- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05855564
Implementing a School-based Mindfulness Curriculum
March 4, 2024 updated by: The Hong Kong Polytechnic University
Implementing a School-based Mindfulness Program in Primary School Curriculum
The outcomes and implementation processes of the school based mindfulness program, as a universal prevention program in classroom as and support group programs for students with special education needs will be investigated.
The study of classroom program will apply quasi-experimental design, comparing the pretest and posttest of seven primary schools with implementation of mindfulness programs with three schools with ordinary school activities only.
A total of 800 students will be recruited to receive an eight session mindfulness program in classroom as a universal prevention program.
Ten support group for students with special education needs will apply mindfulness programs, and its outcome will be evaluated using repeated time measures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, Hong Kong, 852
- The Hong Kong Polytechnic University
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Hong Kong, Hong Kong
- Hong Kong Polytechnic University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- students in participating schools
- students with parent's consent
Exclusion Criteria:
- student without parent's consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: School-based Mindfulness program
Eight session of mindfulness-based program based on Mindfulness Matters developed by Eline Snel
|
Classroom program will be provided to primary one students in eight primary schools and they will receive an 8 session mindfulness matters program, developed by Eline Snel, delivered by their teachers.
Each session lasts for 30 minutes.
The program includes mindfulness exercises, psychoeducation, discussion and sharing activities.
For students with special needs, same programs will be delivered by teachers or social workers in small groups and each groups has 4 to 7 students.
Program content is consistent with the classroom program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
positive self-perception
Time Frame: immediately before the intervention, and immediately after the intervention
|
measured by Self-Evaluation Scale for Children.
Values from 0 to 80.
The higher the score, the stronger the positive self-perception
|
immediately before the intervention, and immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
peer relationship
Time Frame: before the intervention, and immediately after the intervention
|
measured by Assessment Programme for Affective and Social Outcomes (2nd Version).
Values from 6 to 24.
The higher the score, the better the peer relationship
|
before the intervention, and immediately after the intervention
|
|
attitude towards school
Time Frame: before the intervention, and immediately after the intervention
|
measured by Assessment Programme for Affective and Social Outcomes (2nd Version).
Values from 6 to 24.
The higher the score, the stronger the positive attitude towards school.
|
before the intervention, and immediately after the intervention
|
|
organized, nondisruptive, and nonimpulsive behaviors
Time Frame: before the intervention, and immediately after the intervention
|
measured by Self-Evaluation Scale for Children.
Values from 0 to 70.
The higher the score, the higher the severity of problem behaviors
|
before the intervention, and immediately after the intervention
|
|
executive functioning
Time Frame: before the intervention, and immediately after the intervention
|
measured by ratings of parent and teacher of Behavior Rating Inventory of Executive Function, second edition.
The scale includes subscales in inhibit, self-monitor, behavior regulation, emotion regulation, cognitive regulation.
The higher the score, the stronger the functioning.
|
before the intervention, and immediately after the intervention
|
|
creativity
Time Frame: before the intervention, and immediately after the intervention.
|
measured by the Test for Creative Thinking-Drawing Production.
The completed drawings are scored according to the following 10 criteria : (1) continuations, (2) completion, (3) new element, (4 ) connections made with a (5) connections made to produce a theme, (6) boundary breaking that is fragment dependent, (7) boundary breaking that is fragment independent, (8) perspective, (9) humour and affective, (10) unconventionality.
The scores for all the criteria except unconventionality range d from 0 to 6.
Each unconventionality criterion was score d either 0 or 3.
The maximum score is 60.
The higher the score, the higher the creativity.
|
before the intervention, and immediately after the intervention.
|
|
self-regulation
Time Frame: before the intervention, and immediately after the intervention
|
measured by The Head-Toes-Knees-Shoulders (HTKS) task
|
before the intervention, and immediately after the intervention
|
|
cortisol
Time Frame: before the intervention, and immediately after the intervention
|
measured by salivary cortisol (this measure is administered for students with special needs only)
|
before the intervention, and immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2022
Primary Completion (Actual)
July 15, 2023
Study Completion (Actual)
October 15, 2023
Study Registration Dates
First Submitted
April 3, 2023
First Submitted That Met QC Criteria
May 3, 2023
First Posted (Actual)
May 11, 2023
Study Record Updates
Last Update Posted (Estimated)
March 5, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- school (Other Identifier: shanghai jiao tong university)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The funder decided not to share the data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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