Viewing Study NCT06326255



Ignite Creation Date: 2024-05-06 @ 8:18 PM
Last Modification Date: 2024-10-26 @ 3:24 PM
Study NCT ID: NCT06326255
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-22
First Post: 2024-03-04

Brief Title: Feasibility and Acceptability of Laughter Yoga in Children With Autism Spectrum Disorder and Their Parents
Sponsor: The Hong Kong Polytechnic University
Organization: The Hong Kong Polytechnic University

Study Overview

Official Title: The Effects of Laughter Yoga on Reducing Depression and Anxiety in Children With Autism Spectrum Disorder ASDand Parenting Stress in Their Parents a Pilot Randomised Controlled Trial
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 yogas 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 n33 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 n33 will receive the same laughter yoga programme after 3-month follow-up T2

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None