Parent-Led Cbt Delivered Via Online and Telephone Support Alongside Usual School Practice Versus Usual School Practice Only for Young Children Identified as At-Risk for Anxiety Disorders Through Screening in Schools: A Cluster Randomised Controlled Trial

Abstract

Background: Identifying young children at-risk for anxiety disorders through screening in schools, and providing efficient and accessible support for these children, could reduce the frequency of later anxiety disorders. This study aimed to evaluate the effectiveness of providing parent-led cognitive behavioural therapy (CBT) via online and telephone/video call support alongside usual school provision, compared to usual school provision only, for young children identified through screening in schools as having one or more risks for future anxiety disorders.   

Methods: We conducted a pragmatic, parallel group, superiority cluster randomised controlled trial in 95 primary/infant schools in England. Parents of children (aged 4-7 years) in sampled classes completed screening measures, and children who screened positive for at least one risk (elevated anxiety symptoms, and/or inhibition, and/or parent anxiety) were eligible for the trial. Schools (clusters) were randomised (1:1) to intervention or usual school practice, stratified by school-level deprivation.  Schools in both arms continued with usual provision, and parents in intervention schools were offered therapist supported OSI (Online Support and Intervention) for child anxiety. The primary outcome was the presence of an anxiety disorder diagnosis at 12-months, assessed via the Anxiety Disorders Interview Schedule for Children-Parent Interview (ADIS-P) administered by independent assessors. Secondary clinical outcomes included parent-reported measures of child anxiety symptoms, related interference, externalising symptoms, and additional risks and intervention targets at 12-weeks and 12-months. Primary analyses were conducted on the full intention-to-treat population, with imputed missing data. The trial was prospectively registered with IRCTN 82398107.

Findings: Between March, 21 2021 and July, 21 2022, 2328 children were screened. 1172 were eligible for the trial and 865 enrolled. Parent-reported child gender was female for 432 (50%) participants and male for 433 (50%) participants. 48 schools (434 children) were assigned to intervention and 47 schools (431 children) to usual school practice. Parents of 332 (77%) children in the intervention arm completed the core intervention content and the mean therapist time to deliver support sessions was 152 minutes per family. At 12 months, 21/310 (6∙8%) children in the intervention arm compared to 36/312 (11∙5%) in the usual school practice arm had a diagnosable anxiety disorder; this difference was not statistically significant (adjusted odds ratio 0∙70 [0∙37 to 1∙32], p=0∙27). The intervention was, however, superior to usual school practice across all secondary continuous clinical outcomes at both 12-weeks and 12 months (the absolute values of the standardised mean differences were 0∙16 to 0∙47 and 0∙18 to 0∙44 respectively). Parents reported positive experiences of the intervention. No serious adverse events were reported.  

Interpretation: Diagnosable anxiety disorders were relatively low at the 12 month follow-up so longer-term assessment may be needed to determine future preventative effects for diagnostic outcomes. Providing a brief parent-led CBT programme via online and telephone support for young children identified as at-risk through screening in schools did, however, reduce anxiety symptoms, related interference and risks for future anxiety disorders; as such, this presents a valuable approach for prevention and early intervention. 

Trial Registration: The study was registered on ISRCTN (82398107) and the protocol 26 and statistical analysis plan27 were published.

Funding: This study is funded by the Kavli Trust Programme on Health Research. CC, TR and MV were partly supported by the NIHR Oxford Health Biomedical Research Centre and CC and MV received funding from the NIHR Applied Research Collaboration Oxford and Thames Valley at Oxford Health NHS Foundation Trust. OU and BJ are supported by the National Institute for Health and Care Research Applied Research Collaboration South West Peninsula. 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. HD was partly supported by a UKRI Future Leaders Fellowship MR/S017909/1.

Declaration of Interest: CC and CH are developers of the OSI platform. They do not receive any personal financial benefits from the use of OSI. All other authors declare no competing interests.

Ethical Approval: Ethical approval was obtained from the University of Oxford Medical Sciences Interdivisional Research Ethics Committee (Reference: R62531).

Keywords: Anxiety disorder, prevention, early intervention, digital interventions, schools