Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-25 @ 5:54 PM
Study NCT ID:
NCT06346002
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2024-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized cluster trial with a wait-list control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 231}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2024-03-24', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms of Mental Health Disorders', 'timeFrame': 'Baseline, post-intervention (10 weeks)', 'description': '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)'}, {'measure': 'Basic Psychological Needs Satisfaction', 'timeFrame': 'Baseline, post-intervention (10 weeks)', 'description': '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).'}, {'measure': 'Process Measure', 'timeFrame': 'Baseline, post-intervention (10 weeks)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mindfulness-based Intervention', 'Elementary School Children', 'Mental Health Wellness 1']}, 'descriptionModule': {'briefSummary': "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.\n\nAim: 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.\n\nMethod: 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'genderBased': True, 'genderDescription': 'All genders were included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Attending the Préville Elementary School\n* Spoke sufficient French to fill out questionnaires\n\nExclusion Criteria:\n\n* Not attending the Préville Elementary School\n* Level of French was not good enough to fill out questionnaires'}, 'identificationModule': {'nctId': 'NCT06346002', 'briefTitle': 'Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children', 'organization': {'class': 'OTHER', 'fullName': "Bishop's University"}, 'officialTitle': 'Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children: Results From a Randomized Cluster Trial', 'orgStudyIdInfo': {'id': '2026_e_2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness-based condition', 'description': '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.', 'interventionNames': ['Behavioral: Mindfulness-based intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control', 'description': 'Placed on waitlist and then offered the intervention once the data collection phase was over.'}], 'interventions': [{'name': 'Mindfulness-based intervention', 'type': 'BEHAVIORAL', 'description': 'The MBI program implemented comprised ten weekly sessions. Please refer to the arm/group descriptions for further details.', 'armGroupLabels': ['Mindfulness-based condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J4S 1M8', 'city': 'Saint-Lambert', 'state': 'Quebec', 'country': 'Canada', 'facility': 'École primaire Préville', 'geoPoint': {'lat': 45.50008, 'lon': -73.51028}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be available upon request with the PI.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Bishop's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Catherine Malboeuf-Hurtubise', 'investigatorAffiliation': "Bishop's University"}}}}