学校正念训练计划与常规学校教育相比的效果和成本效益的更新：一项随机对照试验的研究方案。
Update to the effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial.
机构信息
Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK.
Kings Health Economics, Kings College London, London, UK.
出版信息
Trials. 2021 Apr 7;22(1):254. doi: 10.1186/s13063-021-05213-9.
BACKGROUND
MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme, compared with normal social and emotional learning (SEL) school provision to enhance mental health, social-emotional-behavioural functioning and well-being in adolescence. The original trial protocol was published in Trials (accessible at https://doi.org/10.1186/s13063-017-1917-4 ). This included recruitment in two cohorts, enabling the learning from the smaller first cohort to be incorporated in the second cohort. Here we describe final amendments to the study protocol and discuss their underlying rationale.
METHODS
Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited was increased based on what we learned in the first cohort; (3) some changes were made to the secondary outcome measures to improve their validity and ability to measure constructs of interest and to reduce the burden on school staff; and (4) the current Coronavirus Disease 2019 (SARS-CoV-2 or COVID-19) pandemic both influences and makes it difficult to interpret the 2-year follow-up primary endpoint results, so we changed our primary endpoint to 1-year follow-up.
DISCUSSION
These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures. Furthermore, the change in the primary endpoint will give a more reliable answer to our primary question because it was collected prior to the COVID-19 pandemic in both cohort 1 and cohort 2. Nevertheless, the longer 2-year follow-up data will still be acquired, although this time-point will be now framed as a second major investigation to answer some new important questions presented by the combination of the pandemic and our study design.
TRIAL REGISTRATION
International Standard Randomised Controlled Trials ISRCTN86619085 . Registered on 3 June 2016.
背景
Myriad（青少年的韧性）是一项优越性、平行组、集群随机对照试验，旨在检验正念训练（MT）方案与正常社会情感学习（SEL）学校教育相比，对增强青少年心理健康、社会情感行为功能和幸福感的有效性和成本效益。原始试验方案发表在 Trials（可在 https://doi.org/10.1186/s13063-017-1917-4 访问）。该试验方案包括招募两个队列，使得从第一个较小的队列中获得的经验可以融入第二个队列中。在这里，我们描述了对研究方案的最终修订，并讨论了其基本原理。
方法
研究方案引入了四项重大变更：（1）资格标准发生了变化，包括更明确的操作性定义来评估学校实施 SEL 的程度，以及避免实验污染的新标准；（2）根据第一个队列中获得的经验，增加了必须招募的学校和学生数量；（3）对次要结局测量进行了一些更改，以提高其有效性和测量感兴趣的结构的能力，并减轻学校工作人员的负担；（4）当前的 2019 年冠状病毒病（SARS-CoV-2 或 COVID-19）大流行既影响也难以解释 2 年随访的主要结局点结果，因此我们将主要结局点更改为 1 年随访。
讨论
这些研究方案的变更已得到试验管理小组、试验指导委员会和数据与伦理监测委员会的批准，并提高了参与者的入组率和测量质量。此外，主要结局点的变更将为我们的主要问题提供更可靠的答案，因为在第 1 队列和第 2 队列中，该结局点都是在 COVID-19 大流行之前收集的。然而，仍将获取更长的 2 年随访数据，尽管此时点现在将作为第二次主要调查来回答由大流行和我们的研究设计相结合带来的一些新的重要问题。
试验注册
国际标准随机对照试验 ISRCTN86619085。于 2016 年 6 月 3 日注册。
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