Clinical effectiveness and cost-effectiveness of a brief accessible cognitive behavioural therapy programme for stress in school-aged adolescents (BESST): a cluster randomised controlled trial in the UK.

BACKGROUND: Depression and anxiety are increasingly prevalent in adolescents. The Brief Educational Workshops in Secondary Schools Trial investigated the effectiveness of a brief accessible stress workshop programme for 16-18-year-olds. We aimed to investigate the clinical effectiveness and cost-effectiveness of the DISCOVER cognitive behavioural therapy (CBT) workshop on symptoms of depression in 16-18-year-olds at 6 months compared with treatment-as-usual. METHODS: We conducted a multicentre, cluster randomised controlled trial in UK schools or colleges with sixth forms to evaluate clinical effectiveness and cost-effectiveness of a brief CBT workshop (DISCOVER) compared with treatment-as-usual. We planned to enrol 60 schools and 900 adolescents, using a self-referral system to recruit participants. Schools were randomised in a 1:1 ratio for participants to receive either the DISCOVER workshop or treatment-as-usual, stratified by site and balanced on school size and index of multiple deprivation. Participants were included if they were 16-18 years old, attending for the full school year, seeking help for stress, and fluent in English and able to provide written informed consent. The outcome assessors, senior health economist, senior statistician, and chief investigator were masked. People with lived experience were involved in the study. The primary outcome was depression symptoms measured with the Mood and Feelings Questionnaire (MFQ) at 6-month follow-up, in the intention-to-treat population of all participants with full covariate data. The trial was registered with the ISRCTN registry (ISRCTN90912799). FINDINGS: 111 schools were invited to participate in the study, seven were deemed ineligible, and 47 did not provide consent. Between Oct 4, 2021, and Nov 10, 2022, 933 students at 57 schools were screened for eligibility, seven were not eligible for inclusion, and 26 did not attend the baseline meeting and assessment, resulting in 900 adolescents participating in the study. The DISCOVER group included 443 participants (295 [67%] female and 136 [31%] male) and the treatment-as-usual group included 457 participants (346 [76%] female and 92 [20%] male). 468 (52%) of the 900 participants were White, and the overall age of the participants was 17·2 years (SD 0·6). 873 (97%) adolescents were followed up in the intention-to-treat population. The primary intention-to-treat analysis (n=854) found an adjusted mean difference in MFQ of -2·06 (95% CI -3·35 to -0·76; Cohen's d=-0·17; p=0·0019) at the 6-month follow-up, indicating a clinical improvement in the DISCOVER group. The probability that DISCOVER is cost- effective compared with treatment-as-usual ranged from 61% to 78% at a £20 000 to £30 000 per quality-adjusted life-year threshold. Nine adverse events (two of which were classified as serious) were reported in the DISCOVER group and 14 (two of which were classified as serious) were reported in the treatment-as-usual group. INTERPRETATION: Our findings indicate that the DISCOVER intervention is modestly clinically effective and economically viable and could be a promising early intervention in schools. Given the importance of addressing mental health needs early in this adolescent population, additional research is warranted to explore this intervention. FUNDING: National Institute for Health and Care Research Health Technology Assessment Programme.

Brief Educational Workshops in Secondary Schools Trial (BESST trial), a school-based cluster randomised controlled trial of the DISCOVER workshop for 16-18-year-olds: recruitment and baseline characteristics.

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.

Is a smartphone application (BlueIce) acceptable and safe for university students who self-harm: an open study.

BACKGROUND: Many university students self-harm but few receive support. Smartphone apps have been identified as acceptable sources of support for students who self-harm, but the use of supportive self-harm apps is yet to be explored in this population. OBJECTIVE: This study sought to explore the acceptability and safety of a specific app (BlueIce) for university students who self-harm. METHODS: This was an exploratory, mixed methods study with 15 university students attending university well-being services with self-harming thoughts and/or behaviours. BlueIce was offered alongside the face-to-face support provided by the well-being service. Self-harming thoughts and behaviours, coping self-efficacy, and symptoms of anxiety and depression were measured before and after using BlueIce for 6 weeks. Follow-up interviews were also undertaken to explore how students perceived BlueIce in more depth. RESULTS: Following app use, there were statistically significant reductions in symptoms of anxiety (baseline M 12.47, SD 4.42; follow-up M 10, SD 4.16) t(14)=2.26, p=0.040, d=0.58 and depression (baseline M 16.5, SD 5.17, follow-up M 12.27, SD 3.66) t(13)=5.50, p<0.001, d=1.47. Qualitative findings showed participants found BlueIce to be acceptable, safe and helpful, and reported that they were more able to cope with difficult feelings and better understand their self-harm triggers following use of the app. CONCLUSION: BlueIce was an acceptable, safe and helpful source of support for university students struggling with self-harm thoughts and/or behaviours. This builds on previous findings with adolescents and suggests that BlueIce could be a particularly acceptable and helpful resource for university students.

Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i).

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.

Four Steps To My Future (4STMF): acceptability, feasibility and exploratory outcomes of a universal school-based mental health and well-being programme, delivered to young adolescents in South Africa.

OBJECTIVE: Mental health disorders affect many children in South Africa, where vulnerability is high, and treatment is limited. We sought to determine the feasibility and acceptability of a universally delivered classroom-based programme for the promotion of mental health in young adolescents. METHOD: We pilot tested an 8 session, cognitive-behavioural therapy-based programme, 4 Steps To My Future (4STMF) in two schools. Participants were grade 5 learners (n = 222; Meanage = 10.62 (Standard deviation = 0.69)). 4STMF was delivered in class time by trained psychology postgraduates. Feasibility (rates of parental opt-out, child assent, assessment completion at baseline and follow-up, programme completion, session attendance and programme fidelity), acceptability (teacher feedback and focus groups with learners), as well as demographic data and data on a battery of a psychological measures were collected at baseline, postintervention and at one-month follow-up. RESULTS: Most eligible learners at both schools agreed to participate (85% - school 1; 91% - school 2) with more than 80% completing postintervention measures. Learner session attendance and programme fidelity were high. Teachers rated facilitators highly on confidence, preparedness, enthusiasm and classroom management and observed children to be enjoying the programme. Focus group data suggest that learners liked the programme, could recall the content and had shared some of the content with their family. An exploratory analysis of outcomes showed significant pre-post differences on self-esteem at school 1 and on emotion regulation at school 1 and school 2, maintained at follow-up. CONCLUSIONS: This pilot study has shown that 4STMF can acceptably and feasibly be delivered, at classroom level, as a universal school-based prevention programme to young adolescent learners in South African primary schools. The programme could fit in with school context, could be delivered by nonspecialists, showed significant improvements on self-esteem and emotion regulation and was liked by the learners.

Characteristics of complex posttraumatic stress disorder (PTSD) in young people with PTSD following multiple trauma exposure.

BACKGROUND: Complex PTSD (CPTSD) is a relatively new diagnosis. The objective of the present study was to investigate how trauma characteristics, comorbid psychopathology and cognitive and social factors experienced by children and adolescents with a posttraumatic stress disorder (PTSD) diagnosis following exposure to multiple traumatic events differs between those who meet the criteria for CPTSD and those who do not. METHOD: The present research used baseline data from the DECRYPT trial (BMJ Open, 2021, 11, e047600). Participants (n = 120) were aged 8-17 years and had exposure to multiple traumas and a PTSD diagnosis. The data collected comprised self-report and parent/caregiver-report questionnaires and interviews. Three primary analyses were conducted, comparing number of trauma types, prevalence of sexual trauma and prevalence of intrafamilial abuse between the CPTSD and PTSD-only groups. A range of comorbid psychopathology and cognitive and social factors were compared between the groups in an exploratory secondary analysis. All analyses were preregistered. RESULTS: The CPTSD group (n = 72, 60%) had a significantly higher frequency of sexual trauma than the PTSD-only group (n = 48, 40%). The groups did not significantly differ on number of trauma types or prevalence of intrafamilial abuse. From the secondary analysis, the CPTSD group were found to have significantly higher scores on measures of negative post-traumatic cognitions, depression and panic. These results were replicated in correlation analyses using a continuous measure of CPTSD symptoms. CONCLUSIONS: A large proportion of youth exposed to multiple traumatic events met criteria for CPTSD. Sexual trauma appears to be related to CPTSD symptoms. Youth with CPTSD appear to have greater severity of comorbid depression and panic symptoms, as well as more negative post-traumatic cognitions. Further investigation could focus on the directionality and mechanisms for these associations.

The multifaceted consequences and economic costs of child anxiety problems: A systematic review and meta-analysis.

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.

Digital technologies to support adolescents with depression and anxiety: review.

Depression and anxiety are common in adolescents, but most affected will not get any formal help. Digital mental health technologies (i.e. resources and interventions to support and improve mental health) are a potential way to extend the reach and increase adolescents' access to therapies, at a relatively low cost. Many young people can access the internet and mobile technologies, including in low- and middle-income countries. There has been increased interest in integrating technologies in a range of settings, especially because of the effect of the COVID-19 pandemic on adolescent mental health, at a time when services are under pressure. This clinical review gives an overview of digital technologies to support the prevention and management of depression and anxiety in adolescence. The technologies are presented in relation to their technological approaches, underlying psychological or other theories, setting, development, evaluations to date and how they might be accessed. There is also a discussion of the potential benefits, challenges and future developments in this field.

Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: study protocol.

INTRODUCTION: A digital programme, MoodHwb, was codesigned with young people experiencing or at high risk of depression, parents/carers and professionals, to provide support for young people with their mood and well-being. A preliminary evaluation study provided support for the programme theory and found that MoodHwb was acceptable to use. This study aims to refine the programme based on user feedback, and to assess the acceptability and feasibility of the updated version and study methods. METHODS AND ANALYSIS: Initially, this study will refine MoodHwb with the involvement of young people, including in a pretrial acceptability phase. This will be followed by a multicentre feasibility randomised controlled trial comparing MoodHwb plus usual care with a digital information pack plus usual care. Up to 120 young people aged 13-19 years with symptoms of depression and their parents/carers will be recruited through schools, mental health services, youth services, charities and voluntary self-referral in Wales and Scotland. The primary outcomes are the feasibility and acceptability of the MoodHwb programme (including usage, design and content) and of trial methods (including recruitment and retention rates), assessed 2 months postrandomisation. Secondary outcomes include potential impact on domains including depression knowledge and stigma, help-seeking, well-being and depression and anxiety symptoms measured at 2 months postrandomisation. ETHICS AND DISSEMINATION: The pretrial acceptability phase was approved by the Cardiff University School of Medicine Research Ethics Committee (REC) and the University of Glasgow College of Medicine, Veterinary and Life Sciences REC. The trial was approved by Wales NHS REC 3 (21/WA/0205), the Health Research Authority(HRA), Health and Care Research Wales (HCRW), university health board Research and Development (R&D) departments in Wales, and schools in Wales and Scotland. Findings will be disseminated in peer-reviewed open-access journals, at conferences and meetings, and online to academic, clinical, and educational audiences and the wider public. TRIAL REGISTRATION NUMBER: ISRCTN12437531.

Promoting mental health and well-being in schools: examining mindfulness, relaxation and strategies for safety and well-being in English primary and secondary schools-study protocol for a multi-school, cluster randomised controlled trial (INSPIRE).

There are increasing rates of internalising difficulties, particularly anxiety and depression, being reported in children and young people in England. School-based universal prevention programmes are thought to be one way of helping tackle such difficulties. This paper describes an update to a four-arm cluster randomised controlled trial ( http://www.isrctn.com/ISRCTN16386254 ), investigating the effectiveness of three different interventions when compared to usual provision, in English primary and secondary pupils. Due to the COVID-19 pandemic, the trial was put on hold and subsequently prolonged. Data collection will now run until 2024. The key changes to the trial outlined here include clarification of the inclusion and exclusion criteria, an amended timeline reflecting changes to the recruitment period of the trial due to the COVID-19 pandemic and clarification of the data that will be included in the statistical analysis, since the second wave of the trial was disrupted due to COVID-19.Trial registration ISRCTN Registry ISRCTN16386254. Registered on 30 August 2018.

Systematic Review and Meta-analysis: Group-Based Interventions for Treating Posttraumatic Stress Symptoms in Children and Adolescents.

OBJECTIVE: Trauma exposure in childhood is common and can lead to a range of negative mental health outcomes, including posttraumatic stress disorder (PTSD). In many settings, resources to address this distress are scarce. Group-based interventions require minimal resources and training, can be delivered by non-mental health specialists, and target larger numbers of children and adolescents. This meta-analysis sought to establish whether such an approach is an effective method for targeting PTSD symptoms and to identify potential moderators of effectiveness. METHOD: PubMed, PsycNET, and PTSDPubs were searched for randomized controlled trials that used a group-based PTSD intervention with children and adolescents aged 6 to 18 years. Data were extracted for PTSD symptoms and depression symptoms. A random-effects meta-analysis was conducted to obtain between-group pooled effect size estimates. This study was registered on PROSPERO (CRD42020187214). RESULTS: The initial search identified 9,650 studies, of which 42 were eligible for inclusion (N = 5,998). Children randomized to a group-based intervention had significantly lower PTSD symptoms after treatment compared with a control group, with a medium pooled effect (g = -0.55, 95% CI [-0.76, -0.35]). Group interventions were superior when compared with either active or passive controls, at follow-up, and for depression symptoms. There was a large amount of heterogeneity, but no evidence that this was explained by whether the intervention was delivered in a low- and middle-income or high-income country, included caregivers, or was universal or targeted. CONCLUSION: Group PTSD interventions, particularly cognitive-behavioral therapy-based interventions, are effective at targeting posttrauma distress in children and adolescents. There was evidence of effectiveness when delivered in highly complex and resource-scarce settings and to a range of trauma-exposed groups, including groups exposed to war/conflict, natural disasters, and abuse.

The impact of universal, school based, interventions on help seeking in children and young people: a systematic literature review.

Reviews into universal interventions to improve help seeking in young people focus on specific concepts, such as behaviour, do not differentiate between interpersonal and intrapersonal help seeking, and often report on statistical significance, rather than effect size. The aim of this review was to address the gaps highlighted above, to investigate the impact of universal, school-based interventions on help-seeking in children and young people, as well as to explore longer term impact. Four databases were searched. Data were extracted on country of origin, design, participant, school, and intervention characteristics, the help-seeking concept measured (e.g. knowledge, attitude/intention, behaviour), the duration between baseline and each follow-up (if applicable) and effect sizes at each follow-up. Quality assessment of the studies was undertaken using the Effective Public Health Practice Project (EPHPP) quality assessment tool. Overall, 14 different interventions met inclusion criteria. The majority of the studies were rated low in the quality assessment. Three constructs were most frequently reported a) intrapersonal attitudes towards help-seeking, b) interpersonal attitudes towards help-seeking and c) intrapersonal intended help-seeking. Findings around intervention effect were mixed. There was tentative evidence that interventions impacting interpersonal attitudes produced small effect sizes when measured between 3 and 6 months post intervention and that when effect sizes were initially observed intrapersonal attitudes, this remained at 3-6 month follow-up. Further work should pay attention to implementation factors, understanding the core ingredients needed to deliver effective interventions and whether embedding mental health education could help sustain or top up effect sizes from help-seeking interventions.

Increasing access to evidence-based treatment for child anxiety problems: online parent-led CBT for children identified via schools.

BACKGROUND: Anxiety problems are extremely common and have an early age of onset. We previously found, in a study in England, that fewer than 3% of children with an anxiety disorder identified in the community had accessed an evidence-based treatment (Cognitive Behavioural Therapy; CBT). Key ways to increase access to CBT for primary school-aged children with anxiety problems include (a) proactive identification through screening in schools, (b) supporting parents and (c) the provision of brief, accessible interventions (and capitalising on technology to do this). METHOD: We provided a brief, therapist guided treatment called Online Support and Intervention (OSI) to parents/carers of children identified, through school-based screening, as likely to have anxiety problems. Fifty out of 131 children from 17 Year 4 classes in schools in England screened positive for 'possible anxiety problems' and 42 (84%) of these (and 7 who did not) took up the offer of OSI. We applied quantitative and qualitative approaches to assess children's outcomes and families' experiences of this approach. RESULTS: Inbuilt outcome monitoring indicated session on session improvements throughout the course of treatment, with substantial changes across measures by the final module (e.g. Child Outcome Rating Scale d = 0.84; Goal Based Outcomes d = 1.52). Parent engagement and satisfaction was high as indicated by quantitative and qualitative assessments, and intervention usage. CONCLUSIONS: We provide promising preliminary evidence for the use of OSI as an early intervention for children identified as having anxiety problems through school-based screening.

Cumulative Risk Exposure and Social Isolation as Correlates of Carer and Child Mental Health During the COVID-19 Pandemic: An Online Study with Families from Various Europeans Countries.

This study adopted a cumulative risk approach to examine the relations between various domains of risk factors (i.e., social isolation and home confinement, other pandemic-related risk factors, and pre-existing psychosocial risk factors) and carers' and children's mental health during the first wave of the COVID-19 pandemic in Europe. The sample consisted of 1475 carers of 6- to 16-year-old children and adolescents residing in five European countries (Portugal, United Kingdom, Romania, Spain, and The Netherlands) who completed an online survey. The results showed that each of the three domains of adversity accounted for unique variation in carers' and children's mental health outcomes. Also, the results indicated that pre-existing psychosocial risk factors moderated the relationship between pandemic-related risk factors and children and carers' anxiety and between social isolation and confinement and carers' well-being. Simple slopes analysis suggested a stronger relationship between these domains of adversities and mental health outcomes in already more vulnerable families. It is important to consider the implications of social isolation measures and confinement for families' mental health, paying special attention to families with pre-existing psychosocial vulnerabilities.

The Acceptability of a Smartphone App (BlueIce) for University Students Who Self-harm.

University students are twice as likely to self-harm than community controls but, unfortunately, help-seeking among this population is particularly low. Given the stigma around self-harm, the face-to-face nature of traditional support for self-harm can be a barrier to help-seeking. Smartphone applications (apps) are a possible alternative source of support, and research has shown that students are receptive to this option. This study sought to assess the acceptability of a smartphone app called BlueIce for university students who self-harm. Semi-structured interviews were conducted with 25 students with a history of self-harm. A qualitative content analysis was undertaken and five categories were identified: the content of BlueIce, the use of BlueIce with university students, the function of BlueIce, comparison with other support, and the implementation and uptake of BlueIce. Responses to BlueIce were very positive with students believing BlueIce to be a helpful resource that was perceived as more accessible than alternative support. Participants believed it could provide help in moments of distress as well as helping individuals learn longer-term coping skills. Others felt that BlueIce would not be adequate for some people and would be better used alongside other face-to-face support. Overall, it was clear that BlueIce was acceptable to the students in this study. Future research should seek to evaluate the feasibility and effectiveness of BlueIce within a university setting with students. HIGHLIGHTSStudents who self-harm found the BlueIce app to be an acceptable and appealing source of support for self-harm as well as other mental health difficulties.Participants felt that the app was more accessible than other forms of support, particularly for individuals who prefer not to discuss self-harm with a professional.Some felt that BlueIce could provide immediate support in moments of distress, while others believed it to be a longer-term solution that could help students learn more adaptive coping strategies.

A feasibility study to explore the use of digital treatment of sleep as a first-step intervention to improve adolescent mental health.

INTRODUCTION: Cognitive behavior therapy for insomnia (CBTi), delivered face-to-face or digitally, can improve the mental health of adults. Although insomnia is common in adolescents, the effects of digital CBTi on adolescent mental health have seldom been investigated. OBJECTIVES: The aims of this study were to explore: (i) the acceptability of a digital CBTi intervention, Sleepio, as a first-step intervention for adolescents referred to specialist mental health services (CAMHS), (ii) the impact on sleep and mental health and (iii) subsequent CAMHS interventions. METHOD: Sleepio is a computerized CBTi intervention comprised of six sequentially delivered sessions. Digital Sleepio was offered to new referrals to CAMHS with poor sleep and mental health problems. Results. Of the 75 eligible adolescents, 70 (93%; 95% CI: 85% to 98%) accepted Sleepio with 59 starting the programme and consenting to participate in the study. Of these, 37 (63%; 95% CI: 49% to 75%) completed at least half of the programme. There were post-intervention improvements in sleep, mood, and anxiety; the improvement in sleep was greater for those who completed at least half the programme compared to those who did not. Of those who completed all the programme, 55% (15/29) did not need any subsequent specialist CAMHS input. Of the 11 adolescents who accepted but never started Sleepio, none engaged with other CAMHS interventions and were subsequently discharged. CONCLUSION: Our study has a number of limitations, in particular the absence of a control group and the loss of follow-up data for programme drop-outs. Nonetheless, these results suggest that digital CBTi may offer a novel and acceptable way of improving the sleep and mental health of adolescents with insomnia. A fully powered randomized controlled trial is required to obtain definitive estimates of the effects of the intervention.

Brief Educational Workshops in Secondary Schools Trial (BESST): protocol for a school-based cluster randomised controlled trial of open-access psychological workshop programme for 16-18-year-olds.

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.

Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i): protocol for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice.

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.

Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i): protocol for single-arm feasibility trial.

BACKGROUND: Anxiety disorders are common among primary-school aged children, but few affected children receive evidence-based treatment. Identifying and supporting children who experience anxiety problems through schools would address substantial treatment access barriers that families and school staff often face. We have worked with families and school staff to co-design procedures that incorporate screening, feedback for parents, and the offer of a brief intervention in primary schools. This study sets out to assess the feasibility of a subsequent school-based cluster randomised controlled trial to evaluate these procedures. Our objectives are to ensure our procedures for identifying and supporting children with anxiety difficulties through primary schools are acceptable and there are no negative impacts, to estimate recruitment and retention rates, and to identify any changes needed to study procedures or measures. METHODS: We will recruit six primary/junior schools in England (2 classes per school), and invite all children (aged 8-9) (n = 360) and their parent/carer and class teacher in participating classes to take part. Children, parents and class teachers will complete questionnaires at baseline and 12-week follow-up. Children who 'screen positive' on a 2-item parent-report child anxiety screen at baseline will be the target population (expected n = 43). Parents receive feedback on screening questionnaire responses, and where the child screens positive the family is offered support (OSI: Online Support and Intervention for child anxiety). OSI is a brief, parent-led online intervention, supported by short telephone sessions with a Children's Wellbeing Practitioner. Participants' experiences of study procedures will be assessed through qualitative interviews/discussion groups. DISCUSSION: Evidence-based procedures for identifying and supporting children with anxiety difficulties through primary schools would improve children's access to timely, effective intervention for anxiety difficulties. TRIAL REGISTRATION: ISRCTN registry: ISRCTN30032471 . Retrospectively registered on 18 May 2021.