A home play program led by parents for young children with autism
Tests a parent-led cooperative game program at home in children with autism.
Key facts
- Who runs it
- Children's Hospital of Fudan University
- Where
- Shanghai, ChinaSee the site
- Trial code
- Registry title
- Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 1 Jun 2025
- Expected to end
- 30 Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Companion Mind-Drawing Cooperative Game Program
- Record updated
- 15 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 3 to 10 with autism spectrum disorder and a parent who can run play activities at home daily for 6 months.
- Age
- Children aged 3 to 10 years.
- Sex
- All sexes.
- Disease stage
- Autism spectrum disorder (DSM-5), confirmed by a specialist doctor. Intelligence quotient of 70 or higher and enough speech to take part in play activities.
- Earlier treatment
- Must not be in another trial aimed at social cognition, communication or behaviour. Comparison group continues usual care.
Main reasons for not taking part
- Genetic syndrome such as Fragile X syndrome, Down syndrome, tuberous sclerosis complex or Rett syndrome
- Neurological disorder such as epilepsy (unless fully controlled for 12 months or more), brain injury or cerebral palsy
- Vision or hearing problem that is not corrected and blocks the tests
- Currently in another trial on social cognition, communication or behaviour
- Parent cannot attend the 2.5-hour training, play daily for 30 minutes, or join monthly online reviews
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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:
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 10 years old?
Where in China
- Children's Hospital Of Fudan UniversityShanghai, ChinaContact: Chunchun HuTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
The 2 groups in the trial
- Parent-play Intervention GroupTreatment being tested
Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision
Treatment: Companion Mind-Drawing Cooperative Game Program
- Treatment-as-Usual Control GroupNo study treatment, for comparison
Continues existing therapies/educational support; no additional intervention provided
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- A home play program led by parents for young children with autismGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07708246, who can take part
- Record updated
- 15 October 2026