Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children

March 28, 2024 updated by: Catherine Malboeuf-Hurtubise, Bishop's University

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

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Saint-Lambert, Quebec, Canada, J4S 1M8
        • École primaire Préville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
No Intervention: Wait-list control
Placed on waitlist and then offered the intervention once the data collection phase was over.

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)
Baseline, post-intervention (10 weeks)
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).
Baseline, post-intervention (10 weeks)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

March 24, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

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)?

NO

IPD Plan Description

Data will be available upon request with the PI.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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