AutismPMSC-ASDNCT07708246
Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder
A study testing Companion Mind-Drawing Cooperative Game Program in people with Autism and Intervention (Training) Condition, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Autism, Intervention (Training) Condition, Social Cognition
- What is being tested?
- Companion Mind-Drawing Cooperative Game Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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 join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Chunchun Hu, 15721445658, 14211240007@fudan.edu.cn
About this study
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
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.
Read more
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.
Read the detailed description
Background Social cognitive impairments - including difficulties in emotion recognition, theory of mind (ToM), empathy, joint attention, self-perception, and social communication - are hallmark features of ASD and significantly impact children's everyday social functioning. Despite the recognized importance of early social cognitive intervention, scalable and family-implemented programs that systematically target multiple social cognitive domains remain limited.
Intervention: "Companion Mind-Drawing Cooperative Game" Program
The "Companion Mind-Drawing Cooperative Game" program is a researcher-designed, parent-mediated intervention comprising a series of structured cooperative game paradigms, each targeting a specific social cognitive domain. The intervention is delivered in three phases:
- Parent Training (In-Person) Parents attend a structured training session of approximately 2.5 hours at the clinical site. During training, parents are taught the theoretical rationale for each game paradigm, the specific social cognitive skills targeted, and standardized procedures for home delivery.
- Home-Based Delivery Following training, parents deliver the intervention at home daily for a minimum of 30 minutes per session over a period of six months. The program targets six social cognitive domains: emotion recognition, theory of mind, empathy, joint attention, self-perception, and social communication.
- Monthly Clinician Supervision Once per month throughout the six-month intervention period, a clinician reviews video recordings submitted by parents and conducts an online video session to provide individualized feedback, address implementation challenges, and reinforce correct delivery techniques.
Comparison Group Participants in the comparison (treatment-as-usual) group continue to receive any existing therapies or educational support received prior to study enrollment. Participants in the comparison group do not receive the "Companion Mind-Drawing Cooperative Game" program during the study period.
Assessments All participants are assessed at two timepoints: baseline (prior to intervention commencement) and 12-month follow-up. Assessments include behavioral experimental tasks and eye-tracking paradigms targeting each of the six social cognitive domains addressed by the intervention.
- Being tested
- Companion Mind-Drawing Cooperative Game Program
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Companion Mind-Drawing Cooperative Game ProgramBehavioural
Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision
| Study group | Role | What they receive |
|---|---|---|
| Parent-play Intervention Group | Experimental | Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision Receives: Behavioral: Companion Mind-Drawing Cooperative Game Program |
| Treatment-as-Usual Control Group | No intervention | Continues existing therapies/educational support; no additional intervention provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social Attention (Eye-Tracking)
The mean fixation proportion (percentage of total trial time) allocated to socially relevant regions of interest (ROIs) - including faces, eyes, and mouth regions - during standardized eye-tracking paradigms, measured via a remote eye-tracker. A higher fixation proportion indicates greater social attention. Change scores are calculated as the difference between follow-up and baseline fixation proportions.
Measured: Baseline →6-month →12-month（11-13mo） follow-up
Change in Theory of Mind Task Accuracy Score
The mean accuracy score (percentage of correct responses) on a battery of researcher-designed Theory of Mind (ToM) behavioral experimental tasks
Measured: Baseline →6-month →12-month（11-13mo） follow-up
Secondary outcomes (4)
Parent intervention fidelity
The total score on a video-coded fidelity checklist completed by trained assessors reviewing monthly parent-submitted video recordings. The checklist evaluates adherence to standardized delivery procedures across domains including correct game administration, appropriate prompting strategies, session duration, and responsiveness to the child. Scores range from 0-100, with higher scores indicating greater fidelity.
Measured: Months 1-6 (intervention group only)
Change in Scores of Emotion recognition accuracy
The mean proportion of correct responses (accuracy rate) on standardized emotion recognition paradigms, in which children are asked to identify or match basic and complex emotional expressions (e.g., happy, sad, angry, fearful, surprised) presented via images or short video clips. Change scores are calculated as the difference in accuracy rate between follow-up and baseline assessments.
Measured: Baseline →6-month →12-month（11-13mo） follow-up
Parent program satisfaction
The total score on a structured parent feedback questionnaire assessing satisfaction with the program content, delivery format, training quality, clinician supervision, and perceived benefit for the child. The questionnaire uses a Likert-scale format (e.g., 1-5), with higher scores indicating greater satisfaction.
Measured: Post-intervention (6 months)
Empathy, Self-perception, Social communication
The mean proportion of correct responses (accuracy rate) on researcher-designed behavioral experimental tasks targeting three social cognitive domains: (a) Empathy - tasks requiring recognition and attribution of others' emotional states in social scenarios; (b) Self-perception - tasks assessing self-recognition and self-referential processing; (c) Social Communication - tasks evaluating pragmatic language use, referential communication, and conversational turn-taking. Each domain is scored separately, and a composite score is also calculated. Change scores are calculated as the difference between follow-up and baseline accuracy rates for each domain.
Measured: Baseline →6-month→ 12-month(11-13mo) follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Jun 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiu Xu, Prof., Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708246
- Sponsor's protocol ID
- TBXHP-ASD
- Acronym
- PMSC-ASD
- Status last verified
- Oct 2026
- First submitted
- 13 Jul 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Consider briefly explaining why IPD will not or might not be shared.