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

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04658043
• Collaborator: Shenzhen University (Other), Guangdong Province, Department of Science and Technology (Other)
• Enrollment: 1,000
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 35.3
• Patients Per Site: 500
• Patients Per Site Per Month: 14.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Other: Intervention on socioemotional functioning	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Early Socioemotional Intervention for Children With Autism Spectrum Disorder in Hong Kong and Mainland China
• Actual Study Start Date: Sep 22, 2019
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Aug 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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.

Secondary Outcome Measures

1. 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

2. 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

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Children aged 3-6

• Living in Shenzhen, Mainland China

• Diagnosed with ASD or suspected of having ASD

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shenzhen University	Shenzhen		China
2	University of Hong Kong	Hong Kong		Hong Kong

Sponsors and Collaborators

• The University of Hong Kong
• Shenzhen University
• Guangdong Province, Department of Science and Technology

Investigators

• Principal Investigator: Terry Kit-fong Au, The University of Hong Kong

Study Documents (Full-Text)

• Informed Consent Form - Dec 7, 2020

More Information

Publications

None provided.

• Responsible Party: Professor Terry Kit-fong Au, Vice-President and Pro-Vice-Chancellor (Academic Staffing and Resources), The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT04658043
• Other Study ID Numbers: EA1811014
• First Posted: Dec 8, 2020
• Last Update Posted: Dec 8, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Professor Terry Kit-fong Au, Vice-President and Pro-Vice-Chancellor (Academic Staffing and Resources), The University of Hong Kong: Autism Spectrum Disorder; ASD; socioemotional functioning; Intervention study
• Additional relevant MeSH terms: Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Study Results

No Results Posted as of Dec 8, 2020