- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06326255
Feasibility and Acceptability of Laughter Yoga in Children With Autism Spectrum Disorder and Their Parents
September 15, 2025 updated by: LAM Chung Yan Hemio
The Effects of Laughter Yoga on Reducing Depression and Anxiety in Children With Autism Spectrum Disorder (ASD)and Parenting Stress in Their Parents: a Pilot Randomised Controlled Trial
This is a pilot randomised controlled trial to explore the acceptability and feasibility of laughter yoga about anxiety and depression reduction in children with ASD and parenting stress reduction for their parents. Hypotheses of this study include:
- Laughter yoga is acceptable to children with ASD and their parents.
- Laughter yoga is feasible for anxiety and depression reduction in children with ASD and parenting stress reduction in their parents.
- Participants in the experimental group will have significantly more reduction in depression, anxiety and parental stress than those in the wait-list-control group.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
The intervention is a laughter yoga programme consisting of twelve sessions (biweekly).
Sixty-six children with ASD and their father or mother from local autism support groups will join this study.
Participants will be given an information sheet.
Participants will be fully informed about laughter yoga's details, benefits and risks.
All participants voluntarily take part in this study.
If the family agrees to participate in this study, the parent will sign the consent form.
Families will be randomized into an experimental group or a wait-list-control group.
Before the laughter yoga programme, baseline data (T0) will be collected.
The experimental group (n=33) will attend the twelve classes led by a certified laughter yoga trainer in an activity room that is suitable for indoor exercise.
A research assistant will assist the laughter yoga teacher and provide first aid if needed.
Parents will complete the questionnaire again immediately at the Programme End (T1) and at a 3-month follow-up (T2).
The wait-list-control group (n=33) will receive the same laughter yoga programme after 3-month follow-up (T2).
Study Type
Interventional
Enrollment (Estimated)
66
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
- The Hong Kong Polytechnic University
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
THE CHILD should:
- aged 8 to 12
- be diagnosed with autism spectrum disorder (according to either The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) or International Classification of Diseases 11th), and
- able to read and understand Chinese and Cantonese, and
- have a parent (father or mother) participating in this study together.
THE PARENT should:
- be able to read and understand Chinese and Cantonese, and
- willing to attend the laughter yoga classes with their child, and
- willing to complete the required post-test.
Exclusion Criteria:
THE CHILD:
- has recently undergone surgery, or
- has a primary diagnosis not ASD, or
- has an intelligence quotient lower than 70, or
- has been diagnosed low functioning ASD, or
- has severe behavioral problems, or
- is receiving medical treatment for anxiety or depression at the start of the laughter yoga program.
THE PARENT has:
- recently undergone surgery, or
- been diagnosed with a psychiatric disorder, or
- no child with ASD is willing to participate in this study.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Laughter Yoga Group
The intervention is a laughter yoga program consisting of 12 sessions, two 1-hour sessions per month.
|
each class, including warm-up exercises, laughter yoga exercises, breathing and a relaxation session and sharing
|
|
No Intervention: wait-list-control group
Participants will receive the same intervention after the 3-Months Follow-up (T2).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response rate
Time Frame: Baseline (immediately before intervention)
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The proportion of eligible potential participants that agree to take part in.
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Baseline (immediately before intervention)
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Attrition rate
Time Frame: 3 Months Follow-up (9 months from baseline)
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The proportion of recruited participants that withdraw from the study at any time.
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3 Months Follow-up (9 months from baseline)
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Attendance rate
Time Frame: Each laughter yoga session, total 12 time points
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The number and percentage of families attend each laughter yoga session.
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Each laughter yoga session, total 12 time points
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Perception on laughter yoga
Time Frame: Programme end (6 months from Baseline)
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Families in the laughter yoga group will be interviewed to explore their perception of laughter yoga and its benefits.
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Programme end (6 months from Baseline)
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Difficulties in laughter yoga
Time Frame: Programme end (6 months from Baseline)
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Families in the laughter yoga group will be interviewed to explore difficulties when they practiced laughter yoga.
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Programme end (6 months from Baseline)
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Safety issues
Time Frame: Programme end (6 months from Baseline)
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Families in the laughter yoga group will be interviewed and explore any discomfort during or after the laughter yoga.
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Programme end (6 months from Baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
|
Parents will rate the 10 items related to their children's depression in the Revised Child Anxiety and Depression Scale - Parent Version.
The scoring ranges from 0 to 30, with higher scores indicating greater severity of symptoms of depression.
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at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
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Anxiety
Time Frame: at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
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Parents will rate their children's social phobia (9 items, score from 0 to 27), panic disorder(9 items, score from 0 to 27), separation anxiety (7 items, score from 0 to 21), generalized anxiety (6 items, score from 0 to 18) and obsessive-compulsive behaviour (6 items, score from 0 to 18) in the Revised Child Anxiety and Depression Scale (RCADS) - Parent Version, with higher scores indicating greater severity of symptom of anxiety.
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at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
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Parenting Stress
Time Frame: at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
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Parents will complete the Chinese version of the Parenting Stress Index - Fourth Edition Short Form (PSI-4-SF), from 36 to 180 (36 items), with higher scores indicating a greater level of parenting stress.
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at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
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Child-parent Relationships
Time Frame: Programme end (6 months from Baseline)
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Families in the laughter yoga group will be interviewed to assess whether any child-parent relationships have changed since practicing laughter yoga.
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Programme end (6 months from Baseline)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chung Yan Lam, The Hong Kong Polytechnic University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
March 15, 2024
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 4, 2024
First Submitted That Met QC Criteria
March 20, 2024
First Posted (Actual)
March 22, 2024
Study Record Updates
Last Update Posted (Estimated)
September 19, 2025
Last Update Submitted That Met QC Criteria
September 15, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LYASD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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