OBJECTIVE:Evidence-based psychotherapies constitute first-line treatments for youth depression, yet their effects remain modest and largely unchanged over the past three decades. A critical gap persists in understanding how and for whom these therapies work. Realist trials address this gap by iteratively developing and testing context-mechanism-outcome configurations (CMOC) within randomized controlled trials (RCTs). As an initial step in that process, this study reports on qualitative research embedded in a pilot realist cluster RCT of group interpersonal therapy (IPT) for depressed adolescents in Nepal. METHODS:Semi-structured interviews and focus groups were conducted with 41 participants purposively sampled across four schools. Data were analyzed thematically, guided by realist principles. RESULTS:Findings highlighted key mechanisms: improved emotion regulation and problem-solving skills, reduced interpersonal conflict, closer relationships, and increased self-efficacy. Contextual factors appeared to interact with these mechanisms: adolescents from lower socioeconomic backgrounds were perceived to benefit more due to greater motivation. The experience of adversity was viewed to alter how mechanisms operated. Sharing feelings openly appeared critical for group IPT to work. CONCLUSION:Findings align with previous work and suggest different mechanisms might be at play for different groups. The refined CMOCs will be quantitatively tested in a forthcoming phase 3 realist RCT.

BACKGROUND:Relationships and sex education (RSE) impacts some sexual behaviours but could be strengthened by incorporating whole-school approaches (eg, building engagement, providing contraception). These can prevent pregnancies and sexually-transmitted infections but are unevaluated in UK schools. METHODS:A cluster-randomised trial of 'Positive Choices' compared it with usual practice in English secondary schools. Intervention comprised: RSE, school-health-promotion councils involving students, student-needs data to tailor provision; student-led campaigns; review of sexual-health services; and parent information. The primary outcome was prevention of non-competent sexual debut (lacking decision autonomy, judging timing as right, partners' equal willingness or contraception). RESULTS:Of 2845 schools invited, 50 (1.76%) consented, 1 leaving post-allocation. Of 25 control and 24 intervention schools, 4 withdrew pre-endline. 6970 (77.3%) students participated at baseline and 6268 (77.9%) at 33-month endline. Fidelity of whole-school components was suboptimal. No schools achieved 'good' fidelity; two achieved 'adequate' fidelity across components. 11 achieved 'adequate fidelity on selected components' (student-needs report, school-health-promotion council meetings, lessons, parent information). Control schools delivered similar activities to intervention schools. Among 780 (12.44%) students sexually debuting between baseline and endline, non-competent debut was reported by 268 (64.42%) in the control and 240 (65.93%) in the intervention group (risk difference=0.020 (95% CI -0.05 to 0.09)). There were no effects on secondary outcomes. Incremental costs were £1337 per school (£10 per student). CONCLUSION:Positive Choices did not prevent non-competent sexual debut (primary outcome) or impact secondary outcomes compared with usual RSE, possibly explained by weak fidelity of whole-school elements and/or comprehensive RSE in control schools. TRIAL REGISTRATION NUMBER:ISRCTN16723909.

Whole-school relationships and sexual health interventions represent promising approaches to promoting healthy sexual development. However, data from a randomised controlled trial of the Positive Choices whole-school intervention demonstrate these may be challenging to implement in English secondary schools. We draw on qualitative data to examine staff perspectives on the implementation of the intervention and the factors affecting delivery. Interviews were conducted with 52 staff in 22 schools. Analysis was guided by May's General Theory of Implementation, focussing on how processes of sense making, cognitive participation, collective action and reflexive monitoring were shaped by intervention capability, school capacity, and staff potential. Quality training, materials and support, alongside a strong commitment to delivery of statutory relationships and sex education promoted curriculum implementation. However, whole-school components were viewed as more challenging to implement and often beyond the 'core business' of schools. Successful implementation of whole-school components was facilitated by a supportive school culture, school leads having the authority to enable collective action and close alignment with school priorities and institutional processes. For whole-school interventions to succeed, sufficient time and resources must be allocated. A pragmatic approach might be to develop whole-school approaches that address health more holistically and build effectively on existing provision.

Objective: Dating and relationship violence (DRV) and gender-based violence (GBV) are reported to be common among adolescents internationally and can have significant adverse long-term consequences, including widening gender inequalities in health outcomes. There is evidence that while school-based curriculum programmes can be effective in preventing DRV, whole-school elements such as student/staff action groups are important for preventing GBV. However, the processes of implementing whole-school components may be challenging in schools with limited capacity. We designed THINK AGAIN, a multi-component programme aiming to prevent DRV and GBV in English secondary schools. Design: Non-controlled feasibility study of THINK AGAIN. Setting: State secondary schools in south-east England. The programme targeted all students in year 9 (aged 13-14) in participating schools. Method: We recruited four schools to assess the feasibility and acceptability of THINK AGAIN in the 2024-25 school year. Our embedded process evaluation assessed programme feasibility, processes of implementation and how context influenced these. We conducted 16 interviews with school staff and analysed the data informed by the General Theory of Implementation. Results: We found that the curriculum component was feasible and prioritised for delivery by schools. However, the whole-school component faced challenges to implementation in terms of both workability and context. Conclusion: Study findings support the progression of THINK AGAIN to a phase III trial of effectiveness, pending full assessment of progression criteria and important refinements to the whole-school component.

BACKGROUND:Academic pressure could increase the risk of adolescent depression and self-harm. However, there are few longitudinal studies of this association, and those that exist have limitations. We aimed to investigate associations between perceived levels of academic pressure and subsequent depressive symptoms and self-harm from adolescence to early adulthood. Our hypothesis was that higher levels of academic pressure would be associated with higher levels of depressive symptoms and self-harm. METHODS:In this longitudinal study, we used data from the Avon Longitudinal Study of Parents and Children (Avon, UK) that includes adolescents born in 1991-92. Our primary exposure of interest was academic pressure measured at age 15 years, using items from a school experiences questionnaire (total scores 0-9). Outcomes were depressive symptoms assessed with the Short Mood and Feelings Questionnaire at five timepoints between age 16 years and 22 years (total scores 0-26), and a self-harm questionnaire at four timepoints between age 16 years and 24 years. Analyses were linear (depressive symptoms) and logistic (self-harm in the previous year) multilevel models in samples with multiply imputed data, before and after adjustments. FINDINGS:We included 4714 adolescents (2725 [57·8%] female, 1989 [42·2%] male). In fully adjusted models, a 1-point increase in academic pressure at age 15 years was associated with a 0·43 (95% CI 0·36-0·51) point increase in depressive symptoms. This association was largest when depressive symptoms were assessed at age 16 years (0·53, 0·42-0·64), but remained at age 22 years (0·35, 0·23-0·47). For self-harm, in fully adjusted models, each 1-point increase in academic pressure was associated with an 8% higher odds of self-harm (adjusted odds ratio 1·08, 1·01-1·16), with no differences over time. INTERPRETATION:Our findings support the hypothesis that academic pressure is a potential modifiable risk factor for adolescent depressive symptoms, and possibly self-harm. Interventions to reduce academic pressure could be developed and evaluated. FUNDING:Sir Henry Dale Fellowship, Wellcome Trust, and Royal Society.

Background Bullying increases during primary school and causes multiple mental/physical health harms. Whole-school interventions offer a feasible means of reducing bullying but few have been evaluated in primary schools. We previously trialled the Learning Together intervention in secondary schools comprising local needs assessment, student and staff participation in decision-making through ‘action groups’, restorative practice, and a social and emotional skills curriculum. This intervention was effective in preventing bullying and improving mental wellbeing. We aimed to adapt Learning Together for primary schools (Learning Together Primary Schools (LTPS)). This paper reports on how we adapted intervention materials to produce the LTPS intervention through a review of research evidence, online survey, and patient and public involvement and engagement (PPIE). Methods We conducted a rapid review of existing systematic reviews, online survey of primary schools in south-east England, and multiple PPIE workshops. PPIE was conducted with two primary schools (10 staff members and 20 pupils), with a group of 10 pupils from five primary schools, and with a group of six parents with primary-school-aged children. Conclusions We refined our initial plans for LTPS, developing an intervention appropriate for primary schools and supported by full materials, training and external facilitation. We retained key components including restorative practice and action groups and made several refinements, including guidance for action group implementation to accommodate for primary schools’ smaller capacities. No refinements were made to the intervention theory of change. We found that it is possible to refine and elaborate interventions to provide full materials and support via processes drawing on evidence review, a survey and PPIE. Although not all PPIE suggestions could be acted upon, PPIE proved valuable in ensuring the feasibility and acceptability of the intervention in primary schools. Future work will include a pilot trial to assess whether progression to a full trial is justified. Study registration ISRCTN10215449 https://doi.org/10.1186/ISRCTN10215449

Previous trials of whole-school relationships and sexual-health programmes have not reported on fidelity, reach or acceptability, despite the importance of these factors for interpreting outcomes. Our trial of the Positive Choices whole-school relationships and sexual-health programme found limited effectiveness in secondary schools in England. We aimed to understand whether sub-optimal fidelity, reach or acceptability might explain the results. A process evaluation was nested within a parallel-arm, cluster randomised-controlled trial in 49 schools from 2021 to 2025. Using staff log-books, researcher observations, student surveys and staff interviews, we assessed the delivery of the programme in 24 schools and awareness and acceptability among students, including subgroup differences. While most schools delivered lessons, fewer completed 'whole-school components', such as school-health promotion councils, sexual-health services reviews and student-led campaigns. No school reached a pre-defined level of 'good fidelity' across all components, and only 11 schools achieved 'adequate fidelity for selected components'. Evidence of programme acceptability and awareness among students was weak, with higher awareness among sexuality- and gender-minority students, and higher acceptability among white students. Findings highlight difficulties implementing whole-school programmes focused on relationships and sexual health. More holistic whole-school programmes addressing multiple health issues, including sexual health, may be more feasible.

Objectives Few studies have examined sleep health among African adolescents. We aimed to understand sleep health among Ugandan secondary school students. Methods We collected quantitative data in two schools through a survey with items on sleep health and insomnia (using the Cleveland Adolescent Sleepiness Questionnaire, Munich Chronotype Questionnaire and Insomnia Severity Index [ISI]) and mental health with the UNICEF Measuring Mental Health Among Adolescents and Young People at the Population Level (MMAPP) tool. We used regression models to assess characteristics associated with ISI score, and of sleep health with depression and anxiety. We conducted focus group discussions and in-depth interviews with students, parents, teachers, and officials. Quantitative and qualitative analyses were guided by the social ecological model of sleep health. Results The 358 participants generally reported poor sleep health (assessed by satisfaction, alertness, timing, efficiency and duration), especially among boarding students. The median sleep duration was 5.1 hours (interquartile range 4.2-6.2). Overall, 36 (10.1%) participants screened positive for moderate/severe insomnia (ISI ≥15), with higher prevalence among females than males (12.7% vs. 6.2%; p = .05). Qualitative interviews highlighted that individual (knowledge and attitudes), social-cultural (religious beliefs, family dynamics, academic demands, peer pressure), environmental (school and home conditions, technological influences), and societal factors (national school schedule guidelines) influenced sleep patterns. Depression and anxiety were associated with multiple dimensions of poor sleep health. Conclusions Ugandan adolescents face substantial sleep challenges, which are associated with poor mental health. Evidence-based interventions should be adapted for specific social-ecological contexts to improve sleep and mental health in this population.

Abstract Background Population-level engagement with public health interventions is needed to achieve impact. Recently, however, there has been evidence of increasing resistance to government-led public health interventions in areas such as vaccination, climate change mitigation, sexual and reproductive healthcare, and non-pharmaceutical-based infection control measures. The rise in populist attitudes that has taken place in many countries over the last two decades may be one potential explanation for this phenomenon, given the importance placed on individual freedom and national sovereignty, and a distrust of scientific, government and other elites within much populist discourse. Methods To understand how populist-aligned views might subsequently influence the receipt of public health interventions, we systematically reviewed quantitative, longitudinal evidence across thirteen bibliographic databases and relevant websites, published between 2008 and 2024. All studies were set in Organisation for Economic Co-operation and Development (OECD) countries and results were synthesised narratively. Results Across 16 included studies, much of the evidence focused on COVID-19. We found evidence that prior populist-aligned attitudes have a negative impact on subsequent receipt of public health interventions, such as the COVID-19 vaccine and non-pharmaceutical-based prevention measures against COVID-19 (i.e., engaging in masking and social distancing) through both existing and increasing distrust in elite institutions and actors over time. We also found preliminary evidence about the potentially negative role of populist-aligned attitudes on the receipt of other vaccinations before and during the COVID-19 pandemic. Conclusions From a policy perspective, the findings from this review suggest the need for proactive efforts by political, scientific and medical establishments to build and maintain trust, thereby strengthening the reputation of both the public health leaders and institutions that engage with those more likely to be resistant to public health interventions to increase overall acceptance and uptake. Trial registration PROSPERO registration number CRD4202451312.

Group psychosocial interventions can be a scalable treatment for depression, anxiety, and post-traumatic stress disorder (PTSD) in low- and middle-income countries (LMICs) but effects are heterogeneous. Little is known about how intervention mechanisms and context interact to generate different outcomes in different populations. We conducted a realist systematic review, combining traditional systematic review methods with analysis of intervention mechanisms and contextual factors to further understanding of complex interventions. This involved: (i) a scoping review to build initial theory and inform data extraction and analysis; (ii) systematically searching six databases for randomised controlled trials (RCTs) of group psychosocial interventions for participants aged 0-19 years in LMICs (21 November 2022, updated 26 April 2024); (iii) extracting data on outcomes, contextual factors, and intervention mechanisms to build hypotheses about how context interacts with mechanisms to generate outcomes (context-mechanism-outcome configurations; CMOCs); (iv) narratively synthesising CMOCs into wider programme theories about how and why psychosocial interventions work; (v) meta-analyses and meta-regressions to assess trends and test CMOCs. We included 38 RCTs with data for 6,086 participants (52% female, mean age 13). These data informed 14 programme theories including theories that interventions work best when adapted for participant cognitive level, incorporating age-appropriate activities, accounting for local gender-specific issues, and being culturally adapted. Pooled post-intervention effect sizes were -0.72 (95% CI -1.01 to -0.42, p < 0.001) for depression, -0.90 (95% CI -1.57 to -0.23, p = 0.014) for anxiety, and -0.71 (95% CI -1.05 to -0.38, p < 0.001) for PTSD. The only significant results in meta-regressions were larger effect sizes for older children and in populations without exposure to conflict for depression symptoms only. Socio-demographic and contextual factors may influence how interventions work and help to explain the heterogeneity of effects. More high-quality RCTs with moderation and mediation analyses are needed to explore the transferability of these interventions.PROSPERO registration: CRD42022364043.

IntroductionThe school environment influences adolescent health through both individual experiences, such as one’s own engagement with school, and broader school-level factors, such as aggregate student levels of engagement, affecting all students. For mental-health outcomes, existing evidence more consistently supports individual-level influences than school-level effects. In relation to depression, negative student-level educational experiences have been associated with increased symptoms, while evidence for school-level associations remains limited and often methodologically weak. We aimed to address this gap through a secondary analysis of longitudinal data from a trial involving 49 English secondary schools.MethodsStudent-reported educational experiences (school belonging, educational commitment, participation at school, relationships with teachers and expectation of university) as well as family affluence were measured at baseline (ages 12–13) and depressive symptoms were assessed at follow-up (ages 15–16). Associations were examined at both the individual student and aggregate school level of educational experiences.ResultsForty-five schools were retained at endline and 4,601 students comprised our analytical sample. At the student level, greater school belonging (beta coefficient = −0.24; 95% confidence interval = −0.29, −0.19) and educational commitment (beta coefficient = −0.19; 95% confidence interval = −0.29, −0.08) were associated with lower risk of depressive symptoms in fully adjusted models. At the school level, only overall educational commitment was associated with reduced depressive symptoms in a partially but not fully adjusted model (beta coefficient = −1.02; 95% confidence interval = −1.86, −0.18).DiscussionThese findings suggest that educational experiences influence depressive symptoms primarily through individual-level mechanisms, for example involving students’ sense of belonging, engagement, participation and relationships) but the general level of educational commitment within a school may also play a meaningful role. (249 words).

Background:Young people's mental health worsened during and since the coronavirus disease discovered in 2019 pandemic. School environments play a key role in young people's mental health. Learning Together for Mental Health is a whole-school intervention aiming to promote mental health in secondary schools, adapted from the previous Learning Together intervention which was found effective in reducing bullying and promoting mental health. Objective:To adapt Learning Together to increase focus on mental health so producing the Learning Together for Mental Health intervention and evaluate the appropriateness of conducting a Phase III trial of the Learning Together for Mental Health intervention regarding pre-defined progression criteria relating to the intervention and trial methods, and assessing intervention feasibility, reach and acceptability, feasibility of trial measures and procedures, potential mechanisms and possible harms. Design and methods:We conducted a feasibility study with baseline and follow-up surveys, process evaluation and economic-evaluation feasibility-testing. Setting and participants:One school participated in intervention adaptation. Our feasibility study included four state, mixed-sex secondary schools in southern England (one of which dropped out after baselines and was replaced with another). We recruited 640 year-7 (age 11-12) students at baseline survey and 566 year-10 (age 14-15) students at 12-month follow-up. Baseline and follow-up participants were different groups, as the focus was assessing feasibility for the age groups to be surveyed at baseline and follow-up in a Phase III randomised controlled trial. Twenty staff, 27 year-8 (age 12-13) students and 22 year-10 students participated in qualitative research as did two trainers and one external facilitator. Interventions:As part of our feasibility study, all schools received the Learning Together for Mental Health intervention for one academic school year. Main outcome measures:Pre-defined criteria for progression to a Phase III trial. Results:The intervention was successfully adapted from the previous intervention using public involvement. The trial met all criteria for progression to Phase III. The all-staff and in-depth restorative practice training were implemented with fidelity in all schools and all schools had at least two staff trained in-depth in restorative practice. Curriculum training was delivered with fidelity in three of four schools. The response rate to the baseline (needs) survey across the three participating schools was 79%. Progression required at least two schools to have delivered the curriculum with at least 50% fidelity, which was achieved; one of the two schools which delivered the curriculum reported over 80% fidelity and the other school reported over 75% fidelity. All students and staff across all four schools who completed the action group survey and 93% of senior leadership team members who completed the senior leadership team survey reported that Learning Together for mental health was a good way to promote student Mental Health. Potential mechanisms of action involve promoting student sense of school belonging and practical reasoning and skills. No harms were reported. Trial measures and procedures were feasible and acceptable to implement. Intervention and trial refinement are suggested. Limitations:Our study involved a small, purposive sample of schools and students which are not representative of those in England. Conclusions:With some minor amendments, Learning Together for Mental Health should be subject to a future Phase III trial of effectiveness. Future work:The intervention should be refined by making the curriculum optional and improving materials. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR131594.

Purpose: Sexual development is a core biopsychosocial process in adolescence. Lack of brief measures of sexual wellbeing for this age group limits understanding of the impact of these processes on broader mental health and wellbeing. This study aimed to develop and validate a brief measure of sexual wellbeing for mid-to-late adolescents (aged 14-19), suitable for use in population surveys. Methods: Measure development was informed by seven agenda-setting workshops with young people (n = 28, aged 14-23), parents (n = 4), and professionals (n = 11) followed by five online focus groups with adolescents (n = 38, aged 14-19). New items were tested and iteratively refined via cognitive interviews with adolescents (n = 18) and expert review (n = 4). Data from a web-based survey of UK adolescents (n = 1710; aged 14-19) were used to assess and eliminate poor performing items. Exploratory and confirmatory factor analyses assessed latent structure, model fit, measurement invariance, and associations with external validation criteria to ensure standardisation and applicability. Results: An initial 33-item pool was reduced to 13 items representing four first-order factors: support, comfort/ respect, safety/agency, and self-esteem, The final model showed good fit (RMSEA 0.064; CFI 0.954; TLI 0.941). Measurement invariance was supported across age groups but only partially across gender. Higher overall sexual wellbeing scores were positively associated with body image, general wellbeing, and sexual and reproductive empowerment, and negatively associated with depression and anxiety. Conclusion: The 13-item Adol-SW is the first validated, brief measure of adolescent sexual wellbeing explicitly designed for population surveys to improve understanding of links between adolescent sexual development and mental wellbeing.

OBJECTIVES:To examine how decision-makers managed the planning process of the Tokyo 2020 and Beijing 2022 Olympic Games, identifying challenges and lessons from planning events during a respiratory pandemic. DESIGN:Multi-method qualitative case study. METHODS:This study conducted a document review of Olympic Playbooks, which outline the COVID-19 countermeasures for Tokyo 2020 and Beijing 2022, and key informant interviews with 12 participants who were directly involved in planning one or both Games. Findings were analyzed using inductive and deductive coding strategies. RESULTS:Content analysis of the Olympic Playbooks highlighted mitigation strategies and measures such as bubble approaches, regular testing programs, quarantine and isolation measures, masking and vaccination. Analysis of interviews identified four themes that represent challenges encountered during the development and implementation of the Playbooks for Tokyo 2020 and Beijing 2022. Themes include navigating complexities of multi-stakeholder environments; ensuring feasibility and equity; responding to uncertainty and opposition; and strengthening operational systems for the event and within the host country. These themes reflect the complexities of organizing a global mass gathering during a respiratory pandemic and contribute to the overarching theme of negotiating public health priorities amid uncertainty and complexity. CONCLUSIONS:Synthesizing insights based on individual experiences from high-profile events such as the Olympics provides a unique perspective into balancing the requirements for hosting mass gatherings under normal conditions and under epidemic or pandemic contexts. Findings highlighted the importance of evidence-informed planning, transparent decision-making, sustained stakeholder engagement and investing in operational data and surveillance systems.

ObjectivesTo determine the type and effectiveness of public health interventions implemented at sporting mass gatherings to mitigate respiratory infectious disease spread and understand how feasible and acceptable the interventions were to implement.DesignSystematic review.Data sourcesMedline, EMBASE, Cochrane Library, Scopus, Web of Science, Global Health, Epistemonikos, Global Index Medicus, WHO Library, WHO IRIS, IOC and FIFA were search in June 2023 and July 2025.Eligibility criteria for selecting studiesStudies that assessed public health strategies for sporting mass gatherings aiming to reduced respiratory infections were included. Publications prior to 2000, predictive modeling studies, commentaries, editorials, literature reviews, pre-prints and studies that did not retrospectively discuss official sporting events were excluded.ResultsThirty-four articles assessing 37 sporting MGs were included. The most common MGs assessed were the Olympic Games (n = 10). Almost all articles described multi-layered intervention packages including bubble approaches, routine testing, country entry screening, masking, physical distancing and/or isolation and quarantine. Based on an effectiveness framework developed for this study, 23 articles described effective intervention packages, three described non-effective packages and six were indeterminate. Feasibility concerns appeared a challenge for MGs with many spectators and linked to scalability issues. Acceptability factors were likely influenced by perceptions of increased work burden, compliance levels and stakeholder engagement.ConclusionThis systematic review provides the first opportunity to comprehensively map pre-pandemic and pandemic-era planning for sporting MGs and underscores the importance of multilayered, context-specific intervention packages which may meaningfully reduce the risk of respiratory disease spread.Systematic Review RegistrationCRD42023433619.

Purpose There is evidence that academic pressure has been rising among adolescents in the UK. While this may be a modifiable risk factor for mental health problems, there are few validated measures of academic pressure and all have limitations. Methods With secondary-school students, we co-produced a student-reported measure of academic pressure, the 7-item Academic Pressure Questionnaire (APQ). This was included in the baseline survey of students aged 12-13 within the Positive Choices trial, a whole-school intervention to promote sexual health in English secondary schools. We ran factor analyses and assessed internal consistency, associations with sex and depressive symptoms, and variation in academic pressure between schools. Results We extracted one factor (Cronbach's alpha 0.76). Female students had higher APQ scores than males (mean difference = 2.18, 95% CI: 1.88 to 2.49). Higher APQ scores were associated with more depressive symptoms (coefficient = 0.51, 95% CI: 0.48 to 0.55) and associations were larger in female than male students (p value for interaction <0.001). School-level factors explained 2.6% of variation in APQ scores after adjusting for individual-level factors (ICC = 0.026, 95% CI: 0.01 to 0.06). Conclusion The APQ is a valid and reliable tool to investigate academic pressure in secondary-school adolescents.

Objective: Dating and relationship violence and gender-based violence are common among adolescents globally and can have significant adverse long-term consequences, including widening health inequalities. There is evidence that while school-based curriculum interventions can be effective in preventing dating and relationship violence, whole-school elements are important for preventing gender-based violence. However, implementing whole-school components may be challenging in schools with limited capacity. We designed THINK AGAIN, a multi-component programme aiming to prevent dating and relationship violence and gender-based violence in schools in England. The programme comprised an assessment and report of student needs, relationships and sex education curriculum, student-staff “Action Aware Group” and staff training. Design: We conducted a non-controlled feasibility study of THINK AGAIN. Setting: State secondary schools in south-east England. The programme targeted all students in year 9 (aged 13–14) in participating schools. Method: We recruited four schools in which to pilot and assess the feasibility and acceptability of THINK AGAIN in the 2024/2025 school year. Our embedded mixed-methods process evaluation assessed the fidelity, reach and acceptability of the intervention. Results: We found that the curriculum component was delivered with fidelity across schools. However, the whole-school component was delivered with fidelity in only two of four schools. Accordingly, acceptability and reach of the curriculum component were mostly higher among both students and staff than the Action Aware Group component. Conclusion: Fidelity, reach and acceptability of the curriculum were greater than the Action Aware Group, suggesting that progression of THINK AGAIN to a phase III trial of effectiveness requires important refinements to the whole-school component.

Background:Poor sexual health, dating and relationship violence and sexual harassment pose significant public health concerns, especially for young people. There is potential for short- and long-term adverse medical, social, educational and economic outcomes. Objective:To optimise the intervention materials and examine the acceptability of implementing, trialling and estimating the cost of the Sexual health and healthy relationships for Further Education (SaFE) intervention, including an assessment of the feasibility of record linkage and a health economic analysis. Design and methods:Optimisation of intervention materials followed by two-arm repeated cross-sectional pilot cluster randomised controlled trial of the SaFE intervention compared to usual practice, including a process evaluation and a health economic assessment. Setting and participants:Optimisation took place using an iterative process with a series of key stakeholders. The pilot cluster randomised controlled trial took place in eight Further Education settings in South Wales and the West of England, United Kingdom. Participants included Further Education students and staff, and sexual health nurses. Intervention:The SaFE intervention had three components: (1) onsite access to sexual health and relationship services provided by sexual health nurses available for 2 hours, 2 days per week; (2) publicity about these services; and (3) Further Education staff training on how to promote sexual health, and recognise, prevent and respond to dating and relationship violence and sexual harassment. Main outcome measures:The primary outcome was feasibility, assessing whether the study met progression criteria relating to: (1) Further Education setting and student recruitment; (2) the acceptability of the intervention; and (3) qualitative data and documentary evidence from students, staff and sexual health nurses on acceptability, fidelity of implementation and receipt. We also assessed the completeness of primary, secondary and intermediate outcome measures and estimated cost of the intervention. Results:Three of the four progression criteria were met. Eight Further Education settings were recruited, randomised and retained. Of students approached, 60.7% (1124/1852) at baseline and 51.9% (1139/2193) at 12-month follow-up completed the questionnaire (target 60%). Over 80% of onsite sexual health services were attended by a nurse; onsite publicity about sexual health services was observed at all intervention settings; and 137 staff were trained. The SaFE intervention was viewed positively by students, staff and nurses but needed more time to embed. The prevalence of self-reported unprotected sex at last intercourse was 15.5% at baseline and 18.7% at follow-up. There was evidence of floor effects in the measure of dating and relationship violence victimisation in the last 12 months. We found low rates of missing data for almost all variables with no discernible differences across arms. Around a quarter of participants at baseline and follow-up said they were not at all, or not very comfortable providing consent to link to their routine health records. The estimated cost per Further Education setting was £38,363.09. Limitations:Coronavirus disease discovered in 2019 pandemic restrictions at Further Education settings meant the intervention was not implemented for as long as planned (up to 23 weeks vs. 39 weeks). Conclusions:Overall the SaFE intervention was implemented and well received by students, staff and nurses. Future work:If strategies to boost student recruitment to the survey can be identified and implemented, progression to a Phase III effectiveness trial of the SaFE intervention is warranted. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number 17/149/12.