Child DevelopmentNCT04069000
Mind Up (MindUP) Evaluation With Grade 3 Students
A study testing Mindfulness-based social-emotional learning program and Regular grade 3 program in people with Child Development, run by Western University, Canada at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Child Development
- What is being tested?
- Mindfulness-based social-emotional learning program and Regular grade 3 program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 429 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2019to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing a Mindfulness-informed, Evidence-based Social and Emotional Program With Kindergarten Students Within a Trauma-informed Framework
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.
Read the 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.
- Conditions
- Child Development
- Being tested
- Mindfulness-based social-emotional learning program, Regular grade 3 program
- Keywords
- Social-Emotional Learning, Classroom Climate, Self-concept, Academic Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based social-emotional learning programBehavioural
Also called MindUP
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.
Regular grade 3 programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Mindfulness-based social-emotional learning program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to 6-month follow-up; one calendar year
Secondary outcomes (6)
Academic skills
Academic skills reported by teachers on SSIS-SEL and/or report card and standardized testing data. Higher scores are better.
Measured: Change from baseline to post-intervention; one school year (approximately 6 months)
Social and Emotional Learning Subscales
Subscales from the SSIS-SEL (self-awareness; self management; social awareness; responsible decision-making; relationships); higher scores are better. Scores are standardized and norm-referenced with a mean of 100 and a standard deviation of 15.
Measured: Change from baseline to post-intervention; one school year (approximately 6 months)
Self-concept
Child's view of themselves as assessed by the Feelings, Attitudes, and Behaviors Scale for Children (FAB-C). Higher scores are indicative of poorer functioning (i.e., feeling negative about oneself or feeling socially unaccepted). T scores are used to interpret the level of concerns as reported by children on the FAB-C. These scores are linear transformations of the raw scale scores (M = 50, SD = 10). T scores provide information about an individual's scores relative to the scores of respondents in the standardization sample. Percentiles represent the percentage of children in the standardization sample with scores at or below the same value. For all FAB-C subscales, T scores over 60 are considered somewhat elevated and T scores over 65 are considered significantly elevated.
Measured: Change from baseline to post-intervention; one school year (approximately 6 months)
Class climate
Classroom cohesion and satisfaction as measured by the My Class Inventory-Short Form. Both cohesion and satisfaction are measured with six yes/no items, such that children can score between 0 and 6 on each subscale. If the two scales are moderately correlated (as expected give the age of the children), then we will sum them for one class climate scale (ranging from 0-12; higher scores indicate higher cohesion and satisfaction in the classroom).
Measured: Change from baseline to post-intervention; one school year (approximately 6 months)
Executive functioning
General executive control deficits as measured by the Behavior Rating Inventory of Executive Function, Second edition (BRIEF-2). Higher scores are indicative of poorer functioning. T scores are used to interpret the level of executive functioning as reported by teachers on the BRIEF-2 rating forms. These scores are linear transformations of the raw scale scores (M = 50, SD = 10). T scores provide information about an individual's scores relative to the scores of respondents in the standardization sample. Percentiles represent the percentage of children in the standardization sample with scores at or below the same value. For all BRIEF-2 clinical scales and indexes, T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated. T scores at or above 70 are considered clinically elevated.
Measured: Change from baseline to post-intervention; one school year (approximately 6 months)
Executive functioning (follow-up)
General executive control deficits as measured by the Behavior Rating Inventory of Executive Function, Second edition (BRIEF-2). Higher scores are indicative of poorer functioning. T scores are used to interpret the level of executive functioning as reported by teachers on the BRIEF-2 rating forms. These scores are linear transformations of the raw scale scores (M = 50, SD = 10). T scores provide information about an individual's scores relative to the scores of respondents in the standardization sample. Percentiles represent the percentage of children in the standardization sample with scores at or below the same value. For all BRIEF-2 clinical scales and indexes, T scores from 60 to 64 are considered mildly elevated, and T scores from 65 to 69 are considered potentially clinically elevated. T scores at or above 70 are considered clinically elevated.
Measured: Change from baseline to 6-month follow-up; one calendar year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Oct 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Why it stopped: We collected pre-intervention data but the COVID-19 pandemic and resulting school closures ended the intervention; thus post-intervention data were not collected. Our funding window has closed and we will not recommence this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Responsible party
- Principal investigator, Claire Crooks, Western University, Canada
- Investigators
- Claire Crooks, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069000
- Sponsor's protocol ID
- 0000039458
- Status last verified
- Jun 2022
- First submitted
- 12 Aug 2019
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Mindfulness-informed, Evidence-based Social and Emotional Program With Kindergarten Students Within a Trauma-informed Framework
- ClinicalTrials.gov ID
- NCT04069000
- Acronym / sponsor ID
- 0000039458
- Conditions
- Child Development
- Keywords
- Social-Emotional Learning, Classroom Climate, Self-concept, Academic Skills
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We collected pre-intervention data but the COVID-19 pandemic and resulting school closures ended the intervention; thus post-intervention data were not collected. Our funding window has closed and we will not recommence this study.
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Regular grade 3 classrooms | Active comparator | Behavioral: Regular grade 3 programStudents 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. |
| First time MindUP participants | Experimental | Behavioral: Mindfulness-based social-emotional learning programStudents 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. |
| Repeat MindUP participants | Experimental | Behavioral: Mindfulness-based social-emotional learning programStudents 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based social-emotional learning programAlso: MindUPGrade 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. | Behavioural | First time MindUP participants, Repeat MindUP participants |
| Regular grade 3 programGrade 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. | Behavioural | Regular grade 3 classrooms |
Primary outcome
Social and emotional learning
Time frame: 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)
Time frame: 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.
6 secondary outcomes
Academic skills
Time frame: Change from baseline to post-intervention; one school year (approximately 6 months)
Social and Emotional Learning Subscales
Time frame: Change from baseline to post-intervention; one school year (approximately 6 months)
Self-concept
Time frame: Change from baseline to post-intervention; one school year (approximately 6 months)
Class climate
Time frame: Change from baseline to post-intervention; one school year (approximately 6 months)
Executive functioning
Time frame: Change from baseline to post-intervention; one school year (approximately 6 months)
Executive functioning (follow-up)
Time frame: Change from baseline to 6-month follow-up; one calendar year
Results and safety
The study was stopped early (reason given: We collected pre-intervention data but the COVID-19 pandemic and resulting school closures ended the intervention; thus post-intervention data were not collected. Our funding window has closed and we will not recommence this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Study websiteLink provided by the sponsor.
- MindUP program websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Crooks, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based social-emotional learning program and Regular grade 3 program in people with Child Development, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We collected pre-intervention data but the COVID-19 pandemic and resulting school closures ended the intervention; thus post-intervention data were not collected. Our funding window has closed and we will not recommence this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social and emotional learning (time frame: Change from baseline to post-intervention; one school year (approximately 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022; AzTrials last refreshed its copy on 27 Oct 2026.