NCT06346002

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
Last Updated

April 3, 2024

Status Verified

March 1, 2024

Enrollment Period

3.1 years

First QC Date

March 24, 2024

Last Update Submit

March 28, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Symptoms of Mental Health Disorders

    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

    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

    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)

Study Arms (2)

Mindfulness-based condition

EXPERIMENTAL

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.

Behavioral: Mindfulness-based intervention

Wait-list control

NO INTERVENTION

Placed on waitlist and then offered the intervention once the data collection phase was over.

Interventions

The MBI program implemented comprised ten weekly sessions. Please refer to the arm/group descriptions for further details.

Mindfulness-based condition

Eligibility Criteria

Age8 Years - 12 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll genders were included.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Attending the Préville Elementary School
  • Spoke sufficient French to fill out questionnaires

You may not qualify if:

  • Not attending the Préville Elementary School
  • Level of French was not good enough to fill out questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

École primaire Préville

Saint-Lambert, Quebec, J4S 1M8, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized cluster trial with a wait-list control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 24, 2024

First Posted

April 3, 2024

Study Start

March 1, 2017

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

April 3, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Data will be available upon request with the PI.

Locations