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NCT Number: NCT06326255

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hong Kong

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laughter Yoga

Behavioral

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

Primary outcomes

  1. Response rate

    Time frame: Baseline (immediately before intervention)

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

  2. 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. Attendance rate

    Time frame: Each laughter yoga session, total 12 time points

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

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

LAM Chung Yan Hemio

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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