e-Article
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).
Document Type
Article
Author
Ball, Susan; 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.
Source
Subject
*MEDICAL screening
*CLUSTER analysis (Statistics)
*STATISTICS
*ANXIETY
*CHILD support
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Language
ISSN
1745-6215
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 [ABSTRACT FROM AUTHOR]