Article Text

Protocol
Protocol for the process evaluation of a complex intervention delivered in schools to prevent adolescent depression: the Future Proofing Study
  1. Joanne R Beames1,
  2. Raghu Lingam2,
  3. Katherine Boydell1,
  4. Alison L Calear3,
  5. Michelle Torok1,
  6. Kate Maston1,
  7. Isabel Zbukvic4,
  8. Kit Huckvale1,
  9. Philip J Batterham3,
  10. Helen Christensen1,
  11. Aliza Werner-Seidler1
  1. 1Black Dog Institute, University of New South Wales, Sydney, New South Wales, Australia
  2. 2School of Women’s and Children’s Health, University of New South Wales, Sydney, New South Wales, Australia
  3. 3Centre for Mental Health Research, Australian National University, Canberra, Australian Capital Territory, Australia
  4. 4Orygen The National Centre of Excellence in Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia
  1. Correspondence to Dr Aliza Werner-Seidler; a.werner-seidler{at}blackdog.org.au

Abstract

Introduction Process evaluations provide insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a cluster randomised trial of a digital depression prevention intervention delivered to secondary school students (the Future Proofing Study). The purpose is to describe the methods that will be used to capture process evaluation data within this trial.

Methods and analysis Using a hybrid type 1 design, a mixed-methods approach will be used with data collected in the intervention arm of the Future Proofing Study. Data collection methods will include semistructured interviews with school staff and study facilitators, automatically collected intervention usage data and participant questionnaires (completed by school staff, school counsellors, study facilitators and students). Information will be collected about: (1) how the intervention was implemented in schools, including fidelity; (2) school contextual factors and their association with intervention reach, uptake and acceptability; (3) how school staff, study facilitators and students responded to delivering or completing the intervention. How these factors relate to trial effectiveness outcomes will also be assessed. Overall synthesis of the data will provide school cluster-level and individual-level process outcomes.

Ethics and dissemination Ethics approval was obtained from the University of New South Wales (NSW) Human Research Ethics Committee (HC180836; 21st January 2019) and the NSW Government State Education Research Applications Process (SERAP 2019201; 19th August 2019). Results will be submitted for publication in peer-reviewed journals and discussed at conferences. Our process evaluation will contextualise the trial findings with respect to how the intervention may have worked in some schools but not in others. This evaluation will inform the development of a model for rolling out digital interventions for the prevention of mental illness in schools.

  • child & adolescent psychiatry
  • depression & mood disorders
  • preventive medicine
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/.

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Footnotes

  • Twitter @ACalear, @alizaws

  • Contributors HC and AW-S conceived the study and secured the funding. AW-S and JRB led the design of the process evaluation, with input from all authors (including KH, IZ and PJB), and expert guidance from RL and KB. AW-S drafted the manuscript, with assistance from JRB. ALC, MT, KM, RL, KB and HC have a continuing role in monitoring the conduct and outcomes of the process evaluation. All named authors contributed substantially to the approved final manuscript.

  • Funding Funding for this project came from an NSW Ministry of Health Early-Mid Career Fellowship awarded to AW-S, and a Black Dog Institute Post-Doctoral Fellowship awarded to JRB, secured by HC. ALC is supported by NHMRC fellowships 1122544 and 1173146. PJB is supported by NHMRC Fellowship 1158707. Funding for the randomised controlled trial within which this process evaluation is embedded came from an NHMRC Project Grant Awarded to HC GNT1120646.

  • Disclaimer The funding bodies had no role in any aspect of the study design or this manuscript.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • 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.

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