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Adapting the ASSIST model of informal peer-led intervention delivery to the Talk to FRANK drug prevention programme in UK secondary schools (ASSIST + FRANK): intervention development, refinement and a pilot cluster randomised controlled trial James White, 1,2 * Jemma Hawkins, 3 Kim Madden, 1 Aimee Grant, 1 Vanessa Er, 4 Lianna Angel, 1 Timothy Pickles, 1 Mark Kelson, 1 Adam Fletcher, 3 Simon Murphy, 3 Luke Midgley, 3 Gemma Eccles, 3 Gemma Cox, 5 William Hollingworth, 4 Rona Campbell, 4 Matthew Hickman, 4 Chris Bonell 6 and Laurence Moore 7 1 Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK 2 Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK 3 DECIPHer, School of Social Sciences, Cardiff University, Cardiff, UK 4 DECIPHer, School of Social and Community Medicine, University of Bristol, Bristol, UK 5 Public Health Wales, Swansea, UK 6 Department of Social and Environmental Health Research, London School of Hygiene & Tropical Medicine, London, UK 7 MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK *Corresponding author whitej11@cf.ac.uk Declared competing interests of authors: Laurence Moore and Rona Campbell are Scientific Advisors to DECIPHer IMPACT, a not-for-profit organisation that licenses the ASSIST smoking prevention programme. Adam Fletcher, Rona Campbell, Matthew Hickman and Chris Bonell are members of the National Institute for Health Research Public Health Research Research Funding Board. Published October 2017 DOI: 10.3310/phr05070

Plain English summary ASSIST + FRANK: intervention development, refinement and pilot RCT Public Health Research 2017; Vol. 5: No. 7 DOI: 10.3310/phr05070 NIHR Journals Library www.journalslibrary.nihr.ac.uk

PUBLIC HEALTH RESEARCH 2017 VOL. 5 NO. 7 (PLAIN ENGLISH SUMMARY) Plain English summary Approximately 24% of 15-year-olds in England have used an illicit drug. Illicit drug use increases the risk of poor physical and mental health. This study adapted an effective peer-led smoking prevention intervention (ASSIST) to prevent illicit drug use using information from the UK national drug education website, Talk to FRANK [www.talktofrank.com (accessed 29 August 2017)]. With stakeholders [young people, teachers (SMT and other roles), parents, ASSIST trainers, drug agency staff and a public health commissioner] we developed, tested and refined two peer-led drug prevention interventions, ASSIST + FRANK and FRANK friends to be delivered in schools to UK Year 9 students (aged 13 14 years). After the interventions had been refined, we conducted a study in 12 high schools in South Wales. Schools were randomly allocated to receive ASSIST + FRANK, FRANK friends, ASSIST or usual practice. A survey was given to all young people whose parents had agreed for them to take part to measure illicit drug use. A total of 1567 young people were recruited to the study. In-depth interviews with school staff, parents and young people explored their views on the interventions. The results showed that it is feasible and acceptable to deliver the interventions. The study was not designed to show conclusively whether ASSIST + FRANK or FRANK friends prevented drug use, but both were viewed positively. In general, FRANK friends was viewed more positively than ASSIST + FRANK. The research shows that there should now be a much bigger study to examine whether or not FRANK friends can prevent illicit drug use in young people. Queen s Printer and Controller of HMSO 2017. This work was produced by White et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. iii

Public Health Research ISSN 2050-4381 (Print) ISSN 2050-439X (Online) This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/). Editorial contact: journals.library@nihr.ac.uk The full PHR archive is freely available to view online at www.journalslibrary.nihr.ac.uk/phr. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Public Health Research journal Reports are published in Public Health Research (PHR) if (1) they have resulted from work for the PHR programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors. Reviews in Public Health Research are termed systematic when the account of the search appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others. PHR programme The Public Health Research (PHR) programme, part of the National Institute for Health Research (NIHR), evaluates public health interventions, providing new knowledge on the benefits, costs, acceptability and wider impacts of non-nhs interventions intended to improve the health of the public and reduce inequalities in health. The scope of the programme is multi-disciplinary and broad, covering a range of interventions that improve public health. The Public Health Research programme also complements the NIHR Health Technology Assessment programme which has a growing portfolio evaluating NHS public health interventions. For more information about the PHR programme please visit the website: http://www.nets.nihr.ac.uk/programmes/phr This report The research reported in this issue of the journal was funded by the PHR programme as project number 12/3060/03. The contractual start date was in March 2014. The final report began editorial review in January 2017 and was accepted for publication in June 2017. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PHR editors and production house have tried to ensure the accuracy of the authors report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report. This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the PHR programme or the Department of Health. Queen s Printer and Controller of HMSO 2017. This work was produced by White et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. Published by the NIHR Journals Library (www.journalslibrary.nihr.ac.uk), produced by Prepress Projects Ltd, Perth, Scotland (www.prepress-projects.co.uk).

Public Health Research Editor-in-Chief Professor Martin White Director of Research and Programme Leader, UKCRC Centre for Diet and Activity Research (CEDAR), MRC Epidemiology Unit, Institute of Metabolic Science, School of Clinical Medicine, University of Cambridge; Visiting Professor, Newcastle University; and Director, NIHR Public Health Research Programme NIHR Journals Library Editor-in-Chief Professor Tom Walley Director, NIHR Evaluation, Trials and Studies and Director of the EME Programme, UK NIHR Journals Library Editors Professor Ken Stein Chair of HTA and EME Editorial Board and Professor of Public Health, University of Exeter Medical School, UK Professor Andrée Le May Chair of NIHR Journals Library Editorial Group (HS&DR, PGfAR, PHR journals) Dr Martin Ashton-Key Consultant in Public Health Medicine/Consultant Advisor, NETSCC, UK Professor Matthias Beck Chair in Public Sector Management and Subject Leader (Management Group), Queen s University Management School, Queen s University Belfast, UK Dr Tessa Crilly Director, Crystal Blue Consulting Ltd, UK Dr Eugenia Cronin Senior Scientific Advisor, Wessex Institute, UK Dr Peter Davidson Director of the NIHR Dissemination Centre, University of Southampton, UK Ms Tara Lamont Scientific Advisor, NETSCC, UK Dr Catriona McDaid Senior Research Fellow, York Trials Unit, Department of Health Sciences, University of York, UK Professor William McGuire Professor of Child Health, Hull York Medical School, University of York, UK Professor Geoffrey Meads Professor of Wellbeing Research, University of Winchester, UK Professor John Norrie Chair in Medical Statistics, University of Edinburgh, UK Professor John Powell Consultant Clinical Adviser, National Institute for Health and Care Excellence (NICE), UK Professor James Raftery Professor of Health Technology Assessment, Wessex Institute, Faculty of Medicine, University of Southampton, UK Dr Rob Riemsma Reviews Manager, Kleijnen Systematic Reviews Ltd, UK Professor Helen Roberts Professor of Child Health Research, UCL Institute of Child Health, UK Professor Jonathan Ross Professor of Sexual Health and HIV, University Hospital Birmingham, UK Professor Helen Snooks Professor of Health Services Research, Institute of Life Science, College of Medicine, Swansea University, UK Professor Jim Thornton Professor of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, University of Nottingham, UK Professor Martin Underwood Director, Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, UK Please visit the website for a list of members of the NIHR Journals Library Board: www.journalslibrary.nihr.ac.uk/about/editors Editorial contact: journals.library@nihr.ac.uk