Back to Search
Start Over
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).
- Source :
-
Trials [Trials] 2024 Jan 17; Vol. 25 (1), pp. 62. Date of Electronic Publication: 2024 Jan 17. - Publication Year :
- 2024
-
Abstract
- Background: The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether 'screening and intervention', consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only - 'usual school practice', for children aged 8-9 years in the following: (1) the 'target population', who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire - iCATS-2, and (2) the 'total population', comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial.<br />Methods and Design: iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses.<br />Trial Registration: ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022.<br /> (© 2024. The Author(s).)
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 25
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 38233861
- Full Text :
- https://doi.org/10.1186/s13063-023-07898-6