An interventional study of Companion Mind-Drawing Cooperative Game Program in Autism, Intervention (Training) Condition and Social Cognition, sponsored by Children's Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Treatment
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.
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:
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.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 60 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 15, 2026. See what changed
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Children：
Caregiver：
Exclusion Criteria:
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Caregiver：
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision
Behavioral: Companion Mind-Drawing Cooperative Game Program
Continues existing therapies/educational support; no additional intervention provided
Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision
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.
Time frame: 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
Time frame: Baseline →6-month →12-month（11-13mo） follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline →6-month→ 12-month(11-13mo) follow-up
Plan to share: No — Consider briefly explaining why IPD will not or might not be shared.
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Dec 2028, 42 months after the start.
Of 354 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's planned 42 months is above that.
Counting every sponsor, half of 366 studies reached it within 26 months; a quarter within 13 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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