Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder (PMSC-ASD)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Autism; Social Cognition; Intervention (Training) Condition; Cognition Improvement
• Intervention / Treatment: Behavioral: Companion Mind-Drawing Cooperative Game Program

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:

1. 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.
2. 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.
3. 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chunchun Hu, Dr.; Phone Number: +8615721445658; Email: 14211240007@fudan.edu.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201102
      • Recruiting
      • Children's Hospital of Fudan University
      • Contact: Chunchun Hu; Phone Number: 15721445658; Email: 14211240007@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision	Behavioral: Companion Mind-Drawing Cooperative Game Program; Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision
No Intervention: Treatment-as-Usual Control Group; Continues existing therapies/educational support; no additional intervention provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Baseline →6-month →12-month（11-13mo） follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline →6-month→ 12-month(11-13mo) follow-up

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Principal Investigator: Xiu Xu, Prof., Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Autism Spectrum Disorder; Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder
• Other Study ID Numbers: TBXHP-ASD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Consider briefly explaining why IPD will not or might not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No