NCT06326255

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

March 4, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

March 4, 2024

Last Update Submit

September 15, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Response rate

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

    Baseline (immediately before intervention)

  • Attrition rate

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

    3 Months Follow-up (9 months from baseline)

  • Attendance rate

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

    Each laughter yoga session, total 12 time points

  • Perception on laughter yoga

    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

    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

    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 Outcomes (4)

  • Depression

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

  • Anxiety

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

  • 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

    Programme end (6 months from Baseline)

Study Arms (2)

Laughter Yoga Group

EXPERIMENTAL

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

Behavioral: laughter yoga

wait-list-control group

NO INTERVENTION

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

Interventions

laughter yogaBEHAVIORAL

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

Laughter Yoga Group

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Links

MeSH Terms

Conditions

Autism Spectrum DisorderDepressionAnxiety Disorders

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Chung Yan Lam

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 22, 2024

Study Start

March 15, 2024

Primary Completion

February 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations