NCT05855564

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

April 3, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

student mental healthschool-based mindfulness trainingstudents with special needs

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • peer relationship

    before the intervention, and immediately after the intervention

  • attitude towards school

    before the intervention, and immediately after the intervention

  • organized, nondisruptive, and nonimpulsive behaviors

    before the intervention, and immediately after the intervention

  • executive functioning

    before the intervention, and immediately after the intervention

  • creativity

    before the intervention, and immediately after the intervention.

  • +2 more secondary outcomes

Study Arms (1)

School-based Mindfulness program

EXPERIMENTAL

Eight session of mindfulness-based program based on Mindfulness Matters developed by Eline Snel

Behavioral: mindfulness matters

Interventions

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.

School-based Mindfulness program

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • students in participating schools
  • students with parent's consent

You may not qualify if:

  • student without parent's consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Hong Kong Polytechnic University

Hong Kong, 852, Hong Kong

Location

Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

May 11, 2023

Study Start

October 1, 2022

Primary Completion

July 15, 2023

Study Completion

October 15, 2023

Last Updated

March 5, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

The funder decided not to share the data.

Locations