Quach Jon L, Deery Ben, Kern Margaret, Clinton Janet, Gold Lisa, Orsini Francesca, Sciberras Emma
Melbourne Graduate School of Education, The University of Melbourne, Carlton, Victoria, Australia
Centre for Community Child Health, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
BMJ Open. 2020 May 10;10(5):e036523. doi: 10.1136/bmjopen-2019-036523.
The first years of school are critical in establishing a foundation for positive long-term academic, social and well-being outcomes. Mindfulness-based interventions may help students transition well into school, but few robust studies have been conducted in this age group. We aim to determine whether compared with controls, children who receive a mindfulness intervention within the first years of primary school have better: (1) immediate attention/short-term memory at 18 months post-randomisation (primary outcome); (2) inhibition, working memory and cognitive flexibility at 18 months post-randomisation; (3) socio-emotional well-being, emotion-regulation and mental health-related behaviours at 6 and 18 months post-randomisation; (4) sustained changes in teacher practice and classroom interactions at 18 months post-randomisation. Furthermore, we aim to determine whether the implementation predicts the efficacy of the intervention, and the cost effectiveness relative to outcomes.
This cluster randomised controlled trial will be conducted in 22 primary schools in disadvantaged areas of Melbourne, Australia. 826 students in the first year of primary school will be recruited to detect between groups differences of Cohen's d=0.25 at the 18-month follow-up. Parent, teacher and child-assessment measures of child attention, emotion-regulation, executive functioning, socio-emotional well-being, mental health-related behaviour and learning, parent mental well-being, teacher well-being will be collected 6 and 18 months post-randomisation. Implementation factors will be measured throughout the study. Intention-to-treat analyses, accounting for clustering within schools and classes, will adopt a two-level random effects linear regression model to examine outcomes for the intervention versus control students. Unadjusted and analyses adjusted for baseline scores, baseline age, gender and family socioeconomic status will be conducted.
Ethics approval has been received by the Human Research Ethics Committee at the University of Melbourne. Findings will be reported in peer-review publications, national and international conference presentations and research snapshots directly provided to participating schools and families.
PRE-RESULTS TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12619000326190).
入学的头几年对于奠定积极的长期学业、社交和幸福成果的基础至关重要。基于正念的干预措施可能有助于学生顺利过渡到学校生活，但针对这个年龄组的严格研究较少。我们旨在确定与对照组相比，在小学头几年接受正念干预的儿童是否在以下方面表现更好：（1）随机分组后18个月的即时注意力/短期记忆（主要结局）；（2）随机分组后18个月的抑制能力、工作记忆和认知灵活性；（3）随机分组后6个月和18个月的社会情感幸福感、情绪调节能力和心理健康相关行为；（4）随机分组后18个月教师教学实践和课堂互动的持续变化。此外，我们旨在确定实施情况是否能预测干预的效果以及相对于结局的成本效益。
这项整群随机对照试验将在澳大利亚墨尔本贫困地区的22所小学进行。将招募826名小学一年级学生，以在18个月的随访中检测组间差异，效应量Cohen's d = 0.25。在随机分组后6个月和18个月收集家长、教师和儿童对儿童注意力、情绪调节、执行功能、社会情感幸福感、心理健康相关行为和学习情况、家长心理健康、教师幸福感的评估指标。在整个研究过程中测量实施因素。意向性分析将考虑学校和班级内的聚类情况，采用两级随机效应线性回归模型来检验干预组与对照组学生的结局。将进行未调整分析以及针对基线分数、基线年龄、性别和家庭社会经济地位进行调整的分析。
已获得墨尔本大学人类研究伦理委员会的伦理批准。研究结果将在同行评审出版物、国内和国际会议报告以及直接提供给参与学校和家庭的研究简报中公布。
澳大利亚新西兰临床试验注册中心（ACTRN12619000326190）
