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Up to 10% of children and young people have a specific phobia that can significantly affect their mental health, development and daily functioning. Cognitive-behavioural therapy-based interventions remain the dominant treatment, but limitations to their provision warrant investigation into low-intensity alternatives. One-session treatment is one such alternative that shares cognitive-behavioural therapy principles but has a shorter treatment period.This research investigated the non-inferiority of one-session treatment to cognitive-behavioural therapy for treating specific phobias in children and young people. The acceptability and cost-effectiveness of one-session treatment were examined.A pragmatic, multicentre, non-inferiority randomised controlled trial, with embedded economic and qualitative evaluations.There were 26 sites, including 12 NHS trusts.Participants were aged 7-16 years and had a specific phobia defined in accordance with established international clinical criteria.Participants were randomised 1 : 1 to receive one-session treatment or usual-care cognitive-behavioural therapy, and were stratified according to age and phobia severity. Outcome assessors remained blind to treatment allocation.The primary outcome measure was the Behavioural Avoidance Task at 6 months' follow-up. Secondary outcomes included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety and Depression Scale, a goal-based outcome measure, Child Health Utility 9D, EuroQol-5 Dimensions Youth version and resource usage. Treatment fidelity was assessed using the Cognitive Behaviour Therapy Scale for Children and Young People and the One-Session Treatment Rating Scale.A total of 274 participants were recruited, with 268 participants randomised to one-session treatment (in/i = 134) or cognitive-behavioural therapy (in/i = 134). A total of 197 participants contributed some data, with 149 participants in the intention-to-treat analysis and 113 in the per-protocol analysis. Mean Behavioural Avoidance Task scores at 6 months were similar across treatment groups when both intention-to-treat and per-protocol analyses were applied [cognitive-behavioural therapy: 7.1 (intention to treat), 7.4 (per protocol); one-session treatment: 7.4 (intention to treat), 7.6 (per protocol); on the standardised scale adjusted mean difference for cognitive-behavioural therapy compared with one-session treatment -0.123, 95% confidence interval -0.449 to 0.202 (intention to treat), mean difference -0.204, 95% confidence interval -0.579 to 0.171 (per protocol)]. These findings were wholly below the standardised non-inferiority limit of 0.4, which suggests that one-session treatment is non-inferior to cognitive-behavioural therapy. No between-group differences in secondary outcome measures were found. The health economics evaluation suggested that, compared with cognitive-behavioural therapy, one-session treatment marginally decreased the mean service use costs and maintained similar mean quality-adjusted life-year improvement. Nested qualitative evaluation found one-session treatment to be considered acceptable by those who received it, their parents/guardians and clinicians. No adverse events occurred as a result of phobia treatment.The COVID-19 pandemic meant that 48 children and young people could not complete the primary outcome measure. Service waiting times resulted in some participants not starting therapy before follow-up.One-session treatment for specific phobia in UK-based child mental health treatment centres is as clinically effective as multisession cognitive-behavioural therapy and highly likely to be cost-saving. Future work could involve improving the implementation of one-session treatment through training and commissioning of improved care pathways.This trial is registered as ISRCTN19883421.This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full iniHealth Technology Assessment/i; Vol. 26, No. 42. See the NIHR Journals Library website for further project information.A phobia is an intense, ongoing fear of an everyday object or situation. The phobia causes distress and the person with the phobia avoids that object or situation. Many children and young people have phobias that affect their daily lives. Cognitive–behavioural therapy helps by changing what people do or think when they have a phobia and is the most common treatment approach. However, cognitive–behavioural therapy is expensive, takes time and is not always easy to get. Different treatments are needed to help children and young people with specific phobias. One such therapy is one-session treatment, which works in similar ways to cognitive–behavioural therapy but takes place over one main 3-hour session. Our study, called ASPECT (Alleviating Specific Phobias Experienced by Children Trial), compared these two treatments to examine whether or not one-session treatment is as effective as cognitive–behavioural therapy. Overall, 274 children and young people aged 7–16 years from 26 sites nationally helped with our research, of whom 268 received either cognitive–behavioural therapy or one-session treatment. The results at 6 months found that one-session treatment and cognitive–behavioural therapy worked as well as each other for treating phobias in children and young people. We also found evidence that one-session treatment is cheaper than cognitive–behavioural therapy. We spoke with children and young people, their parents/guardians and the therapists of the single-session treatment, and we found one-session treatment to be acceptable for their needs. Future research could explore how to make one-session treatment more easily available for children and young people with specific phobias because it can save time and money, and works just as well as cognitive–behavioural therapy.

In 2015, The Alleviating Specific Phobias Experienced by Children Trial (ASPECT) was commissioned by the National Institute for Health and Care Research (NIHR) to compare the clinical and cost-effectiveness of multi-session Cognitive Behavioral Therapy (CBT) for specific phobias in children and young people (CYP) (aged 7–16), with a briefer variant called One Session Treatment (OST). From 2016 to 2020, ASPECT recruited n = 274 CYP with specific phobias and their families from across England, including 26 Child and Adolescent Mental Health Services (CAMHS) centres, three voluntary sector centers and one University-based wellbeing service. Whilst the trial successfully reached its recruitment target, the challenges experienced in its delivery highlight the difficulties of embedding child and adolescent research into clinical settings and routine practice. Using ASPECT as a case in point, this paper explores these challenges and provides important insights and considerations of potential benefit to others conducting research within the field of child and adolescent mental health.

Between 2015 and 2020 the Alleviating Specific Phobias Experienced by Children Trial (ASPECT) was conducted in the UK to examine the non-inferiority of One-Session Treatment in comparison to Cognitive Behavioural Therapy based interventions for children and young people with specific phobias. A nested qualitative evaluation was conducted as part of this trial to examine the acceptability of One-Session Treatment. Qualitative interviews were conducted with children and young people taking part in the trial, their parents/guardians, and clinicians delivering the intervention, about their experiences and the acceptability of One Session Treatment. Interviews were digitally recorded and transcribed verbatim. Analysis followed a qualitative framework approach, a widely used method of analysing primary qualitative data pertaining to healthcare practices with policy relevance. Stakeholder groups found One Session Treatment to be an acceptable intervention and barriers and facilitators for its implementation into services were also identified. Potential barriers included challenges to patient flow and treatment scepticism, whilst facilitators included adopting a child-centred approach, child readiness and suitability, opportunity for increased momentum, parental support and involvement, and proximal and distal gains. For One Session Treatment’s successful implementation into services, consideration of these barriers is needed and suitability guidance for its use in this population should be developed. Further research exploring children and young people’s experiences of receiving Cognitive Behavioural Therapy and its acceptability in comparison to One Session Treatment would be welcomed.

Background In the UK, around 93,000 (0.8%) children and young people (CYP) are experiencing specific phobias that have a substantial impact on daily life. The current gold-standard treatment—multi-session cognitive behavioural therapy (CBT) – is effective at reducing specific phobia severity; however, CBT is time consuming, requires specialist CBT therapists, and is often at great cost and limited availability. A briefer variant of CBT called one session treatment (OST) has been found to offer similar clinical effectiveness for specific phobia as multi-session CBT. The aim of this study was to assess the cost-effectiveness of OST compared to multi-session CBT for CYP with specific phobias through the Alleviating Specific Phobias Experienced by Children Trial (ASPECT), a two-arm, pragmatic, multi-centre, non-inferiority randomised controlled trial. Methods CYP aged seven to 16 years with specific phobias were recruited nationally via Health and Social Care pathways, remotely randomised to the intervention group (OST) or the control group (CBT-based therapies) and analysed (n = 267). Resource use based on NHS and personal social services perspective and quality adjusted life years (QALYs) measured by EQ-5D-Y were collected at baseline and at six-month follow-up. Incremental cost-effectiveness ratio (ICER) was calculated, and non-parametric bootstrapping was conducted to capture the uncertainty around the ICER estimates. The results were presented on a cost-effectiveness acceptability curve (CEAC). A set of sensitivity analyses (including taking a societal perspective) were conducted to assess the robustness of the primary findings. Results After adjustment and bootstrapping, on average CYP in the OST group incurred less costs (incremental cost was -£302.96 (95% CI -£598.86 to -£28.61)) and maintained similar improvement in QALYs (QALYs gained 0.002 (95% CI − 0.004 to 0.008)). The CEAC shows that the probability of OST being cost-effective was over 95% across all the WTP thresholds. Results of a set of sensitivity analyses were consistent with the primary outcomes. Conclusion Compared to CBT, OST produced a reduction in costs and maintained similar improvement in QALYs. Results from both primary and sensitivity analyses suggested that OST was highly likely to be cost saving. Trial registration ISRCTN19883421 (30/11/2016).

Background Depression is one of the leading causes of illness and disability in young people, with approximately 20% having experienced a depressive episode by the age of 18 years. Behavioral activation (BA), a National Institute for Health and Care Excellence–recommended treatment for adults with depression, has shown preliminary support for its use with young people. BA may have the potential to be adapted and delivered in a computerized format to address the barriers often associated with young people accessing support. Despite the benefits of adopting computerized therapy delivery, the limited effectiveness of some programs has been attributed to a failure to tailor interventions to patients and practices. Therefore, while developing new treatments, it is important that target users be involved in the intervention design. Objective This qualitative study aims to explore the views and preferences of young people and health care professionals regarding the development of a new computerized BA therapy for young people with low mood or depression, to ensure that the therapy was suitable for the target user. Methods Semistructured focus groups and individual interviews were conducted with young people (those with experience in accessing support and those without) and health care professionals regarding the development of a new computerized BA therapy for young people with low mood or depression. The data were analyzed using thematic analysis. Results A total of 27 individuals, comprising both health care professionals and young people, participated in this study. Vital information pertaining to the important components of a new therapy, including its presentation, delivery, and content, was collected. Conclusions Variations in perspectives highlighted the need to adopt a systemic approach in therapy development by considering the opinions of young people with and without experience in accessing mental health support and health care professionals.

BACKGROUND Depression is one of the leading causes of illness and disability in young people, with approximately 20% having experienced a depressive episode by the age of 18 years. Behavioral activation (BA), a National Institute for Health and Care Excellence–recommended treatment for adults with depression, has shown preliminary support for its use with young people. BA may have the potential to be adapted and delivered in a computerized format to address the barriers often associated with young people accessing support. Despite the benefits of adopting computerized therapy delivery, the limited effectiveness of some programs has been attributed to a failure to tailor interventions to patients and practices. Therefore, while developing new treatments, it is important that target users be involved in the intervention design. OBJECTIVE This qualitative study aims to explore the views and preferences of young people and health care professionals regarding the development of a new computerized BA therapy for young people with low mood or depression, to ensure that the therapy was suitable for the target user. METHODS Semistructured focus groups and individual interviews were conducted with young people (those with experience in accessing support and those without) and health care professionals regarding the development of a new computerized BA therapy for young people with low mood or depression. The data were analyzed using thematic analysis. RESULTS A total of 27 individuals, comprising both health care professionals and young people, participated in this study. Vital information pertaining to the important components of a new therapy, including its presentation, delivery, and content, was collected. CONCLUSIONS Variations in perspectives highlighted the need to adopt a systemic approach in therapy development by considering the opinions of young people with and without experience in accessing mental health support and health care professionals.

Background Computerised cognitive–behavioural therapy (CCBT) in the care pathway has the potential to improve access to psychological therapies and reduce waiting lists within Child and Adolescent Mental Health Services, however, more randomised controlled trials (RCTs) are needed to assess this. Aims This single-centre RCT pilot study compared a CCBT program (Stressbusters) with an attention control (self-help websites) for adolescent depression at referral to evaluate the clinical and cost-effectiveness of CCBT (trial registration: ISRCTN31219579). Method The trial ran within community and clinical settings. Adolescents (aged 12–18) presenting to their primary mental health worker service for low mood/depression support were assessed for eligibility at their initial appointment, 139 met inclusion criteria (a 33-item Mood and Feelings Questionnaire score of ≥20) and were randomised to Stressbusters (n = 70) or self-help websites (n = 69) using remote computerised single allocation. Participants completed mood, quality of life (QoL) and resource-use measures at intervention completion, and 4 and 12 months post-intervention. Changes in self-reported measures and completion rates were assessed by group. Results There was no significant difference between CCBT and the website group at 12 months. Both showed improvements on all measures. QoL measures in the intervention group showed earlier improvement compared with the website group. Costs were lower in the intervention group but the difference was not statistically significant. The cost-effectiveness analysis found just over a 65% chance of Stressbusters being cost-effective compared with websites. The 4-month follow-up results from the initial feasibility study are reported separately. Conclusions CCBT and self-help websites may both have a place in the care pathway for adolescents with depression.

Purpose The purpose of this paper is to focus upon the challenges faced by a research team when conducting a computerised cognitive behaviour therapy (CCBT) trial for adolescents with low mood/depression and how solutions were sought to eliminate these difficulties in future child and adolescent mental health clinical research. Design/methodology/approach The authors have presented a number of problems faced by the research team when conducting a randomised controlled trial (RCT) concerning adolescents with low mood/depression. Findings From examining the problems faced by the research team, the authors have provided key pieces of advice for prospective adolescent mental health RCTs. This advice includes developing clear project plans, setting strategies to encourage and maintain study information in the community and support recruitment, and keeping your organisation appraised of study needs and network and involve governance departments, IT and finance departments in these discussions early. Originality/value RCTs, particularly those focusing on child and adolescent mental health, can face a number of difficulties throughout its stages of completion (from protocol development to follow-up analysis). Studies involving the use of technologies add a layer of complexity to this. This review will be of value to researchers aiming to run a high-quality RCT concerning child and adolescent mental health.

IntroductionSpecific phobias (intense, enduring fears of an object or situation that lead to avoidance and severe distress) are highly prevalent among children and young people. Cognitive–behavioural therapy (CBT) is a well-established, effective intervention, but it can be time consuming and costly because it is routinely delivered over multiple sessions during several months. Alternative methods of treating severe and debilitating phobias in children are needed, like one-session treatment (OST), to reduce time and cost, and to prevent therapeutic drift and help children recover quickly. Our study explores whether (1) outcomes with OST are ‘no worse’ than outcomes with multisession CBT, (2) OST is acceptable to children, their parents and the practitioners who use it and (3) OST offers good value for money to the National Health Service (NHS) and to society.MethodA pragmatic, non-inferiority, randomised controlled trial will compare OST with multisession CBT-based therapy on their clinical and cost-effectiveness. The primary clinical outcome is a standardised behavioural task of approaching the feared stimulus at 6 months postrandomisation. The outcomes for the within-trial cost-effectiveness analysis are quality-adjusted life years based on EQ-5D-Y, and individual-level costs based of the intervention and use of health and social service care. A nested qualitative evaluation will explore children’s, parents’ and practitioners’ perceptions and experiences of OST. A total of 286 children, 7–16 years old, with DSM-IV diagnoses of specific phobia will be recruited via gatekeepers in the NHS, schools and voluntary youth services, and via public adverts.Ethics and disseminationThe trial received ethical approval from North East and York Research Ethics Committee (Reference: 17/NE/0012). Dissemination plans include publications in peer-reviewed journals, presentations in relevant research conferences, local research symposia and seminars for children and their families, and for professionals and service managers.Trial registration numberISRCTN19883421;Pre-results.

Objectives Computer-administered cognitive–behavioural therapy (CCBT) may be a promising treatment for adolescents with depression, particularly due to its increased availability and accessibility. The feasibility of delivering a randomised controlled trial (RCT) comparing a CCBT program (Stressbusters) with an attention control (self-help websites) for adolescent depression was evaluated. Design Single centre RCT feasibility study. Setting The trial was run within community and clinical settings in York, UK. Participants Adolescents (aged 12–18) with low mood/depression were assessed for eligibility, 91 of whom met the inclusion criteria and were consented and randomised to Stressbusters (n=45) or websites (n=46) using remote computerised single allocation. Those with comorbid physical illness were included but those with psychosis, active suicidality or postnatal depression were not. Interventions An eight-session CCBT program (Stressbusters) designed for use with adolescents with low mood/depression was compared with an attention control (accessing low mood self-help websites). Primary and secondary outcome measures Participants completed mood and quality of life measures and a service Use Questionnaire throughout completion of the trial and 4 months post intervention. Measures included the Beck Depression Inventory (BDI) (primary outcome measure), Mood and Feelings Questionnaire (MFQ), Spence Children9s Anxiety Scale (SCAS), the EuroQol five dimensions questionnaire (youth) (EQ-5D-Y) and Health Utility Index Mark 2 (HUI-2). Changes in self-reported measures and completion rates were assessed by treatment group. Results From baseline to 4 months post intervention, BDI scores and MFQ scores decreased for the Stressbusters group but increased in the website group. Quality of life, as measured by the EQ-5D-Y, increased for both groups while costs at 4 months were similar to baseline. Good feasibility outcomes were found, suggesting the trial process to be feasible and acceptable for adolescents with depression. Conclusions With modifications, a fully powered RCT is achievable to investigate a promising treatment for adolescent depression in a climate where child mental health service resources are limited. Trial registration number ISRCTN31219579.

IntroductionThe 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT).Methods and analysisAdolescents aged 12–18 with low mood/depression, (scoring ≥20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate ‘numbers needed’ to plan a fully powered RCT of clinical and cost-effectiveness.Ethics and disseminationThe current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137).Trial registration numberISRCTN31219579.

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