Bonell Chris, Mathiot Anne, Allen Elizabeth, Bevilacqua Leonardo, Christie Deborah, Elbourne Diana, Fletcher Adam, Grieve Richard, Legood Rosa, Scott Stephen, Warren Emily, Wiggins Meg, Viner Russell M
London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
UCL Great Ormond Street Institute of Child Health, 30 Guilford St, London, WC1N 1EH, UK.
Trials. 2017 May 25;18(1):238. doi: 10.1186/s13063-017-1984-6.
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.
The methods are summarised as follows.
cluster randomised trial.
40 state secondary schools. Outcomes assessed among the cohort of students at the end of year 7 (n = 6667) at baseline.
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.
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.
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.
The trial involves independent research and intervention teams and is supervised by a Trial Steering Committee and a Data Monitoring Committee.
Current Controlled Trials, ISRCTN10751359 . Registered on 11 March 2014.
系统评价表明，多成分干预措施在减少欺凌受害和欺凌行为方面是有效的。我们正在进行一项关于“包容”多成分干预措施的III期随机试验。该试验旨在评估“包容”干预措施在减少英国中学攻击行为和欺凌受害方面的有效性和成本效益。本文更新了2014年发表的原始试验方案（《试验》，2014年第15卷：381），并介绍了过程评价方案和次要结局数据收集方面的变化。
方法总结如下。
整群随机试验。
40所公立中学。在基线时对7年级末的学生队列（n = 6667）进行结局评估。
“包容”是一项多成分学校干预措施，包括社会情感学习课程、学校环境的改变（一个由教职员工和学生组成的行动小组审查当地需求数据，以审查规则和政策并确定其他当地行动）以及恢复性实践方面的教职员工培训。在前两年，干预措施将由独立于研究团队的教育协调员支持学校实施，第三年的干预措施不涉及外部协调，但其他所有要素保持不变。对照：常规做法。
主要结局：在基线和36个月时在学生层面评估的两个主要结局：1. 学校中的攻击行为：爱丁堡青年过渡与犯罪研究学校行为不检分量表（ESYTC）；2. 欺凌和受害情况：盖特豪斯欺凌量表（GBS）。在基线、24个月和36个月时评估的次要结局将包括与经济评价、学生和教职员工的心理社会结局以及学校层面的逃学率和开除率相关的指标。
每组20所学校将提供90%的检验效能，以在5%的显著性水平下识别效应量为0.25标准差的效应。随机化：符合条件并同意参与的学校按单性别与混合性别学校、学校层面的贫困程度和学校学业成绩测量指标进行分层随机分组。
该试验涉及独立的研究和干预团队，并由试验指导委员会和数据监测委员会监督。
当前受控试验，ISRCTN10751359。于2014年3月11日注册。
