NIHR ARC South West Peninsula (PenARC), University of Exeter, Exeter, UK.
Exeter Clinical Trials Unit (ExeCTU), University of Exeter, Exeter, UK.
Trials. 2022 Dec 28;23(1):1054. doi: 10.1186/s13063-022-06899-1.
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.
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.
ISRCTN82398107 . Prospectively registered on 14 January 2021.
正在开展一项名为“通过学校最小化儿童焦虑（Minimising Young Children's Anxiety through Schools，MY-CATS）”的试验，以确定在常规学校实践基础上，额外增加在线循证家长指导认知行为疗法干预是否比常规学校实践更有效且更具成本效益，能否减少被认为有焦虑障碍风险的 4-7 岁儿童的焦虑障碍。本更新文章描述了 MY-CATS 试验的详细统计分析计划，并报告了对基础样本量假设的审查。
MY-CATS 研究是一项两臂、明确优势实用平行组群组随机对照试验，学校将按 1:1 的比例随机分配接受干预（常规学校实践加干预）或仅接受常规学校实践。本试验方案更新版详细描述了研究方法、统计原则、试验人群和计划的统计分析，包括包含工具变量回归和中介分析的额外分析。
ISRCTN82398107。于 2021 年 1 月 14 日前瞻性注册。
