Clinical trial NCT06326255: Feasibility and Acceptability of Laughter Yoga in Children With Autism Spectrum Disorder and Their Parents
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Parenting Stress
Depression
Anxiety
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 66
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Response rate
timeFrame: Baseline (immediately before intervention)
measure: Attrition rate
timeFrame: 3 Months Follow-up (9 months from baseline)
measure: Attendance rate
timeFrame: Each laughter yoga session, total 12 time points
measure: Perception on laughter yoga
timeFrame: Programme end (6 months from Baseline)
measure: Difficulties in laughter yoga
timeFrame: Programme end (6 months from Baseline)
measure: Safety issues
timeFrame: Programme end (6 months from Baseline)
Secondary outcomes:
measure: Depression
timeFrame: at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
measure: Anxiety
timeFrame: at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
measure: Parenting Stress
timeFrame: at baseline (immediately before intervention) , Programme end (6 months from Baseline) and 3-month follow-up (9 months from Baseline)
measure: Child-parent Relationships
timeFrame: Programme end (6 months from Baseline)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Chung Yan Lam
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.