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Mental health
Protocol
Protocol for the process evaluation for a cluster randomised controlled trial evaluating primary school-based screening and intervention delivery for childhood anxiety problems
  1. Victoria Williamson1,2,3,
  2. Michael Larkin4,
  3. Tessa Reardon1,2,
  4. Paul Stallard5,
  5. Susan H Spence6,
  6. Ian Macdonald7,
  7. Obioha C Ukoumunne8,
  8. Tamsin Ford9,
  9. Mara Violato10,
  10. Falko F Sniehotta11,
  11. Jason Stainer12,
  12. Alastair Gray10,
  13. Paul Brown13,
  14. Michelle Sancho14,
  15. Fran Morgan15,
  16. Bec Jasper16,
  17. Lucy Taylor1,2,
  18. Cathy Creswell1,2
  1. 1 Department of Experimental Psychology, University of Oxford, Oxford, UK
  2. 2 Department of Psychiatry, University of Oxford, Oxford, UK
  3. 3 Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK
  4. 4 Institute for Health and Neurodevelopment, Aston University, Birmingham, UK
  5. 5 University of Bath, Claverton Down, Bath, UK
  6. 6 Australian Institute of Suicide Research and Prevention and School of Applied Psychology, Griffith University, Brisbane, Queensland, Australia
  7. 7 Charlie Waller Trust, Newbury, UK
  8. 8 NIHR ARC South West Peninsula, University of Exeter, Exeter, UK
  9. 9 Department of Psychiatry, University of Cambridge, Cambridge, UK
  10. 10 Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK
  11. 11 Division of Public Health, Social and Preventive Medicine, Centre for Preventive Medicine and Digital Health (CPD), Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany
  12. 12 Stanley Primary School, Teddington, UK
  13. 13 Bransgore C Of E Primary School, Christchurch, UK
  14. 14 West Berkshire Council, Council Offices, Newbury, UK
  15. 15 Square Peg (Team Square Peg CIC), Leamington Spa, UK
  16. 16 PACT Parents and Carers Together CIC, Suffolk, UK
  1. Correspondence to Dr Michael Larkin; m.larkin{at}aston.ac.uk

Abstract

Introduction Anxiety problems are prevalent in childhood and, without intervention, can persist into adulthood. Effective evidence-based interventions for childhood anxiety disorders exist, specifically cognitive–behavioural therapy (CBT) in a range of formats. However, only a small proportion of children successfully access and receive treatment. Conducting mental health screening in schools and integrating evidence-based interventions for childhood anxiety problems may be an effective way to ensure support reaches children in need. The Identifying Child Anxiety Through Schools—Identification to Intervention (iCATS i2i) trial involves screening for childhood anxiety problems and offering a brief online parent-led CBT intervention. This paper presents the protocol for the process evaluation of the iCATS i2i trial, which aims to examine the implementation and acceptability of the study procedures, the mechanisms of change and whether any external factors had an impact on procedure engagement or delivery.

Methods and analysis This process evaluation will use both quantitative and qualitative methods to evaluate the implementation and acceptability of and barriers/facilitators to engagement and delivery of the iCATS screening/intervention procedures. Quantitative data sources will include opt-out and completion rates of baseline measures and usage analytics extracted from the online intervention platform. Qualitative interviews will be conducted with children, parents, school staff, iCATS i2i clinicians and researchers delivering study procedures. The Medical Research Council framework for process evaluations will guide study design and analysis.

Ethics and dissemination This study has received ethical approval from the University of Oxford Research Ethics Committee (R66068_RE003). Findings from the study will be disseminated via peer-reviewed publications in academic journals, conferences, digital and social media platforms and stakeholder meetings.

Trial registration ISRCTN76119074.

  • Anxiety disorders
  • Child & adolescent psychiatry
  • QUALITATIVE RESEARCH
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2023-082691

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    Footnotes

    • X @VWilliamson_psy

    • Contributors CC is the guarantor. All authors (VW, ML, TR, PS, SHS, IM, OCU, TF, MV, FFS, JS, AG, PB, MS, FM, BJ, LT and CC) contributed towards the study design, reviewed and approved the manuscript prior to submission.

    • Funding This paper represents independent research funded by the National Institute for Health Research (NIHR; PGfAR—RP-PG-0218-20010) (PI: CC) and hosted by Oxford Health, National Health Service (NHS) Foundation Trust. CC and MV acknowledge support from the Oxford and Thames Valley NIHR Applied Research Collaboration and the NIHR Oxford Health Biomedical Research Centre. OCU was supported by the NIHR Applied Research Collaboration for the South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

    • Competing interests TF's department receives funds from her advisory role at Place2Be, a third-sector organisation that provides mental health training and support to schools in the UK, and the rest of the authors declare no competing interest.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • 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.