【ChiCTR2300073238】Autonomous social robots detect and intervene autism

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基本信息

登记号

ChiCTR2300073238

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2023-07-05

临床申请受理号

靶点

适应症

Autism Spectrum Disorder

试验通俗题目

Autonomous social robots detect and intervene autism

试验专业题目

Autonomous social robot improves eye contact of autistic children

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临床试验信息

试验目的

To examine whether the robot-based intervention (RBI) is effective in promoting eye contact in autistic children, in comparison to the human-based intervention (HBI). There are four hypotheses. H1: Autistic children in the HBI will have fewer eye contact with the agent and less attentive duration than those in the RBI over the four-month intervention. H2: Autistic children in the HBI will be prompted more often by the agent and will be less likely to respond to the prompts than those in the RBI. H3: Autistic children in the RBI will have more eye contact with adults (their parents and human experimenter) than those in the HBI at the end of intervention. Such learning outcome will be maintained one month after the intervention. RBI is more effective for autistic children with more severe autism severity and intellectual disabilities than those with less severe autism severity and intellectual disabilities.

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试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

In order to match the autism severity and intellectual functioning of children between both conditions, thereby reducing sampling errors due to the individual variations in these areas, we divide all children into four groups using the median split of ADOS-2 and WPPSI-4 that measure autism severity and intellectual functioning respectively (high ADOS-2 and low WPPSI-4; low ADOS-2 and low WPPSI-4; high ADOS-2 and high WPPSI-4; low ADOS-2 and high WPPSI-4). Then we randomly assign the children in each group to the two conditions, such that the final sample for each of the two conditions has the same proportion of samples from each group.

盲法

None

试验项目经费来源

RGC General Research Fund

试验范围

目标入组人数

实际入组人数

第一例入组时间

2023-07-01

试验终止时间

2026-06-30

是否属于一致性

入选标准

1. Have their diagnoses of being on the autism spectrum confirmed by a trained professional who had completed ADOS-2 (Autism Diagnostic Observation Schedule - 2nd edition, Lord, 2012) Advanced/Research Training; 2. Have no hearing or vision impairment; 3. Can follow simple commands (e.g., "No", "Come here"); 4. Are aged 4-6; 5. Have IQs 50 or above (WPPSI-4th edition; Wechsler Preschool and Primary Scale of Intelligence™ - Fourth Edition (Chinese) (Weschler, 2013; Chen et al., 2013); 6. Can comprehend phrases with at least two components.；

排除标准

1. Have hearing or vision impairment; 2. Have IQs below 49; 3. Cannot comprehend phrases with at least two components.；

研究者信息

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试验机构

Department of Educational Psychology, The Chinese University of Hong Kong

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