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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision |
|
| Treatment-as-Usual Control Group | No Intervention | Continues existing therapies/educational support; no additional intervention provided |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Companion Mind-Drawing Cooperative Game Program | Behavioral | Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision |
|
| 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 |
| 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. |
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Inclusion Criteria:
Children:
Caregiver:
Exclusion Criteria:
Children:
Caregiver:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunchun Hu, Dr. | Contact | +8615721445658 | 14211240007@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiu Xu, Prof. | Children's Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Recruiting | Shanghai | Shanghai Municipality | 201102 | China |
Consider briefly explaining why IPD will not or might not be shared.
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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 |