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Active, not recruitingNCT06326255Updated Sep 19, 2025

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

An interventional study of laughter yoga in Autism Spectrum Disorder, Parenting Stress and Depression, sponsored by LAM Chung Yan Hemio. Active, not recruiting at 1 site in Hong Kong. Open to participants aged 8 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by LAM Chung Yan Hemio · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
8 Years and older
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Autism Spectrum Disorder
  • Parenting Stress
  • Depression
  • Anxiety
03

In context

Autism Spectrum Disorder

1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.

This study's planned enrollment of 66 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

This is the only study on the registry with LAM Chung Yan Hemio as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Laughter Yoga Group

    The intervention is a laughter yoga program consisting of 12 sessions, two 1-hour sessions per month.

    Behavioral: laughter yoga

  • No intervention
    wait-list-control group

    Participants will receive the same intervention after the 3-Months Follow-up (T2).

Interventions

  • Behaviorallaughter yoga

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

06

What researchers measure

Primary outcomes

  1. Response rate

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

    Time frame: Baseline (immediately before intervention)

  2. Attrition rate

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

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

  3. Attendance rate

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Programme end (6 months from Baseline)

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Programme end (6 months from Baseline)

07

Study locations

1 site
  • The Hong Kong Polytechnic University
    Hong Kong, Hong Kong
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06326255
Lead sponsor
LAM Chung Yan Hemio
Responsible party
LAM Chung Yan Hemio (PhD student, The Hong Kong Polytechnic University) — Sponsor-investigator
First posted
Mar 22, 2024
Start date
Mar 15, 2024
Primary completion
Feb 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Sep 19, 2025

Study contacts

Chung Yan Lam
principal investigator · The Hong Kong Polytechnic University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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