Parent-Mediated Social Cognition Intervention for Young Children With Autism Spectrum Disorder

NCT07708246 | Recruiting

• 1 other identifier: TBXHP-ASD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Intervention (Training) Condition; Social Cognition; Cognition Improvement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Parent intervention fidelity

  Months 1-6 (intervention group only)

• Change in Scores of Emotion recognition accuracy

  Baseline →6-month →12-month（11-13mo） follow-up

• Parent program satisfaction

  Post-intervention (6 months)

• Empathy, Self-perception, Social communication

  Baseline →6-month→ 12-month(11-13mo) follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision

Behavioral: Companion Mind-Drawing Cooperative Game Program

Treatment-as-Usual Control Group

NO INTERVENTION

Continues existing therapies/educational support; no additional intervention provided

Interventions

Companion Mind-Drawing Cooperative Game Program BEHAVIORAL

Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision

Intervention Group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Xiu Xu, Prof.

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunchun Hu, Dr.

CONTACT

+8615721445658; 14211240007@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)