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.

BACKGROUND: Providing accessible CBT for young children identified as at risk for anxiety disorders through screening in schools could reduce later problems. This study aimed to evaluate the effectiveness of parent-led CBT delivered via online and telephone call support alongside usual school provision, compared to usual school provision only for young children identified through screening as having at least one risk. 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) in sampled classes completed screening, and children who screened positive for one or more risks (anxiety symptoms/inhibition/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 parent-led CBT via online and telephone support. The primary outcome was the presence of an anxiety disorder diagnosis at 12 months, assessed via the ADIS-P administered by independent assessors. Secondary clinical outcomes included parent-reported child anxiety symptoms, related interference, externalising symptoms, additional risks and intervention targets at 12 weeks and 12 months. Primary analyses were conducted on the full intention-to-treat population. The trial was prospectively registered with ISRCTN 82398107. RESULTS: In total, 2,328 children were screened; 1,172 were eligible; 865 enrolled. Forty-eight schools (434 children) were assigned to intervention and 47 schools (431 children) to usual school practice. At 12 months, the overall frequency of anxiety disorders was low, 6.8% (21/310) of children in the intervention arm compared to 11.5% (36/312) in the usual school practice arm; this difference was not statistically significant (adjusted odds ratio 0.67 [0.37 to 1.21], p = .19). However, the intervention was superior to usual school practice across all secondary outcomes (standardised mean difference: 0.15 to 0.47 at 12 weeks; 0.19 to 0.41 at 12 months). No serious adverse events were reported. CONCLUSIONS: Although the intervention did not significantly reduce anxiety disorders at 12 months, improvements across all other assessed outcomes indicate this approach brings wider immediate benefits and reduces known risks for future anxiety disorders. Future research needs to consider longer-term preventative effects.