跳至主要内容
临床试验/NCT06179953
NCT06179953招募中不适用

Evaluate the Effect of Social Robot Mediation on the Development of Emotional Skills

Istituto per la Ricerca e l'Innovazione Biomedica2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
Test of Emotional Vocabulary

研究概览

简要总结

Autism is a neurodevelopmental disorder that involves difficulties especially in the sphere of social interaction, social communication, and restricted and stereotyped behavior patterns.

In particular, emotional regulation is a central developmental skill. In fact, the emotional dysregulation observed in children with autism results in increased social and behavioral difficulties over time.

Therefore, the present protocol aims to test the role of a human-assisted social robot as a mediator of social-emotional understanding intervention for children with autism spectrum disorders (ASD).

The children, will be divided into two groups, an experimental one in which training will be conducted through the use of social robot and control group which will be conducted through traditional therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Language in sentences
  • use of connectors
  • ability to narrate events not present
  • ADOS level: module 2
  • Griffiths: QS>75

排除标准

  • presence of other medical disorders

结局指标

主要结局

Test of Emotional Vocabulary

时间窗: The administration has a duration of 15 minutes.

The Test of Emotional Vocabulary contains an initial board, with which the child is introduced to the two protagonists of the subsequent stories, a boy and a girl; there is then a pretest board and 14 storyboards. For each of them, the examiner reads the short story to the child and then asks the child to choose, from two alternative emotional words, the one that best expresses what the protagonist of the story is feeling. In the first part, the child's understanding of emotional vocabulary referring to six basic emotions plus one complex emotion (joy, happiness, sadness, anger, fear, disgust and shame) is assessed; in the second part, the emotional terms all refer to complex emotions (guilt, envy, jealousy, contempt, hate, longing and pride).

Test of emotion comprehension

时间窗: The administration has a duration of 15-20 minutes.

The Test of emotion comprehension (TEC) is an instrument to assess a child's understanding of emotions, in its various aspects, that is, the nature, causes, and ways of controlling and regulating emotions. It is used for children aged 3-4 to 10-11 years. It is administered by telling a story in pictures, the child responds by indicating and finally, it takes about 15-20 minutes.

次要结局

未报告次要终点

研究者

发起方
Istituto per la Ricerca e l'Innovazione Biomedica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Flavia Marino

Head of Unit

Istituto per la Ricerca e l'Innovazione Biomedica

研究点 (2)

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