Skip to main content
OpenTrials
Completed

NCT Number: NCT06346002

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

École primaire Préville

Saint-Lambert, Quebec, J4S 1M8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based Intervention

Behavioral

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

Primary outcomes

  1. 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)

  2. 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).

  3. 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.

Sponsors and collaborators

Lead sponsor

Bishop's University

Other

Registry information

Official study title

Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children: Results From a Randomized Cluster Trial

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2024
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.