- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06346002
Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children
Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children: Results From a Randomized Cluster Trial
Background: Prevention programs for children such as mindfulness-based interventions (MBIs) are often implemented in schools to prevent psychological disorders from emerging and contribute to children' mental health.
Aim: This study used a randomized cluster design and assessed the impact of a MBI on well-being and mental health of elementary school children's.
Method: 13 elementary school classrooms were randomly allocated to the experimental condition (7 classrooms, n = 127 students) or the waitlist control condition (6 classrooms, n = 104 students). Participants in the experimental condition received a 10-week MBI.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Quebec
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Saint-Lambert, Quebec, Canada, J4S 1M8
- École primaire Préville
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Attending the Préville Elementary School
- Spoke sufficient French to fill out questionnaires
Exclusion Criteria:
- Not attending the Préville Elementary School
- Level of French was not good enough to fill out questionnaires
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness-based condition
Classes assigned to this condition received the mindfulness-based intervention.
The MBI program implemented comprised ten weekly sessions.
Activities were drawn from the Mission Méditation program, a MBI intervention specifically tailored for elementary school children.
Activities comprised in this intervention encompassed formal (e.g., body scan, sitting, and breathing meditation) and informal meditations (e.g., mindful eating, listening, and touching, mindful walking), as well as positive psychology exercises (e.g., taking care of oneself, gratitude).
The weekly sessions, lasting 45 to 60 minutes each, were delivered in a group format by the teachers themselves, in their classroom.
|
The MBI program implemented comprised ten weekly sessions.
Please refer to the arm/group descriptions for further details.
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No Intervention: Wait-list control
Placed on waitlist and then offered the intervention once the data collection phase was over.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms of Mental Health Disorders
Time Frame: Baseline, post-intervention (10 weeks)
|
Children completed selected items from the self-report version of the anxiety (three items, e.g., "I worry about little things"), depression (five items, e.g., "Nothing ever goes right for me") and inattention (4 items, e.g., " I forget to do things") subscales of the Behavior Assessment Scale for Children (BASC II)
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Baseline, post-intervention (10 weeks)
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Basic Psychological Needs Satisfaction
Time Frame: Baseline, post-intervention (10 weeks)
|
Participants rated how competent, autonomous, and related they felt in school, by answering a nine-item scale adapted from a scale used in a previous, similar study [57].
Children were asked to rate their agreement with items such as "In school, I feel free to be myself" (autonomy); "I am able to reach my goals" (competence) and "In my relationship with others, I feel appreciated" (relatedness) on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always).
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Baseline, post-intervention (10 weeks)
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Process Measure
Time Frame: Baseline, post-intervention (10 weeks)
|
Finally, participants completed the Mindful Attention and Awareness Scale for Children (e.g., "I find it hard to stay focused on what's happening in the present moment.";
[58]) to evaluate pre-to-post changes in their mindfulness abilities.
They rated their agreement with each item on a 6-point Likert scale ranging from 1 (never) to 6 (almost always).
A higher score on this scale indicates lower levels of mindfulness.
|
Baseline, post-intervention (10 weeks)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2026_e_2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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