Clinical trial NCT04069000: Mind Up (MindUP) Evaluation With Grade 3 Students
Official title: Implementing a Mindfulness-informed, Evidence-based Social and Emotional Program With Kindergarten Students Within a Trauma-informed Framework
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Child Development
Keywords: Social-Emotional Learning
Classroom Climate
Self-concept
Academic Skills
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Public Health Agency of Canada (PHAC)
First posted: 2019-08-28
Enrollment: 429
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children within grade 3 classrooms will be evaluated in one of three conditions. One condition includes classrooms that will implement MindUP with students for the first time. A second condition includes classrooms that will implement MindUP, but has students who have largely been exposed to MindUP every year since kindergarten. The third condition is the comparison group wherein classroom teachers will deliver their usual curriculum and teaching strategies.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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:

The school district partnering on this project will identify 24 classrooms to participate. The first condition (\~150 children in 8-10 classrooms) will participate in MindUP during the school year. The second condition (\~150 children in 8-10 classrooms) includes children who have been participating in MindUP since kindergarten receiving the program in grade 3. The third group is a comparison condition where teachers will not implement the program. All implementing teachers will receive a half-day training on trauma-informed practice and a full-day training in MindUP before beginning the intervention.

Classroom teachers will send home consent forms for guardians to complete. Children will provide their own assent when the researchers come to classrooms to collect data. Surveys will be completed in October 2019 and again in May 2020. In November 2020, the students' grade 4 teachers will provide ratings for a 6-month follow-up.

To understand program implementation, educators will be asked to complete a brief online survey at the end of each week to report on their weekly engagement with MindUP lesson plans generally, and breathing breaks specifically. They will also be asked to report additional SEL activities. Educators in comparison classrooms will complete a weekly summary of their SEL learning activities as well.

Planned Analyses The primary comparisons will be between the group receiving MindUP for the first time versus the comparison groups (both immediately after intervention, and at 6-month follow-up). A secondary set of analyses will compare the group who have received MindUP for three years previously to the comparison group to see if they continue to make gains relative to the comparison group. Finally, we will also conduct moderator analyses using parent-reported adversity to test our hypothesis that students who have experienced more adversity will show greater gains.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Social and emotional learning
timeFrame: Change from baseline to post-intervention; one school year (approximately 6 months)
measure: Social and emotional learning (follow-up)
timeFrame: Change from baseline to 6-month follow-up; one calendar year
Secondary outcomes:
measure: Academic skills
timeFrame: Change from baseline to post-intervention; one school year (approximately 6 months)
measure: Social and Emotional Learning Subscales
timeFrame: Change from baseline to post-intervention; one school year (approximately 6 months)
measure: Self-concept
timeFrame: Change from baseline to post-intervention; one school year (approximately 6 months)
measure: Class climate
timeFrame: Change from baseline to post-intervention; one school year (approximately 6 months)
measure: Executive functioning
timeFrame: Change from baseline to post-intervention; one school year (approximately 6 months)
measure: Executive functioning (follow-up)
timeFrame: Change from baseline to 6-month follow-up; one calendar year
Other outcomes:
Locations:
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
affiliation: Western University
name: Claire Crooks, PhD
role: PRINCIPAL_INVESTIGATOR
References: