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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Difficulties in laughter yoga
研究概览
简要总结
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:
- Laughter yoga is acceptable to children with ASD and their parents.
- Laughter yoga is feasible for anxiety and depression reduction in children with ASD and parenting stress reduction in their parents.
- Participants in the experimental group will have significantly more reduction in depression, anxiety and parental stress than those in the wait-list-control group.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Difficulties in laughter yoga
时间窗: Programme end (6 months from Baseline)
Families in the laughter yoga group will be interviewed to explore difficulties when they practiced laughter yoga.
Response rate
时间窗: Baseline (immediately before intervention)
The proportion of eligible potential participants that agree to take part in.
Attrition rate
时间窗: 3 Months Follow-up (9 months from baseline)
The proportion of recruited participants that withdraw from the study at any time.
Attendance rate
时间窗: Each laughter yoga session, total 12 time points
The number and percentage of families attend each laughter yoga session.
Perception on laughter yoga
时间窗: 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.
Safety issues
时间窗: 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.
次要结局
- Depression(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))
- 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))
研究者
LAM Chung Yan Hemio
PhD student
The Hong Kong Polytechnic University