Protocol for the process evaluation for a cluster randomised controlled trial evaluating primary school-based screening and intervention delivery for childhood anxiety problems

Victoria Williamson; Michael Larkin; Tessa Reardon; Paul Stallard; Susan H Spence; Ian Macdonald; Obioha C Ukoumunne; Tamsin Ford; Mara Violato; Falko F Sniehotta; Jason Stainer; Alastair Gray; Paul Brown; Michelle Sancho; Fran Morgan; Bec Jasper; Lucy Taylor; Cathy Creswell

doi:10.1136/bmjopen-2023-082691

Protocol for the process evaluation for a cluster randomised controlled trial evaluating primary school-based screening and intervention delivery for childhood anxiety problems

Victoria Williamson
, Michael Larkin^*
, Tessa Reardon
, Paul Stallard
, Susan H Spence
, Ian Macdonald
, Obioha C Ukoumunne
, Tamsin Ford
, Mara Violato
, Falko F Sniehotta
, Jason Stainer
, Alastair Gray
, Paul Brown
, Michelle Sancho
, Fran Morgan
, Bec Jasper
, Lucy Taylor
, Cathy Creswell

^*Corresponding author for this work

Institute of Psychiatry, Psychology and Neuroscience, King’s College London, London, UK
Department of Psychiatry, University of Oxford, Oxford, UK
University of Bath, Claverton Down, Bath, Somerset, UK.
School of Applied Psychology and Australian Institute of Suicide Research and Prevention, Griffith University, Brisbane, Queensland, Australia
Charlie Waller Trust, Newbury, UK
NIHR ARC South West Peninsula, University of Exeter, Exeter, UK.
University of Cambridge
Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Heidelberg University, Division of Public Health, Social and Preventive Medicine, Centre for Preventive Medicine and Digital Health (CPD), Medical Faculty Mannheim, Heidelberg, Germany
Stanley Primary School , Teddington , UK
Bransgore C Of E Primary School, Ringwood Rd, Bransgore, Christchurch, UK.
West Berkshire Council, Council Offices, Market St, Newbury, UK.
Square Peg (Team Square Peg CIC), Leamington Spa, UK
PACT Parents and Carers Together CIC, Suffolk, UK

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	e082691
Number of pages	8
Journal	BMJ Open
Volume	15
Issue number	2
Early online date	20 Feb 2025
DOIs	https://doi.org/10.1136/bmjopen-2023-082691
Publication status	Published - 20 Feb 2025

Bibliographical note

Copyright © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ. 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/.

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.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Anxiety disorders
Child & adolescent psychiatry
QUALITATIVE RESEARCH

Access to Document

10.1136/bmjopen-2023-082691Licence: CC BY 4.0

Protocol for the process evaluation for a cluster RCT evaluating primary school-based screening...childhood anxiety problems
Copyright © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ. 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/.
Final published version, 560 KBLicence: CC BY 4.0

Cite this

Williamson, V., Larkin, M., Reardon, T., Stallard, P., Spence, S. H., Macdonald, I., Ukoumunne, O. C., Ford, T., Violato, M., Sniehotta, F. F., Stainer, J., Gray, A., Brown, P., Sancho, M., Morgan, F., Jasper, B., Taylor, L., & Creswell, C. (2025). Protocol for the process evaluation for a cluster randomised controlled trial evaluating primary school-based screening and intervention delivery for childhood anxiety problems. BMJ Open, 15(2), Article e082691. https://doi.org/10.1136/bmjopen-2023-082691

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title = "Protocol for the process evaluation for a cluster randomised controlled trial evaluating primary school-based screening and intervention delivery for childhood anxiety problems",

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.",

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note = "Copyright {\textcopyright} Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ. 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/.",

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Williamson, V, Larkin, M, Reardon, T, Stallard, P, Spence, SH, Macdonald, I, Ukoumunne, OC, Ford, T, Violato, M, Sniehotta, FF, Stainer, J, Gray, A, Brown, P, Sancho, M, Morgan, F, Jasper, B, Taylor, L & Creswell, C 2025, 'Protocol for the process evaluation for a cluster randomised controlled trial evaluating primary school-based screening and intervention delivery for childhood anxiety problems', BMJ Open, vol. 15, no. 2, e082691. https://doi.org/10.1136/bmjopen-2023-082691

TY - JOUR

T1 - Protocol for the process evaluation for a cluster randomised controlled trial evaluating primary school-based screening and intervention delivery for childhood anxiety problems

AU - Williamson, Victoria

AU - Larkin, Michael

AU - Reardon, Tessa

AU - Stallard, Paul

AU - Spence, Susan H

AU - Macdonald, Ian

AU - Ukoumunne, Obioha C

AU - Ford, Tamsin

AU - Violato, Mara

AU - Sniehotta, Falko F

AU - Stainer, Jason

AU - Gray, Alastair

AU - Brown, Paul

AU - Sancho, Michelle

AU - Morgan, Fran

AU - Jasper, Bec

AU - Taylor, Lucy

AU - Creswell, Cathy

N1 - Copyright © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ. 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/.

PY - 2025/2/20

Y1 - 2025/2/20

N2 - 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.

AB - 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.

KW - Anxiety disorders

KW - Child & adolescent psychiatry

KW - QUALITATIVE RESEARCH

UR - https://bmjopen.bmj.com/content/15/2/e082691

UR - https://www.scopus.com/pages/publications/85218672272

U2 - 10.1136/bmjopen-2023-082691

DO - 10.1136/bmjopen-2023-082691

M3 - Article

C2 - 39979045

SN - 2044-6055

VL - 15

JO - BMJ Open

JF - BMJ Open

IS - 2

M1 - e082691

ER -

Protocol for the process evaluation for a cluster randomised controlled trial evaluating primary school-based screening and intervention delivery for childhood anxiety problems

Abstract

Bibliographical note

Funding

UN SDGs

Keywords

Access to Document

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