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

Abstract

Background 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-to-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 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. Trial registration ISRCTN registry ISRCTN76119074. Prospectively registered on 4.1.2022.

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

“…Data are collected at baseline (before randomisation), 4, 12 and 24 months post-randomisation. Full details of the trial background, rationale and design have been published [ 9 ].…”

“…The pathway involves screening, feedback and access to a therapist-supported parent-led online intervention (OSI) for child anxiety problems, as outlined below. Full details are provided in the published protocol [ 9 ].…”

“…Schools were randomised in two separate cohorts: cohort 1 comprising schools in the internal pilot phase (28 schools recruited between October and December 2021 and randomised in March 2022) and cohort 2 comprising schools in the main trial (56 schools recruited between May and September 2022 and randomised in November 2022). Continuation of the trial beyond the pilot phase was approved by the Data Monitoring and Ethics Committee (DMEC) and Programme Steering Committee (PSC), who reviewed trial progress against pre-specified progression criteria, detailed in the protocol [ 9 ]. Allocation of schools was stratified by whether the percentage of children eligible for free school meals (FSM) in the school was above the national median (21.6%) for primary schools in 2020/2021 [ 15 ], using block randomisation with block sizes of 2 and 4.…”

“…WP5 is a cluster RCT (with internal pilot) to establish whether usual school practice and the pathway developed in WP2 and tested in WP3 (comprising universal screening, feedback and treatment — screening and intervention arm) bring clinical and health economic benefits compared to usual school practice and assessment only ( usual school practice arm), for children with anxiety problems (initially identified as experiencing anxiety problems from the two-item parent-report child anxiety questionnaire — iCATS-2, developed in WP1). The protocol for the iCATS-i2i cluster RCT was published in 2022 and included a brief overview of the statistical analyses [ 9 ]. The International Conference on Harmonisation guidelines state that primary statistical analyses should be pre-specified, to prevent data-driven choice of analyses and selective reporting of outcomes [ 10 ], and recent guidelines support early publication of SAPs that prospectively describe planned analyses of RCTs [ 11 ].…”