Comparison of cognitive behaviour therapy versus activity management, both delivered remotely, to treat paediatric chronic fatigue syndrome/myalgic encephalomyelitis: the UK FITNET-NHS RCT.

Design: Parallel-group randomised controlled trial. Methods: Adolescents aged 11-17 years, diagnosed with myalgic encephalomyelitis/chronic fatigue syndrome and with no local specialist treatment centre, were referred to a specialist service in South West England. Interventions: Fatigue In Teenagers on the interNET in the National Health Service is a web-based myalgic encephalomyelitis/chronic fatigue syndrome-focused cognitive-behavioural therapy programme for adolescents, supported by individualised written, asynchronous electronic consultations with a clinical psychologist/cognitive-behavioural therapy practitioner. The comparator was videocall-delivered activity management with a myalgic encephalomyelitis/chronic fatigue syndrome clinician. Both treatments were intended to last 6 months. Objectives: Estimate the effectiveness of Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management for paediatric myalgic encephalomyelitis/chronic fatigue syndrome. Estimate the effectiveness of Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management for those with mild/moderate comorbid mood disorders. From a National Health Service perspective, estimate the cost-effectiveness of Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management over a 12-month horizon. Primary Outcome: 36-item Short Form Health Survey Physical Function subscale at 6 months post randomisation. Randomisation: Web-based, using minimisation with a random component to balance allocated groups by age and gender. Blinding: While the investigators were blinded to group assignment, this was not possible for participants, parents/carers and therapists. Results: The treatment of 314 adolescents was randomly allocated, 155 to Fatigue In Teenagers on the interNET in the National Health Service. Mean age was 14 years old and 63% were female. Primary outcome: At 6 months, participants allocated to Fatigue In Teenagers on the interNET in the National Health Service were more likely to have improved physical function (mean 60.5, standard deviation 29.5, n = 127) compared to Activity Management (mean 50.3, standard deviation 26.5, n = 138). The mean difference was 8.2 (95% confidence interval 2.7 to 13.6, p = 0.003). The result was similar for participants meeting the National Institute for Health and Care Excellence 2021 diagnostic criteria. Secondary outcomes: Fatigue In Teenagers on the interNET in the National Health Service participants attended, on average, half a day more school per week at 6 months than those allocated Activity Management, and this difference was maintained at 12 months. There was no strong evidence that comorbid mood disorder impacted upon the relative effectiveness of the two interventions. Similar improvement was seen in the two groups for pain and the Clinical Global Impression scale, with a mixed picture for fatigue. Both groups continued to improve, and no clear difference in physical function remained at 12 months [difference in means 4.4 (95% confidence interval -1.7 to 10.5)]. One or more of the pre-defined measures of a worsening condition in participants during treatment, combining therapist and patient reports, were met by 39 (25%) participants in the Fatigue In Teenagers on the interNET in the National Health Service group and 42 (26%) participants in the Activity Management group. A small gain was observed for the Fatigue In Teenagers on the interNET in the National Health Service group compared to Activity Management in quality-adjusted life-years (0.002, 95% confidence interval -0.041 to 0.045). From an National Health Service perspective, the costs were £1047.51 greater in the Fatigue In Teenagers on the interNET in the National Health Service group (95% confidence interval £624.61 to £1470.41). At a base cost-effectiveness threshold of £20,000 per quality-adjusted life-year, the incremental cost-effectiveness ratio was £457,721 with incremental net benefit of -£1001 (95% confidence interval -£2041 to £38). Conclusion: At 6 months post randomisation, compared with Activity Management, Fatigue In Teenagers on the interNET in the National Health Service improved physical function and school attendance. The additional cost of Fatigue In Teenagers on the interNET in the National Health Service and limited sustained impact mean it is unlikely to be cost-effective. Trial registration: This trial is registered as ISRCTN18020851. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/192/109) and is published in full in Health Technology Assessment; Vol. 28, No. 70. See the NIHR Funding and Awards website for further award information.

Why did we do the study? The best evidence for the treatment of adolescents with myalgic encephalomyelitis/chronic fatigue syndrome is cognitive­behavioural therapy for fatigue delivered in person. In the United Kingdom, most adolescents with myalgic encephalomyelitis/chronic fatigue syndrome cannot get this specialist treatment where they live. Fatigue In Teenagers on the interNET in the National Health Service is an online treatment using cognitive­behavioural therapy designed for myalgic encephalomyelitis/chronic fatigue syndrome, which has been shown to work in the Netherlands. To find out if Fatigue In Teenagers on the interNET in the National Health Service would be beneficial in the United Kingdom, we compared Fatigue In Teenagers on the interNET in the National Health Service to Activity Management. Activity Management is the treatment most often offered to children and young people with myalgic encephalomyelitis/chronic fatigue syndrome in the United Kingdom, and aims to avoid peaks in activity (sometimes called 'pacing'). What was the question? Does Fatigue In Teenagers on the interNET in the National Health Service lead to greater improvements in children and young people with myalgic encephalomyelitis/chronic fatigue syndrome when compared to Activity Management, when both interventions are delivered remotely? What did we do? We compared Fatigue In Teenagers on the interNET in the National Health Service and Activity Management in two comparable groups of children, and measured physical function at 6 months as the main indication of improvement. We measured how much the treatments cost and we asked children and young people, their parents and treatment providers what they thought about the two interventions. What did we find? At 6 months, adolescents saw greater improvements in physical function, and attended half a day more school per week, with Fatigue In Teenagers on the interNET in the National Health Service compared to Activity Management. Both interventions were associated with improvements over 12 months, with there being no clear difference between them after that time. However, the Fatigue In Teenagers on the interNET in the National Health Service treatment was more expensive. What does this mean? We have shown that cognitive­behavioural therapy for fatigue can be provided online to children as Fatigue In Teenagers on the interNET in the National Health Service, leading to faster improvement in physical function and greater school attendance compared to Activity Management. However, Fatigue In Teenagers on the interNET in the National Health Service is expensive and is unlikely to be good value for money.

Self-harm, suicidal ideation, depression and peer relationships in transgender and gender diverse adolescents accessing specialist mental health services.

BACKGROUND: There are an estimated 25 million transgender and gender diverse (TGD) individuals worldwide, with 1.2%-2.7% of this population being under the age of 18. Community studies describe increased rates of mental health difficulties such as depression, self-harm, suicidal ideation and difficulties with peer relationships for TGD youth over cisgender peers. However, comparatively little is known about the mental health symptomatology of TGD youth attending specialist mental health services (CAMHS) in the UK. METHOD: This cross-sectional study explored data from 170 young people participating in the Beating Adolescent Self-Harm (BASH) trial. Baseline data about self-harm, depression, and impact on daily life was compared for those who identified as TGD (n = 18) with those who identified as cisgender (n = 152). RESULTS: In the transgender group, 18 (100%) scored ≥27 on the MFQ suggesting severe depression and had total scores on the SDQ impact scale of ≥3, in the very high range. In comparison in the cisgender group, 140 (92.1%) scored ≥27 on the MFQ and 103 (67.8%) had total scores on the SDQ impact scale of ≥3. The TGD group reported higher rates of self-harm, poorer peer relationships, less prosocial behaviour and greater interference with friendships and leisure activities and impact in the classroom. Both groups reported similar symptoms of depression. CONCLUSIONS: Whilst this exploratory study has limitations, these results suggest that TGD youth attending CAMHS may experience greater mental health problems than their cisgender peers.

Cost-effectiveness of adding a smartphone app (BlueIce) to the mental health care of adolescents who repeatedly self-harm.

Digital interventions can offer crises support although their cost-effectiveness is unknown. We undertook an economic evaluation alongside a two-arm, single blind, randomised controlled trial. 170 adolescents aged 12-17, receiving child and adolescent mental health care who had self-harmed ≥2 in the past 12 months were randomised to usual care with or without an app (BlueIce). The Risk-Taking and Self-Harm Inventory for Adolescents (RTSHIA), and Child Health Utility 9-Dimensions (CHU-9D) were completed at baseline, 12-weeks, and 6-months. Mental healthcare use was extracted from clinical records. CHU-9D responses were converted to preference-based utility values to estimate quality-adjusted life-years (QALYs). Generalised linear models examined the effect of BlueIce from the NHS and Personal Social Services perspective on costs and QALYs. The cost of BlueIce was £32.26 with the mean cost of mental healthcare over 6 months ranging between £1750 - £2472 per participant. The 6-month difference in mean costs [-£722.09 (95 % CI:1998.84, 334.65)] and the utility score [0.009 (95 %CI:0.033, 0.052)] both favoured BlueIce. Youth derived QALYs showed an incremental net monetary benefit (NMB) at 6-months of £782.09 with an almost 70 % probability of being cost-effective. Given the low intervention cost, the addition of an app could be considered a good investment.

Brief Educational Workshops in Secondary Schools Trial (BESST): a cluster randomised controlled trial. Secondary analysis in those with elevated symptoms of depression.

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

The feasibility and acceptability of delivering a group trauma-focused intervention to children in care.

OBJECTIVE: Young people in care (i.e., in the child welfare system) are a group who have often experienced very high rates of potentially traumatic events, including maltreatment. It is well-documented that they have high rates of trauma-related mental health difficulties, such as posttraumatic stress. To address the needs of the large number of young people who may benefit from support, scalable interventions are crucial. But also important is that they are effective and deliverable - particularly given the complexity of this group and services. We assessed a five-session group CBT-based intervention for PTSD. The primary goal was to understand core procedural and protocol uncertainties to address prior to a definitive trial. METHODS: Participants were 34 10-17 year olds in care, with moderate to severe posttraumatic stress symptoms, and their caregiver. We ran seven groups (four online), delivered in social care and NHS-based mental health teams. Data were collected via pre-, post-, 3-month follow-up questionnaires and qualitative interviews. RESULTS: Of the 34 participants allocated to the intervention, 27 (80%) attended at least three of the five sessions (most attended all). Caregiver attendance was lower (50%). There was generally good completion of assessment measures. Qualitatively, most participants were positive about the intervention, and many reported improvements in areas such as coping, sleep, and willingness to talk about experiences. However, there were important concerns about the lack of ongoing support, given this was a low-intensity intervention for a group who often had complex needs. CONCLUSION: The intervention and research protocols were acceptable to most young people and carers. With modifications, a future definitive trial would likely be possible. However, key considerations include: how (and whether) to screen for PTSD; the trial design; and the option to embed high-intensity support (e.g., via assessing a stepped-care model).

Access to best-evidenced mental health support for care-experienced young people: Learnings from the implementation of cognitive therapy for PTSD.

OBJECTIVES: Rates of PTSD are up to 12 times higher in care-experienced young people (CEYP) compared to their peers. Trauma-focused CBTs (tf-CBT) are the best-evidenced treatment for youth with PTSD, yet, in practice, CEYP often struggle to access this treatment. We worked alongside services to understand barriers and facilitators of the implementation of cognitive therapy for PTSD (a type of tf-CBT) to CEYP. DESIGN: This was an active, open implementation trial. METHODS: We recruited 28 mental health teams across England, including general CAMHS, targeted CAMHS for CEYP and social care-based teams. From these teams, participants were 243 mental health professionals, from a wide variety of professional backgrounds. Following recruitment/intervention training, teams participated in rolling three monthly focus groups and individual interviews, to understand what helped and hindered implementation. Data were analysed using a framework analysis conducted using CFIR 2.0. RESULTS: Almost half of the teams were able to implement, but only approximately one quarter with CEYP, specifically. Universal barriers that were discussed by almost all teams particularly highlighted service structures and poor resourcing as major barriers to delivery to CEYP, as well as the complexities of the young person and their network. Unique factors that differentiated teams who did and did not implement included commissioning practices, the culture of the team, leadership engagement and style, and the development of supervision structures. CONCLUSIONS: Findings offer key considerations for mental health teams, service leads, commissioners and policy-makers to enhance delivery of best-evidenced mental health treatments like CT-PTSD, for CEYP.

Suicidal Thoughts and Behaviors in Parents Caring for Children with Disabilities and Long-Term Illnesses.

OBJECTIVE: There is a growing body of evidence on suicide risk in family carers, but minimal research on parents caring for children with disabilities and long-term illnesses. The aim of this study was to conduct the first dedicated research on suicide risk in parent carers and identify: (1) the number of parent carers experiencing suicidal thoughts and behaviors, and (2) the risk and protective factors for suicidality in this population. METHOD: A cross-sectional survey of parent carers in England (n = 750), co-produced with parent carers. Suicidal thoughts and behaviors were measured with questions from the Adult Psychiatric Morbidity Survey. Frequencies summarized the proportion of carers experiencing suicidal thoughts and behaviors. Logistic regressions identified risk and protective factors. RESULTS: 42% of parents had experienced suicidal thoughts and behaviors while caring for a disabled or chronically ill child. Only half had sought help for these experiences. Depression, entrapment, dysfunctional coping, and having a mental health diagnosis prior to caring, were significant risk factors. CONCLUSION: Parent carers contemplate suicide at levels that exceed those of other family carers and the general public. There is an urgent need, in policy and practice, to recognize parent carers as a priority group for prevention and intervention.

This is the first dedicated study of suicide risk in parent carers.More than 40% of parents had considered suicide while caring for a disabled or chronically ill child.The risk factors for suicidal ideation in parent carers were depression, entrapment, dysfunctional coping strategies, and having a mental health diagnosis prior to becoming a carer.Parent carers may be a high-risk group for suicide and need urgent support.

Clinical effectiveness and safety of adding a self-harm prevention app (BlueIce) to specialist mental health care for adolescents who repeatedly self-harm: A single blind randomised controlled trial (the BASH study).

No randomised controlled trials have evaluated whether the addition of a smartphone app to usual child and adolescent mental health care (CAMHS) can reduce self-harm in adolescents (<18 years) with repeated self-harm. We enrolled 170 participants aged 12-17, receiving CAMHS treatment who had self-harmed ≥2 in the past 12 months. Participants were randomised via an independent web-based system (1:1, minimised for gender, age, self-harm frequency, and depression severity) to treatment as usual (TAU) or treatment as usual plus BlueIce (TAU+BI). BlueIce is a self-harm prevention app that includes techniques from CBT and DBT that was co-designed with adolescents who self-harm. The primary outcome was change from baseline to 12-weeks on the self-harm scale of the Risk Taking and Self-Harm Inventory for Adolescents (RTSHIA), analysed by intention to treat (ITT). Emergency department attendances or admissions for self-harm were assessed over 6-months via a review of clinical records. Both groups improved but there were no statistically significant between group differences at 12 weeks or 6 months on the self-harm scale of the RTSHIA. There were fewer emergency department attendances and admissions in those who received the app, a finding that approached statistical significance. BlueIce can be helpful in some important aspects by contributing to fewer emergency department admissions and attendances. TRIAL REGISTRATION: Trial registration number ISRCTN10541045.

Acceptability, use and safety of the BlueIce self-harm prevention app: qualitative findings from the Beating Adolescent Self-Harm (BASH) randomised controlled trial.

BACKGROUND: Little is known about the social validity of self-harm prevention apps for young adolescents with severe mental health problems who repeatedly self-harm. OBJECTIVE: We assessed the acceptability, use and safety of BlueIce, a self-harm prevention app for young adolescents who self-harm. METHODS: Mixed methods study involving a content analysis of postuse interviews. Participants were a clinical group of 60 UK adolescents aged 12-17 with repeated self-harm, randomised to receive BlueIce. FINDINGS: BlueIce was used by 57/60 (95%) respondents with 47/57 (82%) using BlueIce when thinking about self-harm. 17/47 (36%) who were thinking about self-harm used it on more than six occasions with 36/47 (77%) reporting that BlueIce prevented at least one episode of self-harm. 33/47 (70%) reported occasions when they used the app but still went on to self-harm. Reasons why the app was not used or not helpful included feeling too distressed, a negative mindset, prior decision to self-harm or forgetting. BlueIce was rated 4.09 (SD=0.75) out of 5 stars, with high mean ratings out of 10 for ease of use (8.70, SD=1.37) and good for acceptability (7.68, SD=2.05) and helpfulness (6.77, SD=1.72). No respondent identified BlueIce as triggering any episode of self-harm. CONCLUSION: These findings are consistent with previous evaluations and highlight the acceptability, use and safety of BlueIce. Self-reports indicate that BlueIce prevented some episodes of self-harm. CLINICAL IMPLICATIONS: Our results highlight the acceptability of the BlueIce self-harm app for young adolescents who repeatedly self-harm.

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.