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

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.