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

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.

Study Overview

• Status: Unknown
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: Intervention on socioemotional functioning

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Terry Kit-fong Au; Phone Number: (852) 2219 4776; Email: terryau@hku.hk
• Study Contact Backup: Name: Kathy Kar-man Shum; Phone Number: (852) 3917 4223; Email: kkmshum@hku.hk

Study Locations

• China
  • Shenzhen, China
    • Recruiting
    • Shenzhen University
    • Contact: Lamei Wang, PhD; Phone Number: (86 755) 8658 1084; Email: wanglamei@szu.edu.cn
    • Sub-Investigator: Xinru Yao, MSc
    • Sub-Investigator: Mingjing Chen, MSc
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • University of Hong Kong
    • Contact: Terry Kit-fong Au, PhD; Phone Number: (852) 2219 4776; Email: terryau@hku.hk
    • Contact: Kathy Kar-man Shum, PhD; Phone Number: (852) 3917-4223; Email: kkmshum@hku.hk
    • Sub-Investigator: An Tong Gong, DClinPsy
    • Sub-Investigator: Alice Yuen-ching Keung, PsyD
    • Sub-Investigator: Shuang Lu, PhD
    • Sub-Investigator: Maureen Mo Yee Kong, PsyD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ASD Intervention Group; Participants in the ASD intervention group will receive training to help children improve socioemotional functioning.	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
NO_INTERVENTION: Wait List Control Group; 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?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Guangdong Province, Department of Science and Technology; Shenzhen University
• Investigators: Principal Investigator: Terry Kit-fong Au, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 22, 2019
• Primary Completion (ANTICIPATED): August 31, 2022
• Study Completion (ANTICIPATED): August 31, 2022

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (ACTUAL): December 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: ASD; Autism Spectrum Disorder; Intervention study; socioemotional functioning
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: EA1811014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No