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Background: Some local areas in England stopped have gluten‐free prescriptions for coeliac disease. An explanatory mixed‐methods study has investigated the impact of these changes. Methods: A cross‐sectional survey with 1697 participants was followed by 24 qualitative interviews. The survey included questions on the use of prescriptions and healthcare services, as well as the Coeliac Disease Assessment Questionnaire (CDAQ) to assess quality of life. The survey data were analysed by descriptive statistics, analysis of variance and regression analysis, and the interviews were analysed by thematic analysis. Findings from the interviews guided the survey analysis. Results: Dietary burden was significantly different between prescribing and nonprescribing areas, with little impact on other aspects of quality of life. Survey participants in nonprescribing areas who felt more impacted by the prescription changes reported a lower quality of life. Satisfaction with and use of services was lower in nonprescribing areas. Interviews indicated that, after initial frustrations, most people adapted to the changed prescription policy. However, there was a clear preference for gluten‐free prescriptions to be available, in particular for staple foods. Conclusions: The main quality of life impact was on Dietary burden. It is encouraging that most participants in the present study maintained a good quality of life. However, issues of worse experiences of care, lower follow‐up opportunities and inequity arose, and these should be taken into consideration in decisions on gluten‐free food prescriptions. The new guidelines for the National Health Service in England have retained prescriptions for bread and flour mixes, which is more limited than the range of staple foods preferred in the present study. [ABSTRACT FROM AUTHOR]

Background: Assessing the cost-effectiveness of interventions targeting childhood excess weight requires estimates of the hazards of transitioning between weight status categories. Current estimates are based on studies characterized by insufficient sample sizes, a lack of national representativeness, and untested assumptions., Objectives: We sought to (1) estimate transition probabilities and hazard ratios for transitioning between childhood weight status categories, (2) test the validity of the underlying assumption in the literature that transitions between childhood bodyweight categories are time-homogeneous, (3) account for complex sampling procedures when deriving nationally representative transition estimates, and (4) explore the impact of child, maternal, and sociodemographic characteristics., Methods: We applied a multistate transition modeling approach accounting for complex survey design to UK Millennium Cohort Study (MCS) data to predict transition probabilities and hazard ratios for weight status movements for children aged 3-17. Surveys were conducted at ages 3 (wave 2 in 2004), 5 (wave 3 in 2006), 7 (wave 4 in 2008), 11 (wave 5 in 2012), 14 (wave 6 in 2015), and 17 (wave 7 in 2018) years. We derived datasets that included repeated body mass index measurements across waves after excluding multiple births and children with missing or implausible bodyweight records. To account for the stratified cluster sample design of the MCS, we incorporated survey weights and jackknife replicates of survey weights. Using a validation dataset from the MCS, we tested the validity of our models. Finally, we estimated the relationships between state transitions and child, maternal, and sociodemographic factors., Results: The datasets for our primary analysis consisted of 10,399 children for waves 2-3, 10,729 for waves 3-4, 9685 for waves 4-5, 8593 for waves 5-6, and 7085 for waves 6-7. All datasets consisted of roughly equal splits of boys and girls. Under the assumption of time-heterogeneous transition rates (our base-case model), younger children (ages 3-5 and 5-7 years) had significantly higher annual transition probabilities of moving from healthy weight to overweight (0.033, 95% confidence interval [CI] 0.026-0.041, and 0.027, 95% CI 0.021-0.033, respectively) compared to older children (0.015, 95% CI 0.012-0.018, at ages 7-11; 0.018, 95% CI 0.013-0.023, at ages 11-14; and 0.018, 95% CI 0.013-0.025 at ages 14-17 years). However, the resolution of unhealthy weight was more strongly age-dependent than transitions from healthy weight to non-healthy weight states. Transition hazards differed by child, maternal, and sociodemographic factors., Conclusions: Our models generated estimates of bodyweight status transitions in a representative UK childhood population. Compared to our scenario models (i.e., time-homogeneous transition rates), our base-case model fits the observed data best, indicating a non-time-homogeneous pattern in transitions between bodyweight categories during childhood. Transition hazards varied significantly by age and across subpopulations, suggesting that conducting subgroup-specific cost-effectiveness analyses of childhood weight management interventions will optimize decision-making., (© 2024. Crown.)

Background: Anxiety problems are common in children, yet few affected children access evidence-based treatment. Digitally augmented psychological therapies bring potential to increase availability of effective help for children with mental health problems. This study aimed to establish whether therapist-supported, digitally augmented, parent-led cognitive behavioural therapy (CBT) could increase the efficiency of treatment without compromising clinical effectiveness and acceptability., Methods: We conducted a pragmatic, unblinded, two-arm, multisite, randomised controlled non-inferiority trial to evaluate the clinical effectiveness and cost-effectiveness of therapist-supported, parent-led CBT using the Online Support and Intervention (OSI) for child anxiety platform compared with treatment as usual for child (aged 5-12 years) anxiety problems in 34 Child and Adolescent Mental Health Services in England and Northern Ireland. We examined acceptability of OSI plus therapist support via qualitative interviews. Participants were randomly assigned (1:1) to OSI plus therapist support or treatment as usual, minimised by child age, gender, service type, and baseline child anxiety interference. Outcomes were assessed at week 14 and week 26 after randomisation. The primary clinical outcome was parent-reported interference caused by child anxiety at week 26 assessment, using the Child Anxiety Impact Scale-parent report (CAIS-P). The primary measure of health economic effect was quality-adjusted life-years (QALYs). Outcome analyses were conducted blind in the intention-to-treat (ITT) population with a standardised non-inferiority margin of 0·33 for clinical analyses. The trial was registered with ISRCTN, 12890382., Findings: Between Dec 5, 2020, and Aug 3, 2022, 706 families (706 children and their parents or carers) were referred to the study information. 444 families were enrolled. Parents reported 255 (58%) child participants' gender to be female, 184 (41%) male, three (<1%) other, and one (<1%) preferred not to report their child's gender. 400 (90%) children were White and the mean age was 9·20 years (SD 1·79). 85% of families for whom clinicians provided information in the treatment as usual group received CBT. OSI plus therapist support was non-inferior for parent-reported anxiety interference on the CAIS-P (SMD 0·01, 95% CI -0·15 to 0·17; p<0·0001) and all secondary outcomes. The mean difference in QALYs across trial arms approximated to zero, and OSI plus therapist support was associated with lower costs than treatment as usual. OSI plus therapist support was likely to be cost effective under certain scenarios, but uncertainty was high. OSI plus therapist support acceptability was good. No serious adverse events were reported., Interpretation: Digitally augmented intervention brought promising savings without compromising outcomes and as such presents a valuable tool for increasing access to psychological therapies and meeting the demand for treatment of child anxiety problems., Funding: Department for Health and Social Care and United Kingdom Research and Innovation Research Grant, National Institute for Health and Care (NIHR) Research Policy Research Programme, Oxford and Thames Valley NIHR Applied Research Collaboration, Oxford Health NIHR Biomedical Research Centre., Competing Interests: Declaration of interests CC is the author of a book for parents that is used in many of the participating clinical teams to augment treatment as usual for child anxiety problems and receives royalties from sales. CC and CH are developers of the OSI platform. They do not receive any personal financial benefits from the use of OSI. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Changes to prescribing policies in England have restricted or stopped access to gluten-free food on prescription for people with coeliac disease in some geographical areas. The present study aimed to explore the impact of these changes on the affordability and obtainability of gluten-free foods for adults with coeliac disease., Methods: Semi-structured qualitative interviews (n = 24) were conducted with people with coeliac disease living in areas where prescriptions for gluten-free foods were no longer available, were restricted or followed national guidelines. Interviews explored the impact of gluten-free prescribing changes on the affordability and obtainability of gluten-free food, as well as dietary adherence., Results: All participants considered gluten-free substitute foods to be expensive. Participants felt the availability of gluten-free foods has improved over time, also acknowledging some challenges remain, such as limited local availability. For most, the withdrawal of prescriptions had minimal impact requiring small adjustments such as reducing the quantity of foods obtained. However, greater challenges were faced by those less mobile, permanently sick or disabled and/or on lower incomes., Conclusions: The majority of participants affected by the withdrawal of prescriptions were able to adapt to cope with these changes. However, participants with mobility issues, who are permanently sick or disabled and/or on lower incomes were struggling to afford and obtain gluten-free substitute foods from elsewhere. The withdrawal of prescriptions may further widen health inequalities. Further research should focus on the long-term impacts of prescription withdrawal for the vulnerable groups identified., (© 2023 The Authors. Journal of Human Nutrition and Dietetics published by John Wiley & Sons Ltd on behalf of British Dietetic Association.)

Background: A lifelong gluten-free diet is the only treatment for coeliac disease. The cost and availability of gluten-free substitute food (GFSF) remain challenging. Some local areas in England have stopped gluten-free prescriptions for coeliac disease. The aim of this paper is to present the quantitative findings of the financial impact of prescription withdrawal on people with coeliac disease., Methods: A cross-sectional survey with adults in England who reported having been diagnosed with coeliac disease by a health professional. The postal survey was distributed by Coeliac UK to their members in 13 prescribing and 13 non-prescribing local areas that were matched for geographical location and level of deprivation. Additionally, an advertisement for the survey was placed on social media. The questionnaire contained items on the availability and use of prescriptions; the weekly amount spent on GFSF; amount of specific GFSF bought; affordability of GFSF; demographics and health-related variables. Data were analysed by descriptive statistics, analysis of variance and regression analysis., Results: Of the 1697 participants, 809 resided in areas that provided prescriptions and 888 in non-prescribing areas. Participants self-report of their prescription did not always match the local area prescription policy. There was no statistically significant difference between prescribing and non-prescribing areas in how easy or difficult participants found it to obtain GFSF (p = 0.644) and its availability in various locations. Participants in non-prescribing areas purchased most types of GFSF items in statistically significantly higher quantities and thereby spent an additional £11.32/month on GFSF items than participants in prescribing areas (p < 0.001). While taking into account the self-reported prescription status, the amount increased to £14.09/month (p < 0.001). Although affordability to buy GFSF did not differ based on local area prescription policy or self-reported prescription status, it was dependent on equivalised annual income. However, affordability did not influence spending on GFSF. Regression analysis indicated that males and households with additional members with coeliac disease spent more on GFSF., Conclusions: The study has highlighted that gluten-free prescription withdrawal can have financial implications for people with coeliac disease. Any future changes to the prescription policy of GFSF should consider the impact on the population, especially lower income households., (© 2024. The Author(s).)

Background: The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether 'screening and intervention', consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only - 'usual school practice', for children aged 8-9 years in the following: (1) the 'target population', who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire - iCATS-2, and (2) the 'total population', comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial., Methods and Design: iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses., Trial Registration: ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022., (© 2024. The Author(s).)

We implemented a clustered randomized controlled trial with 6,963 residents in six rural Ghana districts to estimate the causal impact of financial incentives on coronavirus disease 2019 (COVID-19) vaccination uptake. Villages randomly received one of four video treatment arms: a placebo, a standard health message, a high cash incentive (60 Ghana cedis) and a low cash incentive (20 Ghana cedis). For the first co-primary outcome-COVID-19 vaccination intentions-non-vaccinated participants assigned to the cash incentive treatments had an average rate of 81% (1,733 of 2,168) compared to 71% (1,895 of 2,669) for those in the placebo treatment arm. For the other co-primary outcome of self-reported vaccinations 2 months after the initial intervention, the average rate for participants in the cash treatment was 3.5% higher than for participants in the placebo treatment (95% confidence interval (CI): 0.001, 6.9; P = 0.045): 40% (602 of 1,486) versus 36.3% (672 of 1,850). We also verified vaccination status of participants: in the cash treatment arm, 36.6% (355 of 1,058) of verified participants had at least one dose of the COVID-19 vaccine compared to 30.3% (439 of 1,544) for those in the placebo-a difference of 6.3% (95% CI: 2.4, 10.2; P = 0.001). For the intention and the vaccination outcomes, the low cash incentive (20 Ghana cedis) had a larger positive effect on COVID-19 vaccine uptake than the high cash incentive (60 Ghana cedis). Trial identifier: AEARCTR-0008775 ., (© 2023. The Author(s).)

Vaccine hesitancy has the potential to cripple efforts to end the COVID-19 pandemic. Policy makers need to be informed about the scale, nature and drivers of this problem, both domestically and globally, so that effective interventions can be designed. To this end, we conducted a statistical analysis of data from the CANDOUR survey (n = 15,536), which was carried out in 13 countries representing approximately half of the global population. Both pooled and country-level ordered regression models were estimated to identify predictors of vaccine hesitancy and reasons for not getting vaccinated. We found high levels of hesitancy, particularly in high-income countries. Factors driving moderate hesitancy differed from those driving extreme hesitancy. A lack of trust in health care providers was consistently the underlying driver of more extreme hesitancy. Predictors of moderate hesitancy varied across countries, though being younger and female was typically associated with greater hesitancy. While political ideology played a role in vaccine hesitancy in some countries, this effect was often moderated by income level, particularly in the US. Overall, the results suggest that different interventions such as mass-media campaigns and monetary incentives may be needed to target the moderately versus extremely hesitant. The lack of trust in health care professionals that drives extreme hesitancy may reflect deep societal mistrust in science and institutions and be challenging to overcome., Competing Interests: Declaration of Competing Interest None. As corresponding author, I confirm that the manuscript has been read and approved for submission by all the named authors. All the authors contributed to the writing of the final manuscript. The research was supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) and the COVID-19 Oxford Vaccine Trial. Mara Violato receives funding from the NIHR Applied Research Collaboration Oxford and Thames Valley at Oxford Health NHS Foundation Trust. Mara Violato and Paolo Candio were partly supported by the NIHR Applied Research Collaboration (ARC) Oxford and Thames Valley. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. The funding bodies had no involvement in the study design, in the collection, analysis, and interpretation of the data and the writing of the manuscript., (Copyright © 2023. Published by Elsevier B.V.)

Background: Children from low income families are likely to have poorer mental health than their more affluent peers. However, it is unclear how this association varies at different developmental stages and what the potential underpinning mechanisms are. This study investigates the relationship between family income and mental health problems from early childhood to adolescence in the UK, and examines the potential mediating role of family-related factors over time., Methods: Data were drawn from the UK Millennium Cohort Study at ages 3, 5, 7, 11, 14 and 17 years. Child mental health was measured by the Strengths and Difficulties Questionnaire Total Difficulties Score, and the Internalising and Externalising subscales. Family income was operationalised as permanent income. Cross-sectional analyses were conducted at each age to examine the association between income and mental health problems, and to examine potential mechanisms based on the Parental Stress and Parental Investment theories., Results: The samples included 8096 children aged up to 14 years, of which 5667 remained in the study at age 17. Results indicated a statistically significant association between lower family income and poorer mental health in all age groups after adjusting for confounding factors. The strength of the association was reduced after adjustment for Parental Stress and Parental Investment factors, with the larger attenuation driven by Parental Stress factors in most cases. Fully adjusted models suggested an increased independent association between maternal psychological distress and children's mental health as children grew older., Conclusions: While lower family income is associated with a child's poorer mental health, much of this association is explained by other factors such as maternal psychological distress, and therefore the direct association is relatively small. This suggests that policies targeting income redistribution may reduce child mental health problems, and also benefit the wider family, reducing the prevalence of other associated risk factors., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors.)

This systematic review critically appraised and synthesized evidence from economic evaluations of interventions targeting childhood excess weight. We conducted systematic searches in 11 databases from inception to April 19, 2023. Studies were eligible if they evaluated interventions targeting children up to 18 years and the study intervention(s) targeted childhood excess weight or sought to improve diet or physical activity, regardless of the type of economic evaluation or the underpinning study design. We synthesized evidence using narrative synthesis methods. One-hundred fifty-one studies met the eligibility criteria and were classified into three groups based on the intervention approach: prevention-only (13 studies), prevention and treatment (100 studies), and treatment-only (38 studies). The predominant setting and study design differed considerably between the three groups of studies. However, compared with usual care, most interventions were deemed cost-effective. The study participants' ages, sex, and socioeconomic status were crucial to intervention cost-effectiveness. Interventions whose effects were projected beyond childhood, such as bariatric surgery, lower protein infant formula, and home-based general practitioner consultations, tended to be cost-effective. However, cost-effectiveness was sensitive to the assumptions underlying the persistence and intensity of such effects. Our findings can inform future recommendations on the conduct of economic evaluations of interventions targeting childhood overweight and obesity, as well as practice and policy recommendations., (© 2023 The Authors. Obesity Reviews published by John Wiley & Sons Ltd on behalf of World Obesity Federation.)

Background: Depression is common and the prevalence increasing worldwide; at least 1 in 10 people will experience depression in their lifetime. It is associated with economic costs at the individual, healthcare and societal level. Recommended treatments include medication and psychological therapies. However, given the long waiting times, and sometimes poor concordance and engagement with these treatments, a greater range of approaches are needed. Evidence for the potential of outdoor swimming as an intervention to support recovery from depression is emerging, but randomised controlled trials (RCTs) evaluating clinical and cost-effectiveness are lacking. This study seeks to investigate the feasibility of conducting a definitive superiority RCT, comparing an 8-session outdoor swimming course offered in addition to usual care compared to usual care only, in adults who are experiencing mild to moderate symptoms of depression. Feasibility questions will examine recruitment and retention rates, acceptability of randomisation and measures, and identify the primary outcome measure that will inform the sample size calculation for a definitive full-scale RCT. This study will also explore potential facilitators and barriers of participation through evaluation questionnaires, focus-group discussions and interviews., Methods/design: To address these aims and objectives, a feasibility superiority RCT with 1:1 allocation will be undertaken. We will recruit 88 participants with mild to moderate symptoms of depression through social prescribing organisations and social media in three sites in England. Participants will be randomised to either (1) intervention (8-session outdoor swimming course) plus usual care or (2) usual care only. Both groups will be followed up for a further 8 weeks., Discussion: If findings from this feasibility RCT are favourable, a fully powered RCT will be conducted to investigate the clinical- and cost-effectiveness of the intervention. Findings from the definitive trial will provide evidence about outdoor swimming for depression for policymakers and has the potential to lead to greater choice of interventions for adults experiencing symptoms of depression., Trial Registration: Current controlled trial registration number is ISRCTN 90851983 registered on 19 May 2022., (© 2023. The Author(s).)

Background: Over a quarter of people have an anxiety disorder at some point in their life, with many first experiencing difficulties during childhood or adolescence. Despite this, gaps still exist in the current evidence base of the multiple consequences of childhood anxiety problems and their costs., Methods: A systematic review of Medline, PsycINFO, EconLit and the National Health Service Economic Evaluation Database was conducted for longitudinal and economic studies reporting on the association between childhood anxiety problems and at least one individual-, family- or societal-level outcome or cost. All studies were synthesised narratively. For longitudinal studies, 'effect direction' was used as a common metric, with random effects meta-analysis undertaken where possible., Results: Eighty-three studies met inclusion criteria and were synthesised narratively. We identified 788 separate analyses from the longitudinal studies, which we grouped into 15 overarching outcome domains. Thirteen of the studies were incorporated into 13 meta-analyses, which indicated that childhood anxiety disorders were associated with future anxiety, mood, behaviour and substance disorders. Narrative synthesis also suggested associations between anxiety problems and worse physical health, behaviour, self-harm, eating, relationship, educational, health care, employment, and financial outcomes. 'Effect direction' was conflicting in some domains due to a sparse evidence base. Higher economic costs were identified for the child, their families, healthcare providers and wider society, although evidence was limited and only covered short follow-up periods, up to a maximum of 2 years. Total annual societal costs per anxious child were up to £4040 (2021 GBP)., Conclusions: Childhood anxiety problems are associated with impaired outcomes in numerous domains, and considerable economic costs, which highlight the need for cost-effective interventions and policies to tackle them. More economic evidence is needed to inform models of the long-term, economic-related, consequences of childhood anxiety problems., Competing Interests: TF's team receives funding from Place2Be, a third sector organisation providing mental health support for schools that supports team members. The remaining authors have declared that they have no competing or potential conflicts of interest., (© 2023 The Authors. JCPP Advances published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.)

Background: Most research on the Coronavirus Disease 2019 (COVID-19) health burden has focused on confirmed cases and deaths, rather than consequences for the general population's health-related quality of life (HRQoL). It is also important to consider HRQoL to better understand the potential multifaceted implications of the COVID-19 pandemic in various international contexts. This study aimed to assess the association between the COVID-19 pandemic and changes in HRQoL in 13 diverse countries., Methods and Findings: Adults (18+ years) were surveyed online (24 November to 17 December 2020) in 13 countries spanning 6 continents. Our cross-sectional study used descriptive and regression-based analyses (age adjusted and stratified by gender) to assess the association between the pandemic and changes in the general population's HRQoL, measured by the EQ-5D-5L instrument and its domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), and how overall health deterioration was associated with individual-level (socioeconomic, clinical, and experiences of COVID-19) and national-level (pandemic severity, government responsiveness, and effectiveness) factors. We also produced country-level quality-adjusted life years (QALYs) associated to COVID-19 pandemic-related morbidity. We found that overall health deteriorated, on average across countries, for more than one-third of the 15,480 participants, mostly in the anxiety/depression health domain, especially for younger people (<35 years old) and females/other gender. This translated overall into a 0.066 mean "loss" (95% CI: -0.075, -0.057; p-value < 0.001) in the EQ-5D-5L index, representing a reduction of 8% in overall HRQoL. QALYs lost associated with morbidity were 5 to 11 times greater than QALYs lost based on COVID-19 premature mortality. A limitation of the study is that participants were asked to complete the prepandemic health questionnaire retrospectively, meaning responses may be subject to recall bias., Conclusions: In this study, we observed that the COVID-19 pandemic was associated with a reduction in perceived HRQoL globally, especially with respect to the anxiety/depression health domain and among younger people. The COVID-19 health burden would therefore be substantially underestimated if based only on mortality. HRQoL measures are important to fully capture morbidity from the pandemic in the general population., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: AL is a Board member of the EuroQol Group which is responsible for licensing the EQ-5D. The EQ-5D was used in the present study. The other authors have declared that no competing interests exist., (Copyright: © 2023 Violato et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Competing Interests: MH leads the RADAR-CNS consortium, a private–public pre-competitive collaboration on mobile health, through which his university receives in-kind and cash contributions from Janssen, Biogen, UCB, Merck, and Lundbeck. All other authors declare no competing interests.

Background: The Minimising Young Children's Anxiety through Schools (MY-CATS) trial is being conducted to determine whether an online evidence-based parent-guided cognitive behavioural therapy intervention in addition to usual school practice is effective and cost-effective compared with usual school practice in reducing anxiety disorders in children aged 4-7 deemed 'at risk' of anxiety disorders. This update article describes the detailed statistical analysis plan for the MY-CATS trial and reports a review of the underpinning sample size assumptions., Methods and Design: The MY-CATS study is a two-arm, definitive superiority pragmatic parallel group cluster randomised controlled trial in which schools will be randomised 1:1 to receive either the intervention (in addition to usual school practice) or the usual school practice only. This update to the (published) protocol provides a detailed description of the study methods, the statistical principles, the trial population and the planned statistical analyses, including additional analyses comprising instrumental variable regression and mediation analysis., Trial Registration: ISRCTN82398107 . Prospectively registered on 14 January 2021., (© 2022. The Author(s).)

Background: In the context of COVID-19, NHS Child and Adolescent Mental Health Services (CAMHS) and other children's mental health services have faced major challenges in providing psychological treatments that (i) work when delivered remotely and (ii) can be delivered efficiently to manage increases in referrals as social distancing measures have been relaxed. Anxiety problems are a common reason for referral to CAMHS, children with pre-existing anxiety problems are particularly vulnerable in the context of COVID-19, and there were concerns about increases in childhood anxiety as schools reopened. The proposed research will evaluate the clinical and cost-effectiveness of a brief online parent-led cognitive behavioural treatment (CBT) delivered by the OSI (Online Support and Intervention for child anxiety) platform with remote support from a CAMHS therapist compared to 'COVID-19 treatment as usual' (C-TAU) in CAMHS and other children's mental health services throughout the COVID-19 pandemic., Methods: We will conduct a two-arm, multi-site, randomised controlled non-inferiority trial to evaluate the clinical and cost-effectiveness of OSI with therapist support compared to CAMHS and other child mental health services 'COVID-19 treatment as usual' (C-TAU) during the COVID-19 outbreak and to explore parent and therapists' experiences., Discussion: If non-inferiority is shown, the research will provide (1) a solution for efficient psychological treatment for child anxiety disorders while social distancing (for the COVID-19 context and future pandemics); (2) an efficient means of treatment delivery as 'normal service' resumes to enable CAMHS to cope with the anticipated increase in referrals; and (3) a demonstration of rapid, high-quality evaluation and application of online interventions within NHS CAMHS to drive forward much-needed further digital innovation and evaluation in CAMHS settings. The primary beneficiaries will be children with anxiety disorders and their families, NHS CAMHS teams, and commissioners who will access a potentially effective, cost-effective, and efficient treatment for child anxiety problems., Trial Registration: ISRCTN ISRCTN12890382 . Registered prospectively on 23 October 2020., (© 2022. The Author(s).)

Background: Systematically screening for child anxiety problems, and offering and delivering a brief, evidence-based intervention for children who are identified as likely to benefit would minimise common barriers that families experience in accessing treatment. We have developed a short parent-report child anxiety screening questionnaire, and procedures for administering screening questionnaires, sharing screening outcomes with families, and offering and delivering a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety) through schools. This trial aims to evaluate clinical and health economic outcomes for (1) children (aged 8-9) who screen positive for anxiety problems at baseline (target population) and (2) the wider population of all children in participating classes (total population) in schools randomly allocated to receive identification-to-intervention procedures and usual school practice ('screening and intervention'), compared to assessment and usual school practice only ('usual school practice').  METHODS: The trial design is a parallel-group, superiority cluster randomised controlled trial, with schools (clusters) randomised to 'screening and intervention' or 'usual school practice' arms in a 1:1 ratio stratified according to the level of deprivation within the school. We will recruit schools and participants in two phases (a pilot phase (Phase 1) and Phase 2), with progression criteria assessed prior to progressing to Phase 2. In total, the trial will recruit 80 primary/junior schools in England, and 398 children (199 per arm) who screen positive for anxiety problems at baseline (target population). In schools allocated to 'screening and intervention': (1) parents/carers will complete a brief parent-report child anxiety screening questionnaire (at baseline) and receive feedback on their child's screening outcomes (after randomisation), (2) classes will receive a lesson on managing fears and worries and staff will be provided with information about the intervention and (3) parents/carers of children who screen positive for anxiety problems (target population) will be offered OSI. OSI will also be available for any other parents/carers of children in participating classes (total population) who request it. We will collect child-, parent- and teacher-report measures for the target population and total population at baseline (before randomisation), 4 months, 12 months and 24 months post-randomisation. The primary outcome will be the proportion of children who screen positive for anxiety problems at baseline (target population) who screen negative for anxiety problems 12 months post-randomisation., Discussion: This trial will establish if systematic screening for child anxiety problems, sharing screening outcomes with families and delivering a brief parent-led online intervention through schools is effective and cost-effective., Trial Registration: ISRCTN registry ISRCTN76119074. Prospectively registered on 4.1.2022., (© 2022. The Author(s).)