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Autism Spectrum DisorderNCT06326255

Feasibility and Acceptability of Laughter Yoga in Children With Autism Spectrum Disorder and Their Parents

A study testing laughter yoga in people with Autism Spectrum Disorder and Parenting Stress, run by LAM Chung Yan Hemio at 1 site in Hong Kong.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 8 years and olderHealthy volunteers can take part
What is being tested?
laughter yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteHong Kong
Study dates
15 Mar 2024to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • The Hong Kong Polytechnic University

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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.
Read the 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).

Being tested
laughter yoga
Medical subject headings
Autism Spectrum Disorder, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • laughter yogaBehavioural

    each class, including warm-up exercises, laughter yoga exercises, breathing and a relaxation session and sharing

Study groups in NCT06326255
Study groupRoleWhat they receive
Laughter Yoga GroupExperimentalThe intervention is a laughter yoga program consisting of 12 sessions, two 1-hour sessions per month.
Receives: Behavioral: laughter yoga
wait-list-control groupNo interventionParticipants will receive the same intervention after the 3-Months Follow-up (T2).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    The proportion of eligible potential participants that agree to take part in.

    Measured: Baseline (immediately before intervention)

  2. Attrition rate

    The proportion of recruited participants that withdraw from the study at any time.

    Measured: 3 Months Follow-up (9 months from baseline)

  3. Attendance rate

    The number and percentage of families attend each laughter yoga session.

    Measured: Each laughter yoga session, total 12 time points

  4. Perception on laughter yoga

    Families in the laughter yoga group will be interviewed to explore their perception of laughter yoga and its benefits.

    Measured: Programme end (6 months from Baseline)

  5. Difficulties in laughter yoga

    Families in the laughter yoga group will be interviewed to explore difficulties when they practiced laughter yoga.

    Measured: Programme end (6 months from Baseline)

  6. Safety issues

    Families in the laughter yoga group will be interviewed and explore any discomfort during or after the laughter yoga.

    Measured: Programme end (6 months from Baseline)

Secondary outcomes (4)

  1. Depression

    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.

    Measured: at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)

  2. Anxiety

    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.

    Measured: at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)

  3. Parenting Stress

    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.

    Measured: at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)

  4. Child-parent Relationships

    Families in the laughter yoga group will be interviewed to assess whether any child-parent relationships have changed since practicing laughter yoga.

    Measured: Programme end (6 months from Baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2024
  2. Study start15 Mar 2024
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06326255
Sponsor's protocol ID
LYASD
Status last verified
Sep 2025
First submitted
4 Mar 2024
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chung JOK, Lam CY, Leung SF, Bressington D, Chong ACY. Effects of laughter yoga on reducing depression and anxiety in children with autism spectrum disorder and parenting stress in their parents: study protocol for a randomised-controlled feasibility trial. BMJ Open. 2026 Jun 16;16(6):e112368. doi: 10.1136/bmjopen-2025-112368.

    PubMed 42303395

Questions about this trial

What is this clinical trial studying?

A study testing laughter yoga in people with Autism Spectrum Disorder and Parenting Stress, run by LAM Chung Yan Hemio at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: Baseline (immediately before intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06326255, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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