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)
Author:
Ball SusanORCID, Reardon Tessa, Creswell Cathy, Taylor Lucy, Brown Paul, Ford Tamsin, Gray Alastair, Hill Claire, Jasper Bec, Larkin Michael, Macdonald Ian, Morgan Fran, Pollard Jack, Sancho Michelle, Sniehotta Falko F., Spence Susan H., Stainer Jason, Stallard Paul, Violato Mara, Ukoumunne Obioha C.
Abstract
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.
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
Funder
Programme Grants for Applied Research
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference41 articles.
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