Update | Open | Open Peer Review | Published:
Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol
Trialsvolume 18, Article number: 238 (2017)
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.
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.
Primary: Two primary outcomes at student level assessed at baseline and at 36 months:
Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC)
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.
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.
Changes to the original protocol
The team suggested changes to the process evaluation section of the original protocol . These changes were endorsed by our Trial Steering Committee (TSC) and approved by UCL Research Ethics Committee (5/10/2015, ref 5248/001).
The deviations from the original protocol and rationales for these changes are provided in Table 1.
The main reason for changing the protocol is to limit the data collection’s burden imposed on schools and re-direct the resources to in-depth data analysis and additional data collection collected from intervention schools.
The study executive team thought it would be in the interest of the study to add a question on bullying perpetration. The change was supported by our TSC and has been approved by UCL Research Ethics Committee (23/03/2016, ref 5248/001). This added a new secondary outcome to the study and an additional question in the students’ questionnaire delivered in the year 2 and year 3 follow-up surveys. The protocol has been amended accordingly in the secondary outcome section, and with a minor correction in the statistical section.
The question is taken from the Centers for Disease Control and Prevention (CDC) guidance document on bullying measures . The only measure that it recommends that focuses on specific occasions of recent bullying perpetration is the Modified Aggression Scale Bullying subscale (Cronbach’s alpha = 0.83) . This is an existing, established measure with evidence of reliability.
The current approved protocol (v1.5) had some details missing in the Process Evaluation section of the protocol. These details were in our Process Evaluation (PE) protocol, approved by our TSC, so the team thought it important to align the main protocol with the PE protocol by adding more details in the main section, new version 1.6. The amendment was approved on 10/10/2016.
The additional details added:
Section Trial arm fidelity: “termly (from year 3 annual) restorative practice surveys (n = 20)” and “We will also draw on administrative documents (e.g. minutes, attendance sheets, training satisfaction feedback)”
Section Reception and responsiveness: “We will also interview n = 2 students involved in restorative practice sessions per year in each case study school.”
Centers for Disease Control and Prevention
Data Monitoring Committee
Edinburgh Study of Youth Transitions and Crime
Gatehouse Bullying Scale
Trial Steering Committee
Bonell C, Allen E, Christie D, Elbourne D, Fletcher A, Grieve R, LeGood R, Mathiot A, Scott S, Wiggins M, Viner RM. Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): study protocol for a cluster randomised controlled trial. Trials. 2014;15:381.
Hamburger ME, Basilem KC, Vivolom AM. Measuring bullying victimization, perpetration, and bystander experiences: a compendium of assessment tools. Atlanta: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control; 2011.
Bosworth K, Espelage DL, Simon TR. Factors associated with bullying behavior in middle school students. J Early Adolesc. 1999;19:341–62.
Funding for this trial has been provided by the UK National Institute for Health Research (NIHR) Public Health Research Programme and by the Educational Endowment Fund. The funding bodies will not be involved in the study design, in collection, analysis and interpretation of data or in the writing of the manuscript.
The study has been funded by the UK National Institute for Health Research (NIHR) Public Health Research (12/153/60) and by the Educational Endowment Fund.
RV and CB conceived the study, led funding applications, participated in the design of the study and led the drafting of the manuscript. CB designed the process evaluation. EA and DE contributed to the design of the study and wrote the analysis plan. AF contributed to the intervention development, design of the study and design of the process evaluation. RG and RLG designed the economic evaluation. AM and LB obtained ethical permission and contributed to the writing of the manuscript. DC, SS and EW contributed to the design of the study and writing of the manuscript. MW contributed to intervention development and design of the study. All authors read and approved the final manuscript.
The authors declare that they have no competing interests.
Consent for publication
Ethics approval and consent to participate
The study has been approved by the Institute of Education Research Ethics Committee (18/11/13 ref. FCL 566) and the University College London Research Ethics Committee (30/1/14, Project ID: 5248/001). All participants to the surveys and the interviews are giving informed consent before each data collection activity. Further information on the consent pathways in the trial are provided in the full protocol paper .
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