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临床试验/NCT04069000
NCT04069000终止不适用

Implementing a Mindfulness-informed, Evidence-based Social and Emotional Program With Kindergarten Students Within a Trauma-informed Framework

Western University, Canada2 个研究点 分布在 1 个国家目标入组 429 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
429
试验地点
2
主要终点
Social and emotional learning

研究概览

简要总结

Mind Up (MindUP) is a mindfulness-based social-emotional learning program for children that has shown promising evidence of effectiveness across several domains (including executive functioning and behavioral symptoms). MindUP has exploded in popularity in recent years, but much of the existing research is limited by sample size, lack of accounting for clustering, or has been conducted by the program developers. In this study we are evaluating MindUP with grade three students (~age 8) in three conditions; students who receive MindUP for the first time (n=~150 in 8-10 classrooms), students have been receiving MindUP since kindergarten (~150 in 8-10 classrooms), and students in comparison classrooms (i.e., no intervention; ~150 students in 8-10 classrooms). Regular classrooms teachers will receive training in trauma-informed approaches and the MindUP program prior to implementing. Students will be assessed in the fall and at the end of the school year using structured rating scales; they will also provide self-report data. In November 2020, students' grade 4 teachers will provide another set of ratings to be used as 6-month follow-up data. The primary outcome is social-emotional learning. Secondary outcomes include executive functioning, academic skills, classroom climate, and self-concept.

详细描述

Study Design and Overview:

Social-emotional learning programs have a strong evidence base documenting their effectiveness. More recently, there has been increasing interest in social-emotional learning programs that include mindfulness; however, there is much less research on these programs, and much of the existing work has been hampered by small sample sizes. In this project, the investigators will examine the association between participation in the MindUP program and social-emotional outcomes in grade three students. The investigators are using a quasi-experimental design with pre-post data collection from students and educators. Students are nested in classrooms, and the clustered nature of the data will be accounted for in analyses. The study will identify changes in social-emotional behaviour, executive functioning, classroom climate, academic skills, and self-concept through a combination of teacher and self-report data using standardized scales.

Participants:

The investigators plan to recruit approximately 24 educators and 450 grade three students in approximately 24 classrooms. More or fewer classrooms will be recruited as needed to reach the intended sample size of 150 students in each of the three conditions.

Procedures:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

Due to the nature of the intervention (i.e., classroom teachers both implement the program (or not) and provide ratings of students' behaviour, it is not feasible to have blinded conditions. Most school-based prevention programs of this type are not blinded.

入排标准

性别
All
接受健康志愿者

入选标准

  • Decision to implement the MindUP program is made at the school level, with agreement from classroom teachers
  • All students in a classroom in any of the three arms of the study are eligible to participate

排除标准

  • Students with very low literacy or cognitive functioning may not be able to complete the self-report measures, but can still participate in the teacher-rating component of the study

结局指标

主要结局

Social and emotional learning

时间窗: Change from baseline to post-intervention; one school year (approximately 6 months)

Composite Social-Emotional Learning (SEL) score from the Social Skills Improvement System-Social Emotional Learning Edition (SSIS-SEL); the score is transformed from a raw score based on norms provided in the manual; higher scores are better. Scores are standardized with a mean of 100 and a standard deviation (SD) of 15.

Social and emotional learning (follow-up)

时间窗: Change from baseline to 6-month follow-up; one calendar year

Composite Social-Emotional Learning (SEL) score from the Social Skills Improvement System-Social Emotional Learning Edition (SSIS-SEL); the score is transformed from a raw score based on norms provided in the manual; higher scores are better. Scores are standardized with a mean of 100 and a standard deviation of 15.

次要结局

  • Academic skills(Change from baseline to post-intervention; one school year (approximately 6 months))
  • Class climate(Change from baseline to post-intervention; one school year (approximately 6 months))
  • Executive functioning (follow-up)(Change from baseline to 6-month follow-up; one calendar year)
  • Social and Emotional Learning Subscales(Change from baseline to post-intervention; one school year (approximately 6 months))
  • Self-concept(Change from baseline to post-intervention; one school year (approximately 6 months))
  • Executive functioning(Change from baseline to post-intervention; one school year (approximately 6 months))

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Principal Investigator
主要研究者

Claire Crooks

Professor; Director, Centre for School Mental Health

Western University, Canada

研究点 (2)

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