Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder
Condition(s) studied
Investigational drug(s) / intervention(s)
Companion Mind-Drawing Cooperative Game Program: Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision
Study 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.
Eligibility
Primary outcome measure(s)
- Change in Social Attention (Eye-Tracking) — Baseline →6-month →12-month(11-13mo) follow-up
The mean fixation proportion (percentage of total trial time) allocated to socially relevant regions of interest (ROIs) - including faces, eyes, and mouth regions - during standardized eye-tracking paradigms, measured via a remote eye-tracker. A higher fixation proportion indicates greater social attention. Change scores are calculated as the difference between follow-up and baseline fixation proportions. - Change in Theory of Mind Task Accuracy Score — Baseline →6-month →12-month(11-13mo) follow-up
The mean accuracy score (percentage of correct responses) on a battery of researcher-designed Theory of Mind (ToM) behavioral experimental tasks
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | Recruiting |
More Children's Hospital of Fudan University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07708246 on ClinicalTrials.gov ↗ ← All trials in China