NCT04069000

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
429

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

August 12, 2019

Last Update Submit

June 6, 2022

Conditions

Keywords

Social-Emotional LearningClassroom ClimateSelf-conceptAcademic Skills

Outcome Measures

Primary Outcomes (2)

  • Social and emotional learning

    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.

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

  • Social and emotional learning (follow-up)

    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.

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

Secondary Outcomes (6)

  • Academic skills

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

  • 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)

  • Class climate

    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)

  • +1 more secondary outcomes

Study Arms (3)

Regular grade 3 classrooms

ACTIVE COMPARATOR

Students in this condition will participate in the regular grade 3 program. Educators will use their usual teaching methods to meet educational outcomes, including standards for social-emotional learning.

Behavioral: Regular grade 3 program

First time MindUP participants

EXPERIMENTAL

Students in this condition will participate in MindUP for the first time. Their classroom teachers will receive training and implement the program during the school year.

Behavioral: Mindfulness-based social-emotional learning program

Repeat MindUP participants

EXPERIMENTAL

Students in this condition are in schools where MindUP has been implemented since they were in kindergarten (although some students may not have participated in those first three years, depending on when they moved to the school). Their classroom teachers will receive training and implement the program during the school year.

Behavioral: Mindfulness-based social-emotional learning program

Interventions

Grade 3 teachers implement MindUP in their classrooms over the academic year. MindUP is a manualized program informed by cognitive-developmental neuroscience, contemplative science, positive psychology, and social-emotional learning. The curriculum consists of 15 sequential lessons taught in 10-15 minute chunks and cross-curricular extension activities. There are four lesson units: Getting Focused (introduction to brain structure and function, the core practice, and how focused awareness affects brains and feelings), Sharpening Your Senses (focus on internal experiences such as mindful smelling and tasting), It's All About Attitude (focus on cognitive experiences such as positive mindset, perspective-taking, and practicing gratitude), and Taking Action Mindfully (performing acts of kindness to others and building positive relationships). An essential component is the core practice, a focused breathing exercise and mindfulness practice that is implemented three times daily.

Also known as: MindUP
First time MindUP participantsRepeat MindUP participants

Grade 3 teachers are expected to implement activities to achieve a number of pre-specified social-emotional learning outcomes that are identified by the Ministry of Education. Educators have leeway over how they achieve these curriculum expectations and they will report on a weekly basis regarding their implementation of social-emotional learning activities.

Regular grade 3 classrooms

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western University

London, Ontario, N6G 1G7, Canada

Location

Related Links

Study Officials

  • Claire Crooks, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor; Director, Centre for School Mental Health

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 28, 2019

Study Start

October 1, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

June 9, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations