Mindfulness-based InterventionNCT06346002
Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children
A study testing Mindfulness-based intervention in people with Mindfulness-based Intervention and Elementary School Children, run by Bishop's University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness-based Intervention, Elementary School Children, Mental Health Wellness 1
- What is being tested?
- Mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2017to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attending the Préville Elementary School
- Spoke sufficient French to fill out questionnaires
Who cannot join
- Not attending the Préville Elementary School
- Level of French was not good enough to fill out questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Mindfulness-based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based interventionBehavioural
The MBI program implemented comprised ten weekly sessions. Please refer to the arm/group descriptions for further details.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness-based intervention |
| Wait-list control | No intervention | Placed on waitlist and then offered the intervention once the data collection phase was over. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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.
Measured: Baseline, post-intervention (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Mar 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mindfulness-based InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized cluster trial with a wait-list control
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bishop's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Malboeuf-Hurtubise, Bishop's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346002
- Sponsor's protocol ID
- 2026_e_2017
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon request with the PI.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children: Results From a Randomized Cluster Trial
- ClinicalTrials.gov ID
- NCT06346002
- Acronym / sponsor ID
- 2026_e_2017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Bishop's UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cluster trial with a wait-list control
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based condition | Experimental | Behavioral: Mindfulness-based interventionClasses 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. |
| Wait-list control | No intervention | –Placed on waitlist and then offered the intervention once the data collection phase was over. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Attending the Préville Elementary School
- Spoke sufficient French to fill out questionnaires
Key exclusion criteria (2 listed)
- Not attending the Préville Elementary School
- Level of French was not good enough to fill out questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based interventionThe MBI program implemented comprised ten weekly sessions. Please refer to the arm/group descriptions for further details. | Behavioural | Mindfulness-based condition |
Primary outcome
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)
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No. Data will be available upon request with the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based intervention in people with Mindfulness-based Intervention and Elementary School Children, run by Bishop's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of Mental Health Disorders (time frame: Baseline, post-intervention (10 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.