Autism Spectrum DisorderNCT04658043
Early Socioemotional Intervention for Children With Autism Spectrum Disorder in Hong Kong and Mainland China
A study testing Intervention on socioemotional functioning in people with Autism Spectrum Disorder, run by The University of Hong Kong at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Intervention on socioemotional functioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Sep 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3-6
- Living in Shenzhen, Mainland China
- Diagnosed with ASD or suspected of having ASD
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site, 1 recruiting
- Recruiting
Shenzhen University
Shenzhen
Lamei Wang, PhD, (86 755) 8658 1084, wanglamei@szu.edu.cn
Xinru Yao, MSc
Hong Kong1 site, 1 recruiting
- Recruiting
University of Hong Kong
Hong Kong
Terry Kit-fong Au, PhD, (852) 2219 4776, terryau@hku.hk
Kathy Kar-man Shum, PhD, (852) 3917-4223, kkmshum@hku.hk
About this study
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Intervention on socioemotional functioning
- Keywords
- Autism Spectrum Disorder, ASD, socioemotional functioning, Intervention study
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| ASD Intervention Group | Experimental | Participants in the ASD intervention group will receive training to help children improve socioemotional functioning. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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)
PSI-4-SF is a parent-report measure used in this study to measure change in parenting stress
Measured: pre-intervention, immediately after the intervention, and 4-month post-intervention
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
Measured: pre-intervention, immediately after the intervention, and 4-month post-intervention
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
Measured: pre-intervention, immediately after the intervention, and 4-month post-intervention
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
Measured: pre-intervention, immediately after the intervention, and 4-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start22 Sep 2019
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen University, Guangdong Province, Department of Science and Technology
- Responsible party
- Principal investigator, Professor Terry Kit-fong Au, The University of Hong Kong
- Investigators
- Terry Kit-fong Au, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658043
- Sponsor's protocol ID
- EA1811014
- Status last verified
- Dec 2020
- First submitted
- 10 Nov 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Socioemotional Intervention for Children With Autism Spectrum Disorder in Hong Kong and Mainland China
- ClinicalTrials.gov ID
- NCT04658043
- Acronym / sponsor ID
- EA1811014
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, ASD, socioemotional functioning, Intervention study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Shenzhen University, Guangdong Province, Department of Science and Technology
- Study start
- 22 Sep 2019 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD Intervention Group | Experimental | Other: Intervention on socioemotional functioningParticipants in the ASD intervention group will receive training to help children improve 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 |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3-6
- Living in Shenzhen, Mainland China
- Diagnosed with ASD or suspected of having ASD
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention on socioemotional functioningA 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 | Other | ASD Intervention Group |
Primary outcome
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
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
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.
4 secondary outcomes
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
Change in Self-Efficacy in Nurturing Role Questionnaire
Time frame: 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
Change in Social Responsiveness Scale, Second Edition (SRS-2)
Time frame: pre-intervention, immediately after the intervention, and 4-month post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Kit-fong Au principal investigator
The University of Hong Kong
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention on socioemotional functioning in people with Autism Spectrum Disorder, run by The University of Hong Kong at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Terry Kit-fong Au ((852) 2219 4776, terryau@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) (time frame: pre-intervention and 4-month post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.