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)
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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
et al.
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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
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Trials
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25
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Clinical sciences
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Statistical analysis plan
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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, 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), Trials, 2024, 25 , pp. 62