INCLUSIVE trial protocol v 1.1 24/02/2014 Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): trial protocol Sponsor: UCL Institute of Child Health 30 Guilford Street WC1N 1EH London Funder: National Institute for Health research (NIHR) Public Health Research Programme Funder ref: 12/153/60 UCL Ethics Project ID 5248/001 This protocol has been authorised by: Name Role: Signature Date Prof R Viner Chief Investigator Prof C Bonell Co-Chief Investigator Contact Details –Study Team: Chief Investigator Prof Russell Viner UCL Institute of Child Health 30 Guilford Street London WC1N 1EH Tel : +44 (0) 207 905 2190 E-mail : [email protected] Co-Chief Investigator Prof Chris Bonell Institute of Education Department of Children, Families and Health Institute of Education University of London 18 Woburn Square London WC1H 0NR 1 INCLUSIVE trial protocol v 1.1 24/02/2014 +44 (0)20 7612 6731 E-mail: [email protected] TRIAL MANAGER Anne Mathiot 30 Guilford Street London WC1N 1EH Tel : +44 (0) 207 905 2772 Fax : +44 (0) 207 905 2834 E-mail : [email protected] DATA MANAGER Joanna Sturgess Clinical Trial Units London School of Hygiene and Tropical Medicine Room 186, Keppel Street WC1E 7HT London +44 (0)20 7958 8122 +44 (0) 20 7299 4663 [email protected] Please contact the Study Manager for general queries and supply of trial/study documentation 2 INCLUSIVE trial protocol v 1.1 24/02/2014 Table of Content: Aim page 4 Research objective milestones page 4 Design page 4 Study population page 4 Inclusion/Exclusion criteria page 4 Recruitment and randomization page 5 Intervention and comparison groups page 5 Assessments page 7 Outcomes page 7 Power and sample size page 9 Economic evaluation page 9 Process evaluation page 10 Analysis page 11 Ethical issues page 12 Study Governance page 12 Timetable page 13 Annex 1: Amendment History page 15 3 INCLUSIVE trial protocol v 1.1 24/02/2014 Aim Our aim is to evaluate the effectiveness and cost-effectiveness of the INCLUSIVE intervention over three school years (two externally facilitated; one internally facilitated) using a cluster RCT design with integral process and economic evaluation to address the following research questions (RQ): RQ1. Is the INCLUSIVE intervention implemented over three school years more effective and cost- effective than standard practice in reducing bullying and aggression among 12-15 year olds in English secondary schools? RQ2. Is the INCLUSIVE intervention more effective than standard practice in improving students’ quality of life, well-being, psychological function and attainments, and reducing school exclusion and truancy, substance use, sexual risk, NHS use, police contacts among students, and improving staff quality of life and attendance and reducing burn-out? RQ3. What pre-hypothesised factors moderate and mediate the effectiveness of the INCLUSIVE intervention; including, do effects vary by socioeconomic status and sex? Research objective milestones: (i) To recruit and undertake baseline student and staff surveys in 40 schools by June 2014. (ii) To randomly allocate schools and schedule key meetings in intervention schools by July 2014. (iii) To deploy education facilitators, convene action groups and provide schools with data on local needs by September 2014. (iv) To deliver restorative training and the INCLUSIVE curriculum, review school policies and plan and implement local actions as planned in the 2014/5 and 2015/6 academic years. (v) To have completed all externally facilitated aspects of the intervention and to have assessed the fidelity and acceptability of this by July 2016. (vi) To provide intervention schools with data on local progress and needs by Sept 2015 and 2016. (vii) To assess processes of unfacilitated third year of intervention by July 2017. (viii) To collect follow-up data on student and staff outcomes by July 2016 and July 2017. (ix) To have completed all data cleaning and analysis by December 2017. (x) To submit final report by March 2018. Design Cluster RCT with integral economic evaluation and process evaluation, with schools as the unit of allocation. Study population INCLUSIVE is a universal intervention, aimed at all 11 to 16 year olds in participating secondary schools in England. While the intervention aims to have effects on the whole school, our study population of students will be those at the end of year 7 (age 11-12 years) at baseline and be at the end of year 10 at final follow-up (age 14-15), as well as all school teaching and teaching assistant staff. All students in the school in that year and all teaching staff will be surveyed at each time-point, not only those who participated at baseline. Inclusion/Exclusion criteria Planned inclusion/exclusion criteria: (applied only to schools). (i) Secondary schools within the state education system (including community, academy or free schools, and mixed or single sex) in England. We will take the widest definition of a ‘state school’ and will only exclude private schools, non-mainstream schools (e.g. for those with learning 4 INCLUSIVE trial protocol v 1.1 24/02/2014 disabilities) and pupil referral units. The latter two will be excluded as it is unlikely that INCLUSIVE will be appropriate for their populations. (ii) Ofsted rating (most recent) of ‘requires improvement’/’satisfactory’ or better; we will exclude schools with an ‘inadequate’/’poor’ Ofsted rating because such schools are subject to special measures which are likely to impede INCLUSIVE delivery. To maximize generalisability we will not exclude schools by deprivation status. Note there are no inclusion/ exclusion criteria for students. Recruitment and randomisation For pragmatic reasons we will target the secondary schools in Greater London and the surrounding Boroughs (Surrey, Kent, Essex, Hertfordshire, Buckinghamshire, Windsor) with a maximum travel time of 1 hours, of whom the majority will be eligible for this study. Further schools can be recruited from elsewhere in south-eastern or south central England if required. To aid recruitment, we will partner with existing schools networks such as the UCL Partners Schools Network, Institute of Education Teaching Schools and schools that are part of our collaborating schools network, Challenge Partners (>180 schools nationally). We will approach approximately 250 eligible schools, initially by letter and email with a telephone follow-up by an educational facilitator, complying with good practice and research governance for undertaking studies within the education system. Forty schools will be recruited during the study set-up phase (Months 1-5, February to June 2014). Suitable schools (see inclusion criteria below) whose head-teacher give informed written consent to participate will be allocated with a 1:1 ratio between intervention and control arms. Randomisation will be undertaken remotely by the Clinical Trials Unit (CTU) at the London School of Hygiene & Tropical Medicine (LSHTM). To promote baseline equivalence, we will stratify by key school-level determinants of violence: single sex versus mixed sex school; school level deprivation, as measured by percentage of students eligible for free school meals (low/ moderate 0-23%; high >23%); and school Best 8 value added in GCSE exams (above and below median for England of 1000). Value added (VA) scores is a school-level measure of students’ attainment in public exams adjusting for their attainment on entry to the school. We use VA rather than Ofsted ratings for schools as there is better evidence for VA being associated with violence rates. Within each of these 8 strata, schools will be allocated using stratified randomisation. Protecting against bias: (1) School level: The randomisation schedule will be drawn up once the schools have consented and after the baseline survey thus guarding against selection biases at entry of clusters to the trial. This may occur sequentially in blocks of ten schools, should there be any delays with reaching final sample size or with baseline surveys in some schools. As with most social intervention trials, schools, their students, teachers and other staff cannot be ‘blinded’ to allocation status. However, data-input staff will be blinded to each school’s status throughout the study and analysis of follow-up quantitative data will be undertaken blind to allocation. Retention of control schools will be maximised by ensuring regular senior liaison and provision of participation incentives (£500). (2) Student level: We had very high student participation in our pilot study: 96% of students’ eligible at baseline and 93% at follow-up. To minimise bias, we will use in-school, mail and telephone contacts to try to include all enrolled students absent at either baseline or follow-up questionnaires. Note we will not attempt to follow-up students who have left the school. Intervention and comparison groups: 1. Intervention: The intervention is intended principally to augment rather than to replace existing activities (e.g. training, curricula, etc.) in intervention schools. However, it is intended to replace existing non- restorative disciplinary school policies and practices where restorative approaches are deemed by the action group to be more appropriate. 5 INCLUSIVE trial protocol v 1.1 24/02/2014 The two-year facilitated phase provides the following inputs: i) annual surveys of local needs and assets (bullying, aggression, prevalence and determinants) and progress in addressing these ii) support from an external expert education facilitator