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

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ClinicalTrials.gov Identifier: NCT04658043
Recruitment Status : Recruiting
First Posted : December 8, 2020
Last Update Posted : December 8, 2020
Sponsor:
Collaborators:
Shenzhen University
Guangdong Province, Department of Science and Technology
Information provided by (Responsible Party):
Professor Terry Kit-fong Au, 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Other: Intervention on socioemotional functioning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 22, 2019
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. Change in Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658043


Contacts
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Contact: Terry Kit-fong Au (852) 2219 4776 terryau@hku.hk
Contact: Kathy Kar-man Shum (852) 3917 4223 kkmshum@hku.hk

Locations
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China
Shenzhen University Recruiting
Shenzhen, China
Contact: Lamei Wang, PhD    (86 755) 8658 1084    wanglamei@szu.edu.cn   
Sub-Investigator: Xinru Yao, MSc         
Sub-Investigator: Mingjing Chen, MSc         
Hong Kong
University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Terry Kit-fong Au, PhD    (852) 2219 4776    terryau@hku.hk   
Contact: Kathy Kar-man Shum, PhD    (852) 3917-4223    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         
Sponsors and Collaborators
The University of Hong Kong
Shenzhen University
Guangdong Province, Department of Science and Technology
Investigators
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Principal Investigator: Terry Kit-fong Au The University of Hong Kong
  Study Documents (Full-Text)

Documents provided by Professor Terry Kit-fong Au, The University of Hong Kong:
Informed Consent Form  [PDF] December 7, 2020

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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: December 8, 2020    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020

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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, The University of Hong Kong:
Autism Spectrum Disorder
ASD
socioemotional functioning
Intervention study
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders