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Background The need to engage boys in gender-transformative relationships and sexuality education (RSE) to reduce adolescent pregnancy is endorsed by the World Health Organization and the United Nations Educational, Scientific and Cultural Organization. Objectives To evaluate the effects of If I Were Jack on the avoidance of unprotected sex and other sexual health outcomes. Design A cluster randomised trial, incorporating health economics and process evaluations. Setting Sixty-six schools across the four nations of the UK. Participants Students aged 13–14 years. Intervention A school-based, teacher-delivered, gender-transformative RSE intervention (If I Were Jack) versus standard RSE. Main outcome measures Self-reported avoidance of unprotected sex (sexual abstinence or reliable contraceptive use at last sex) after 12–14 months. Secondary outcomes included knowledge, attitudes, skills, intentions and sexual behaviours. Results The analysis population comprised 6556 students: 86.6% of students in the intervention group avoided unprotected sex, compared with 86.4% in the control group {adjusted odds ratio 0.85 [95% confidence interval (CI) 0.58 to 1.26], p = 0.42}. An exploratory post hoc analysis showed no difference for sexual abstinence [78.30% intervention group vs. 78.25% control group; adjusted odds ratio 0.85 (95% CI 0.58 to 1.24), p = 0.39], but more intervention group students than control group students used reliable contraception at last sex [39.62% vs. 26.36%; adjusted odds ratio 0.52 (95% CI 0.29 to 0.920), p = 0.025]. Students in schools allocated to receive the intervention had significantly higher scores on knowledge [adjusted mean difference 0.18 (95% CI 0.024 to 0.34), p = 0.02], gender-equitable attitudes and intentions to avoid unintended pregnancy [adjusted mean difference 0.61 (95% CI 0.16 to 1.07), p = 0.01] than students in schools allocated to receive the control. There were positive but non-significant differences in sexual self-efficacy and communication skills. The total mean incremental cost of the intervention compared with standard RSE was £2.83 (95% CI –£2.64 to £8.29) per student. Over a 20-year time horizon, the intervention is likely to be cost-effective owing to its impact on unprotected sex because it would result in 379 (95% CI 231 to 477) fewer unintended pregnancies, 680 (95% CI 189 to 1467) fewer sexually transmitted infections and a gain of 10 (95% CI 5 to 16) quality-adjusted life-years per 100,000 students for a cost saving of £9.89 (95% CI –£15.60 to –£3.83). Limitations The trial is underpowered to detect some effects because four schools withdrew and the intraclass correlation coefficient (0.12) was larger than that in sample size calculation (0.01). Conclusions We present, to our knowledge, the first evidence from a randomised trial that a school-based, male engagement gender-transformative RSE intervention, although not effective in increasing avoidance of unprotected sex (defined as sexual abstinence or use of reliable contraception at last sex) among all students, did increase the use of reliable contraception at last sex among students who were, or became, sexually active by 12–14 months after the intervention. The trial demonstrated that engaging all adolescents early through RSE is important so that, as they become sexually active, rates of unprotected sex are reduced, and that doing so is likely to be cost-effective. Future work Future studies should consider the longer-term effects of gender-transformative RSE as students become sexually active. Gender-transformative RSE could be adapted to address broader sexual health and other settings. Trial registration This trial is registered as ISRCTN10751359. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (PHR 15/181/01) and will be published in full in Public Health Research; Vol. 11, No. 8. See the NIHR Journals Library website for further project information. Plain language summary Adolescent pregnancy is often thought to be an issue for young women alone, but it is important to engage young men to tackle the problem and find solutions. The If I Were Jack intervention was especially designed to engage with boys as well as girls aged 14 years and to promote positive masculinity and gender equality to prevent adolescent pregnancy and promote positive sexual health. It uses tailored interactive films and resources, made with the help of students and teachers, to make it relevant to each of the four UK nations. This relationship and sexuality education intervention encourages adolescents to avoid unprotected sex by delaying sexual activity until they feel ready and to use reliable contraception once sexually active. It also promotes knowledge, attitudes (such as beliefs about gender and masculinities), skills and intentions for safe and pleasurable relationships. In this trial, we compared students in 33 schools randomly allocated to deliver the intervention with students in 33 schools that continued with their usual relationship and sexuality education practices. Four schools withdrew, two because of COVID-19 school closures. This left a total of 6556 students who completed questionnaires at the start of the study and 12–14 months later. Responses from all these students showed that If I Were Jack had a positive impact on knowledge, attitudes and intentions required for safe and pleasurable relationships, but did not have a significant effect on overall avoidance of unprotected sex. This was because the intervention had no effect on delaying sexual activity. However, we found that the intervention was effective in increasing the use of reliable contraception as students became sexually active, as well as for those who already were sexually active prior to receiving the intervention. We also found that If I Were Jack was likely to provide value for money by reducing unintended pregnancies and improving sexual health. Scientific summary Background The need for relationship and sexuality education (RSE) to especially engage with young men and boys to promote positive sexual health for all, and to be gender transformative to challenge the gender inequalities that underlie young women’s generally poorer sexual health outcomes (especially in relation to sexual violence, adolescent pregnancy and sexually transmitted infections), is widely endorsed by the World Health Organization and the United Nations Educational, Scientific and Cultural Organization, among others. Objectives The JACK trial evaluated the effectiveness and cost-effectiveness of the If I Were Jack intervention, a schools-based RSE intervention, which is designed to especially engage young men as well as young women and promote joint responsibility in preventing adolescent pregnancy by avoiding unprotected sex and in promoting positive sexual health and relationships. We assessed whether there would be higher rates of self-reported avoidance of unprotected sex (either by remaining sexually abstinent or by using a reliable form of contraception) among students in schools allocated to use If I Were Jack than among those in schools that continued with their usual RSE. Design We undertook a multicentre, parallel-group cluster randomised trial of the If I Were Jack intervention with schools as the unit of randomisation. We incorporated a health economic cost–consequences analysis and process evaluation. Setting The trial was conducted in secondary-level schools across the four nations of the UK. Recruitment We sampled schools from Department of Education-listed secondary schools in each nation of the UK (Northern Ireland, Wales, Scotland and England), with consideration of the socioeconomic status of schools [based on the proportion of students eligible for free school meals (FSM) as indicated by the School Meal Census]. In each nation, eligible schools were stratified into two levels according to FSM eligibility rates (schools above and below the median national percentage of FSM for all eligible schools). Independent private, special, and Irish/Welsh-medium and Scottish Gaelic schools and schools with

Background: Despite high rates of adolescent mental health problems, there are few effective school-based interventions to address this. Whole-school interventions offer a feasible and sustainable means of promoting mental health, but few have to date been evaluated. Previously we trialled the Learning Together intervention comprising local needs assessment, student and staff participation in decision-making, restorative practice, and a social and emotional skills curriculum. This was effective not only in preventing bullying (primary outcome), but also in promoting mental well-being and psychological functioning (secondary outcomes)., Objective: We aimed to adapt Learning Together to develop Learning Together for Mental Health, focused on promoting mental health. This paper reports on how we refined and elaborated intervention materials to produce the Learning Together for Mental Health intervention including through patient and public involvement and engagement., Design: We reviewed evidence to inform choice of the curriculum component and the contents of our needs assessment survey. We conducted patient and public involvement and engagement with school staff and students, and children and young people from the National Children's Bureau to adapt the intervention. We also conducted a systematic review of reviews to inform a menu of evidence-based actions, but this is reported separately., Setting: Southern England., Participants: Patient and public involvement and engagement was conducted with four staff and five students from one secondary school, and a group of two school senior leadership team members from different schools, and about eight children and young people who were members of the Young National Children's Bureau., Interventions: None., Results: We refined and elaborated our initial plans for Learning Together for Mental Health to generate an intervention supported by full materials, training and external facilitation. We focused needs assessment on mental health, added a menu of evidence-based whole-school mental health actions, and switched to a different social and emotional skills curriculum. We retained restorative practice and staff/student involvement in decisions. No further refinements were made to the intervention theory of change or overall approach. Patient and public involvement and engagement was useful, but not all suggestions were acted on either because some participants suggested dropping pre-determined elements (e.g. needs survey) or because suggestions (e.g. to include aromatherapy) lacked evidence of effectiveness., Limitations: Not all of our engagements with patient and public involvement and engagement stakeholders were sustained over time. Our patient and public involvement and engagement work was affected by its having occurred within the recovery period from COVID-19 when schools were more stressed than normal. We had planned for the school involved in patient and public involvement and engagement to be above average in student free-school-meals eligibility, but the school initially recruited dropped out at the last minute. Its replacement had a lower-than-average rate of free-school-meal entitlement., Conclusions: This paper reports on the process of adaptation and reflects on the various ways in which engagement and evidence review were useful in this process. We found that it is possible to refine interventions and elaborate them to provide full materials and support via processes drawing on evidence review and patient and public involvement and engagement. The latter proved valuable in informing refinement of Learning Together for Mental Health in terms of ensuring its feasibility, acceptability, and inclusiveness. However, in our opinion, not all suggestions from patient and public involvement and engagement can or should be acted on, especially when they do not align with the evidence base., Future Work: A feasibility study to optimise the intervention and assess whether progression to a full trial is justified., Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR131594.

Background: Whole-school interventions modify the school environment to promote health. A subset of these interventions promotes student commitment to school to prevent substance (tobacco, alcohol, other drugs) use and/or violence. A previous review identified the theory of human functioning and school organisation as a comprehensive theory of such interventions, and found evidence that these interventions reduce substance use and/or violence., Objectives: The objectives were to search for, appraise and synthesise evidence to address the following questions: (1) What whole-school interventions promoting student commitment to school to prevent substance use and/or violence have been evaluated, what intervention subtypes are apparent and how closely do these align with the theory of human functioning and school organisation? (2) What factors relating to setting, population and intervention affect implementation? (3) What are the effects on student substance use, violence and educational attainment? (4) What is the cost-effectiveness of such interventions? (5) Are intervention effects mediated by student commitment to school or moderated by setting or population?, Data Sources: A total of 56 information sources were searched (in January 2020), then an updated search of 48 of these was carried out (in May 2021). Reference lists were also searched and experts were contacted., Review Methods: Eligible studies were process/outcome evaluations of whole-school interventions to reduce student violence or substance use among students aged 5-18 years attending schools, via actions aligning with the theory of human functioning and school organisation: modifying teaching to increase engagement, enhancing student-staff relationships, revising school policies, encouraging volunteering or increasing parental involvement. Data extraction and quality assessments used existing tools. Theory and process reports were synthesised qualitatively. Outcome and economic data were synthesised narratively; outcome data were meta-analysed., Results: Searches retrieved 63 eligible reports on 27 studies of 22 interventions. We identified four intervention subtypes focused on student participation in school-wide decisions, improving staff-student relationships, increasing engagement in learning and involving parents. The theories of change of most intervention subtypes aligned closely with the theory of human functioning and school organisation, and informed refinement of an intervention theory of change. Theories of change for interventions increasing learning engagement did not align with this theory, aiming instead to increase school commitment primarily via social skills curricula. Factors influencing the implementation included whether or not interventions were tailorable, workable and well explained. Interventions with action groups comprising staff/students, etc. and providing local data were well implemented. Implementation was also affected by whether or not schools accepted the need for change and staff had the resources for delivery. Meta-analyses suggest small, but significant, intervention effects in preventing violence victimisation and perpetration, and substance use. There was sparse and inconsistent evidence of moderation and some evidence of mediation by student commitment to school. Two economic evaluations suggested that there is the potential for the interventions to be cost-effective., Limitations: The quality of the studies was variable and the economic synthesis was limited to two studies., Conclusions: Whole-school interventions aiming to promote student commitment to school share similar theories of change and factors affecting implementation. They have the potential to contribute to preventing violence and substance use among young people. Future trials should aim to optimise intervention effectiveness by better theorisation, and assess implementation and effect moderators and mediators., Study Registration: This study is registered as PROSPERO CRD42019154334., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 17/151/05) and is published in full in Public Health Research ; Vol. 12, No. 2. See the NIHR Funding and Awards website for further award information.

Background: Schools have a duty of care to prevent violence between students but a significant amount of dating and relationship violence and gender-based violence occurs in schools. These are important public health issues with important longitudinal consequences for young people., Objectives: To understand functioning and effectiveness of school-based interventions for the prevention of dating and relationship violence and gender-based violence., Review Methods: We undertook a mixed-methods systematic review to synthesise different types of evidence relating to school-based interventions for the prevention of dating and relationship violence and gender-based violence to understand if, how and in what ways these interventions are effective. We searched 21 databases and 2 trial registers and undertook forwards and backwards citation chasing, author contact and other supplementary search methods. Searches identified all literature published to June 2021. All screening was undertaken in duplicate and independently, and we quality appraised all included studies., Results: We included 247 reports (68 outcome evaluations, 137 process evaluations). Synthesis of intervention components produced an intervention typology: single-component, curricular, multicomponent, and multilevel programmes. Synthesis of intervention theories suggested that interventions aiming to increase students' sense of school belonging and sense of safety in the school building could encourage increased learning of prosocial skills and increased prosocial peer norms, and so potentially reducing dating and relationship violence and gender-based violence. Synthesis of factors affecting delivery highlighted school organisation and leaders who believed in the importance of addressing dating and relationship violence/gender-based violence, along with time and resources to deliver the interventions. The ease with which the intervention could be delivered and modified was also important. Meta-analysis found stronger evidence for intervention effectiveness in reducing dating and relationship violence than for gender-based violence, with significant long-term impacts on dating and relationship violence victimisation and perpetration, and some evidence that interventions in high-income countries could be effective for reducing victimisation and perpetration of gender-based violence in the long-term. Impacts on knowledge and attitudes were primarily short-term. Network meta-analysis did not suggest superiority of any intervention type. Moderation evidence suggested interventions reduced dating and relationship violence perpetration in boys more than girls, but reduced gender-based violence perpetration more in girls. Metaregression by intervention component did not explain heterogeneity in effectiveness, but qualitative comparative analysis suggested that reducing perpetration was important to reducing victimisation, and that perpetration could be reduced via focus on interpersonal skills, guided practice and (for gender-based violence) implementation of social structural components., Limitations: Despite an exhaustive search, trials may have been missed and risk of publication bias was high for several analyses., Conclusions: This is the most comprehensive systematic review of school-based interventions for dating and relationship violence and gender-based violence to date. It is clear that the prevention of dating and relationship violence and gender-based violence in schools will require longer-term investment to show benefit., Future Work: Future research is needed to understand why intervention effectiveness appears stronger for dating and relationship violence than gender-based violence., Study Registration: The study is registered as PROSPERO CRD42020190463., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: NIHR130144) and is published in full in Public Health Research ; Vol. 12, No. 3. See the NIHR Funding and Awards website for further award information.

Background: Looked-after children (LAC) are at greater risk of teenage pregnancy than non-LAC, which is associated with adverse health and social consequences. Existing interventions have failed to reduce rates of teenage pregnancy in LAC. Peer mentoring is proposed as a means of addressing many of the factors associated with the increased risk of teenage pregnancy in this group., Objective: To develop a peer mentoring intervention to reduce teenage pregnancy in LAC., Design: Phase I and II randomised controlled trial of a peer mentoring intervention for LAC; scoping exercise and literature search; national surveys of social care professionals and LAC; and focus groups and interviews with social care professionals, mentors and mentees., Setting: Three local authorities (LAs) in England., Participants: LAC aged 14-18 years (mentees/care as usual) and 19-25 years (mentors)., Intervention: Recruitment and training of mentors; randomisation and matching of mentors to mentees; and 1-year individual peer mentoring., Primary Outcome: pregnancy in LAC aged 14-18 years., Secondary Outcomes: sexual attitudes, behaviour and knowledge; psychological health; help-seeking behaviour; locus of control; and attachment style. A health economic evaluation was also carried out., Results: In total, 54% of target recruitment was reached for the exploratory trial and 13 out of 20 mentors (65%) and 19 out of 30 LAC aged 14-18 years (63%) (recruited during Phases I and II) were retained in the research. The training programme was acceptable and could be manualised and replicated. Recruitment and retention difficulties were attributed to systemic problems and LA lack of research infrastructure and lack of additional funding to support and sustain such an intervention. Mentees appeared to value the intervention but had difficulty in meeting weekly as required. Only one in four of the relationships continued for the full year. A future Phase III trial would require the intervention to be modified to include provision of group and individual peer mentoring; internal management of the project, with support from an external agency such as a charity or the voluntary sector; funds to cover LA research costs, including the appointment of a dedicated project co-ordinator; a reduction in the lower age for mentee recruitment and an increase in the mentor recruitment age to 21 years; and the introduction of a more formal recruitment and support structure for mentors., Conclusions: Given the problems identified and described in mounting this intervention, a new development phase followed by a small-scale exploratory trial incorporating these changes would be necessary before proceeding to a Phase III trial., Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 85. See the NIHR Journals Library website for further project information.

Background: Youth bullying and other aggressive behaviours are a major public health concern owing to their impact on adolescent physical and mental health and well-being. Whole-school restorative approaches have been identified as a promising method of addressing aggressive behaviour but there have been no randomised trials undertaken to examine their effects., Aim: To examine the feasibility and acceptability of implementing and trialling the INCLUSIVE (initiating change locally in bullying and aggression through the school environment) intervention in English secondary schools., Design: Cluster randomised controlled pilot trial in eight schools (1 : 1 computer-generated random allocation post baseline by a statistician blind to the identity of clusters) and process evaluation., Setting: Secondary schools in England (purposively sampled to ensure diversity)., Participants: Year 8 students (aged 12-13 years), teachers, other school staff and intervention providers., Intervention: Whole-school restorative approach to address bullying and aggression, involving the following standard processes: school action group formation and external facilitation to review needs assessment data, identify priorities, and plan and monitor school-level actions; staff training in restorative practices; and a new social and emotional skills curriculum., Comparison Group: Standard practice., Main Outcome Measures: (1) The primary outcome of interest was the feasibility and acceptability of delivering and trialling the intervention according to prespecified criteria; (2) process data were analysed to explore participants' experiences of implementing and trialling the intervention and how these varied according to school context; and (3) indicative primary outcomes (aggressive behaviour measures), secondary outcomes, intermediate outcomes and economic evaluation methods were piloted., Data Sources: Students (n = 1144 baseline; n = 1114 follow-up) and teachers (n = 387 baseline; n = 336 follow-up) were surveyed at the start and end of the 2011-12 academic year (baseline September 2011; follow-up June-July 2012). A total of 1017 students surveyed at baseline remained in the study at follow-up (89%). Other quantitative data were collected via intervention provider checklists (n = 4) and action group surveys (n = 44); qualitative data were collected via interviews (n = 34), focus groups (n = 20) and observations of action group meetings (n = 16)., Results: (1) All prespecified feasibility and acceptability criteria were met. (2) Qualitative data indicated that all intervention components and the trial design were feasible and acceptable to students and staff, including in more disadvantaged school contexts. Qualitative data also suggested that student participation may be a core component in improving relationships and engagement across the school. The later-than-planned project start (July) and the timing of the baseline surveys (September), which needed to be completed pre allocation, caused delays in launching the intervention, staff training and other intervention outputs. (3) Three pilot primary outcomes were examined (completion rate at follow-up range: 91.7-94.2%) and the Gatehouse Bullying Scale and the Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale were acceptable, discriminating and reliable measures of bullying and aggression in this context. Our pilot economic analyses support the use of the Child Health Utility 9D scale with this population and the feasibility of cost-utility analysis, although this should be supplemented with a cost-consequence analysis. There was no evidence of harm., Conclusions: It is feasible and acceptable to implement and trial the INCLUSIVE intervention in English secondary schools, although a longer lead-in time is required to enable timely intervention outputs to occur. A Phase III cluster randomised controlled trial is required to examine the effectiveness and cost-effectiveness over a 3-year period of implementation for reducing aggressive behaviours, promoting mental health and well-being, and reducing health inequalities., Trial Registration: Current Controlled Trials ISRCTN88527078., Funding: The National Institute for Health Research Health Technology Assessment programme (research), the Paul Hamlyn Foundation, the Big Lottery Fund and the Coutts Charitable Trust (intervention). The report will be published in full in Health Technology Assessment; Vol. 19, No. 53. See the NIHR Journals Library website for further project information.