Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorChildren's Hospital of Fudan University
About this trial
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 criteria
Qualifiers
Aged 2.5 to 14 years at time of enrollment, with a primary recruitment focus on children aged 3 to 10 years.
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.
Disqualifiers
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.
Currently enrolled in another interventional clinical study targeting social cognition, communication, or behavioral outcomes.
Trial design
Treatments tested in this trial
- Companion Mind-Drawing Cooperative Game Program
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov