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

NCT ID: NCT04658043

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-22

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Keywords

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Autism Spectrum Disorder ASD socioemotional functioning Intervention study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ASD Intervention Group

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

Group Type EXPERIMENTAL

Intervention on socioemotional functioning

Intervention Type OTHER

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children aged 3-6
* Living in Shenzhen, Mainland China
* Diagnosed with ASD or suspected of having ASD
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen University

OTHER

Sponsor Role collaborator

Guangdong Province, Department of Science and Technology

OTHER_GOV

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Professor Terry Kit-fong Au

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Terry Kit-fong Au

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Shenzhen University

Shenzhen, , China

Site Status RECRUITING

University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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China Hong Kong

Central Contacts

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Terry Kit-fong Au

Role: CONTACT

Phone: (852) 2219 4776

Email: [email protected]

Kathy Kar-man Shum

Role: CONTACT

Phone: (852) 3917 4223

Email: [email protected]

Facility Contacts

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Lamei Wang, PhD

Role: primary

Terry Kit-fong Au, PhD

Role: primary

Kathy Kar-man Shum, PhD

Role: backup

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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EA1811014

Identifier Type: -

Identifier Source: org_study_id