School-based screening and intervention reduced parent-reported anxiety in children aged eight to nine years

BACKGROUND: Screening for anxiety problems in primary schools and offering parent-led cognitive behavioural therapy (CBT) via online and telephone support for those who screen positive could address key barriers to effective early intervention for some of the most prevalent child mental disorders. We aimed to evaluate outcomes from a screening-to-intervention pathway for child anxiety problems alongside usual school provision compared with assessment and usual school provision only. METHODS: iCATSi2i was a pragmatic, parallel-group, superiority, cluster-randomised, controlled trial in 84 primary and junior schools in England with at least two year-4 classes. Children aged 8-9 years in participating classes who were not opted out by their parent were eligible to participate. After baseline assessments, schools (clusters) were randomly assigned (1:1) to screening, feedback, and intervention, alongside usual school practice (intervention group) or assessment and usual school practice only (control group), stratified by school-level deprivation. Before allocation, schools were ordered by the number of children who screened positive for anxiety problems at baseline (target population). Block randomisation was used with block sizes of two and four. Trial statisticians were masked to group allocation until datasets were ready for final analysis. In schools in the intervention group all parents in sampled classes were invited to complete a two-item screening questionnaire (iCATS-2) at baseline and received feedback on the screening outcome (after randomisation); parents of children who screened positive for anxiety problems (target population) were offered parent-led CBT delivered via online and telephone support, using the Online Support and Intervention for Child Anxiety (OSI) platform (and this was available for other families on request); a single whole-class session on identifying and managing fears and worries was also provided. In both groups, assessments (including the screening questionnaire) were completed and schools continued with usual provision. The primary outcome was screen-negative for anxiety problems (score 0-2 on the parent-reported iCATS-2) versus screen-positive (score 3-6) in the target population at 12 months. Primary analyses were conducted in the intention-to-treat population, with missing data imputed. Adverse events were monitored and recorded throughout. The trial was registered with the ISRCTN registry, ISRCTN76119074, and the study is complete. The study management group included individuals with relevant lived experience. FINDINGS: We recruited participants and collected baseline assessments between Jan 6, and Nov 30, 2022. Parents of 1459 children (27% of 5335 children in participating classes) completed the screening questionnaire, and 409 screened positive (target population). On the basis of parent report, 222 (54%) of 408 children who screened positive were female, 185 (45%) were male, and one (<1%) preferred not to report child gender. 325 (85%) of 384 children were reported by the school as White. The mean age was 8·8 years (SD 0·3). 42 schools were randomly assigned to the intervention group (target population: 205 children) and 42 to the control group (target population: 204 children). In the target population at 12 months, more children screened negative for anxiety problems in the intervention group (89 [61%] of 145 children) than the control group (62 [38%] of 163 children), with an adjusted odds ratio of 2·32 (95% CI 1·41-3·81; p=0·0009) in the primary analysis based on imputed data. No serious adverse events related to trial procedures or the intervention or adverse events related to the intervention were reported. INTERPRETATION: An integrated screening-to-intervention pathway for child anxiety problems in primary schools reduced parent-reported child anxiety problems compared with assessment and usual provision only, providing a promising way to improve access to effective early intervention. FUNDING: National Institute for Health and Care Research Programme Grants for Applied Research.