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.
Bibliographical note© The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License http://creativecommons.org/licenses/by/4.0/, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.
Funding information: This study is funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Reference Number: RP-PG-0218–20010). CC was supported by the Oxford and Thames Valley National Institute for Health Research Applied Research Collaboration. OU and SB were supported by the National Institute for Health Research Applied Research Collaboration South West Peninsula. AG was partly supported by the NIHR Biomedical Research Centre Oxford. MV was partly supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) and receives funding from the National Institute for Health Research (NIHR) Applied Research Collaboration Oxford and Thames Valley at Oxford Health NHS Foundation Trust. The views expressed are those of the authors and not necessarily those of the NHS, NIHR or the Department of Health and Social Care.
- Study Protocol
- Early intervention
- Online intervention
- Parent-led intervention