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

December 7, 2020 updated by: Professor Terry Kit-fong Au, The University of Hong Kong
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Terry Kit-fong Au
  • Phone Number: (852) 2219 4776
  • Email: terryau@hku.hk

Study Contact Backup

  • Name: Kathy Kar-man Shum
  • Phone Number: (852) 3917 4223
  • Email: kkmshum@hku.hk

Study Locations

  • China
      • Shenzhen, China
        • Recruiting
        • Shenzhen University
        • Contact:
        • Sub-Investigator:
          • Xinru Yao, MSc
        • Sub-Investigator:
          • Mingjing Chen, MSc
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • University of Hong Kong
        • Contact:
          • Terry Kit-fong Au, PhD
          • Phone Number: (852) 2219 4776
          • Email: terryau@hku.hk
        • Contact:
          • Kathy Kar-man Shum, PhD
          • Phone Number: (852) 3917-4223
          • Email: 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
pre-intervention and 4-month post-intervention
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
pre-intervention, immediately after the intervention, and 4-month post-intervention
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.
pre-intervention, immediately after the intervention, and 4-month post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
pre-intervention, immediately after the intervention, and 4-month post-intervention
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
pre-intervention, immediately after the intervention, and 4-month post-intervention
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
pre-intervention, immediately after the intervention, and 4-month post-intervention
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
pre-intervention, immediately after the intervention, and 4-month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guangdong Province, Department of Science and Technology
Shenzhen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Terry Kit-fong Au, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EA1811014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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