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

Not Applicable

• Conditions: Autism Spectrum Disorder
• Interventions: Other: Intervention on socioemotional functioning

• Registration Number: NCT04658043
• Lead Sponsor: The University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-09-22
• Study First Submitted: 2020-11-10
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-07
• Last Update Submitted: 2020-12-07
• Study First Posted: 2020-12-08
• Last Update Posted: 2020-12-08
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Children aged 3-6
• Living in Shenzhen, Mainland China
• Diagnosed with ASD or suspected of having ASD

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASD Intervention Group	Intervention on socioemotional functioning	Participants in the ASD intervention group will receive training to help children improve socioemotional functioning.

Primary Outcome Measures

Name	Time	Method
Change in Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)	pre-intervention and 4-month post-intervention	ADOS-2 is a diagnostic measure used in this study to assess the change in children's ASD symptoms
Change in Dyadic Parent-Child Interaction Coding System (DPICS system)	pre-intervention, immediately after the intervention, and 4-month post-intervention	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.
Change in the Autism Spectrum Quotient (AQ)	pre-intervention, immediately after the intervention, and 4-month post-intervention	AQ is a parent-report measure used in this study to measure change in children's ASD symptoms

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Shenzhen University; 🇨🇳 Shenzhen, China

University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong