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

NCT07708246 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-16

No results posted yet for this 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.

Conditions

  • Autism
  • Intervention (Training) Condition
  • Social Cognition
  • Cognition Improvement

Interventions

BEHAVIORAL

Companion Mind-Drawing Cooperative Game Program

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

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Xiu Xu, Prof. · Children's Hospital of Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2028-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07708246 on ClinicalTrials.gov