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:

  1. Laughter yoga is acceptable to children with ASD and their parents.
  2. Laughter yoga is feasible for anxiety and depression reduction in children with ASD and parenting stress reduction in their parents.
  3. 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

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

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 (Estimated)

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.
66

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The 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
  • 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

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: Laughter Yoga Group
The intervention is a laughter yoga program consisting of 12 sessions, two 1-hour sessions per month.
Behavioral: laughter yoga
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).

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
Response rate
Time Frame: Baseline (immediately before intervention)
The proportion of eligible potential participants that agree to take part in.
Baseline (immediately before intervention)
Attrition rate
Time Frame: 3 Months Follow-up (9 months from baseline)
The proportion of recruited participants that withdraw from the study at any time.
3 Months Follow-up (9 months from baseline)
Attendance rate
Time Frame: Each laughter yoga session, total 12 time points
The number and percentage of families attend each laughter yoga session.
Each laughter yoga session, total 12 time points
Perception on laughter yoga
Time Frame: Programme end (6 months from Baseline)
Families in the laughter yoga group will be interviewed to explore their perception of laughter yoga and its benefits.
Programme end (6 months from Baseline)
Difficulties in laughter yoga
Time Frame: Programme end (6 months from Baseline)
Families in the laughter yoga group will be interviewed to explore difficulties when they practiced laughter yoga.
Programme end (6 months from Baseline)
Safety issues
Time Frame: Programme end (6 months from Baseline)
Families in the laughter yoga group will be interviewed and explore any discomfort during or after the laughter yoga.
Programme end (6 months from Baseline)

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
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.
at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
Anxiety
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 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.
at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
Parenting Stress
Time Frame: at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
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.
at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
Child-parent Relationships
Time Frame: Programme end (6 months from Baseline)
Families in the laughter yoga group will be interviewed to assess whether any child-parent relationships have changed since practicing laughter yoga.
Programme end (6 months from Baseline)

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.
LAM Chung Yan Hemio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

Helpful Links

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.
March 15, 2024

Primary Completion (Estimated)

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.
February 1, 2026

Study Completion (Estimated)

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.
December 1, 2026

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).
March 4, 2024

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.
March 20, 2024

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.
March 22, 2024

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.
September 19, 2025

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.
September 15, 2025

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.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • 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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