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

2026年7月13日 更新者:Children's Hospital of Fudan University

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、201102
        • 招聘中
        • Children's Hospital of Fudan University
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention Group
Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision
Parent-mediated structured play program; daily 30-min home sessions × 6 months; monthly clinician video supervision
无干预:Treatment-as-Usual Control Group
Continues existing therapies/educational support; no additional intervention provided

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Social Attention (Eye-Tracking)
大体时间:Baseline →6-month →12-month(11-13mo) follow-up
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
大体时间:Baseline →6-month →12-month(11-13mo) follow-up
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

次要结果测量

结果测量
措施说明
大体时间
Parent intervention fidelity
大体时间:Months 1-6 (intervention group only)
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
大体时间:Baseline →6-month →12-month(11-13mo) follow-up
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
大体时间:Post-intervention (6 months)
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
大体时间:Baseline →6-month→ 12-month(11-13mo) follow-up
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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Xiu Xu, Prof.、Children's Hospital of Fudan University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年6月1日

初级完成 (估计的)

2028年12月30日

研究完成 (估计的)

2028年12月30日

研究注册日期

首次提交

2026年7月13日

首先提交符合 QC 标准的

2026年7月13日

首次发布 (实际的)

2026年7月16日

研究记录更新

最后更新发布 (实际的)

2026年7月16日

上次提交的符合 QC 标准的更新

2026年7月13日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • TBXHP-ASD

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Consider briefly explaining why IPD will not or might not be shared.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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