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Can Therapist-Guided, Online Parent-Led CBT Increase Treatment Efficiency Without Compromising Outcomes in Routine Child Mental Health Services? A Pragmatic, Non-Inferiority Effectiveness Randomised Controlled Trial

47 Pages Posted: 17 Jul 2023

See all articles by Cathy Creswell

Cathy Creswell

University of Oxford - Department of Experimental Psychology

Lucy Taylor

University of Oxford - Department of Experimental Psychology

Sophie Giles

NHS Foundation Trust - Sussex Partnership

Sophie Howitt

Oxford Health NHS Foundation Trust

Lucy Radley

University of Oxford - Department of Experimental Psychology

Emily Whitaker

University of Oxford - Department of Experimental Psychology

Emma Brooks

University of Oxford - Department of Psychiatry

Polly Waite

University of Oxford - Department of Experimental Psychology

Fauzia Knight

University of Westminster - Centre for Psychological Sciences

Mara Violato

University of Oxford - Nuffield Department of Population Health

Vanessa Raymont

University of Oxford - Department of Psychiatry

Claire Hill

University of Reading - School of Psychology and Clinical Language Sciences

James van Santen

University of Oxford - Nuffield Department of Primary Care Health Sciences

Nicola Williams

University of Oxford - Primary Care Clinical Trials Unit

Sam Mort

University of Oxford - Nuffield Department of Primary Care Health Sciences

Victoria Harris

University of Oxford - Nuffield Department of Primary Care Health Sciences

Ly-Mee Yu

University of Oxford - Nuffield Department of Primary Care Health Sciences

More...

Abstract

Background: Digitally augmented psychological therapies bring potential to increase availability of effective help for children with mental health problems.

Methods: We did a two-arm, multi-site, randomised controlled non-inferiority trial to evaluate the effectiveness of therapist supported online parent-led Cognitive Behaviour Therapy (OSI+TS) compared to treatment as usual for child anxiety problems in routine child mental health services (C-TAU) in 34 organisations in England and Northern Ireland. We examined acceptability of OSI+TS via qualitative interviews with parents and therapists. Children aged 5 to 12 years who were offered treatment for child anxiety problems were eligible. Participants were randomly assigned (1:1) to either OSI+TS or C-TAU, with minimisation by child age, gender, service type, and baseline child anxiety interference, including permuted block size. Outcomes were assessed 14 and 26 weeks after randomisation. The primary outcome was parent-reported interference caused by child anxiety. Outcome analyses were conducted blind in the intention-to-treat population. The trial is registered with the ISRCTN registry 12890382.

Findings: Between December 5, 2020 and August 3, 2022, 706 families were referred to study information. 444 were enrolled. 255 (58%) participants were girls, 184 (41%) were boys. 400 (90%) were White. Mean age was 9·20 years (SD 1·79). 222 participants were randomly assigned to OSI+TS and 222 to C-TAU. 85% of C-TAU families received Cognitive Behaviour Therapy. At 26 weeks OSI+TS was non-inferior for parent reported anxiety interference (SMD= 0·01 (95% CI -0·15 to 0·17), p < 0·0001) and all secondary outcomes. Therapist time for treatment delivery averaged 185·93 minutes (SD = 98·12) for OSI+TS compared to 308·57 (SD=173·02) for C-TAU. OSI+TS acceptability was good. No serious adverse events were reported.

Interpretation: The therapist supported online intervention brought substantial savings in therapist time without compromising outcomes for children being treated for anxiety problems in routine child mental health services.

Trial Registration: he trial is registered with the ISRCTN registry 12890382.

Funding: Department for Health and Social Care/ United Kingdom Research and Innovation Research Grant (managed by the Medical Research Council), National Institute of Health Research Policy Research Programme, Oxford and Thames Valley National Institute of Health Research Applied Research Collaboration, Oxford Health NIHR Biomedical Research Centre.

Declaration of Interest: The Online Support and Intervention (OSI) intervention is based on underpinning evaluations of a book‐based treatment approach for child anxiety disorders. No investigators receive any financial reward for the use of OSI; however, CC receives royalties for the sale of a parent book and a therapist book that some of the underpinning work is based on.

Ethical Approval: This study was approved on 04/09/2020 by London ‐ City & East Research Ethics Committee (Bristol Research Ethics Committee Centre, Whitefriars, Level 3 Block B, Lewins Mead, Bristol, BS1 2NT, UK; +44 (0)207 104 8214; cityandeast. rec@hra.nhs.uk), ref: 20/HRA/4431.

Keywords: digital, online, Anxiety, child, mental health, psychological therapy, CBT

Suggested Citation

Creswell, Cathy and Taylor, Lucy and Giles, Sophie and Howitt, Sophie and Radley, Lucy and Whitaker, Emily and Brooks, Emma and Waite, Polly and Knight, Fauzia and Violato, Mara and Raymont, Vanessa and Hill, Claire and van Santen, James and Williams, Nicola and Mort, Sam and Harris, Victoria and Yu, Ly-Mee, Can Therapist-Guided, Online Parent-Led CBT Increase Treatment Efficiency Without Compromising Outcomes in Routine Child Mental Health Services? A Pragmatic, Non-Inferiority Effectiveness Randomised Controlled Trial. Available at SSRN: https://ssrn.com/abstract=4463516 or http://dx.doi.org/10.2139/ssrn.4463516

Cathy Creswell (Contact Author)

University of Oxford - Department of Experimental Psychology ( email )

Lucy Taylor

University of Oxford - Department of Experimental Psychology ( email )

Sophie Giles

NHS Foundation Trust - Sussex Partnership ( email )

Sophie Howitt

Oxford Health NHS Foundation Trust ( email )

Oxford
United Kingdom

Lucy Radley

University of Oxford - Department of Experimental Psychology ( email )

Emily Whitaker

University of Oxford - Department of Experimental Psychology ( email )

Emma Brooks

University of Oxford - Department of Psychiatry ( email )

Polly Waite

University of Oxford - Department of Experimental Psychology ( email )

Fauzia Knight

University of Westminster - Centre for Psychological Sciences ( email )

Mara Violato

University of Oxford - Nuffield Department of Population Health ( email )

Vanessa Raymont

University of Oxford - Department of Psychiatry ( email )

Warneford Hospital
Warneford Ln
Oxford, OX3 7JX
United Kingdom

Claire Hill

University of Reading - School of Psychology and Clinical Language Sciences ( email )

James Van Santen

University of Oxford - Nuffield Department of Primary Care Health Sciences ( email )

Nicola Williams

University of Oxford - Primary Care Clinical Trials Unit ( email )

Sam Mort

University of Oxford - Nuffield Department of Primary Care Health Sciences ( email )

Victoria Harris

University of Oxford - Nuffield Department of Primary Care Health Sciences ( email )

Oxford
United Kingdom

Ly-Mee Yu

University of Oxford - Nuffield Department of Primary Care Health Sciences ( email )

Oxford
United Kingdom

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