAU was selected as a comparator because the public health nature meant that an active comparator was not appropriate due to the pragmatic, rapid implementation of the trial. Individuals randomised to FAU will receive no intervention for the first two months while the data for baseline (T1), T2 and T3 are collected. They will then be given full access to the app until 30th November 2021. Main outcomes Outcome measures will be collected remotely through Qualtrics according to the Co-SPACE schedule at baseline (T1), which will be the Co-SPACE survey data obtained immediately prior to randomisation, and then at one month (T2) and two months (T3) post-randomisation. Measures will be collected to assess group differences in child and parent outcomes, costs and service utilisation, and adverse events. Usage of Parent Positive will also be tracked. The primary outcome is parent-reported child conduct problems at one-month post-randomisation measured using the Strengths and Difficulties Questionnaire conduct problems subscale. Randomisation Enrolled participants will be allocated to Parent Positive or FAU at the ratio of 1:1 by simple randomisation using the Randomizer function within the Qualtrics programme. Neither blocking nor stratification will be used. Blinding (masking) It is not possible to blind parents enrolled in the study and Qualtrics will automatically inform parents of their group allocation. Blinded members of the research team and the senior statistician will not be given access to the Qualtrics system or the data in order to remain blinded until after the analysis is complete. We do not anticipate any serious harms associated with taking part in the intervention, therefore there will be no need to unblind any blinded staff during the study. The junior statistician will be unblinded throughout. Numbers to be randomised (sample size) A total of 616 will be recruited into the trial with 308 consenting parents randomised to each treatment arm. Trial status V1.0; 15.03.2021. Not yet recruiting. Anticipated start date: 1st April 2021. Anticipated end date for recruitment: 31st July 2021. Trial registration Clinicaltrial.gov: NCT04786080 . The trial was prospectively registered on 8 March 2021. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

Abstract Background There is a lack of well-designed randomized controlled trials (RCTs) to investigate the efficacy of psychological therapies for children in foster care with emotional and behavioural difficulties. Mentalization-based therapy (MBT) focuses on supporting the carer-child relationship by promoting reflective capacity. This study examined the feasibility and acceptability of an RCT of MBT, delivered in a family-format, for children who are in foster care in the UK. Method Herts and Minds was a phase II, blinded feasibility RCT with follow-up of at 12 and 24 weeks post-randomisation. Participants were children (age 5–16) in foster care referred to a targeted mental health service, who had some level of difficulty as identified by the Strengths and Difficulties Questionnaire (SDQ). Aims were to assess: the feasibility of recruitment processes and study uptake; capacity to train mental health practitioners to deliver MBT to an acceptable level of treatment integrity; establish acceptability and credibility of MBT as an intervention for children in foster care; establish feasibility and acceptability to participants of conducting an RCT; and estimate the likely treatment efficacy effect size. Participants were randomly allocated to either MBT (n = 15) or Usual Clinical Care (UCC) (n = 21) individually or in sibling groups. A range of qualitative and quantitative data was gathered to assess feasibility. Results Feasibility was established with regard to: capacity to recruit participants to a study; capacity to train mental health practitioners to deliver MBT to an acceptable level of treatment integrity; acceptability and credibility of MBT; and feasibility and acceptability to participants of conducting an RCT. A number of issues made it difficult to estimate a likely treatment efficacy effect size. Conclusion With modifications, it is feasible to run an RCT of MBT for children in foster care. Both the therapy and research design were acceptable to participants, but modifications may be needed regarding both the timing of assessments and the identification of appropriate primary outcome measures. Given the lack of evidenced based therapies for this population, such a trial would be a significant contribution to the field. Findings may be useful for other groups planning clinical trials of psychological therapies for children in foster care. Trial registration ISRCTN 90349442. The trial was retrospectively registered on 6 May 2016.

Abstract Background Many people who have common mental disorders, such as depression and anxiety, also have some psychotic experiences. These experiences are associated with higher clinical complexity, poor treatment response, and negative clinical outcomes. Psychological interventions have the potential to improve outcomes for people with psychotic experiences. The aims of this systematic review are to (1) synthesise the evidence on the effectiveness and cost-effectiveness of psychological interventions to reduce psychotic experiences and their associated distress and (2) identify key components of effective interventions. Methods Our search strategy will combine terms for (1) psychological interventions, (2) psychotic experiences, and (3) symptoms associated with psychotic experiences. We will search the following online databases: MEDLINE, Embase, PsycINFO, all Cochrane databases, British Nursing Index (BNI), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Health Management Information Consortium (HMIC), Education Resources Information Center (ERIC), and EconLit. Our primary outcome is the proportion of people who recovered or remitted from psychotic experiences after the intervention. Our secondary outcomes are changes in positive psychotic symptoms, negative psychotic symptoms, depression, anxiety, functioning (including social, occupational, and academic), quality of life, and cost-effectiveness. Two independent reviewers will judge each study against pre-specified inclusion and exclusion criteria and will extract study characteristics, outcome data, and intervention components. Risk of bias and methodological quality will be assessed using the Effective Public Health Practice Project Quality Assessment Tool for Quantitative Studies and the Drummond Checklist. Results will be synthesised using random-effects meta-analysis and narrative synthesis. Discussion The identification of effective psychological interventions and of specific components associated with intervention effectiveness will augment existing evidence that can inform the development of a new, tailored intervention to improve outcomes related to psychotic symptoms, anxiety and depression, distress, functioning, and quality of life. Systematic review registration PROSPERO CRD42016033869

Background Post-traumatic stress disorder (PTSD) is a distressing and disabling condition that affects significant numbers of children and adolescents. Youth exposed to multiple traumas (eg, abuse, domestic violence) are at particular risk of developing PTSD. Cognitive therapy for PTSD (CT-PTSD), derived from adult work, is a theoretically informed, disorder-specific form of trauma-focused cognitive–behavioural therapy. While efficacious for child and adolescent single-event trauma samples, its effectiveness in routine settings with more complex, multiple trauma-exposed youth has not been established. The Delivery of Cognitive Therapy for Young People after Trauma randomised controlled trial (RCT) examines the effectiveness of CT-PTSD for treating PTSD following multiple trauma exposure in children and young people in comparison with treatment as usual (TAU).Methods/design This protocol describes a two-arm, patient-level, single blind, superiority RCT comparing CT-PTSD (n=60) with TAU (n=60) in children and young people aged 8–17 years with a diagnosis of PTSD following multiple trauma exposure. The primary outcome is PTSD severity assessed using the Children’s Revised Impact of Event Scale (8-item version) at post-treatment (ie, approximately 5 months post-randomisation). Secondary outcomes include structured interview assessment for PTSD, complex PTSD symptoms, depression and anxiety, overall functioning and parent-rated mental health. Mid-treatment and 11-month and 29-month post-randomisation assessments will also be completed. Process–outcome evaluation will consider which mechanisms underpin or moderate recovery. Qualitative interviews with the young people, their families and their therapists will be undertaken. Cost-effectiveness of CT-PTSD relative to TAU will be also be assessed.Ethics and dissemination This trial protocol has been approved by a UK Health Research Authority Research Ethics Committee (East of England–Cambridge South, 16/EE/0233). Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations and clinical workshops.Trial registration ISRCTN12077707. Registered 24 October 2016 (http://www.isrctn.com/ISRCTN12077707). Trial recruitment commenced on 1 February 2017. It is anticipated that recruitment will continue until June 2021, with 11-month assessments being concluded in May 2022.

Introduction Most individuals treated for heroin use disorder receive opioid agonist treatment (OAT)(methadone or buprenorphine). However, OAT is associated with high attrition and persistent, occasional heroin use. There is some evidence for the effectiveness of contingency management (CM), a behavioural intervention involving modest financial incentives, in encouraging drug abstinence when applied adjunctively with OAT. UK drug services have a minimal track record of applying CM and limited resources to implement it. We assessed a CM intervention pragmatically adapted for ease of implementation in UK drug services to promote heroin abstinence among individuals receiving OAT.Design Cluster randomised controlled trial.Setting and participants 552 adults with heroin use disorder (target 660) enrolled from 34 clusters (drug treatment clinics) in England between November 2012 and October 2015.Interventions Clusters were randomly allocated 1:1:1 to OAT plus 12× weekly appointments with: (1) CM targeted at opiate abstinence at appointments (CM Abstinence); (2) CM targeted at on-time attendance at appointments (CM Attendance); or (3) no CM (treatment as usual; TAU). Modifications included monitoring behaviour weekly and fixed incentives schedule.Measurements Primary outcome: heroin abstinence measured by heroin-free urines (weeks 9–12). Secondary outcomes: heroin abstinence 12 weeks after discontinuation of CM (weeks 21–24); attendance; self-reported drug use, physical and mental health.Results CM Attendance was superior to TAU in encouraging heroin abstinence. Odds of a heroin-negative urine in weeks 9–12 was statistically significantly greater in CM Attendance compared with TAU (OR=2.1; 95% CI 1.1 to 3.9; p=0.030). CM Abstinence was not superior to TAU (OR=1.6; 95% CI 0.9 to 3.0; p=0.146) or CM Attendance (OR=1.3; 95% CI 0.7 to 2.4; p=0.438) (not statistically significant differences). Reductions in heroin use were not sustained at 21–24 weeks. No differences between groups in self-reported heroin use.Conclusions A pragmatically adapted CM intervention for routine use in UK drug services was moderately effective in encouraging heroin abstinence compared with no CM only when targeted at attendance. CM targeted at abstinence was not effective.Trial registration number ISRCTN 01591254.

Background: Behaviour problems emerge early in childhood and place children at risk for later psychopathology. Objectives: To evaluate the clinical effectiveness and cost-effectiveness of a parenting intervention to prevent enduring behaviour problems in young children. Design: A pragmatic, assessor-blinded, multisite, two-arm, parallel-group randomised controlled trial. Setting: Health visiting services in six NHS trusts in England. Participants: A total of 300 at-risk children aged 12–36 months and their parents/caregivers. Interventions: Families were allocated in a 1 : 1 ratio to six sessions of Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) plus usual care or usual care alone. Main outcome measures: The primary outcome was the Preschool Parental Account of Children’s Symptoms, which is a structured interview of behaviour symptoms. Secondary outcomes included caregiver-reported total problems on the Child Behaviour Checklist and the Strengths and Difficulties Questionnaire. The intervention effect was estimated using linear regression. Health and social care service use was recorded using the Child and Adolescent Service Use Schedule and cost-effectiveness was explored using the Preschool Parental Account of Children’s Symptoms. Results: In total, 300 families were randomised: 151 to VIPP-SD plus usual care and 149 to usual care alone. Follow-up data were available for 286 (VIPP-SD, n = 140; usual care, n = 146) participants and 282 (VIPP-SD, n = 140; usual care, n = 142) participants at 5 and 24 months, respectively. At the post-treatment (primary outcome) follow-up, a group difference of 2.03 on Preschool Parental Account of Children’s Symptoms (95% confidence interval 0.06 to 4.01; p = 0.04) indicated a positive treatment effect on behaviour problems (Cohen’s d = 0.20, 95% confidence interval 0.01 to 0.40). The effect was strongest for children’s conduct [1.61, 95% confidence interval 0.44 to 2.78; p = 0.007 (d = 0.30, 95% confidence interval 0.08 to 0.51)] versus attention deficit hyperactivity disorder symptoms [0.29, 95% confidence interval –1.06 to 1.65; p = 0.67 (d = 0.05, 95% confidence interval –0.17 to 0.27)]. The Child Behaviour Checklist [3.24, 95% confidence interval –0.06 to 6.54; p = 0.05 (d = 0.15, 95% confidence interval 0.00 to 0.31)] and the Strengths and Difficulties Questionnaire [0.93, 95% confidence interval –0.03 to 1.9; p = 0.06 (d = 0.18, 95% confidence interval –0.01 to 0.36)] demonstrated similar positive treatment effects to those found for the Preschool Parental Account of Children’s Symptoms. At 24 months, the group difference on the Preschool Parental Account of Children’s Symptoms was 1.73 [95% confidence interval –0.24 to 3.71; p = 0.08 (d = 0.17, 95% confidence interval –0.02 to 0.37)]; the effect remained strongest for conduct [1.07, 95% confidence interval –0.06 to 2.20; p = 0.06 (d = 0.20, 95% confidence interval –0.01 to 0.42)] versus attention deficit hyperactivity disorder symptoms [0.62, 95% confidence interval –0.60 to 1.84; p = 0.32 (d = 0.10, 95% confidence interval –0.10 to 0.30)], with little evidence of an effect on the Child Behaviour Checklist and the Strengths and Difficulties Questionnaire. The primary economic analysis showed better outcomes in the VIPP-SD group at 24 months, but also higher costs than the usual-care group (adjusted mean difference £1450, 95% confidence interval £619 to £2281). No treatment- or trial-related adverse events were reported. The probability of VIPP-SD being cost-effective compared with usual care at the 24-month follow-up increased as willingness to pay for improvements on the Preschool Parental Account of Children’s Symptoms increased, with VIPP-SD having the higher probability of being cost-effective at willingness-to-pay values above £800 per 1-point improvement on the Preschool Parental Account of Children’s Symptoms. Limitations: The proportion of participants with graduate-level qualifications was higher than among the general public. Conclusions: VIPP-SD is effective in reducing behaviour problems in young children when delivered by health visiting teams. Most of the effect of VIPP-SD appears to be retained over 24 months. However, we can be less certain about its value for money. Trial registration: Current Controlled Trials ISRCTN58327365. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 29. See the NIHR Journals Library website for further project information.

Background There is growing research support for the use of mindfulness training (MT) in schools, but almost no high-quality evidence about different training models for people wishing to teach mindfulness in this setting. Effective dissemination of MT relies on the development of scalable training routes. Objective To compare 4 training routes for school teachers wishing to deliver MT differing in intensity and potential scalability, considering teaching competency, training acceptability, and cost-effectiveness. Methods Schools were randomized to an existing route comprising an 8-session instructor-led personal mindfulness course, combined with 4-day MT program training, or 1 of 3 more scalable, lower intensity, alternatives: an instructor-led personal mindfulness course combined with 1-day MT program training, a self-taught personal mindfulness course (delivered through a course book) combined with 4-day MT program training, and a self-taught personal mindfulness course combined with 1-day MT program training. Results Attrition from training was substantial across all routes. The instructor-led course was more effective than the self-taught course in increasing teachers’ personal mindfulness skills. Even the most intensive (existing) training route brought only 29% of the teachers commencing training, and 56% of those completing the study protocol, to the required minimum competency threshold (an advanced beginner rating on an adapted version of the Mindfulness-based Interventions Teaching Assessment Criteria). The differences in levels of competency achieved by existing training compared with the more scalable alternatives were modest, with economic evaluation suggesting that the existing route was both more expensive and more effective than lower intensity alternatives, but with no statistically significant differences between routes. Conclusions This research questions the move toward abbreviating teacher training to increase scalability and suggests instead that many teachers require additional support to ensure competency from first delivery of MT in the classroom.

Background: The Systemic Therapy for At Risk Teens (START) trial is a randomised controlled trial of multisystemic therapy (MST) compared with management as usual (MAU). The present study reports on long-term follow-up of the trial (to 60 months). Objectives: The primary objective was to compare MST and MAU for the proportion of young people in each group with criminal convictions up to 60 months post baseline. Secondary outcomes included group comparisons of psychological and behavioural factors. An economic analysis was carried out to determine the cost-effectiveness of MST compared with MAU. Two qualitative studies were conducted to better understand the subjective experiences of the participants. Design: Primary outcomes (collected up to 60 months) were collected using a centralised police database. Secondary outcomes were evaluated using self-report questionnaires completed by both young people and parents or carers at the 24-, 36- and 48-month follow-ups. Research assistants were blind to treatment allocation. Setting: Participants were recruited from participating MST sites in nine areas of England. Secondary outcomes were typically collected within the family home. Participants: A total of 684 families were recruited into the START trial and allocated randomly to a treatment group. Of these, 487 remained in the second phase of the trial. Young people were aged, on average, 13.8 years at baseline, with 63% male and 37% female. Interventions: MST is a manualised programme for young people exhibiting antisocial behaviour and their families that uses principles from cognitive–behavioural and family therapy to provide an individualised approach. MAU content was not prespecified, but consisted of the standard care offered to young people who met eligibility for the trial. Main outcome measures: Young people’s offending was evaluated using the Police National Computer. Secondary measures included validated self-report measures completed by both the young person and their parent or carer. The economic evaluation took a broad perspective and outcomes were assessed in terms of quality-adjusted life-years and offending. Results: No significant differences were found in the proportion of offending between the groups (hazard ratio 1.03, 95% confidence interval 0.84 to 1.26; p = 0.78). No differences were found between the groups on secondary outcome measures, with a few exceptions that did not hold up consistently across the follow-up period. The economic analysis did not find evidence to support the cost-effectiveness of MST compared with MAU. Outcomes from the qualitative studies suggest that families mostly felt positive about MST, and that MST was associated with greater maturity in young men. Limitations: Some intended evaluations were not possible to deliver. Selective attrition may have influenced the nature of the sample size. It is also unclear how representative the MAU services were of reality. Future research: Recommendations are made for the evaluation of MST in populations with more severe behavioural problems, as well as for identifying and testing new moderators. Conclusions: The results of the second phase of the START trial do not support the long-term superiority of MST to MAU, but elements of the intervention may be adapted successfully. Trial registration: Current Controlled Trials ISRCTN77132214 and London South-East REC registration number 09/H1102/55. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 8, No. 23. See the NIHR Journals Library website for further project information.

Abstract Background Behavioural problems are common in early childhood, and can result in enduring costs to the individual and society, including an increased risk of mental and physical illness, criminality, educational failure and drug and alcohol misuse. Most previous research has examined the impact of interventions targeting older children when difficulties are more established and harder to change, and have rarely included fathers. We are conducting a trial of a psychological intervention delivered to families with very young children, engaging both parents where possible. Methods This study is a two-arm, parallel group, researcher-blind, randomized controlled trial, to test the clinical effectiveness and cost-effectiveness of a parenting intervention, Video Feedback Intervention to Promote Positive Parenting and Sensitive Discipline (VIPP-SD) for parents of young children (12–36 months) at risk of behavioural difficulties. VIPP-SD is an evidence-based parenting intervention developed at Leiden University in the Netherlands which uses a video-feedback approach to support parents, particularly by enhancing parental sensitivity and sensitive discipline in caring for children. The trial will involve 300 families, who will be randomly allocated into either an intervention group, who will receive the video-feedback intervention (n = 150), or a control group, who will receive treatment as usual (n = 150). The trial will evaluate whether VIPP-SD, compared to treatment as usual, leads to lower levels of behavioural problems in young children who are at high risk of developing these difficulties. Assessments will be conducted at baseline, and 5 and 24 months post-randomization. The primary outcome measure is a modified version of the Preschool Parental Account of Child Symptoms (Pre-PACS), a structured clinical interview of behavioural symptoms. Secondary outcomes include caregiver-reported behavioural difficulties, parenting behaviours, parental sensitivity, parental mood and anxiety and parental relationship adjustment. An economic evaluation will also be carried out to assess the cost-effectiveness of the intervention compared to treatment as usual. Discussion If shown to be effective, the intervention could be delivered widely to parents and caregivers of young children at risk of behavioural problems as part of community based services. Trial registration ISRCTN Registry: ISRCTN58327365 . Registered 19 March 2015.

Abstract Background Mindfulness-based approaches for adults are effective at enhancing mental health, but few controlled trials have evaluated their effectiveness or cost-effectiveness for young people. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of a mindfulness training (MT) programme to enhance mental health, wellbeing and social-emotional behavioural functioning in adolescence. Methods/design To address this aim, the design will be a superiority, cluster randomised controlled, parallel-group trial in which schools offering social and emotional provision in line with good practice (Formby et al., Personal, Social, Health and Economic (PSHE) Education: A mapping study of the prevalent models of delivery and their effectiveness, 2010; OFSTED, Not Yet Good Enough: Personal, Social, Health and Economic Education in schools, 2013) will be randomised to either continue this provision (control) or include MT in this provision (intervention). The study will recruit and randomise 76 schools (clusters) and 5700 school students aged 12 to 14 years, followed up for 2 years. Discussion The study will contribute to establishing if MT is an effective and cost-effective approach to promoting mental health in adolescence. Trials registration International Standard Randomised Controlled Trials, identifier: ISRCTN86619085 . Registered on 3 June 2016.

BackgroundNumerous economic models have assessed the cost-effectiveness of antipsychotic medications in schizophrenia. It is important to understand what key impacts of antipsychotic medications were considered in the existing models and limitations of existing models in order to inform the development of future models.ObjectivesThis systematic review aims to identify which clinical benefits, clinical harms, costs and cost savings of antipsychotic medication have been considered by existing models, to assess quality of existing models and to suggest good practice recommendations for future economic models of antipsychotic medications.MethodsAn electronic search was performed on multiple databases (MEDLINE, EMBASE, PsycInfo, Cochrane database of systematic reviews, The NHS Economic Evaluation Database and Health Technology Assessment database) to identify economic models of schizophrenia published between 2005-2020. Two independent reviewers selected studies for inclusion. Study quality was assessed using the National Institute for Health and Care Excellence (NICE) checklist and the Cooper hierarchy. Key impacts of antipsychotic medications considered by exiting models were descriptively summarised.ResultsSixty models were included. Existing models varied greatly in key impacts of antipsychotic medication included in the model, especially in clinical outcomes used for assessing reduction in psychotic symptoms and types of adverse events considered in the model. Quality of existing models was generally low due to failure to capture the health and cost impact of adverse events of antipsychotic medications and input data not obtained from best available source. Good practices for modelling antipsychotic medications are suggested.DiscussionsThis review highlights inconsistency in key impacts considered by different models, and limitations of the existing models. Recommendations on future research are provided.

BackgroundAlthough evidence suggests that the EuroQoL-5 dimension (EQ-5D) and Short Form-6 dimension (SF-6D) have equivalent psychometric properties in people with depression, there is some evidence that the EQ-5D may lack responsiveness in certain populations with depression.AimsTo examine the psychometric properties of the five-level EQ-5D (EQ-5D-5L) and SF-6D measures of health-related quality of life in a representative sample of pregnant women with depression.MethodData were taken from a cohort of pregnant women identified at or soon after the first antenatal care contact and followed-up at 3 months postpartum. Health-related quality of life was measured using both the EQ-5D-5L and the SF-6D at baseline and follow-up. We examined acceptability and conducted psychometric validation in the aspects of concurrent validity, convergent validity, known-group validity and responsiveness in 421 women with available data.ResultsThe EQ-5D-5L and SF-6D have similarly high levels of acceptability. However, concurrent validation shows a lack of concordance between the EQ-5D-5L and SF-6D. The EQ-5D-5L tends to be higher than the SF-6D in individuals with better health states. The SF-6D tends to be higher than EQ-5D-5L in individuals with poorer health states. Convergent and known-group validity are comparable between the two utility measures. Longitudinally, women who recovered show larger increase in SF-6D utilities than those who did not recover at follow-up. With the EQ-5D-5L, this is not the case. Additionally, the ceiling effects were more apparent in the EQ-5D-5L.ConclusionsThe effectiveness of perinatal mental health interventions may be better captured by the SF-6D than the EQ-5D-5L but this needs to be cross-validated in more studies.Declaration of interestL.M.H. chaired the National Institute for Health and Care Excellence CG192 guidelines development group on antenatal and postnatal mental health in 2012–2014. L.M.H. reports grants from NIHR, MRC, Nuffield and the Stefanou Foundation, UK. K.T., M.H. and S.B. report funding by NIHR and the Stefanou Foundation, UK.

Objectives This study aimed to estimate the incidence of DSM5 anorexia nervosa in young people in contact with child and adolescent mental health services in the UK and Ireland.Design Observational, surveillance study, using the Child and Adolescent Psychiatry Surveillance System, involving monthly reporting by child and adolescent psychiatrists between 1st February 2015 and 30th September 2015.Setting The study was based in the UK and Ireland.Participants Clinician-reported data on young people aged 8–17 in contact with child and adolescent mental health services for a first episode of anorexia nervosa.Main outcome measures Annual incidence rates (IRs) estimated as confirmed new cases per 100 000 population at risk.Results 305 incident cases of anorexia nervosa were reported over the 8-month surveillance period and assessed as eligible for inclusion. The majority were young women (91%), from England (70%) and of white ethnicity (92%). Mean age was 14.6 years (±1.66) and mean percentage of median expected body mass index for age and sex was 83.23% (±10.99%). The overall IR, adjusted for missing data, was estimated to be 13.68 per 100 000 population (95% CI 12.88 to 14.52), with rates of 25.66 (95% CI 24.09 to 27.30) for young women and 2.28 (95% CI 1.84 to 2.79) for young men. Incidence increased steadily with age, peaking at 15 (57.77, 95% CI 50.41 to 65.90) for young women and 16 (5.14, 95% CI 3.20 to 7.83) for young men. Comparison with earlier estimates suggests IRs for children aged 12 and under have increased over the last 10 years.Conclusion These results provide new estimates of the incidence of anorexia nervosa in young people. Service providers and commissioners should consider evidence to suggest an increase in incidence in younger children.Trial registration number ISRCTN12676087.

Background: Evidence suggests that investing in specialist eating disorders services for young people with anorexia nervosa could have important implications for the NHS, with the potential to improve health outcomes and reduce costs through reductions in the number and length of hospital admissions. Objectives: The primary objectives were to evaluate the costs and cost-effectiveness of alternative community-based models of service provision for young people with anorexia nervosa and to model the impact of potential changes to the provision of specialist services. Design: Observational surveillance study using the Child and Adolescent Psychiatry Surveillance System. Setting: Community-based secondary or tertiary child and adolescent mental health services (CAMHS) in the UK and the Republic of Ireland. Participants: A total of 298 young people aged 8–17 years in contact with CAMHS for a first episode of anorexia nervosa in accordance with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, diagnostic criteria. Interventions: Community-based specialist eating disorders services and generic CAMHS. Main outcome measures: Children’s Global Assessment Scale (CGAS) score (primary outcome) and percentage of median expected body mass index (BMI) for age and sex (%mBMI) (secondary outcome) were assessed at baseline and at 6 and 12 months. Data sources: Data were collected by clinicians from clinical records. Results: Total costs incurred by young people initially assessed in specialist eating disorders services were not significantly different from those incurred by young people initially assessed in generic CAMHS. However, adjustment for baseline covariates resulted in observed differences favouring specialist services (costs were lower, on average) because of the significantly poorer clinical status of the specialist group at baseline. At the 6-month follow-up, mean %mBMI was significantly higher in the specialist group, but no other significant differences in outcomes were evident. Cost-effectiveness analyses suggest that initial assessment in a specialist service has a higher probability of being cost-effective than initial assessment in generic CAMHS, as determined by CGAS score and %mBMI. However, no firm conclusion can be drawn without knowledge of society’s willingness to pay for improvements in these outcomes. Decision modelling did not support the hypothesis that changes to the provision of specialist services would generate savings for the NHS, with results suggesting that cost per 10-point improvement in CGAS score (improvement from one CGAS category to the next) varies little as the percentage of participants taking the specialist or generic pathway is varied. Limitations: Follow-up rates were lower than expected, but the sample was still larger than has been achieved to date in RCTs carried out in this population in the UK, and an exploration of the impact of missing cost and outcome data produced very similar results to those of the main analyses. Conclusions: The results of this study suggest that initial assessment in a specialist eating disorders service for young people with anorexia nervosa may have a higher probability of being cost-effective than initial assessment in generic CAMHS, although the associated uncertainty makes it hard to draw firm conclusions. Although costs and outcomes were similar, young people in specialist services were more severely ill at baseline, suggesting that specialist services were achieving larger clinical effectiveness gains without the need for additional expenditure. The results did not suggest that providing more specialist services would save money for the NHS, given similar costs and outcomes, so decisions about which service type to fund could be made with reference to other factors, such as the preferences of patients and carers. Future work: Data on measures of quality of life capable of generating quality-adjusted life-years are needed to confirm the cost-effectiveness of specialist services. Trial registration: Current Controlled Trials ISRCTN12676087. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 7, No. 37. See the NIHR Journals Library website for further project information.

BackgroundRefractory depression is a major contributor to the economic burden of depression. Radically open dialectical behaviour therapy (RO DBT) is an unevaluated new treatment targeting overcontrolled personality, common in refractory depression, but it is not yet known whether the additional expense of RO DBT is good value for money.AimsTo estimate the cost-effectiveness of RO DBT plus treatment as usual (TAU) compared with TAU alone in people with refractory depression (trial registration: ISRCTN85784627).MethodWe undertook a cost-effectiveness analysis alongside a randomised trial evaluating RO DBT plus TAU versus TAU alone for refractory depression in three UK secondary care centres. Our economic evaluation, 12 months after randomisation, adopted the perspective of the UK National Health Service (NHS) and personal social services. It evaluated cost-effectiveness by comparing the net cost of RO DBT with the net gain in quality-adjusted life-years (QALYs), estimated using the EQ-5D-3L measure of health-related quality of life.ResultsThe additional cost of RO DBT plus TAU compared with TAU alone was £7048 and was associated with a difference of 0.032 QALYs, yielding an incremental cost-effectiveness ratio (ICER) of £220 250 per QALY. This ICER was well above the National Institute for Health and Care Excellence (NICE) upper threshold of £30 000 per QALY. A cost-effectiveness acceptability curve indicated that RO DBT had a zero probability of being cost-effective compared with TAU at the NICE £30 000 threshold.ConclusionsIn its current resource-intensive form, RO DBT is not a cost-effective use of resources in the UK NHS.Declaration of interestR.H. is co-owner and director of Radically Open Ltd, the RO DBT training and dissemination company. D.K. reports grants outside the submitted work from the National Institute for Health Research (NIHR). T.L. receives royalties from New Harbinger Publishing for sales of RO DBT treatment manuals, speaking fees from Radically Open Ltd, and a grant outside the submitted work from the Medical Research Council. He was co-director of Radically Open Ltd between November 2014 and May 2015 and is married to Erica Smith-Lynch, the principal shareholder and one of two directors of Radically Open Ltd. H.O'M. reports personal fees outside the submitted work from the Charlie Waller Institute and Improving Access to Psychological Therapy. S.R. provides RO DBT supervision through her company S C Rushbrook Ltd. I.R. reports grants outside the submitted work from NIHR and Health & Care Research Wales. M. Stanton reports personal fees outside the submitted work from British Isles DBT Training, Stanton Psychological Services Ltd and Taylor & Francis. M. Swales reports personal fees outside the submitted work from British Isles DBT Training, Guilford Press, Oxford University Press and Taylor & Francis. B.W. was co-director of Radically Open Ltd between November 2014 and February 2015.

Background: Poor mental health in childhood is common, persistent and associated with a range of adverse outcomes that include persistent psychopathology, as well as risk-taking behaviour, criminality and educational failure, all of which may also compromise health. There is a growing policy focus on children’s mental health and the role of schools in particular in addressing this. Objectives: To evaluate whether or not the Incredible Years® (IY) Teacher Classroom Management (TCM) training improved children’s mental health, behaviour, educational attainment and enjoyment of school, improved teachers’ mental health and relationship with work, and was cost-effective in relation to potential improvements. Design: A two-arm, pragmatic, parallel-group, superiority, cluster randomised controlled trial. Setting: A total of 80 UK schools (clusters) were recruited in three distinct cohorts between 2012 and 2014 and randomised to TCM (intervention) or teaching as usual [(TAU) control] with follow-ups at 9, 18 and 30 months. Schools and teachers were not masked to allocation. Participants: Eighty schools (n = 2075 children) were randomised: 40 (n = 1037 children) to TCM and 40 (n = 1038 children) to TAU. Interventions: TCM was delivered to teachers in six whole-day sessions, spread over 6 months. The explicit goals of TCM are to enhance classroom management skills and improve teacher–student relationships. Main outcome measures: The primary planned outcome was the teacher-reported Strengths and Difficulties Questionnaire Total Difficulties (SDQ-TD) score. Random-effects linear regression and marginal logistic regression models using generalized estimating equations were used to analyse outcomes. Results: The intervention reduced the SDQ-TD score at 9 months [adjusted mean difference (AMD) –1.0, 95% confidence interval (CI) –1.9 to –0.1; p = 0.03] but there was little evidence of effects at 18 months (AMD –0.1, 95% CI –1.5 to 1.2; p = 0.85) and 30 months (AMD –0.7, 95% CI –1.9 to 0.4; p = 0.23). Planned subgroup analyses suggested that TCM is more effective than TAU for children with poor mental health. Cost-effectiveness analysis using the SDQ-TD suggested that the probability of TCM being cost-effective compared with TAU was associated with some uncertainty (range of 40% to 80% depending on the willingness to pay for a unit improvement in SDQ-TD score). In terms of quality-adjusted life-years (QALYs), there was evidence to suggest that TCM was cost-effective compared with TAU at the National Institute for Health and Care Excellence thresholds of £20,000–30,000 per QALY at 9- and 18-month follow-up, but not at 30-month follow-up. There was evidence of reduced disruptive behaviour (p = 0.04) and reductions in inattention and overactivity (p = 0.02) at the 30-month follow-up. Despite no main effect on educational attainment, subgroup analysis indicated that the intervention’s effect differed between those who did and those who did not have poor mental health for both literacy (interaction p = 0.04) and numeracy (interaction p = 0.03). Independent blind observations and qualitative feedback from teachers suggested that teachers’ behaviour in the classroom changed as a result of attending TCM training. Limitations: Teachers were not masked to allocation and attrition was marked for parent-reported data. Conclusions: Our findings provide tentative evidence that TCM may be an effective universal child mental health intervention in the short term, particularly for primary school children who are identified as struggling, and it may be a cost-effective intervention in the short term. Future work: Further research should explore TCM as a whole-school approach by training all school staff and should evaluate the impact of TCM on academic progress in a more thorough and systematic manner. Trial registration: Current Controlled Trials ISRCTN84130388. Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 7, No. 6. See the NIHR Journals Library website for further project information. Funding was also provided by the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula (NIHR CLAHRC South West Peninsula).