- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05058365
Effects of Mindfulness Training on the Psychological Well-being of Preschoolers
September 16, 2021 updated by: Professor Lam Shui-fong, The University of Hong Kong
The present study is a randomized controlled trial to evaluate the effectiveness of a mindfulness course on the psychological well-being of preschoolers (i.e., attention and impulsivity, prosocial behavior, empathy, emotion regulation and conduct).
Participants will be randomized to either intervention (dots Curriculum) or wait-list control condition.
Participants will complete a computerized task and they will be interviewed to complete a scenario test before (baseline) and after the intervention.
The parents and class teacher will also be invited to complete a survey at baseline and after the intervention.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
16
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
- Jockey Club "Peace and Awareness" Mindfulness Culture in Schools Initiative, Faculty of Social Sciences, The University of Hong Kong
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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
3 years to 6 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
- Aged 3-6 years
- Studying in pre-school settings
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
|
dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings.
The program consists of 15-minute twice weekly lessons that span for fifteen weeks.
dots has various suggestions for "Have A Go" after each session - both in the classroom and at home.
|
No Intervention: Wait-list control
Participants in wait-list control group will receive the same intervention, two months after their counterparts in experimental group completed the intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Attention and Impulsivity
Time Frame: Baseline, Immediately after intervention
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A computerized task of attention and impulsivity (Conners Kiddie Continuous Performance Test 2nd Edition, K-CPT 2)
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Baseline, Immediately after intervention
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Change in Prosocial Behavior and Empathy
Time Frame: Baseline, Immediately after intervention
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Scenario test depicting common social interactions face by preschoolers, A and B version (each with four scenarios), score on a scale of 0 to 2
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Baseline, Immediately after intervention
|
Change in Attention, Emotion Regulation, Prosocial Behavior and Conduct
Time Frame: Baseline, Immediately after intervention
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Parent and teacher surveys adapted from the Strengths and Difficulties Questionnaire (SDQ), 12 items, 5-point Likert scale ranging from 1 (never) to 5 (always)
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Baseline, Immediately after intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 1, 2021
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
June 30, 2022
Study Registration Dates
First Submitted
September 16, 2021
First Submitted That Met QC Criteria
September 16, 2021
First Posted (Actual)
September 27, 2021
Study Record Updates
Last Update Posted (Actual)
September 27, 2021
Last Update Submitted That Met QC Criteria
September 16, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- UHongKong(JC PandA)
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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