NCT04658043

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

2.9 years

First QC Date

November 10, 2020

Last Update Submit

December 7, 2020

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum DisorderASDsocioemotional functioningIntervention study

Outcome Measures

Primary Outcomes (3)

  • 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

    pre-intervention and 4-month post-intervention

  • 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

    pre-intervention, immediately after the intervention, and 4-month post-intervention

  • 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.

    pre-intervention, immediately after the intervention, and 4-month post-intervention

Secondary Outcomes (4)

  • 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 Self-Efficacy in Nurturing Role Questionnaire

    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 Social Responsiveness Scale, Second Edition (SRS-2)

    pre-intervention, immediately after the intervention, and 4-month post-intervention

Study Arms (2)

ASD Intervention Group

EXPERIMENTAL

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

Other: Intervention on socioemotional functioning

Wait List Control Group

NO INTERVENTION

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

Interventions

Intervention on socioemotional functioningOTHER

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

ASD Intervention Group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shenzhen University

Shenzhen, China

RECRUITING

University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Terry Kit-fong Au

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Terry Kit-fong Au

CONTACT

(852) 2219 4776terryau@hku.hk

Kathy Kar-man Shum

CONTACT

(852) 3917 4223kkmshum@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-President and Pro-Vice-Chancellor (Academic Staffing and Resources)

Study Record Dates

First Submitted

November 10, 2020

First Posted

December 8, 2020

Study Start

September 22, 2019

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

December 8, 2020

Record last verified: 2020-12

Locations

CN(1)HK(1)