Parent-Mediated Social-Cognition Intervention for Young Children with Autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this study, parents receive in-person training to deliver a structured set of cooperative games at home for six months, with monthly clinician feedback to keep the program on track. Children with autism are assigned to either the parent-mediated intervention or usual care. The program targets emotion recognition, theory of mind, empathy, joint attention, self-perception, and social communication. Outcomes focus on social-cognitive improvements and everyday social functioning. The trial is conducted at the Children's Hospital of Fudan University in Shanghai.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

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.

Where it's running

• Children's Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Xiu Xu, Prof. — Children's Hospital of Fudan University
• Study coordinator: Chunchun Hu, Dr.
• Email: 14211240007@fudan.edu.cn
• Phone: +8615721445658

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.