Mental Health Wellness 1NCT05855564
Implementing a School-based Mindfulness Curriculum
A study testing mindfulness matters in people with Mental Health Wellness 1, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- mindfulness matters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Oct 2022to 15 Oct 2023
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- students in participating schools
- students with parent's consent
Who cannot join
- student without parent's consent
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
The Hong Kong Polytechnic University
Hong Kong, 852
Hong Kong Polytechnic University
Hong Kong
About this study
Official title: 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.
- Conditions
- Mental Health Wellness 1
- Being tested
- mindfulness matters
- Keywords
- student mental health, school-based mindfulness training, students with special needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness mattersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| School-based Mindfulness program | Experimental | Eight session of mindfulness-based program based on Mindfulness Matters developed by Eline Snel Receives: Behavioral: mindfulness matters |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive self-perception
measured by Self-Evaluation Scale for Children. Values from 0 to 80. The higher the score, the stronger the positive self-perception
Measured: immediately before the intervention, and immediately after the intervention
Secondary outcomes (7)
peer relationship
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
Measured: before the intervention, and immediately after the intervention
attitude towards school
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.
Measured: before the intervention, and immediately after the intervention
organized, nondisruptive, and nonimpulsive behaviors
measured by Self-Evaluation Scale for Children. Values from 0 to 70. The higher the score, the higher the severity of problem behaviors
Measured: before the intervention, and immediately after the intervention
executive functioning
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.
Measured: before the intervention, and immediately after the intervention
creativity
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.
Measured: before the intervention, and immediately after the intervention.
self-regulation
measured by The Head-Toes-Knees-Shoulders (HTKS) task
Measured: before the intervention, and immediately after the intervention
cortisol
measured by salivary cortisol (this measure is administered for students with special needs only)
Measured: before the intervention, and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Oct 2022
- Primary completion15 Jul 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855564
- Sponsor's protocol ID
- School
- Status last verified
- Mar 2023
- First submitted
- 3 Apr 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The funder decided not to share the data.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a School-based Mindfulness Program in Primary School Curriculum
- ClinicalTrials.gov ID
- NCT05855564
- Acronym / sponsor ID
- School
- Conditions
- Mental Health Wellness 1
- Keywords
- student mental health, school-based mindfulness training, students with special needs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 11 May 2023 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| School-based Mindfulness program | Experimental | Behavioral: mindfulness mattersEight session of mindfulness-based program based on Mindfulness Matters developed by Eline Snel |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- students in participating schools
- students with parent's consent
Key exclusion criteria (1 listed)
- student without parent's consent
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 mattersClassroom 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. | Behavioural | School-based Mindfulness program |
Primary outcome
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
7 secondary outcomes
peer relationship
Time frame: before the intervention, and immediately after the intervention
attitude towards school
Time frame: before the intervention, and immediately after the intervention
organized, nondisruptive, and nonimpulsive behaviors
Time frame: before the intervention, and immediately after the intervention
executive functioning
Time frame: before the intervention, and immediately after the intervention
creativity
Time frame: before the intervention, and immediately after the intervention.
self-regulation
Time frame: before the intervention, and immediately after the intervention
cortisol
Time frame: before the intervention, and immediately after the intervention
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 5 Mar 2024.
- Individual participant dataSharing planned: No. The funder decided not to share the data.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness matters in people with Mental Health Wellness 1, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
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 1 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 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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?
positive self-perception (time frame: immediately before the intervention, and immediately after the intervention). 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 5 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.