Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder (NCT07708246) | Clinical Trial Compass
RecruitingNot Applicable
Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder
China60 participantsStarted 2025-06-01
Plain-language summary
This study evaluates the efficacy of the Companion Mind-Drawing Cooperative Game Program, a parent-mediated, home-based structured play intervention targeting social cognitive development in young children with autism spectrum disorder (ASD).
Children with ASD in the intervention group will receive a structured program in which parents attend an in-person training session (approximately 2.5 hours) at the hospital, where parents are taught to administer a series of researcher-designed cooperative game paradigms at home. Parents then deliver the intervention daily for at least 30 minutes per session over a period of six months. Monthly online video reviews by a clinician provide parents with individualized feedback and guidance to ensure program fidelity and quality.
Children with ASD in the comparison group will continue to receive usual care and will not receive the program during the study period.
Social cognitive outcomes - including emotion recognition, theory of mind, empathy, joint attention, self-perception, and social communication - will be assessed at baseline and at 12-month follow-up using behavioral experimental tasks and eye-tracking paradigms. This study aims to provide evidence for the efficacy of a scalable, family-implemented social cognition intervention for young children with ASD.
Who can participate
Age range
4 Years – 8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Children：
* Aged 2.5 to 14 years at time of enrollment, with a primary recruitment focus on children aged 3 to 10 years.
* Meets diagnostic criteria for autism spectrum disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a specialist clinician.
* Full-scale intelligence quotient (FSIQ) ≥ 70 as assessed by an age-appropriate Wechsler intelligence scale administered.
* Possesses sufficient verbal ability to engage with structured play-based intervention activities, as judged by the recruiting clinician.
* Resides with and is cared for by a participating parent or legal guardian who meets the caregiver eligibility criteria below.
Caregiver：
* Is the primary caregiver (parent or legal guardian) of the enrolled child and resides in the same household.
* Is able and willing to attend an in-person parent training session (approximately 2.5 hours) at the study site prior to intervention commencement.
* Is able and willing to commit to administering the structured intervention program to the child for a minimum of 30 minutes per day throughout the 6-month intervention period.
* Is able and willing to participate in monthly online video supervision sessions with the study clinician.
* Has sufficient literacy and comprehension ability to understand program training materials and follow intervention procedures.
* Provides written informed consent on behalf of the child and for their own partici…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.