Clinical trial NCT05531669: Effect of PLAY Project Intervention Program on Children With ASD
Official title: Effect of PLAY Project Intervention Program on Children With Autism Spectrum Disorder: A Multi-center, Randomized Control Study in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
PLAY Project
functional developmental level
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Fuzhou Children's Hospital of Fujian Medical University
name: Third Affiliated Hospital of Zhengzhou University
name: Shenzhen Hospital of Southern Medical University
name: Children's Hospital of Zhejiang University School of Medicine
First posted: 2022-09-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Age of 18 months to 6 years old at the time of enrollment, no gender requirement;
2. Children who were diagnosed with autism spectrum disorder in 5 research centers, meet the diagnostic criteria by Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-Ⅴ), and the Autism Diagnostic Observation Schedule-Second Edition (ADOS-2).
3. Complete pre-assessments in outpatient clinics, 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.
4. Parents agreed to participate in the study provided written informed consent at recruitment.

Exclusion Criteria:

1. High functioning ASD children with abnormal social communication but high language level. Language development quotient\>85 in GDS;
2. Suffering from:

   1. hereditary diseases, such as Rett syndrome, Fragile X syndrome, trisomy 21 or tuberous sclerosis;
   2. abnormal vision or hearing impairment;
   3. movement disorders, such as cerebral palsy;
   4. epilepsy;
3. Receive 7 hours or more per week of 1:1 intensive intervention, such as Applied Behavior Analysis (ABA), Parent-Implemented Language training, etc.
4. Parents scoring \<90 by SPM, or report being severely depressed by HAMD, will be excluded from the study.

Primary outcomes:
measure: Changes in Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-Ⅴ) in ASD children
timeFrame: baseline, 6th-months, 12th-months
measure: Changes in Autism Diagnostic Observation Schedule-Second Edition (ADOS-2) in ASD children
timeFrame: baseline, 6th-months, 12th-months
measure: Changes in Child Autism Rating Scale (CARS) in ASD children
timeFrame: baseline, 6th-months, 12th-months
measure: Changes in Social Communication Questionnaire (SCQ) in ASD children
timeFrame: baseline, 6th-months, 12th-months
measure: Changes in Gesell Developmental Schedules (GDS) in ASD children
timeFrame: baseline, 6th-months, 12th-months
measure: Changes in Pivotal Behavior Rating Scale (PBRS) in ASD children
timeFrame: baseline, 6th-months, 12th-months
measure: Changes in Maternal Behavior Rating Scale (MBRS) in the interaction between ASD children and their parents
timeFrame: baseline, 6th-months, 12th-months
Secondary outcomes:
measure: Raven's Standard Progressive Matrices (SPM)
timeFrame: baseline
measure: Hamilton Depression Scale (HAMD)
timeFrame: baseline
measure: Changes in Parenting Stress Index-Short Form (PSI-SF) in parents of ASD children
timeFrame: baseline, 6th-months, 12th-months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fuzhou Children's Hospital of Fujian Medical University
state: Fujian
city: Shenzhen
country: China
facility: Shenzhen Hospital of Southern Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: The Third Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
state: Hubei
city: Hangzhou
country: China
facility: Children's Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Tongji Hospital
name: Yan Hao, doctor
role: PRINCIPAL_INVESTIGATOR
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