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

Depression Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06326255
• Other study ID #: LYASD
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: The Hong Kong Polytechnic University
• Contact: Chung Yan Lam
• Phone: +852 61983735
• Email: 20074672r[@]connect.polyu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: December 31, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Depression
• Parenting Stress

Intervention

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

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

Piqueras JA, Martin-Vivar M, Sandin B, San Luis C, Pineda D. The Revised Child Anxiety and Depression Scale: A systematic review and reliability generalization meta-analysis. J Affect Disord. 2017 Aug 15;218:153-169. doi: 10.1016/j.jad.2017.04.022. Epub 2017 Apr 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	The proportion of eligible potential participants that agree to take part in.	Baseline (immediately before intervention)
Primary	Attrition rate	The proportion of recruited participants that withdraw from the study at any time.	3 Months Follow-up (9 months from baseline)
Primary	Attendance rate	The number and percentage of families attend each laughter yoga session.	Each laughter yoga session, total 12 time points
Primary	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)
Primary	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)
Primary	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	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.	at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
Secondary	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.	at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
Secondary	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.	at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
Secondary	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.	Programme end (6 months from Baseline)

External Links

•   Official website of Chinese version of the Parenting Stress Index, Fourth Edition Short Form
•   The Revised Child Anxiety and Depression Scale (RCADS)