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Lookup NU author(s): Professor Falko Sniehotta
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2024, The Author(s).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. 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. Trial registration: ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022
Author(s): Ball S, Reardon T, Creswell C, Taylor L, Brown P, Ford T, Gray A, Hill C, Jasper B, Larkin M, Macdonald I, Morgan F, Pollard J, Sancho M, Sniehotta FF, Spence SH, Stainer J, Stallard P, Violato M, Ukoumunne OC
Publication type: Article
Publication status: Published
Journal: Trials
Year: 2024
Volume: 25
Issue: 1
Online publication date: 17/01/2024
Acceptance date: 19/12/2023
Date deposited: 29/01/2024
ISSN (print): 1745-6215
Publisher: BioMed Central Ltd
URL: https://doi.org/10.1186/s13063-023-07898-6
DOI: 10.1186/s13063-023-07898-6
Data Access Statement: Datasets and study materials generated during the current study will be made available in a public repository.
PubMed id: 38233861
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