Minimising Young Children's Anxiety through Schools (MY-CATS): statistical analysis plan for a cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of an online parent-led intervention compared with usual school practice for young children identified as at risk for anxiety disorders

Jones, B. G. ORCID: https://orcid.org/0000-0001-7374-1107, Reardon, T., Creswell, C., Dodd, H. F., Hill, C., Jasper, B., Lawrence, P. J., Morgan, F., Rapee, R. M., Violato, M., Placzek, A. and Ukoumunne, O. C. (2022) Minimising Young Children's Anxiety through Schools (MY-CATS): statistical analysis plan for a cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of an online parent-led intervention compared with usual school practice for young children identified as at risk for anxiety disorders. Trials, 23 (1). 1054. ISSN 1745-6215 doi: 10.1186/s13063-022-06899-1

Abstract/Summary

Background The Minimising Young Children’s Anxiety through Schools (MY-CATS) trial is being conducted to determine whether an online evidence-based parent-guided cognitive behavioural therapy intervention in addition to usual school practice is effective and cost-effective compared with usual school practice in reducing anxiety disorders in children aged 4–7 deemed ‘at risk’ of anxiety disorders. This update article describes the detailed statistical analysis plan for the MY-CATS trial and reports a review of the underpinning sample size assumptions. Methods and design The MY-CATS study is a two-arm, definitive superiority pragmatic parallel group cluster randomised controlled trial in which schools will be randomised 1:1 to receive either the intervention (in addition to usual school practice) or the usual school practice only. This update to the (published) protocol provides a detailed description of the study methods, the statistical principles, the trial population and the planned statistical analyses, including additional analyses comprising instrumental variable regression and mediation analysis.

Item Type	Article
URI	https://reading-clone.eprints-hosting.org/id/eprint/110270
Identification Number/DOI	10.1186/s13063-022-06899-1
Refereed	Yes
Divisions	Life Sciences > School of Psychology and Clinical Language Sciences > Anxiety and Depression in Young People (AnDY)
Uncontrolled Keywords	Clustering, Anxiety, School-based, Mediation, Random Effects, Statistical Analysis Plan, Cluster Randomised Trial, Humans, Anxiety Disorders, Schools, School Health Services, Cost-Benefit Analysis, Randomized Controlled Trials as Topic
Publisher	Springer
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