Article Text
Abstract
Introduction Drinking has adverse impacts on health, well-being, education and social outcomes for adolescents. Adolescents in England are among the heaviest drinkers in Europe. Recently, the proportion of adolescents who drink alcohol has fallen, although consumption among those who do drink has actually increased. This trial seeks to investigate how effective and efficient an alcohol brief intervention is with 11–15 years olds to encourage lower alcohol consumption.
Methods and analysis This is an individually randomised two-armed trial incorporating a control arm of usual school-based practice and a leaflet on a healthy lifestyle (excl. alcohol), and an intervention arm that combines usual practice with a 30 min brief intervention delivered by school learning mentors and a leaflet on alcohol. At least 30 schools will be recruited from four regions in England (North East, North West, London, Kent and Medway) to follow-up 235 per arm. The primary outcome is total alcohol consumed in the last 28 days, using the 28 day Timeline Follow Back questionnaire measured at the 12-month follow-up. The analysis of the intervention will consider effectiveness and cost-effectiveness. A qualitative study will explore, via 1:1 in-depth interviews with (n=80) parents, young people and school staff, intervention experience, intervention fidelity and acceptability issues, using thematic narrative synthesis to report qualitative data.
Ethics and dissemination Ethical approval was granted by Teesside University. Dissemination plans include academic publications, conference presentations, disseminating to local and national education departments and the wider public health community, including via Fuse, and engaging with school staff and young people to comment on whether and how the project can be improved.
Trial registration trial ISRCTN45691494; Pre-results.
- Alcohol
- Brief Intervention
- Randomised Controlled Trial
- School Setting
This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
Statistics from Altmetric.com
Footnotes
Twitter Follow Dorothy Newbury-Birch @dotbirch
Contributors DN-B is the chief investigator and ELG is the project manager of the SIPS JR-HIGH trial. The disciplines represented in the team include: public health research (EK, DN-B, SS, RM, ELG, GJM, NH, HS, LT, SB, JF, JF, GS, NH); alcohol and policy expertise (EK, DN-B, SS, RM); conducting research with children and young people (SS, RM); health psychology (PD); addiction psychiatry (CD, EG); criminology (DNB); medical statistics (DH, SC, ES) and trial methodology (EM, SC, EK, CD, DH), and health economics (LV, VA, EG). LT has experience of education and learning mentors. The Newcastle Clinical Trials Unit is a UK CRC-registered Clinical Trials Unit, with a strong track record in the design, conduct, and analysis of NIHR-funded trials, including those of complex interventions and feasibility/pilot trials. ELG and DN-B wrote the first draft of the paper and all authors contributed to successive drafts. All authors read and approved the final manuscript.
Funding This work is supported by the National Institute for Health Research Public Health Research (NIHR) Programme Grant Number 13/117/02. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the PHR Programme, NIHR, NHS, or the Department of Health. CD is partly funded by the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King's College London, and is partly funded by the NIHR Collaborations for Leadership in Applied Health Research and Care South London at King's College Hospital NHS Foundation Trust. EK is funded by the NIHR School of Primary Care Research and the NIHR School of Public Health as a member of Fuse, a UKCRC Centre of Excellence in Public Health. RM is funded through an NIHR Post Doctorate Fellowship. SS is funded by the NIHR School of Public Health. Trial Sponsor: Mrs Lois Neal, Faculty of Medical Sciences, Newcastle University, Framlington Place, Newcastle on Tyne, Tyne and Wear NE2 4HH, UK; lois.neal@newcastle.ac.uk.
Competing interests EG is a reviewer for NIHR. DH was a member of the NIHR Health Services and Delivery Research Commissioning Board until December 2015, and is a subpanel member for NIHR Programme Grants for Applied Research from February 2016. EK is a funding board member of the NIHR Public Health Research funding board and the NIHR Senior Fellowships panel. EM is a subpanel member for NIHR Programme Grants for Applied Research. LV is a member of the NIHR Health Technology Assessment Clinical Evaluation and Trials Panel, NIHR Programme Grants for Applied Research Panel and Director of NIHR Research Design Service for the North East.
Ethics approval The trial is approved by Teesside University Ethical Committee, 164/15.
Provenance and peer review Not commissioned; externally peer reviewed.