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

Study acronym: PMSC-ASD
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Lead sponsor: Children's Hospital of Fudan University to Children's Hospital of Fudan University Show 4 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised
    • Study description expanded, about 3 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07708246
Lead Sponsor Children's Hospital of Fudan University
Conditions
(from sponsor)		 Autism, Intervention (Training) Condition, Social Cognition, Cognition Improvement
Related terms Autistic Disorder
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov