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Open Access 01-12-2022 | Anxiety or Fear-Related Disorders | Update

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

Authors: Benjamin G. Jones, Tessa Reardon, Cathy Creswell, Helen F. Dodd, Claire Hill, Bec Jasper, Peter J. Lawrence, Fran Morgan, Ronald M. Rapee, Mara Violato, Anna Placzek, Obioha C. Ukoumunne

Published in: Trials | Issue 1/2022

Abstract

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.

Trial registration

ISRCTN82398107. Prospectively registered on 14 January 2021

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Title: 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
Authors: Benjamin G. Jones
Tessa Reardon
Cathy Creswell
Helen F. Dodd
Claire Hill
Bec Jasper
Peter J. Lawrence
Fran Morgan
Ronald M. Rapee
Mara Violato
Anna Placzek
Obioha C. Ukoumunne
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Anxiety or Fear-Related Disorders
Anxiety
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06899-1

Keynote webinar | Spotlight on medication adherence

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Abstract

Background

Methods and design

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods and design

Trial registration

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