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

Mental Health Wellness 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06346002
• Other study ID #: 2026_e_2017
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2024
• Source: Bishop's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

Behavioral:
• Mindfulness-based intervention
The MBI program implemented comprised ten weekly sessions. Please refer to the arm/group descriptions for further details.

Locations

Country	Name	City	State
Canada	École primaire Préville	Saint-Lambert	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Bishop's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)