Implementing a School-based Mindfulness Curriculum

Mental Health Wellness 1 Clinical Trial

Official title:

Implementing a School-based Mindfulness Program in Primary School Curriculum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05855564
• Other study ID #: School
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: March 2023
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: October 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

Inclusion Criteria:

• students in participating schools

• students with parent's consent

Exclusion Criteria:

• student without parent's consent

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Hong Kong Polytechnic University	Hong Kong
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	immediately before the intervention, and immediately after the intervention
Secondary	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	before the intervention, and immediately after the intervention
Secondary	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.	before the intervention, and immediately after the intervention
Secondary	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	before the intervention, and immediately after the intervention
Secondary	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.	before the intervention, and immediately after the intervention
Secondary	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.	before the intervention, and immediately after the intervention.
Secondary	self-regulation	measured by The Head-Toes-Knees-Shoulders (HTKS) task	before the intervention, and immediately after the intervention
Secondary	cortisol	measured by salivary cortisol (this measure is administered for students with special needs only)	before the intervention, and immediately after the intervention