You are here

  • Home
  • Archive
  • Volume 9, Issue 8
  • School-based intervention study examining approaches for well-being and mental health literacy of pupils in Year 9 in England: study protocol for a multischool, parallel group cluster randomised controlled trial (AWARE)

Article Text

Article menu

This article has a correction. Please see:

Download PDFPDF

XML
Mental health
Protocol
School-based intervention study examining approaches for well-being and mental health literacy of pupils in Year 9 in England: study protocol for a multischool, parallel group cluster randomised controlled trial (AWARE)
  1. Daniel Hayes1,
  2. Anna Moore1,
  3. Emily Stapley1,
  4. Neil Humphrey2,
  5. Rosie Mansfield2,
  6. Joao Santos2,
  7. Emma Ashworth2,
  8. Praveetha Patalay3,
  9. Eva Bonin4,
  10. Sara Evans-Lacko5,
  11. Bettina Moltrecht1,
  12. Kirsty Nisbet1,
  13. Emma Thornton6,
  14. Aurelie Lange1,
  15. Paul Stallard7,
  16. Abigail Thompson1,
  17. Jan Rasmus Boehnke8,
  18. Jessica Deighton1
  1. 1Evidence Based Practice Unit (EBPU), University College London and Anna Freud National Centre for Children and Families (AFNCCF), London, UK
  2. 2Institute of Education, University of Manchester, Manchester, UK
  3. 3MRC Unit for Lifelong Health and Ageing and the Centre for Longitudinal Studies, University College London, London, UK
  4. 4Personal Social Services Research Unit, London School of Economics and Political Science, London, UK
  5. 5Care Policy and Evaluation Centre (CPEC), London School of Economics and Political Science, London, UK
  6. 6Manchester Institute of Education, The University of Manchester, Manchester, UK
  7. 7Department for Health, University of Bath, Bath, UK
  8. 8School of Nursing and Health Sciences, University of Dundee, Dundee, UK
  1. Correspondence to Dr Jessica Deighton; ebpu{at}annafreud.org

Abstract

Introduction The prevalence of emotional difficulties in young people is increasing. This upward trend is largely accounted for by escalating symptoms of anxiety and depression. As part of a public health response, there is increasing emphasis on universal prevention programmes delivered in school settings. This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools.

Method A three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. Overall, 144 secondary schools in England will be recruited, involving 8600 Year 9 pupils. The primary outcome for YAM is depressive symptoms, and for The Guide it is intended help-seeking. These will be measured at baseline, 3–6 months and 9–12 months after the intervention commenced. Secondary outcomes measured concurrently include changes to: positive well-being, behavioural difficulties, support from school staff, stigma-related knowledge, attitudes and behaviours, and mental health first aid. An economic evaluation will assess the cost-effectiveness of the interventions, and a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, feasibility, utility), and their moderating effects on the outcomes of interest, and perceived impact.

Ethics and dissemination This trial has been approved by the University College London Research Ethics Committee. Findings will be published in a report to the Department for Education, in peer-reviewed journals and at conferences.

Trial registration number ISRCTN17631228.

Protocol V1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).

  • adolescent
  • young person
  • teacher
  • cluster randomised controlled trial
  • mental health
  • well-being
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-029044

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors NH, EA, RM and ES led on decisions for the process and implementation strand of the project. EB led on decisions for the economic strand of the project and contributed to the writing of this section of the protocol. SL led on decisions for the economic strand for Wave 3. JB led on statistical and study design elements of the project. PP led on measures and their psychometric properties as well as mediation and moderation analysis. JS led on decisions relating to data management for Waves 1 and 2. ET led on decisions relating to data management for Wave 3. DH, supported by AM, led on decisions relating to trial management for Waves 1 and 2. AT, supported by KN, led on decisions relating to trial management for Wave 3. DH also led on ethical procedures for Waves 1 and 2 and contributed to writing this section of the protocol. AT led on ethical procedures for Wave 3. BM provided input and expertise into mindfulness practices and measures. KN checked for consistency across waves. JD is the Principal Investigator, conceptualised the overall trial design, and has final decision sign off. A measures group consisting of PP, JD, DH, AM, NH, EA, RM, JS, EB, and JB finalised measures for the trial. AL wrote this update which AT finalised. All authors read and approved the final manuscript. A Wider Advisory Group consisting of DH, PP, NH and PS provided ongoing advice.

    • Funding This research was commissioned and funded by the Department for Education. The Department selected the interventions to be trialled and also chairs an advisory group the researchers report to regarding the progress and quality of the research. JD was (in part) supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Bart’s Health NHS Trust.

    • Disclaimer The views expressed are those of the authors and not necessarily those of the Department for Education, the NHS, the NIHR or the Department of Health and Social Care. The Department for Education had no role in the design of this study and will not have any role in the analyses, interpretation of data or decision to submit results.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

    Linked Articles