Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-30 @ 3:27 PM
Study NCT ID:
NCT05531669
Status:
UNKNOWN
Last Update Posted:
2022-09-27
First Post:
2022-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of PLAY Project Intervention Program on Children With ASD
Sponsor:
Tongji Hospital
Organization:
Study Overview
Official Title:
Effect of PLAY Project Intervention Program on Children With Autism Spectrum Disorder: A Multi-center, Randomized Control Study in China
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
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:
The objective of this study is to evaluate the effectiveness of the Play and Language for Autistic Youngsters (PLAY) Project Home Consultation model to improve parent-child interaction, child development, and autism symptomatology in young children with autism spectrum disorders (ASDs) in China.
Detailed Description:
The present multi-center randomized controlled trial will recruit 200 children with ASD aged 18 months to 6 years from 5 hospitals including Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science \& Technology, Fuzhou Children's Hospital of Fujian Medical University, The Third Affiliated Hospital of Zhengzhou University, Shenzhen Hospital of Southern Medical University and Children's Hospital of Zhejiang University School of Medicine from 2022.8 to 2023.1.Children who meet the inclusion criteria will be stratified by ASD severity, age and gender and randomly assigned (1:1) to either study group or control group. Using the waitlist-control group design, the study group will receive 12 months of Play Project + Parental Education intervention, the control group receive Parental Education intervention in the first 6 months, and then receive Play Project + Parental Education intervention in the next 6 months. Pre-, 6th month and post- assessments for both groups will be conducted, including Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-Ⅴ), Autism Diagnostic Observation Schedule-Second Edition (ADOS-2), Social Communication Questionnaire (SCQ), Child Autism Rating Scale (CARS), Gesell Developmental Schedules (GDS) for children; Raven's Standard Progressive Matrices (SPM), Hamilton Depression Scale (HAMD) and Parenting Stress Index-Short Form (PSI-SF) for parents, Maternal Behavior Rating Scale (MBRS) and Pivotal Behavior Rating Scale (PBRS).
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?: