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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • The Hong Kong Polytechnic University
      • Hong Kong, Hong Kong
        • Hong Kong Polytechnic University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: School-based Mindfulness program
Eight session of mindfulness-based program based on Mindfulness Matters developed by Eline Snel
Behavioral: mindfulness matters
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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