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NCT07708246Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 15 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
13 Jul 2026
Start date
1 Jun 2025
Primary completion date
30 Dec 2028
Lead sponsor
Children's Hospital of Fudan University
Diseases
Autism
NCT number
NCT07708246

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 1 Jun 2025 to the primary completion date, 30 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Known diagnosis of a genetic syndrome associated with ASD or intellectual disability, including but not limited to Fragile X syndrome, Down syndrome, tuberous sclerosis complex, or Rett syndrome.
  • Presence of a neurological disorder, including epilepsy (unless fully controlled with stable medication for ≥ 12 months), acquired brain injury, cerebral palsy, or other significant neurological condition that may confound assessment of social cognition.
  • Uncorrected vision or hearing impairment that would preclude participation in behavioral or eye-tracking assessments.
  • Any medical, psychiatric, or developmental condition that, in the opinion of the recruiting clinician, would interfere with the child's ability to participate in or benefit from the intervention.
    • Caregiver:

Other

  • Children:
  • Currently enrolled in another interventional clinical study targeting social cognition, communication, or behavioral outcomes.
  • Unable to attend the in-person parent training session at the study site due to geographic, occupational, or other constraints.
  • Unable to commit to the daily home-based intervention schedule or monthly online supervision sessions for the full 6-month intervention period.
  • Presence of significant mental health difficulties or other circumstances that, in the opinion of the recruiting clinician, would substantially impair the caregiver's ability to deliver the intervention with adequate fidelity.

Who the study is looking for

  • Children:
  • Aged 3 to 10 years at time of enrollment.
  • 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 participation prior to any study procedures.

Age in the registry: 3 years to 10 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Hospital Of Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.