Classroom-based cognitive behaviour therapy (FRIENDS): a cluster randomised controlled trial to Prevent Anxiety in Children through Education in Schools (PACES)

Background Anxiety in children is common, impairs everyday functioning, and increases the risk of severe mental health disorders in adulthood. We investigated the effect of a classroom-based cognitive behaviour therapy prevention programme (FRIENDS) on anxiety symptoms in children. Methods Preventing Anxiety in Children though Education in Schools (PACES) is a three-group parallel cluster randomised controlled trial. Interventions were given between September, 2011, and July, 2012, with schools as the unit of allocation and individual participants as the unit of analysis. We enrolled state-funded junior schools in southwest England. We sent information to all eligible schools (state-funded junior schools in southwest England) inviting them to enrol in the study. School year groups were assigned by computer-generated randomisation (1:1:1) to receive either school-led FRIENDS (led by teacher or school staff member), health-led FRIENDS (led by two trained health facilitators), or usual school provision. Children were not masked to treatment allocation. The allocated programme was given to all students (aged 9–10 years) in the school year (ie, universal delivery) as part of the school curriculum as nine, 60 min weekly sessions. Outcomes were collected by self-completed questionnaire administered by researchers masked to allocation. Primary outcome was symptoms of anxiety and low mood at 12 months assessed by the Revised Child Anxiety and Depression Scale (RCADS 30). Analyses were intention to treat and accounted for the clustered nature of the design. The study is registered, number ISRCTN23563048. Findings 45 schools were enrolled: 14 (n=497 children) were randomly assigned to school-led FRIENDS, 14 (n=509) to health-led FRIENDS, and 12 (n=442) to usual school provision. 1257 (92%) children completed 12 month assessments (449 in health-led FRIENDS, 436 in school-led FRIENDS, and 372 in usual school provision). We recorded a difference at 12 months in adjusted mean child-reported RCADS scores for health-led versus school-led FRIENDS (19·49 [SD 14·81] vs 22·86 [15·24]; adjusted difference −3·91, 95% CI −6·48 to −1·35; p=0·0004) and health-led FRIENDS versus usual school provision (19·49 [14·81] vs 22·48 [15·74]; −2·66, −5·22 to −0·09; p=0·043). We noted no differences in parent or teacher ratings. Training teachers to deliver mental health programmes was not as effective as delivery by health professionals. Interpretation Universally delivered anxiety prevention programmes can be effective when used in schools. However, programme effectiveness varies depending on who delivers them