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RECRUITING
NCT07708246
NA

Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder

Sponsor: Children's Hospital of Fudan University

View on ClinicalTrials.gov

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.

Official title: Efficacy of a Parent-Mediated, Home-Based Structured Play Intervention on Social Cognitive Development in Young Children With Autism Spectrum Disorder: A Non-Randomized Controlled Study

Key Details

Gender

All

Age Range

4 Years - 8 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-06-01

Completion Date

2028-12-30

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

BEHAVIORAL

Companion Mind-Drawing Cooperative Game Program

Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision

Locations (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China