Whole-school interventions promoting student commitment to school to prevent substance use and violence, and improve educational attainment: a systematic review.

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.

Whole-school health interventions aim to modify how schools are run, to promote students' health. Some aim to promote student commitment to school to prevent the important interlinked outcomes of substance (tobacco, alcohol, other drugs) use and violence. We searched for all evaluations of such interventions. We summarised what this research said about the sorts of interventions used, how they are meant to work, what factors affect delivery, whether or not they reduce violence and substance use and whether or not they are worth the money. We found 63 reports on 27 studies of 22 interventions. We identified four subtypes of interventions. These aimed to involve students in school decisions, improve staff­student relationships, increase engagement in learning or involve parents. Most of these interventions were intended to work by making sure schools focused on student needs, or by improving relationships between staff and students, between different areas of learning or between schools and communities. This aimed to make students feel committed to school and therefore avoid violence or substance use. A few aimed to work mostly by teaching students how to avoid violence and substance use. We found that interventions were well implemented if they were tailored for each school and had good materials and support. Interventions were well delivered if they were led by action groups (comprising staff, students, etc.) or provided schools with information on students' needs. Implementation was affected by whether or not schools accepted the need for change and whether or not staff had the necessary time and money to do the work. These interventions appear to have small, but significant, intervention impacts in preventing violence and substance use among young people. There was not consistent evidence of different effects for different students. A small number of studies suggest that such interventions might show economic benefit, but this would need further research. Future research should focus on interventions that are refined to make sure that they can be well delivered.

Are school-based interventions to prevent dating and relationship violence and gender-based violence equally effective for all students? Systematic review and equity analysis of moderation analyses in randomised trials.

School-based interventions for the prevention of dating and relationship violence (DRV) and gender-based violence (GBV) take advantage of universal opportunities for intervention. Information on differential effectiveness of interventions is important to assess if they ameliorate or worsen social gradients in specific outcomes. This is especially important in DRV and GBV prevention given the gendered context of these behaviours and their common aetiologies in patriarchal gender norms, and social acceptance in school contexts of sexual harassment, such as catcalling or unwanted groping. We undertook a systematic review of moderation analyses in randomised trials of school-based interventions for DRV and GBV prevention. We searched 21 databases and used supplementary search methods without regard to publication type, language or year of publication, and synthesised moderation tests relating to equity-relevant characteristics (principally sex and prior history of the outcome) for DRV and GBV perpetration and victimisation. Across 23 included outcome evaluations, programme effects on DRV victimisation were not moderated by gender or prior experience of DRV victimisation, but DRV perpetration outcomes were greater for boys, particularly for emotional and physical DRV perpetration. Findings for GBV outcomes were counterintuitive. Our findings suggest that practitioners should carefully monitor local intervention effectiveness and equity to ensure that interventions are working as intended. However, one of the most surprising findings from our analysis-with clear relevance for uncertainties in practice-was that differential impacts by sexuality or sexual minority status were not frequently evaluated.

Involving men and boys in family planning: A systematic review of the effective components and characteristics of complex interventions in low- and middle-income countries.

Background: Involving men and boys as both users and supporters of Family Planning (FP) is now considered essential for optimising maternal and child health outcomes. Evidence on how to engage men and boys to meet FP needs is therefore important. Objectives: The main objective of this review was to assess the strength of evidence in the area and uncover the effective components and critical process- and system-level characteristics of successful interventions. Search Methods: We searched nine electronic databases, seven grey literature databases, organisational websites, and the reference lists of systematic reviews relating to FP. To identify process evaluations and qualitative papers associated with the included experimental studies, we used Connected Papers and hand searches of reference lists. Selection Criteria: Experimental and quasi-experimental studies of behavioural and service-level interventions involving males aged 10 years or over in low- and middle-income countries to increase uptake of FP methods were included in this review. Data Collection and Analysis: Methodology was a causal chain analysis involving the development and testing of a logic model of intervention components based on stakeholder consultation and prior research. Qualitative and quantitative data relating to the evaluation studies and interventions were extracted based on the principles of 'effectiveness-plus' reviews. Quantitative analysis was undertaken using r with robust variance estimation (RVE), meta-analysis and meta-regression. Qualitative analysis involved 'best fit' framework synthesis. Results: We identified 8885 potentially relevant records and included 127 in the review. Fifty-nine (46%) of these were randomised trials, the remainder were quasi-experimental studies with a comparison group. Fifty-four percent of the included studies were assessed as having a high risk of bias. A meta-analysis of 72 studies (k = 265) showed that the included group of interventions had statistically significantly higher odds of improving contraceptive use when compared to comparison groups (odds ratio = 1.38, confidence interval = 1.21 to 1.57, prediction interval = 0.36 to 5.31, p < 0.0001), but there were substantial variations in the effect sizes of the studies (Q = 40,647, df = 264, p < 0.0001; I 2 = 98%) and 73% was within cluster/study. Multi-variate meta-regression revealed several significant intervention delivery characteristics that moderate contraceptive use. These included community-based educational FP interventions, interventions delivered to women as well as men and interventions delivered by trained facilitators, professionals, or peers in community, home and community, or school settings. None of the eight identified intervention components or 33 combinations of components were significant moderators of effects on contraceptive use. Qualitative analysis highlighted some of the barriers and facilitators of effective models of FP that should be considered in future practice and research. Authors' Conclusions: FP interventions that involve men and boys alongside women and girls are effective in improving uptake and use of contraceptives. The evidence suggests that policy should continue to promote the involvement of men and boys in FP in ways that also promote gender equality. Recommendations for research include the need for evaluations during conflict and disease outbreaks, and evaluation of gender transformative interventions which engage men and boys as contraceptive users and supporters in helping to achieve desired family size, fertility promotion, safe conception, as well as promoting equitable family planning decision-making for women and girls.

Systematic Review of the Economics of School-Based Interventions for Dating Violence and Gender-Based Violence.

Dating and relationship violence (DRV) and gender-based violence (GBV) among children and young people incur a high cost to individuals and society. School-based interventions present an opportunity to prevent DRV and GBV early in individuals' lives. However, with school resources under pressure, policymakers require guidance on the economics of implementing interventions. As part of a large systematic review funded by the National Institute for Health and Care Research (NIHR), we searched for economic evaluations and costing studies of school-based interventions for DRV and GBV. No formal economic evaluations were identified. Seven studies reporting costs, cost savings, or resource use for eight interventions were identified. The largest costs of implementing interventions were related to staff training and salaries but savings could be made by implementing interventions on a large scale. The potential cost savings of avoided DRV and GBV far outweighed the costs of implementation.

What factors influence implementation of whole-school interventions aiming to promote student commitment to school to prevent substance use and violence? Systematic review and synthesis of process evaluations.

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.

The Positive Choices trial: update to study protocol for a phase-III RCT trial of a whole-school social-marketing intervention to promote sexual health and reduce health inequalities.

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.

Initial impacts of the COVID-19 pandemic on sexual and reproductive health service use and unmet need in Britain: findings from a quasi-representative survey (Natsal-COVID).

BACKGROUND: The COVID-19 pandemic has affected sexual and reproductive health (SRH) service use and unmet need, but the impact is unknown. We aimed to determine the proportion of participants reporting sexual risk behaviours, SRH service use and unmet need, and to assess remote sexually transmitted infection (STI) testing service use after the first national lockdown in Britain. METHODS: We used data from the National Surveys of Sexual Attitudes and Lifestyles (Natsal)-COVID cross-sectional, quasi-representative web survey (Natsal-COVID Wave 1). Adults aged 18-59 years who resided in England, Scotland, or Wales completed the survey between July 29 and Aug 10, 2020, which included questions about the approximate 4-month period after announcement of the initial lockdown in Britain (March 23, 2020). Quota-based sampling and weighting were used to achieve a quasi-representative population sample. Participants aged 45-59 years were excluded from services analysis due to low rates of SRH service use. Among individuals aged 18-44 years, we estimated reported SRH service use and inability to access, and calculated age-adjusted odds ratios (aORs) among sexually experienced individuals (those reporting any sexual partner in their lifetime) and sexually active individuals (those reporting any sexual partner in the past year). Unweighted denominators and weighted estimates are presented hereafter. FINDINGS: 6654 individuals had complete interviews and were included in the analysis. Among 3758 participants aged 18-44 years, 82·0% reported being sexually experienced, and 73·7% reported being sexually active. 20·8% of sexually experienced participants aged 18-44 years reported using SRH services in the 4-month period. Overall, 9·7% of 3108 participants (9·5% of men; 9·9% of women) reported being unable to use a service they needed, although of the participants who reported trying but not being able to use a SRH service at least once, 76·4% of participants also reported an instance of successful use. 5·9% of 1221 sexually active men and 3·6% of 1560 sexually active women reported use of STI-related services and 14·8% of 1728 sexually experienced women reported use of contraceptive services, with SRH service use highest among individuals aged 18-24 years. Sexually active participants reporting condomless sex with new partners since lockdown were much more likely to report using STI-related services than those who did not report condomless sex (aOR 23·8 [95% CI 11·6-48·9]) for men, 10·5 [3·9-28·2] for women) and, among men, were also more likely to have an unsuccessful attempt at STI-service use (aOR 13·3 [5·3-32·9]). Among 106 individuals who reported using STI testing services, 64·4% accessed services remotely (telephone, video, or online). Among 2581 women aged 25-59 years, 2·4% reported cervical screening compared with an estimated 6% in a comparable 4-month period before the pandemic. INTERPRETATION: Many people accessed SRH care during the initial lockdown; however, young people and those reporting sexual risk behaviours reported difficulties in accessing services and thus such services might need to address a backlog of need. FUNDING: Wellcome Trust, The Economic and Social Research Council, The National Institute for Health Research, Medical Research Council/Chief Scientist Office and Public Health Sciences Unit, and UCL Coronavirus Response Fund.

The Positive Choices trial: study protocol for a Phase-III RCT trial of a whole-school social marketing intervention to promote sexual health and reduce health inequalities.

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.

Cost-Utility Analysis of a Complex Intervention to Reduce School-Based Bullying and Aggression: An Analysis of the Inclusive RCT.

OBJECTIVES: Bullying and aggression among children and young people are key public mental health priorities. In this study, we evaluated the cost-effectiveness of a complex school-based intervention to address these outcomes within a large-cluster randomized trial (Inclusive). METHODS: Forty state secondary schools were randomly allocated (1:1) to receive the intervention or continue with current practice as controls. Data were collected using paper questionnaires completed in classrooms including measures of their health-related quality of life using the Childhood Utility Index and police and National Health Service resource use. Further detailed data were collected on the cost of delivering the intervention. We calculated incremental cost-effectiveness ratios following the intention-to-treat principle using multilevel linear regression models that allowed for clustering of pupils at the school level. RESULTS: Overall, we found that the intervention was highly cost-effective, with cost-per quality-adjusted life year thresholds of £13 284 and £1875 at 2 years and 3 years, respectively. Analysis of uncertainty in the result at 2 years revealed a 65% chance of being cost-effective, but after 3 years there was a 90% chance that it was cost-effective. CONCLUSION: This study provides strong evidence collected prospectively from a randomized study that this school-based intervention is highly cost-effective. Education- and health-sector policy makers should consider investment in scaling up this intervention.

Assessing the effectiveness of a comprehensive menstrual health intervention program in Ugandan schools (MENISCUS): process evaluation of a pilot intervention study.

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.

The sustainability of public health interventions in schools: a systematic review.

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.

The clustering of risk behaviours in adolescence and health consequences in middle age.

INTRODUCTION: There is increasing interest in the clustering of risk behaviours in adolescence. However, few studies have examined what clusters of risk behaviours exist among adolescents, their early-life predictors, and their associations with later health. METHODS: We analysed data derived from 8754 participants (women 53.3%) in the 1970 British Cohort Study. Latent class analysis was used to identify clusters of risk behaviours at age 16. Regression modelling was then used to examine predictors of clusters and their consequences of risk behaviours and health outcomes at age 42. RESULTS: We identified two latent classes: a risky-behaviour (men: 20.0%, women: 23.6%) and less-risky-behaviour class. Among men, those in the risky-behaviour class were more likely to report smoking, multiple binge drinking, sexual debut before 16, involvement in fights and delinquency than were women. Membership in risky-behaviour class was mainly predicted by sociodemographic and parental risk behaviours and monitoring. The risky-behaviour class at age 16 was associated with the following outcome age 42: smoking status (more strongly among women), excessive alcohol consumption (more strongly among men), worse self-rated health (more strongly among men), and psychological distress (only among women). CONCLUSIONS: Engagement in multiple risk behaviours in adolescence is an important driver of health inequalities later in life. Early life intervention, for example via school-based interventions, may be warranted for favourable lifelong health.

Pilot phase of an internet-based RCT of HIVST targeting MSM and transgender people in England and Wales: advertising strategies and acceptability of the intervention.

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.

Protocol for pilot cluster RCT of project respect: a school-based intervention to prevent dating and relationship violence and address health inequalities among young people.

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.

Risk factors associated with early smoking onset in two large birth cohorts.

We use prospective data from the ongoing British Cohort Study (BCS) and Millennium Cohort Study (MCS) to: 1) document changes in the prevalence of childhood smoking onset; 2) assess whether broad historic shifts in key risk factors, such as maternal education, parental smoking, and peer childhood smoking, explain observed cohort changes in childhood smoking; and 3) evaluate whether inequalities in onset have narrowed or widened during this period. The children in these two studies were born 31 years apart (i.e., BCS in 1970; MCS in 2001), and were followed from infancy through early adolescence (n = 23,506 children). Our outcome variable is child self-reports of smoking (ages 10, 11). Early life risk factors were assessed via parent reports in infancy and age 5. Findings reveal that the odds of childhood smoking were over 12 times greater among children born in 1970 versus 2001. The decline in childhood smoking by cohort was partly explained by increases in maternal education, decreases in mothers' and fathers' smoking, and declines in the number of children whose friends smoked. Results also show that childhood smoking is now more linked to early life disadvantages, as MCS children were especially likely to smoke if their mother had low education or used cigarettes, or if the child had a friend who smoked. Although the prevalence of child and adult smoking has dropped dramatically in the past three decades, policy efforts should focus on the increased social inequality resulting from the concentration of early life cigarette use among disadvantaged children.

Study protocol for the optimisation, feasibility testing and pilot cluster randomised trial of Positive Choices: a school-based social marketing intervention to promote sexual health, prevent unintended teenage pregnancies and address health inequalities in England.

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).

Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services.

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.

Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol.

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.