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

Primary Purpose

Autism Spectrum Disorder

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intervention on socioemotional functioning
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, ASD, socioemotional functioning, Intervention study

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Shenzhen UniversityRecruiting
  • University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ASD Intervention Group

Wait List Control Group

Arm Description

Participants in the ASD intervention group will receive training to help children improve socioemotional functioning.

Participants in this group will be placed on the wait list and receive the ASD intervention training 2 months after the other groups

Outcomes

Primary Outcome Measures

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
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
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.

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
November 10, 2020
Last Updated
December 7, 2020
Sponsor
The University of Hong Kong
Collaborators
Shenzhen University, Guangdong Province, Department of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04658043
Brief Title
Early Socioemotional Intervention for Children With Autism Spectrum Disorder in Hong Kong and Mainland China
Official Title
Early Socioemotional Intervention for Children With Autism Spectrum Disorder in Hong Kong and Mainland China
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 22, 2019 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Shenzhen University, Guangdong Province, Department of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, ASD, socioemotional functioning, Intervention study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASD Intervention Group
Arm Type
Experimental
Arm Description
Participants in the ASD intervention group will receive training to help children improve socioemotional functioning.
Arm Title
Wait List Control Group
Arm Type
No Intervention
Arm Description
Participants in this group will be placed on the wait list and receive the ASD intervention training 2 months after the other groups
Intervention Type
Other
Intervention Name(s)
Intervention on socioemotional functioning
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
Description
ADOS-2 is a diagnostic measure used in this study to assess the change in children's ASD symptoms
Time Frame
pre-intervention and 4-month post-intervention
Title
Change in the Autism Spectrum Quotient (AQ)
Description
AQ is a parent-report measure used in this study to measure change in children's ASD symptoms
Time Frame
pre-intervention, immediately after the intervention, and 4-month post-intervention
Title
Change in Dyadic Parent-Child Interaction Coding System (DPICS system)
Description
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.
Time Frame
pre-intervention, immediately after the intervention, and 4-month post-intervention
Secondary Outcome Measure Information:
Title
Change in Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF)
Description
PSI-4-SF is a parent-report measure used in this study to measure change in parenting stress
Time Frame
pre-intervention, immediately after the intervention, and 4-month post-intervention
Title
Change in Self-Efficacy in Nurturing Role Questionnaire
Description
Self-Efficacy in Nurturing Role Questionnaire is a parent-report measure used in this study to measure change in parents' self-efficacy
Time Frame
pre-intervention, immediately after the intervention, and 4-month post-intervention
Title
Change in Classroom Observation Scale (COS)
Description
COS is a teacher-report measure used in this study to measure children's social behaviours in classroom setting
Time Frame
pre-intervention, immediately after the intervention, and 4-month post-intervention
Title
Change in Social Responsiveness Scale, Second Edition (SRS-2)
Description
SRS-2 is a teacher-report measure used in this study to measure children's social behaviours
Time Frame
pre-intervention, immediately after the intervention, and 4-month post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged 3-6 Living in Shenzhen, Mainland China Diagnosed with ASD or suspected of having ASD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Terry Kit-fong Au
Phone
(852) 2219 4776
Email
terryau@hku.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy Kar-man Shum
Phone
(852) 3917 4223
Email
kkmshum@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Kit-fong Au
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen University
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lamei Wang, PhD
Phone
(86 755) 8658 1084
Email
wanglamei@szu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xinru Yao, MSc
First Name & Middle Initial & Last Name & Degree
Mingjing Chen, MSc
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Kit-fong Au, PhD
Phone
(852) 2219 4776
Email
terryau@hku.hk
First Name & Middle Initial & Last Name & Degree
Kathy Kar-man Shum, PhD
Phone
(852) 3917-4223
Email
kkmshum@hku.hk
First Name & Middle Initial & Last Name & Degree
An Tong Gong, DClinPsy
First Name & Middle Initial & Last Name & Degree
Alice Yuen-ching Keung, PsyD
First Name & Middle Initial & Last Name & Degree
Shuang Lu, PhD
First Name & Middle Initial & Last Name & Degree
Maureen Mo Yee Kong, PsyD

12. IPD Sharing Statement

Learn more about this trial

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

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