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Background: Despite high rates of adolescent mental-health problems, there are few effective whole-school interventions to address this. Whole-school interventions offer a feasible and sustainable means of promoting mental health. We previously evaluated the Learning Together (LT) intervention which was effective in preventing bullying (primary outcome), promoting mental well-being, psychological functioning, and reducing substance use (secondary outcomes). We adapted LT to develop Learning Together for Mental Health (LTMH) with a new menu of evidence-based actions to address mental health and an enhanced SEL curriculum., Methods: We undertook a feasibility study of LTMH, a whole-school intervention featuring needs assessment, student and staff participation in decision-making via action groups selecting actions from an evidence-based menu, restorative practice, and a SEL and resilience skills curriculum between 2022 and 2023. This article examines the feasibility, acceptability, and potential mechanisms of LTMH, qualitatively, drawing on interviews and focus groups with 49 students in years 8 and 10, and 20 staff across four state secondary schools in southern England., Results: The intervention was feasible and acceptable to implement. In terms of feasibility, the SEL curriculum was the most challenging to implement and was not prioritised by schools that had existing social and emotional learning lessons. Training and external facilitation were well-rated. Some schools struggled with the resourcing and workload implications of implementing actions from the evidence-based menu. Some aspects were not clear. Some staff were not aware that the various components worked together. Needs reports were not easy to understand for all. Students were generally supportive of restorative practice and SEL lessons. Data supported a potential mechanism involving increased school belonging and developing practical knowledge and skills to manage emotions and relationships. The intervention has little potential for harm., Conclusions: The intervention is ready for phase III trial with minor adaptations. A phase III trial of effectiveness is justified., Trial Registration: ISRCTN15301591 https://doi.org/10.1186/ISRCTN15301591., Competing Interests: Declarations Ethics approval and consent to participate Ethics approval for the Learning Together for Mental Health study UCL Research Ethics Committee (REC) on 30 March 2022 (UCL Ethics Project ID Number: 21179/001) and the London School of Hygiene & Tropical Medicine REC 26 August 2022 (ref. 27994). The research was performed in accordance with the Declaration of Helsinki. All participants gave informed consent for participation. Consent for publication Not applicable. Competing interests NS, OLH, JS, EA, RL, and RV are funded by several NIHR grants. CB and RV are NIHR Senior Investigators. CB is a member of the NIHR Reduce Demand for Illicit Substances funding board. DN is supported by the NIHR Applied Research Collaboration Northwest London and NIHR Imperial BRC. RV is Chief Science Advisor at the Department for Education. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. All authors declare they have no competing interests., (© 2024. The Author(s).)

Background: Parental domestic violence and abuse (DVA), mental ill-health (MH), and substance misuse (SU) can have a negative impact on both parents and children. However, it remains unclear if and how parental DVA, MH, and SU cluster and the impacts this clustering might have. We examined how parental DVA, MH, and SU cluster during early childhood, the demographic/contextual profiles of these clusters, and how these clusters relate to child MH trajectories., Methods: We examined data from 15,377 families in the UK Millennium Cohort Study. We used: (1) latent class analysis to create groups differentially exposed to parental DVA, MH, and SU at age three; (2) latent growth curve modelling to create latent trajectories of child MH from ages 3-17; and (3) a case-weight approach to relate latent classes to child MH trajectories., Results: We identified three latent classes: high-frequency alcohol use (11.9%), elevated adversity (3.5%), and low-level adversity (84.6%). Children in the elevated adversity class had higher probabilities of being from low-socioeconomic backgrounds and having White, younger parents. Children exposed to elevated adversity displayed worse MH at age three (intercept = 2.274; p < 0.001) compared the low-level adversity (intercept = 2.228; p < 0.001) and high-frequency alcohol use class (intercept = 2.068; p < 0.001). However, latent growth factors (linear and quadratic terms) of child MH did not differ by latent class., Conclusions: Parental DVA, MH, and SU cluster during early childhood and this has a negative impact on children's MH at age three, leading to similar levels of poor MH across time. Intervening early to prevent the initial deterioration, using a syndemic-approach is essential., (© 2024. The Author(s).)

Background: We sought to determine whether the Good School Toolkit-Primary violence prevention intervention was associated with reduced victimisation and perpetration of peer and intimate partner violence four years later, and if any associations were moderated by sex and early adolescent: family connectedness, socio-economic status, and experience of violence outside of school., Methods: Drawing on schools involved in a randomised controlled trial of the intervention, we used a quasi-experimental design to compare violence outcomes between those who received the intervention during our trial (n = 1388), and those who did not receive the intervention during or after the trial (n = 522). Data were collected in 2014 (mean age 13.4, SD 1.5 years) from participants in 42 schools in Luwero District, Uganda, and 2018/19 from the same participants both in and out of school (mean age 18, SD: 1.77 years). We compared children who received the Good School Toolkit-Primary, a whole school violence prevention intervention, during a randomised controlled trial, to those who did not receive the intervention during or after the trial. Outcomes were measured using items adapted from the International Society for the Prevention of Child Abuse and Neglect Child Abuse Screening Tool-Child Institutional. We used mixed-effect multivariable logistic regression, with school fitted as a random-effect to account for clustering., Results: 1910 adolescents aged about 16-19 years old were included in our analysis. We found no evidence of an average long-term intervention effect on our primary outcome, peer violence victimization at follow-up (aOR = 0.81, 95%CI = 0.59-1.11); or for any secondary outcome. However, exposure to the intervention was associated with: later reductions in peer violence, for adolescents with high family connectedness (aOR = 0.70, 95% CI 0.49 to 0.99), but not for those with low family connectedness (aOR = 1.07, 95% CI 0.69 to 1.6; p-interaction = 0.06); and reduced later intimate partner violence perpetration among males with high socio-economic status (aOR = 0.32, 95%CI 0.11 to 0.90), but not low socio-economic status (aOR = 1.01 95%CI 0.37 to 2.76, p-interaction = 0.05)., Conclusions: Young adolescents in connected families and with higher socio-economic status may be better equipped to transfer violence prevention skills from primary school to new relationships as they get older., Trial Registration: Clinicaltrials.gov, NCT01678846, registration date 24 August 2012. Protocol for this paper:  https://www.researchprotocols.org/2020/12/e20940 ., (© 2024. The Author(s).)

Background: Whole-school interventions go beyond classroom health education to modify the school environment to promote health. A sub-set aim to promote student commitment to school to reduce substance use and violence (outcomes associated with low commitment). It is unclear what factors influence implementation of such interventions., Methods: We conducted a systematic review including synthesis of evidence from process evaluations examining what factors affect implementation. Meta-ethnographic synthesis was informed by May's General Theory of Implementation., Results: Sixteen reports, covering 13 studies and 10 interventions were included in our synthesis. In terms of May's concept of 'sense-making', we found that school staff were more likely to understand what was required in implementing an intervention when provided with good-quality materials and support. Staff could sometimes wilfully or unintentionally misinterpret interventions. In terms of May's concept of 'cognitive participation', whereby staff commit to implementation, we found that lack of intervention adaptability could in particular undermine implementation of whole-school elements. Interventions providing local data were reported as helping build staff commitment. School leaders were more likely to commit to an intervention addressing an issue they already intended to tackle. Collaborative planning groups were reported as useful in ensuring staff 'collective action' (May's term for working together) to enact interventions. Collective action was also promoted by the presence of sufficient time, leadership and relationships. Implementation of whole-school interventions took time to build. Considering May's concept of 'reflexive monitoring' (formal or informal review of progress), this was important in assessing and enhancing implementation. 'Quick wins' could help maintain collective impetus to implement further intervention activities., Conclusion: We identified novel factors influencing implementation of whole-school elements such as: local adaptability of interventions; providing local data to build commitment; interventions addressing an issue already on school leaders' agenda; collaborative planning groups; and 'reflexive monitoring' as an explicit intervention component., (© 2022. The Author(s).)

Background: Menstrual health is an increasingly recognised public health issue, defined as complete physical, mental, and social well-being in relation to the menstrual cycle. The MENISCUS trial aims to assess whether a multi-component intervention addressing physical and emotional aspects of menstrual health improves educational attainment, mental health problems, menstrual management, self-efficacy, and quality of life among girls in secondary school in Uganda., Methods: The study is a parallel-arm cluster-randomised controlled trial with 60 schools (clusters) in Wakiso and Kalungu districts, with a mixed-methods process evaluation to assess intervention fidelity and acceptability and economic and policy analyses. The schools will be randomised 1:1 to immediate intervention or to optimised usual care with delayed intervention delivery. The intervention includes creation of a Menstrual Health Action Group at schools and NGO-led training of trainers on puberty education, development of a drama skit, delivery of a menstrual health kit including reusable pads and menstrual cups, access to pain management strategies including analgesics, and basic improvements to school water, sanitation, and hygiene facilities. Baseline data will be collected from secondary 2 students in 2022 (median age ~15.5 years), with endline after 1 year of intervention delivery (~3600 females and a random sample of ~900 males). The primary outcomes assessed in girls are (i) examination performance based on the Mathematics, English, and Biology curriculum taught during the intervention delivery (independently assessed by the Uganda National Examinations Board) and (ii) mental health problems using the Total Difficulties Scale of the Strengths and Difficulties 25-item questionnaire. Secondary outcomes are menstrual knowledge and attitudes in girls and boys and, in girls only, menstrual practices, self-efficacy in managing menstruation, quality of life and happiness, prevalence of urogenital infections, school and class attendance using a self-completed menstrual daily diary, and confidence in maths and science., Discussion: The trial is innovative in evaluating a multi-component school-based menstrual health intervention addressing both physical and emotional aspects of menstrual health and using a "training of trainers" model designed to be sustainable within schools. If found to be cost-effective and acceptable, the intervention will have the potential for national and regional scale-up., Trial Registration: ISRCTN 45461276 . Registered on 16 September 2021., (© 2022. The Author(s).)

Background: Positive Choices is a whole-school social-marketing intervention to promote sexual health among secondary school students. Intervention comprises the following: school health promotion council involving staff and students coordinating delivery, student survey to inform local tailoring, teacher-delivered classroom curriculum, student-run campaigns, parent information and review of sexual/reproductive health services to inform improvements. This trial builds on an optimisation/pilot-RCT study which met progression criteria, plus findings from another pilot RCT of the Project Respect school-based intervention to prevent dating and relationship violence which concluded such work should be integrated within Positive Choices. Young people carry a disproportionate burden of adverse sexual health; most do not report competence at first sex. Relationships and sex education in schools can contribute to promoting sexual health but effects are small, inconsistent and not sustained. Such work needs to be supplemented by 'whole-school' (e.g. student campaigns, sexual health services) and 'social marketing' (harnessing commercial marketing to social ends) approaches for which there is good review-level evidence but not from the UK., Methods: We will conduct a cluster RCT across 50 schools (minimum 6440, maximum 8500 students) allocated 1:1 to intervention/control assessing outcomes at 33 months. Our primary outcome is non-competent first sex. Secondary outcomes are non-competent last sex, age at sexual debut, non-use of contraception at first and last sex among those reporting heterosexual intercourse, number of sexual partners, dating and relationship violence, sexually transmitted infections and pregnancy and unintended pregnancy for girls and initiation of pregnancy for boys. We will recruit 50 school and undertake baseline surveys by March 2022, implement the intervention over the 2022-2024 school years and conduct the economic and process evaluations by July 2024; undertake follow-up surveys by December 2024; complete analyses, all patient and policy involvement and draft the study report by March 2025 and engage in knowledge exchange from December 2024., Discussion: This trial is one of a growing number focused on whole-school approaches to public health in schools. The key scientific output will be evidence about the effectiveness, costs and potential scalability and transferability of Positive Choices., Trial Registration: ISRCTN No: ISRCTN16723909 . Registered on 3 September 2021., (© 2022. The Author(s).)

Background: The healthy context paradox, originally described with respect to school-level bullying interventions, refers to the generation of differences in mental wellbeing amongst those who continue to experience bullying even after interventions successfully reduce victimisation. Using data from the INCLUSIVE trial of restorative practice in schools, we relate this paradox to the need to theorise potential harms when developing interventions; formulate the healthy context paradox in a more general form defined by mediational relationships and cluster-level interventions; and propose two statistical models for testing the healthy context paradox informed by multilevel mediation methods, with relevance to structural and individual explanations for this paradox., Methods: We estimated two multilevel mediation models with bullying victimisation as the mediator and mental wellbeing as the outcome: one with a school-level interaction between intervention assignment and the mediator; and one with a random slope component for the student-level mediator-outcome relationship predicted by school-level assignment. We relate each of these models to contextual or individual-level explanations for the healthy context paradox., Results: Neither model suggested that the INCLUSIVE trial represented an example of the healthy context paradox. However, each model has different interpretations which relate to a multilevel understanding of the healthy context paradox., Conclusions: Greater exploration of intervention harms, especially when those accrue to population subgroups, is an essential step in better understanding how interventions work and for whom. Our proposed tests for the presence of a healthy context paradox provide the analytic tools to better understand how to support development and implementation of interventions that work for all groups in a population., Trial Registration: Current Controlled Trials, ISRCTN10751359 ., (© 2022. The Author(s).)

Background: Qualitative data show negative impacts of menstruation on health and education in many settings, but there are few longitudinal quantitative studies of the impact of menstruation. We analyse associations with menstrual anxiety and school attendance in a study of Ugandan secondary school students., Methods: Data were from a longitudinal pilot study of a menstrual health intervention (MENISCUS), conducted in two secondary schools in Entebbe sub-district, Uganda. Self-completed menstrual-related data, including menstrual anxiety, were collected from 232 participants pre- and post-intervention. A sub-cohort of 100 randomly-selected post-menarcheal girls were asked to self-complete daily diaries during 10 months of follow-up, with data on menstrual flow, pain, and school attendance. We used multivariable logistic regression to estimate associations with menstrual anxiety among all girls at baseline, and random-effects logistic regression to estimate associations of menstrual characteristics with school non-attendance for 3 months pre-intervention in the sub-cohort, adjusting for within-girl clustering., Results: Overall, 130/222 (58.6%) of menstruating girls reported being anxious about their next period. Menstrual anxiety was higher in those not living with their mother (adjusted odds ratio (OR) = 1.91; 95% confidence interval (CI) 1.01-3.60), believing menstrual myths (aOR = 1.83; 0.95-3.50 for not agreeing that it is healthy for a girl to run, dance or cycle during her period; aOR = 1.97; 1.04-3.73 for agreeing that when a girl has her period she is unclean), lower menstrual confidence (aOR = 2.49; 1.33-4.65 for avoiding physical activity during her period; aOR = 1.68; 0.89-3.17 for not feeling comfortable to talk to other girls about her period; aOR = 2.89; 1.28-6.54 for agreeing that boys/girls tease them about their periods; and aOR = 2.27; 1.21-4.27 for worrying about being teased during her period). Those with lower knowledge about menstruation were less likely to report anxiety (aOR = 0.44; 0.23-0.84). During the pre-intervention period of the sub-cohort, school non-attendance was associated with menstrual pain, with 21.7% of girls missing school on days when they reported pain vs. 8.3% on days when no pain was reported (aOR = 3.82; 1.66-8.77)., Conclusions: Menstruation causes substantial anxiety in Ugandan schoolgirls, and menstrual pain is associated with missing school on period-days. Menstrual health interventions should address socio-cultural aspects of menstruation to reduce anxiety, and provide education on pain management strategies to support school attendance., (© 2021. The Author(s).)

Background: Positive Choices is a whole-school social marketing intervention to promote sexual health among secondary school students. Intervention comprises school health promotion council involving staff and students coordinating delivery; student survey to inform local tailoring; teacher-delivered classroom curriculum; student-run campaigns; parent information; and review of sexual/reproductive health services to inform improvements. This trial builds on an optimisation/pilot RCT study which met progression criteria, plus findings from another pilot RCT of the Project Respect school-based intervention to prevent dating and relationship violence which concluded such work should be integrated within Positive Choices. Young people carry a disproportionate burden of adverse sexual health; most do not report competence at first sex. Relationships and sex education in schools can contribute to promoting sexual health but effects are small, inconsistent and not sustained. Such work needs to be supplemented by 'whole-school' (e.g. student campaigns, sexual health services) and 'social marketing' (harnessing commercial marketing to social ends) approaches for which there is good review-level evidence but not from the UK., Methods: We will conduct a cluster RCT across 50 schools (minimum 6440, maximum 8500 students) allocated 1:1 to intervention/control assessing outcomes at 33 months. Our primary outcome is non-competent first sex. Secondary outcomes are non-competent last sex, age at sexual debut, non-use of contraception at first and last sex among those reporting heterosexual intercourse, number of sexual partners, dating and relationship violence, sexually transmitted infections, and pregnancy and unintended pregnancy for girls and initiation of pregnancy for boys. We will recruit 50 school and undertake baseline surveys by March 2022; implement the intervention over the 2022-2024 school years and conduct the economic and process evaluations by July 2024; undertake follow-up surveys by December 2024; complete analyses, all patient and policy involvement and draft the study report by March 2025; and engage in knowledge exchange from December 2024., Discussion: This trial is one of a growing number focused on whole-school approaches to public health in schools. The key scientific output will be evidence about the effectiveness, costs and potential scalability and transferability of Positive Choices., Trial Registration: ISRCTN No: ISRCTN16723909 . Trial registration summary: Date:. Funded by: National Institute for Health Research Public Health Research Programme (NIHR131487)., Sponsor: LSHTM. Public/scientific contact: Chris Bonell. Public title: Positive Choices trial. Scientific title: Phase-III RCT of Positive Choices: a whole-school social marketing intervention to promote sexual health and reduce health inequalities. Countries of recruitment: UK., Intervention: Positive Choices., Inclusion Criteria: Students in year 8 (age 12-13 years) at baseline deemed competent by schools to participate in secondary schools excluding pupil referral units, schools for those with special educational needs and disabilities, and schools with 'inadequate' Ofsted inspections., Study Type: interventional study with superiority phase III cluster RCT design. Enrollment: 1/9/21-31/3/22., Sample Size: 50 schools and 6440-8500 students. Recruitment status: pending., Primary Outcome: binary measure of non-competent first sex., Secondary Outcomes: non-competent last sex; age at sexual debut; non-use of contraception at first and last sex; number of sexual partners; dating and relationship violence (DRV) victimisation; sexually transmitted infections; pregnancy and unintended pregnancy for girls and initiation of pregnancy for boys using adapted versions of the RIPPLE measures. Ethics review: LSHTM research ethics committee (reference 26411). Completion data: 1/3/25. Sharing statement: Data will be made available after the main trial analyses have been completed on reasonable request from researchers with ethics approval and a clear protocol. Amendments to the protocol will be communicated to the investigators, sponsor, funder, research ethics committee, trial registration and the journal publishing the protocol. Amendments affecting participants' experience of the intervention or important amendments affecting the overall design and conduct of the trial will be communicated to participants., (© 2021. The Author(s).)

Background: Syndemic theory highlights the potential for health problems to interact synergistically, compounding impact. Young adults not in education, employment or training (NEET) are more likely to experience disadvantage and poorer general health outcomes. However, there is little research on their sexual health, or the extent to which this clusters with mental and physical health outcomes., Methods: Analysis of data from 16 to 24 year olds (1729 men, 2140 women) interviewed 2010-12 for Britain's third National Survey of Sexual Attitudes and Lifestyles. Natsal-3 is a national probability sample survey using computer-assisted personal interviewing with computer-assisted self-interviewing. Participants were classified as workers, students or NEET. We used multivariable logistic regression to examine associations between being NEET (relative to worker or student) and risk behaviours and outcomes in physical, sexual and mental health domains. We then examined how risk behaviours and poor health outcomes cluster within and across domains., Results: 15% men and 20% women were NEET; 36% men and 32% women were workers; and 49% men and 48% women were students. Young people who were NEET were more likely to report smoking and drug use (men) than other young people. There were few differences in sexual health, although NEETs were more likely to report condomless sex, and NEET women, unplanned pregnancy (past year). Risk behaviours clustered more within and across domains for NEET men. Among NEET women, poor health outcomes clustered across mental, physical and sexual health domains., Conclusions: Harmful health behaviours (men) and poor health outcomes (women) clustered more in those who are NEET. This points to a possible syndemic effect of NEET status on general ill health, especially for women. Our paper is novel in highlighting that elevated risk pertains to sexual as well as mental and physical health.

Background: Whole-school interventions represent promising approaches to promoting adolescent sexual health, but they have not been rigorously trialled in the UK and it is unclear if such interventions are feasible for delivery in English secondary schools. The importance of involving intended beneficiaries, implementers and other key stakeholders in the co-production of such complex interventions prior to costly implementation and evaluation studies is widely recognised. However, practical accounts of such processes remain scarce. We report on co-production with specialist providers, students, school staff, and other practice and policy professionals of two new whole-school sexual heath interventions for implementation in English secondary schools., Methods: Formative qualitative inquiry involving 75 students aged 13-15 and 23 school staff. A group of young people trained to advise on public health research were consulted on three occasions. Twenty-three practitioners and policy-makers shared their views at a stakeholder event. Detailed written summaries of workshops and events were prepared and key themes identified to inform the design of each intervention., Results: Data confirmed acceptability of addressing unintended teenage pregnancy, sexual health and dating and relationships violence via multi-component whole-school interventions and of curriculum delivery by teachers (providing appropriate teacher selection). The need to enable flexibility for the timetabling of lessons and mode of parent communication; ensure content reflected the reality of young people's lives; and develop prescriptive teaching materials and robust school engagement strategies to reflect shrinking capacity for schools to implement public-health interventions were also highlighted and informed intervention refinements. Our research further points to some of the challenges and tensions involved in co-production where stakeholder capacity may be limited or their input may conflict with the logic of interventions or what is practicable within the constraints of a trial., Conclusions: Multi-component, whole-school approaches to addressing sexual health that involve teacher delivered curriculum may be feasible for implementation in English secondary schools. They must be adaptable to individual school settings; involve careful teacher selection; limit additional burden on staff; and accurately reflect the realities of young people's lives. Co-production can reduce research waste and may be particularly useful for developing complex interventions, like whole-school sexual health interventions, that must be adaptable to varying institutional contexts and address needs that change rapidly. When co-producing, potential limitations in relation to the representativeness of participants, the 'depth' of engagement necessary as well as the burden on participants and how they will be recompensed must be carefully considered. Having well-defined, transparent procedures for incorporating stakeholder input from the outset are also essential. Formal feasibility testing of both co-produced interventions in English secondary schools via cluster RCT is warranted., Trial Registration: Project Respect: ISRCTN12524938 . Positive Choices: ISRCTN65324176.

Background: Sexual risk, substance use, and mental ill health constitute a syndemic of co-occurring, mutually reinforcing epidemics amongst men who have sex with men (MSM). Developed since 1995, e-health interventions offer accessible, anonymous support and can be effective in addressing these outcomes, suggesting the potential value of developing e-health interventions that address these simultaneously amongst MSM. We conducted a systematic review of e-health interventions addressing one or more of these outcomes amongst MSM and in this paper describe the theories of change underpinning relevant interventions, what these offer and how they might complement each other., Methods: We identified eligible reports via expert requests, reference-checking and database and Google searches. Results were screened for reports published in 1995 or later; focused on MSM; reporting on e-health interventions providing ongoing support to prevent HIV/STIs, sexual risk behaviour, substance use, anxiety or depression; and describing intervention theories of change. Reviewers assessed report quality, extracted intervention and theory of change data, and developed a novel method of synthesis using diagrammatic representations of theories of change., Results: Thirty-three reports on 22 intervention theories of change were included, largely of low/medium-quality. Inductively grouping these theories according to their core constructs, we identified three distinct groupings of theorised pathways. In the largest, the 'cognitive/skills' grouping, interventions provide information and activities which are theorised to influence behaviour via motivation/intention and self-efficacy/perceived control. In the 'self-monitoring' grouping, interventions are theorised to trigger reflection, self-reward/critique and self-regulation. In the 'cognitive therapy' grouping, the theory of change is rooted in cognitive therapy techniques, aiming to reframe negative emotions to improve mental health., Conclusions: The synthesised theories of change provide a framework for developing e-health interventions that might holistically address syndemic health problems amongst MSM. Improving reporting on theories of change in primary studies of e-health interventions would enable a better understanding of how they are intended to work and the evidence supporting this. The novel diagrammatic method of theory of change synthesis used here could be used for future reviews where interventions are driven by existing well-defined behaviour and behaviour change theories., Systematic Review Registration: PROSPERO CRD42018110317.

Objectives: Restricting mobility is a central aim for lowering contact rates and preventing COVID-19 transmission. Yet the impact on mobility of different non-pharmaceutical countermeasures in the earlier stages of the pandemic is not well-understood., Design: Trends were evaluated using Citymapper's mobility index covering 2nd to 26th March 2020, expressed as percentages of typical usage periods from 0% as the lowest and 100% as normal. China and India were not covered. Multivariate fixed effects models were used to estimate the association of policies restricting movement on mobility before and after their introduction. Policy restrictions were assessed using the Oxford COVID-19 Government Response Stringency Index as well as measures coding the timing and degree of school and workplace closures, transport restrictions, and cancellation of mass gatherings., Setting: 41 cities worldwide., Main Outcome Measures: Citymapper's mobility index., Results: Mobility declined in all major cities throughout March. Larger declines were seen in European than Asian cities. The COVID-19 Government Response Stringency Index was strongly associated with declines in mobility (r = - 0.75, p < 0.001). After adjusting for time-trends, we observed that implementing non-pharmaceutical countermeasures was associated with a decline of mobility of 10.0% for school closures (95% CI: 4.36 to 15.7%), 15.0% for workplace closures (95% CI: 10.2 to 19.8%), 7.09% for cancelling public events (95% CI: 1.98 to 12.2%), 18.0% for closing public transport (95% CI: 6.74 to 29.2%), 13.3% for restricting internal movements (95% CI: 8.85 to 17.8%) and 5.30% for international travel controls (95% CI: 1.69 to 8.90). In contrast, as expected, there was no association between population mobility changes and fiscal or monetary measures or emergency healthcare investment., Conclusions: Understanding the effect of public policy on mobility in the early stages is crucial to slowing and reducing COVID-19 transmission. By using Citymapper's mobility index, this work provides the first evidence about trends in mobility and the impacts of different policy interventions, suggesting that closure of public transport, workplaces and schools are particularly impactful.

Background: This study reports on qualitative research conducted within a randomised controlled trial to explore possible intervention mechanisms. It focuses on the 'Learning Together' whole-school intervention delivered in secondary schools in England from 2014 to 2017 aiming to prevent bullying and aggression and improve student health. Intervention schools received staff training in restorative practice, a social and emotional learning curriculum, and an external facilitator and manual to convene and run a student/staff action group tasked with coordinating the intervention, focusing this on local needs., Methods: Informed by realist approaches to evaluation, we analysed qualitative data to explore intervention mechanisms and how these might interact with school contexts to generate outcomes. Qualitative analysis drew on 45 interviews and 21 focus groups across three case-study schools and employed thematic content analysis to explore how intervention resources were taken up and used by local actors, how participants described the intervention mechanisms that then ensued, and how these might have generated beneficial outcomes., Results: The thematic content analysis identified three social mechanisms that recurred in participant accounts: (1) building student commitment to the school community, (2) building healthy relationships by modelling and teaching pro-social skills, and (3) de-escalating bullying and aggression and enabling re-integration within the school community., Conclusions: Our analysis provides in-depth exploration of possible mechanisms and the contextual contingencies associated with these, allowing refinement of the initial intervention theory of change., Trial Registration: ISRCTN registry 10751359 . Registered on 11 March 2014.

Background: Poor menstrual health and hygiene (MHH) is a globally recognised public health challenge. A pilot study of an MHH intervention was conducted in two secondary schools in Entebbe, Uganda, over 9 months. The intervention included five components delivered by the implementing partner (WoMena Uganda) and the research team: (i) training teachers to implement government guidelines for puberty education, (ii) a drama skit to reduce stigma about menstruation, (iii) training in use of a menstrual kit (including re-usable pads), (iv) guidance on pain relief methods including provision of analgesics and (v) improvements to school water, sanitation and hygiene (WASH) facilities. The aim of the process evaluation was to examine implementation, context and possible causal pathways., Methods: We collected information on fidelity, dose, reach, acceptability, context and mechanisms of impact using (i) quantitative survey data collected from female and male students in year 2 of secondary school (ages 13-21; 450 at the baseline and 369 at endline); (ii) qualitative data from 40 in-depth interviews with parents, teachers and female students, and four focus group discussions with students, stratified by gender; (iii) data from unannounced visits checking on WASH facilities throughout the study; and (iv) routine data collected as part of the implementation. Quantitative data were used primarily to assess fidelity, dose and reach. Qualitative data were used primarily to assess acceptability, context and possible mechanisms., Results: Both schools received all intervention elements that were delivered by the research team and implementing partner. The drama skit, menstrual kit and pain management intervention components were delivered with fidelity. Intervention components that relied on school ownership (puberty education training and WASH improvements) were not fully delivered. Overall, the intervention was acceptable to participants. Multilevel contextual factors including schools' social and physical environment, and family, cultural and social factors influenced the acceptability of the intervention in the school setting. The intervention components reinforced one another, as suggested in our theoretical framework., Conclusion: The intervention was feasible to deliver and acceptable to the schools and students. We propose a full-scale cluster-randomised trial to evaluate the intervention, adding a school-based MHH leadership group to address issues with school ownership., Trial Registration: ClinicalTrials.gov NCT04064736. Registered August 22, 2019, retrospectively registered., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Background: The sustainability of school-based health interventions after external funds and/or other resources end has been relatively unexplored in comparison to health care. If effective interventions discontinue, new practices cannot reach wider student populations and investment in implementation is wasted. This review asked: What evidence exists about the sustainability of school-based public health interventions? Do schools sustain public health interventions once start-up funds end? What are the barriers and facilitators affecting the sustainability of public health interventions in schools in high-income countries?, Methods: Seven bibliographic databases and 15 websites were searched. References and citations of included studies were searched, and experts and authors were contacted to identify relevant studies. We included reports published from 1996 onwards. References were screened on title/abstract, and those included were screened on full report. We conducted data extraction and appraisal using an existing tool. Extracted data were qualitatively synthesised for common themes, using May's General Theory of Implementation (2013) as a conceptual framework., Results: Of the 9677 unique references identified through database searching and other search strategies, 24 studies of 18 interventions were included in the review. No interventions were sustained in their entirety; all had some components that were sustained by some schools or staff, bar one that was completely discontinued. No discernible relationship was found between evidence of effectiveness and sustainability. Key facilitators included commitment/support from senior leaders, staff observing a positive impact on students' engagement and wellbeing, and staff confidence in delivering health promotion and belief in its value. Important contextual barriers emerged: the norm of prioritising educational outcomes under time and resource constraints, insufficient funding/resources, staff turnover and a lack of ongoing training. Adaptation of the intervention to existing routines and changing contexts appeared to be part of the sustainability process., Conclusions: Existing evidence suggests that sustainability depends upon schools developing and retaining senior leaders and staff that are knowledgeable, skilled and motivated to continue delivering health promotion through ever-changing circumstances. Evidence of effectiveness did not appear to be an influential factor. However, methodologically stronger primary research, informed by theory, is needed., Trial Registration: The review was registered on PROSPERO: CRD42017076320, Sep. 2017.

Background: The SELPHI study (An HIV Self-Testing Public Health Intervention) is an online randomised controlled trial (RCT) of HIV self-testing (HIVST). The aim of this study was to assess the feasibility of recruiting UK men who have sex with men (cis and trans) and trans women who have sex with men to the SELPHI pilot, and the acceptability of the HIVST intervention used among those randomised to receive a kit., Methods: A mixed-methods approach to assessing trial feasibility and intervention acceptability was taken, using quantitative data from advertising sources and RCT surveys alongside qualitative data from a nested sub-study., Results: Online recruitment and intervention delivery was feasible. The recruitment strategy led to the registration of 1370 participants of whom 76% (1035) successfully enrolled and were randomised 60/40 to baseline testing vs no baseline testing. Advertising platforms performed variably. Reported HIVST kit use increased from 83% at two weeks to 96% at three months. Acceptability was very high across all quantitative measures. Participants described the instructions as easy to use, and the testing process as simple. The support structures in SELPHI were felt to be adequate. Described emotional responses to HIVST varied., Conclusions: Recruiting to a modest sized HIVST pilot RCT is feasible, and the recruitment, intervention and HIVST kit were acceptable. Research on support needs of individuals with reactive results is warranted.

Background: Public health policies sometimes have unexpected effects. Understanding how policies and interventions lead to outcomes is essential if policymakers and researchers are to intervene effectively and reduce harmful and other unintended consequences (UCs) of their actions. Yet, evaluating complex mechanisms and outcomes is challenging, even before considering how to predict assess and understand outcomes and UCs when interventions are scaled up. We aimed to explore with UK policymakers why some policies have UCs, and how researchers and policymakers should respond., Methods: We convened a one-day workshop with 14 people involved in developing, implementing or evaluating social and public health policies, and/or evaluating possible unintended effects. This included senior evaluators, policymakers from government and associated agencies, and researchers, covering policy domains from public health, social policy, poverty, and international development., Results: Policymakers suggested UCs happen for a range of reasons: poor policy design, unclear articulation of policy mechanisms or goals, or unclear or inappropriate evidence use, including evaluation techniques. While not always avoidable, it was felt that UCs could be partially mitigated by better use of theory and evidence, better involvement of stakeholders in concurrent design and evaluation of policies, and appropriate evaluation systems., Conclusions: UCs can be used to explore the mechanisms underpinning social change caused by public health policies. Articulating these mechanisms is essential for truly evidence-informed decision-making, to enable informed debate about policy options, and to develop evaluation techniques. Future work includes trying to develop a holistic stakeholder-led evaluation process.

Background: Dating and relationship violence (DRV)-intimate partner violence during adolescence-encompasses physical, sexual and emotional abuse. DRV is associated with a range of adverse health outcomes including injuries, sexually transmitted infections, adolescent pregnancy and mental health issues. Experiencing DRV also predicts both victimisation and perpetration of partner violence in adulthood.Prevention targeting early adolescence is important because this is when dating behaviours begin, behavioural norms become established and DRV starts to manifest. Despite high rates of DRV victimisation in England, from 22 to 48% among girls and 12 to 27% among boys ages 14-17 who report intimate relationships, no RCTs of DRV prevention programmes have taken place in the UK. Informed by two school-based interventions that have shown promising results in RCTs in the USA-Safe Dates and Shifting Boundaries-Project Respect aims to optimise and pilot a DRV prevention programme for secondary schools in England., Methods: Design: optimisation and pilot cluster RCT. Trial will include a process evaluation and assess the feasibility of conducting a phase III RCT with embedded economic evaluation. Cognitive interviewing will inform survey development.Participants: optimisation involves four schools and pilot RCT involves six (four intervention, two control). All are secondary schools in England. Baseline surveys conducted with students in years 8 and 9 (ages 12-14). Follow-up surveys conducted with the same cohort, 16 months post-baseline. Optimisation sessions to inform intervention and research methods will involve consultations with stakeholders, including young people.Intervention: school staff training, including guidance on reviewing school policies and addressing 'hotspots' for DRV and gender-based harassment; information for parents; informing students of a help-seeking app; and a classroom curriculum for students in years 9 and 10, including a student-led campaign.Primary outcome: the primary outcome of the pilot RCT will be whether progression to a phase III RCT is justified. Testing within the pilot will also determine which of two existing scales is optimal for assessing DRV victimisation and perpetration in a phase III RCT., Discussion: This will be the first RCT of an intervention to prevent DRV in the UK. If findings indicate feasibility and acceptability, we will undertake planning for a phase III RCT of effectiveness., Trial Registration: ISRCTN, ISRCTN 65324176. Registered 8 June 2017., Competing Interests: This study was approved by the London School of Hygiene and Tropical Medicine Ethics Committee (reference: 11986) and by the National Society for the Prevention of Cruelty to Children Research Ethics Committee (reference: R/17/106). All study participants provide informed consent (for adults) or assent (for those under age 18) to participate in data collection.Not applicable; no study data are included in this publication.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Background: Within increasingly constrained school timetables, interventions that integrate academic and health education to reduce substance use and violence may hold promise as a category of intervention that can positively affect both academic and health outcomes. There are no current systematic reviews exploring the effectiveness of such interventions or factors that affect their implementation., Methods: A total of 19 bibliographic databases and 32 websites were searched. References were also extracted from the reference lists of included studies, and experts and authors were contacted to identify relevant studies. We included reports with no restrictions on language or date. References were screened on title/abstract and those not thus excluded were screened on full report. Data extraction and appraisal followed the Critical Appraisal Skills Programme, Evidence for Policy and Practice Information and Co-ordinating Centre and Cochrane tools. Extracted process data were qualitatively meta-synthesised for common themes., Results: Seventy-eight thousand four hundred fifty-one unique references were identified, and 62 reports were included. A total of 16 reports (reporting on 15 studies of 12 interventions) evaluated process. Key facilitators of integrated academic and health curricula were supportive senior management and alignment of the intervention with school ethos; a positive teaching environment, including positive perceptions around the ability to be flexible in the adaptation and delivery of integrated academic and health curricula; positive pre-existing student and teacher attitudes towards intervention content; and parental support of interventions, largely through reinforcement of messaging at home. Important barriers were over-burdened teachers, with little time to learn and implement integrated curricula., Conclusion: Several useful facilitating and inhibiting factors linked to the implementation of interventions that integrate academic and health education for reduced substance use and/or violence were identified, providing tentative but insightful evidence of context-specific issues that may impact intervention success. However, overall, there is still a considerable gap in our understanding of how to achieve the successful implementation of these interventions.

Background: Schools can play an important role in promoting health. However, many education policies and institutions are increasingly emphasising academic attainment targets, which appear to be diminishing the time available for health education lessons. Interventions that integrate both health and academic learning may present an ideal solution, simultaneously addressing health education and academic development. The theories of change underlying these interventions are therefore of interest, but are poorly studied., Methods: A systematic review of evaluations of interventions that integrate academic and health education for reduced substance use and/or violence was carried out. As part of this, reports describing theory were assessed for quality and data extracted. Theoretical data were synthesised within and across individual interventions using reciprocal translation and meta-ethnographic line of argument synthesis to produce an overall theory of change for interventions that integrate health and academic education to prevent substance use and violence., Results: Forty-eight reports provided theoretical descriptions of 18 interventions. An overarching theory that emerged was that eroding 'boundaries' at multiple and mutually reinforcing levels-by integrating academic and health education, by transforming relationships between teachers and students, by generalising learning from classrooms to the wider school environment and by ensuring consistent messages from schools and families-is intended to lead to the development of a community of engaged students oriented towards pro-social behaviour and away from substance use, violence and other risk behaviours., Conclusions: Eroding 'boundaries' between health and academic education, teachers and students, classrooms and the wider school and schools and families were seen to be the most critical to establishing new frameworks of family, classroom or school organisation that are conducive to promoting both academic and social-emotional outcomes. Whether such interventions are feasible to implement and effective in reducing risk behaviours will be examined in other reports arising from the review.

Background: Since the introduction of the Teenage Pregnancy Strategy (TPS), England's under-18 conception rate has fallen by 55%, but a continued focus on prevention is needed to maintain and accelerate progress. The teenage birth rate remains higher in the UK than comparable Western European countries. Previous trials indicate that school-based social marketing interventions are a promising approach to addressing teenage pregnancy and improving sexual health. Such interventions are yet to be trialled in the UK. This study aims to optimise and establish the feasibility and acceptability of one such intervention: Positive Choices., Methods: Design: Optimisation, feasibility testing and pilot cluster randomised trial.Interventions: The Positive Choices intervention comprises a student needs survey, a student/staff led School Health Promotion Council (SHPC), a classroom curriculum for year nine students covering social and emotional skills and sex education, student-led social marketing activities, parent information and a review of school sexual health services.Systematic optimisation of Positive Choices will be carried out with the National Children's Bureau Sex Education Forum (NCB SEF), one state secondary school in England and other youth and policy stakeholders.Feasibility testing will involve the same state secondary school and will assess progression criteria to advance to the pilot cluster RCT.Pilot cluster RCT with integral process evaluation will involve six different state secondary schools (four interventions and two controls) and will assess the feasibility and utility of progressing to a full effectiveness trial.The following outcome measures will be trialled as part of the pilot:Self-reported pregnancy and unintended pregnancy (initiation of pregnancy for boys) and sexually transmitted infections,Age of sexual debut, number of sexual partners, use of contraception at first and last sex and non-volitional sexEducational attainmentThe feasibility of linking administrative data on births and termination to self-report survey data to measure our primary outcome (unintended teenage pregnancy) will also be tested., Discussion: This will be the first UK-based pilot trial of a school-wide social marketing intervention to reduce unintended teenage pregnancy and improve sexual health. If this study indicates feasibility and acceptability of the optimised Positive Choices intervention in English secondary schools, plans will be initiated for a phase III trial and economic evaluation of the intervention., Trial Registration: ISRCTN registry (ISCTN12524938. Registered 03/07/2017)., Competing Interests: This study was approved by the London School of Hygiene and Tropical Medicine (LSHTM) on 21 March 2017, Ref. 11927. Informed written opt-in consent will be sought from all research participants, including students, judged competent to provide this as per the process outlined under ‘Informed consent’.All authors read and approved the final manuscript for publication.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Background: We have previously proposed that trials of social interventions can be done within a "realist" research paradigm. Critics have countered that such trials are irredeemably positivist and asked us to explain our philosophical position., Methods: We set out to explore what is meant by positivism and whether trials adhere to its tenets (of necessity or in practice) via a narrative literature review of social science and philosophical discussions of positivism, and of the trials literature and three case studies of trials., Results: The philosophical literature described positivism as asserting: (1) the epistemic primacy of sensory information; (2) the requirement that theoretical terms equate with empirical terms; (3) the aim of developing universal laws; and (4) the unity of method between natural and social sciences. Regarding (1), it seems that rather than embodying the epistemic primacy of sensory data, randomised controlled trials (RCTs) of social interventions in health embrace an anti-positivist approach aiming to test hypotheses derived deductively from prior theory. Considering (2), while some RCTs of social interventions appear to limit theorisation to concepts with empirical analogues, others examine interventions underpinned by theories engaging with mechanisms and contextual contingencies not all of which can be measured. Regarding (3), while some trialists and reviewers in the health field do limit their role to estimating statistical trends as a mechanistic form of generalisation, this is not an inevitable feature of RCT-based research. Trials of social interventions can instead aim to generalise at the level of theory which specifies how mechanisms are contingent on context. In terms of (4), while RCTs are used to examine biomedical as well as social interventions in health, RCTs of social interventions are often distinctive in using qualitative analyses of data on participant accounts to examine questions of meaning and agency not pursued in the natural sciences., Conclusion: We conclude that the most appropriate paradigm for RCTs of social interventions is realism not positivism.

Background: Existing guidance for developing public health interventions does not provide information for researchers about how to work with intervention providers to co-produce and prototype the content and delivery of new interventions prior to evaluation. The ASSIST + Frank study aimed to adapt an existing effective peer-led smoking prevention intervention (ASSIST), integrating new content from the UK drug education resource Talk to Frank ( www.talktofrank.com ) to co-produce two new school-based peer-led drug prevention interventions. A three-stage framework was tested to adapt and develop intervention content and delivery methods in collaboration with key stakeholders to facilitate implementation., Methods: The three stages of the framework were: 1) Evidence review and stakeholder consultation; 2) Co-production; 3) Prototyping. During stage 1, six focus groups, 12 consultations, five interviews, and nine observations of intervention delivery were conducted with key stakeholders (e.g. Public Health Wales [PHW] ASSIST delivery team, teachers, school students, health professionals). During stage 2, an intervention development group consisting of members of the research team and the PHW ASSIST delivery team was established to adapt existing, and co-produce new, intervention activities. In stage 3, intervention training and content were iteratively prototyped using process data on fidelity and acceptability to key stakeholders. Stages 2 and 3 took the form of an action-research process involving a series of face-to-face meetings, email exchanges, observations, and training sessions., Results: Utilising the three-stage framework, we co-produced and tested intervention content and delivery methods for the two interventions over a period of 18 months involving external partners. New and adapted intervention activities, as well as refinements in content, the format of delivery, timing and sequencing of activities, and training manuals resulted from this process. The involvement of intervention delivery staff, participants and teachers shaped the content and format of the interventions, as well as supporting rapid prototyping in context at the final stage., Conclusions: This three-stage framework extends current guidance on intervention development by providing step-by-step instructions for co-producing and prototyping an intervention's content and delivery processes prior to piloting and formal evaluation. This framework enhances existing guidance and could be transferred to co-produce and prototype other public health interventions., Trial Registration: ISRCTN14415936 , registered retrospectively on 05 November 2014.

Background: Bullying and cyberbullying are common phenomena in schools. These negative behaviours can have a significant impact on the health and particularly mental health of those involved in such behaviours, both as victims and as bullies. This UK study aims to investigate student-level and school-level characteristics of those who become involved in bullying and cyberbullying behaviours as victims or perpetrators., Methods: We used data from 6667 Year 7 students from the baseline survey of a cluster randomized trial in 40 English schools to investigate the associations between individual-level and school-level variables with bullying victimization, cyberbullying perpetration, and cyberbullying victimization. We ran multilevel models to examine associations of bullying outcomes with individual-level variables and school-level variables., Results: In multilevel models, at the school level, school type and school quality measures were associated with bullying risk: students in voluntary-aided schools were less likely to report bullying victimization (0.6 (0.4, 0.9) p = 0.008), and those in community (3.9 (1.5, 10.5) p = 0.007) and foundation (4.0 (1.6, 9.9) p = 0.003) schools were more likely to report being perpetrators of cyberbullying than students in mainstream academies. A school quality rating of "Good" was associated with greater reported bullying victimization (1.3 (1.02, 1.5) p = 0.03) compared to ratings of "Outstanding.", Conclusions: Bullying victimization and cyberbullying prevalence vary across school type and school quality, supporting the hypothesis that organisational/management factors within the school may have an impact on students' behaviour. These findings will inform future longitudinal research investigating which school factors and processes promote or prevent bullying and cyberbullying behaviours., Trial Registration: Trial ID: ISRCTN10751359 Registered: 11/03/2014 (retrospectively registered).

Background: Systematic reviews suggest that multi-component interventions are effective in reducing bullying victimisation and perpetration. We are undertaking a phase III randomised trial of the INCLUSIVE multi-component intervention. This trial aims to assess the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying victimisation in English secondary schools. This paper updates the original trial protocol published in 2014 (Trials 15:381, 2014) and presents the changes in the process evaluation protocol and the secondary outcome data collection., Methods: The methods are summarised as follows., Design: cluster randomised trial., Participants: 40 state secondary schools. Outcomes assessed among the cohort of students at the end of year 7 (n = 6667) at baseline., Intervention: INCLUSIVE is a multi-component school intervention including a social and emotional learning curriculum, changes to school environment (an action group comprising staff and students reviews local data on needs to review rules and policies and determine other local actions) and staff training in restorative practice. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third intervention year involving no external facilitation but all other elements. Comparator: normal practice., Outcomes: Primary: Two primary outcomes at student level assessed at baseline and at 36 months: 1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC) 2. Bullying and victimisation: Gatehouse Bullying Scale (GBS) Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates., Sample Size: 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level. Randomisation: eligible consenting schools were randomised stratified for single-sex versus mixed-sex schools, school-level deprivation and measures of school attainment., Discussion: The trial involves independent research and intervention teams and is supervised by a Trial Steering Committee and a Data Monitoring Committee., Trial Registration: Current Controlled Trials, ISRCTN10751359 . Registered on 11 March 2014.

Background: Preventing adolescent substance use and youth violence are public health priorities. Positive youth development interventions are widely deployed often with the aim of preventing both. However, the theorised mechanisms by which PYD is intended to reduce substance use and violence are not clear and existing evaluated interventions are under-theorised. Using innovative methods, we systematically searched for and synthesised published theoretical literature describing what is meant by positive youth development and how it might reduce substance use and violence, as part of a broader systematic review examining process and outcomes of PYD interventions., Methods: We searched 19 electronic databases, review topic websites, and contacted experts between October 2013 and January 2014. We included studies written in English, published since 1985 that reported a theory of change for positive youth development focused on prevention of smoking, alcohol consumption, drug use or violence in out-of-school settings. Studies were independently coded and quality-assessed by two reviewers., Results: We identified 16 studies that met our inclusion criteria. Our synthesis suggests that positive youth development aims to provide youth with affective relationships and diverse experiences which enable their development of intentional self-regulation and multiple positive assets. These in turn buffer against or compensate for involvement in substance use and violence. Existing literature is not clear on how intentional self-regulation is developed and which specific positive assets buffer against substance use or violence., Conclusions: Our synthesis provides: an example of a rigorous systematic synthesis of theory literature innovatively applying methods of qualitative synthesis to theoretical literature; a clearer understanding of how PYD might reduce substance use and violence to inform future interventions and empirical evaluations.

Background: Randomised controlled trials (RCTs) of social interventions are often criticised as failing to open the 'black box' whereby they only address questions about 'what works' without explaining the underlying processes of implementation and mechanisms of action, and how these vary by contextual characteristics of person and place. Realist RCTs are proposed as an approach to evaluation science that addresses these gaps while preserving the strengths of RCTs in providing evidence with strong internal validity in estimating effects., Methods: In the context of growing interest in designing and conducting realist trials, there is an urgent need to offer a worked example to provide guidance on how such an approach might be practically taken forward. The aim of this paper is to outline a three-staged theoretical and methodological process of undertaking a realist RCT using the example of the evaluation of a whole-school restorative intervention aiming to reduce aggression and bullying in English secondary schools., Discussion: First, informed by the findings of our initial pilot trial and sociological theory, we elaborate our theory of change and specific a priori hypotheses about how intervention mechanisms interact with context to produce outcomes. Second, we describe how we will use emerging findings from the integral process evaluation within the RCT to refine, and add to, these a priori hypotheses before the collection of quantitative, follow-up data. Third, we will test our hypotheses using a combination of process and outcome data via quantitative analyses of effect mediation (examining mechanisms) and moderation (examining contextual contingencies). The results are then used to refine and further develop the theory of change., Conclusion: The aim of the realist RCT approach is thus not merely to assess whether the intervention is effective or not, but to develop empirically informed mid-range theory through a three-stage process. There are important implications for those involved with reporting and reviewing RCTs, including the use of new, iterative protocols., Trial Registration: Current Controlled Trials ISRCTN10751359 (Registered 11 March 2014).

Background: Multiple interventions meta-analysis has been recommended in the methodological literature as a tool for evidence synthesis when a heterogeneous set of interventions is included in the same review—and, more recently, when a heterogeneous set of complex interventions is included. However, there is little guidance on the use of this method with complex interventions. This article suggests two approaches to model complexity and heterogeneity through this method., Discussion: 'Clinically meaningful units' groups interventions by modality or similar theory of change, whereas 'components and dismantling' separates out interventions into combinations of components and either groups interventions by the combination of components they demonstrate or extracts effects for each identified component and, possibly, interactions between components. Future work in systematic review methodology should aim to understand how to develop taxonomies of components or theories of change that are internally relevant to the studies in these multiple interventions meta-analyses., Summary: Despite little meaningful prior guidance to its use in this context, multiple interventions meta-analysis has the potential to be a useful tool for synthesising heterogeneous sets of complex interventions. Researchers should choose an approach in accordance with their specific aims in their systematic review.

Background: Randomised controlled trials (RCTs) are widely viewed as the gold standard for assessing effectiveness in health research; however many researchers and practitioners believe that RCTs are inappropriate and un-doable in social care settings, particularly in relation to looked after children. The aim of this article is to describe the challenges faced in conducting a pilot study and phase II RCT of a peer mentoring intervention to reduce teenage pregnancy in looked after children in a social care setting., Methods: Interviews were undertaken with social care professionals and looked after children, and a survey conducted with looked after children, to establish the feasibility and acceptability of the intervention and research design., Results: Barriers to recruitment and in managing the intervention were identified, including social workers acting as informal gatekeepers; social workers concerns and misconceptions about the recruitment criteria and the need for and purpose of randomisation; resource limitations, which made it difficult to prioritise research over other demands on their time and difficulties in engaging and retaining looked after children in the study., Conclusions: The relative absence of a research infrastructure and culture in social care and the lack of research support funding available for social care agencies, compared to health organisations, has implications for increasing evidence-based practice in social care settings, particularly in this very vulnerable group of young people.

Background: Obesity is an important public health issue. Finding ways to increase physical activity and improve nutrition, particularly in children, is a clear priority. Our Cochrane review of the World Health Organization's Health Promoting Schools (HPS) framework found this approach improved students' physical activity and fitness, and increased fruit and vegetable intake. However, there was considerable heterogeneity in reported impacts. This paper synthesises process evaluation data from these studies to identify factors that might explain this variability., Methods: We searched 20 health, education and social-science databases, and trials registries and relevant websites in 2011 and 2013. No language or date restrictions were applied. We included cluster randomised controlled trials. Participants were school students aged 4-18 years. Studies were included if they: took an HPS approach (targeting curriculum, environment and family/community); focused on physical activity and/or nutrition; and presented process evaluation data. A framework approach was used to facilitate thematic analysis and synthesis of process data., Results: Twenty-six studies met the inclusion criteria. Most were conducted in America or Europe, with children aged 12 years or younger. Although interventions were acceptable to students and teachers, fidelity varied considerably across trials. Involving families, while an intrinsic element of the HPS approach, was viewed as highly challenging. Several themes emerged regarding which elements of interventions were critical for success: tailoring programmes to individual schools' needs; aligning interventions with schools' core aims; working with teachers to develop programmes; and providing on-going training and support. An emphasis on academic subjects and lack of institutional support were barriers to implementation., Conclusions: Stronger alliances between health and education appear essential to intervention success. Researchers must work with schools to develop and implement interventions, and to evaluate their impact on both health and educational outcomes as this may be a key determinant of scalability. If family engagement is attempted, better ways to achieve this must be developed and evaluated. Further evaluations of interventions to promote physical activity and nutrition during adolescence are needed. Finally, process evaluations must move beyond simple measures of acceptability/fidelity to include detailed contextual information to illuminate exactly what works, for whom, in what contexts and why.

Background: Healthy children achieve better educational outcomes which, in turn, are associated with improved health later in life. The World Health Organization's Health Promoting Schools (HPS) framework is a holistic approach to promoting health and educational attainment in school. The effectiveness of this approach has not yet been rigorously reviewed., Methods: We searched 20 health, education and social science databases, and trials registries and relevant websites in 2011 and 2013. We included cluster randomised controlled trials. Participants were children and young people aged four to 18 years attending schools/colleges. HPS interventions had to include the following three elements: input into the curriculum; changes to the school's ethos or environment; and engagement with families and/or local communities. Two reviewers identified relevant trials, extracted data and assessed risk of bias. We grouped studies according to the health topic(s) targeted. Where data permitted, we performed random-effects meta-analyses., Results: We identified 67 eligible trials tackling a range of health issues. Few studies included any academic/attendance outcomes. We found positive average intervention effects for: body mass index (BMI), physical activity, physical fitness, fruit and vegetable intake, tobacco use, and being bullied. Intervention effects were generally small. On average across studies, we found little evidence of effectiveness for zBMI (BMI, standardized for age and gender), and no evidence for fat intake, alcohol use, drug use, mental health, violence and bullying others. It was not possible to meta-analyse data on other health outcomes due to lack of data. Methodological limitations were identified including reliance on self-reported data, lack of long-term follow-up, and high attrition rates., Conclusion: This Cochrane review has found the WHO HPS framework is effective at improving some aspects of student health. The effects are small but potentially important at a population level.

Background: Systematic reviews suggest that interventions that address school organisation are effective in reducing victimisation and bullying. We successfully piloted a school environment intervention modified from international studies to incorporate 'restorative justice' approaches. This trial aims to establish the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying in English secondary schools., Design: cluster randomised trial., Participants: 40 state-supported secondary schools. OUTCOMES assessed among the cohort of students in year 8 (n = approximately 6,000) in intervention year 1., Intervention: INCLUSIVE is a school-led intervention which combines changes to the school environment with the promotion of social and emotional skills and restorative practices through: the formation of a school action group involving students and staff supported by an external facilitator to review local data on needs, determine priorities, and develop and implement an action plan for revising relevant school policies/rules and other actions to improve relationships at school and reduce aggression; staff training in restorative practices; and a new social and emotional skills curriculum. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third locally facilitated intervention year.Comparator: normal practice., Outcomes: primary: 2 primary outcomes at student level assessed at baseline and at 36 months:1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC)2. Bullying and victimisation: Gatehouse Bullying Scale (GBS)Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates., Sample Size: 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level.Randomisation: eligible consenting schools will be randomised stratified for single sex versus mixed sex schools, school-level deprivation and measures of school attainment., Discussion: The trial will be run by independent research and intervention teams and supervised by a Trial Steering Committee and a Data Monitoring Committee (DMC)., Trial Registration: Current Controlled Trials ISRCTN10751359 (Registered 11 March 2014).

Background: Men who have sex with men (MSM) are at increased risk of HIV infection in both high- and low-income settings. Mass media campaigns have been used as a means of communicating HIV health promotion messages to large audiences of MSM. There is no consensus on which designs are most appropriate to evaluate the process and outcomes of such interventions., Methods: An exploratory review was conducted to assess research examining awareness, acceptability, effects on HIV testing, disclosure and sexual risk, and cost-effectiveness of HIV mass media campaigns targeting MSM. We searched for quantitative and qualitative studies published between 1990 and May 2011 via the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Psych Info, ISI Web of Science, OpenGrey and COPAC, and contacting experts. No exclusions were made on the basis of study design or methods because our primary aim was to map evidence. We appraised study quality and present a narrative synthesis of findings., Results: Sixteen reports from 12 studies were included. All were from high-income countries and most examined multi-media interventions. Half of the studies were single cross-sectional surveys. Three repeat cross-sectional studies collected data pre and post the campaign launch. The remaining three studies monitored routine data. Three studies included a nested qualitative component. Campaign coverage was the most commonly reported outcome (9 studies). Imagery, tone of language, content and relevance were identified in the qualitative research as factors influencing campaign acceptability. HIV testing rates (or intention to test) were reported by five studies. Two studies reported that testing rates were higher among men who had seen the campaigns compared to men who had not, but this may reflect confounding. Findings were less consistent regarding reductions in sexual risk behaviours (4 studies). None of the studies examined cost-effectiveness., Conclusions: Campaigns aim to provide MSM with information to help prevent transmission of HIV and to address increasing motivation and changing norms towards precautionary behaviours. However, the limitations of mass media in imparting skills in effecting behaviour change should be recognised, and campaigns supplemented by additional components may be better-suited to achieving these goals.

Background: There is increasing interest in promoting young people's health by modifying the school environment. However, existing research offers little guidance on how the school context enables or constrains students' health behaviours, or how students' backgrounds relate to these processes. For these reasons, this paper reports on a meta-ethnography of qualitative studies examining: through what processes does the school environment (social and physical) influence young people's health?, Methods: Systematic review of qualitative studies. Sixteen databases were searched, eliciting 62,329 references which were screened, with included studies quality assessed, data extracted and synthesized using an adaptation of Noblit and Hare's meta-ethnographic approach., Results: Nineteen qualitative studies were synthesised to explore processes through which school-level influences on young people's health might occur. Four over-arching meta-themes emerged across studies focused on a range of different health issues. First, aggressive behaviour and substance use are often a strong source of status and bonding at schools where students feel educationally marginalised or unsafe. Second, health-risk behaviours are concentrated in unsupervised 'hotspots' at the school. Third, positive relationships with teachers appear to be critical in promoting student wellbeing and limiting risk behaviour; however, certain aspects of schools' organisation and education policies constrain this, increasing the likelihood that students look for a sense of identity and social support via health-risk behaviours. Fourth, unhappiness at school can cause students to seek sources of 'escape', either by leaving school at lunchtime or for longer unauthorized spells or through substance use. These meta-themes resonate with Markham and Aveyard's theory of human functioning and school organisation, and we draw on these qualitative data to refine and extend this theory, in particular conceptualising more fully the role of young people's agency and student-led 'systems' in constituting school environments and generating health risks., Conclusion: Institutional features which may shape student health behaviours such as lack of safety, poor student-staff relationships and lack of student voice are amenable to interventions and should be the subject of future investigation. Future qualitative research should focus on health behaviours which are under-theorised in this context such as physical activity, sexual and mental health.

Background: Schools may have important effects on students' and staff's health. Rather than treating schools merely as sites for health education, 'school-environment' interventions treat schools as settings which influence health. Evidence concerning the effects of such interventions has not been recently synthesised., Methods/design: Systematic review aiming to map and synthesise evidence on what theories and conceptual frameworks are most commonly used to inform school-environment interventions or explain school-level influences on health; what effects school-environment interventions have on health/health inequalities; how feasible and acceptable are school-environment interventions; what effects other school-level factors have on health; and through what processes school-level influences affect health.We will examine interventions aiming to promote health by modifying schools' physical, social or cultural environment via actions focused on school policies and practices relating to education, pastoral care and other aspects of schools beyond merely providing health education. Participants are staff and students age 4-18 years.We will review published research unrestricted by language, year or source. Searching will involve electronic databases including Embase, ERIC, PubMed, PsycInfo and Social Science Citation Index using natural-language phrases plus reference/citation checking.Stage 1 will map studies descriptively by focus and methods. Stage 2 will involve additional inclusion criteria, quality assessment and data extraction undertaken by two reviewers in parallel. Evidence will be synthesised narratively and statistically where appropriate (undertaking subgroup analyses and meta-regression and where no significant heterogeneity of effect sizes is found, pooling these to calculate a final effect size)., Discussion: We anticipate: finding a large number of studies missed by previous reviews; that non-intervention studies of school effects examine a greater breadth of determinants than are addressed by intervention studies; and that intervention effect estimates are greater than for school-based health curriculum interventions without school-environment components.