Identifying Child Anxiety Through Schools – identification to intervention (iCATS-i2i): protocol for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice

This is the final version. Available on open access from BMC via the DOI in this recordAvailability of data and materials: Datasets and study materials generated during the current study will be made available in a public repositoryBackground Systematically screening for child anxiety problems, and offering and delivering a brief, evidence-based intervention for children who are identified as likely to benefit would minimise common barriers that families experience in accessing treatment. We have developed a short parent-report child anxiety screening questionnaire, and procedures for administering screening questionnaires, sharing screening outcomes with families, and offering and delivering a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety) through schools. This trial aims to evaluate clinical and health economic outcomes for: 1) children (aged 8-9) who screen positive for anxiety problems at baseline (target population), and 2) the wider population of all children in participating classes (total population) in schools randomly allocated to receive identification-to15 intervention procedures and usual school practice (‘screening and intervention’), compared to assessment and usual school practice only (‘usual school practice’). Methods The trial design is a parallel group, superiority cluster randomised controlled trial, with schools (clusters) randomised to ‘screening and intervention’ or ‘usual school practice’ arms in a 1:1 ratio stratified according to the level of deprivation within the school. We will recruit schools and participants in two phases (a pilot phase (Phase 1) and Phase 2), with progression criteria assessed prior to progressing to Phase 2. In total, the trial will recruit 80 primary/junior schools in England, and 398 children (199 per arm) who screen positive for anxiety problems at baseline (target population). In schools allocated to ‘screening and intervention’: 1) parents/carers will complete a brief parent-report child anxiety screening questionnaire (at baseline) and receive feedback on their child’s screening outcomes (after randomisation), 2) classes will receive a lesson on managing fears and worries and staff will be provided with information about the intervention, and 3) parents/carers of children who screen positive for anxiety problems (target population) will be offered OSI. OSI will also be available for any other parents/carers of children in participating classes (total population) who request it. We will collect child-, parent-, and teacher-report measures for the target population and total population at baseline (before randomisation), 4-months, 12-months and 7 24-months post-randomisation. The primary outcome will be the proportion of children who screen positive for anxiety problems at baseline (target population) who screen negative for anxiety problems 12-months post-randomisation. Discussion This trial will establish if systematic screening for child anxiety problems, sharing screening outcomes with families, and delivering a brief parent-led online intervention through schools is effective and cost-effective.National Institute for Health Research (NIHR