Early Socioemotional Intervention for Children With Autism Spectrum Disorder in Hong Kong and Mainland China

Study Overview
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Brief Summary
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This study aims to develop a culturally-sensitive parent-training intervention to enhance socioemotional functioning of young children (aged 3-6) with Autism Spectrum Disorder (ASD) in Mainland China. The investigators will conduct randomized controlled trials to evaluate the effectiveness and feasibility of this program in a pilot study and then a large-scale community-based study in Shenzhen, China, to examine the generalizability of the treatment outcomes of this intervention for Chinese children with ASD.

Official Title
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Early Socioemotional Intervention for Children With Autism Spectrum Disorder in Hong Kong and Mainland China

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Other: Intervention on socioemotional functioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 3-6 Living in Shenzhen, Mainland China Diagnosed with ASD or suspected of having ASD

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASD Intervention Group<br>Participants in the ASD intervention group will receive training to help children improve socioemotional functioning. | Other: Intervention on socioemotional functioning<br>* A culturally sensitive intervention based on the train the trainer (or coach the coach) model for enhancing the social adaptive functioning of young children (aged 3-6) with ASD in China, via providing training for parents<br>|
| No Intervention: Wait List Control Group<br>Participants in this group will be placed on the wait list and receive the ASD intervention training 2 months after the other groups | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) | ADOS-2 is a diagnostic measure used in this study to assess the change in children's ASD symptoms | pre-intervention and 4-month post-intervention | 
| Change in the Autism Spectrum Quotient (AQ) | AQ is a parent-report measure used in this study to measure change in children's ASD symptoms | pre-intervention, immediately after the intervention, and 4-month post-intervention | 
| Change in Dyadic Parent-Child Interaction Coding System (DPICS system) | The DPICS system is used in this study to measure the change in the quality of parent-child interaction through observations of dyads during free and structured play in the clinical setting and 5-minute parents' description of their children. The code categories include the number of command, praise, joint attention and verbal responsiveness, words used by parents and the intonation in their language. | pre-intervention, immediately after the intervention, and 4-month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF) | PSI-4-SF is a parent-report measure used in this study to measure change in parenting stress | pre-intervention, immediately after the intervention, and 4-month post-intervention | 
| Change in Self-Efficacy in Nurturing Role Questionnaire | Self-Efficacy in Nurturing Role Questionnaire is a parent-report measure used in this study to measure change in parents' self-efficacy | pre-intervention, immediately after the intervention, and 4-month post-intervention | 
| Change in Classroom Observation Scale (COS) | COS is a teacher-report measure used in this study to measure children's social behaviours in classroom setting | pre-intervention, immediately after the intervention, and 4-month post-intervention | 
| Change in Social Responsiveness Scale, Second Edition (SRS-2) | SRS-2 is a teacher-report measure used in this study to measure children's social behaviours | pre-intervention, immediately after the intervention, and 4-month post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASD, Autism Spectrum Disorder, socioemotional functioning, Intervention study