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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04658043
• Other study ID #: EA1811014
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: December 2020
• Source: The University of Hong Kong
• Contact: Terry Kit-fong Au
• Phone: (852) 2219 4776
• Email: terryau[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• Children aged 3-6

• Living in Shenzhen, Mainland China

• Diagnosed with ASD or suspected of having ASD

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Other:
• Intervention on socioemotional functioning
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

Locations

Country	Name	City	State
China	Shenzhen University	Shenzhen
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
The University of Hong Kong	Guangdong Province, Department of Science and Technology, Shenzhen University

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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