NCT07708246 Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder
| NCT ID | NCT07708246 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Autism |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-06-01 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: Children： * 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. * 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. Exclusion Criteria: Children： * 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. * 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： * 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.
Contact & Investigator
Xiu Xu, Prof.
PRINCIPAL INVESTIGATOR
Children's Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT07708246 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 8 Years, studying Autism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07708246 currently recruiting?
Yes, NCT07708246 is actively recruiting participants. Contact the research team at 14211240007@fudan.edu.cn for enrollment information.
Where is the NCT07708246 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07708246 clinical trial?
NCT07708246 is sponsored by Children's Hospital of Fudan University. The principal investigator is Xiu Xu, Prof. at Children's Hospital of Fudan University. The trial plans to enroll 60 participants.