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Clinical Trials/NCT04658043
NCT04658043
Unknown
N/A

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

The University of Hong Kong2 sites in 2 countries1,000 target enrollmentSeptember 22, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
The University of Hong Kong
Enrollment
1000
Locations
2
Primary Endpoint
Change in Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 22, 2019
End Date
August 31, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Professor Terry Kit-fong Au

Vice-President and Pro-Vice-Chancellor (Academic Staffing and Resources)

The University of Hong Kong

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

  • Change in Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF)(pre-intervention, immediately after the intervention, and 4-month post-intervention)
  • Change in Classroom Observation Scale (COS)(pre-intervention, immediately after the intervention, and 4-month post-intervention)
  • Change in Self-Efficacy in Nurturing Role Questionnaire(pre-intervention, immediately after the intervention, and 4-month post-intervention)
  • Change in Social Responsiveness Scale, Second Edition (SRS-2)(pre-intervention, immediately after the intervention, and 4-month post-intervention)

Study Sites (2)

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