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临床试验/NCT06179927
NCT06179927招募中不适用

Enhancing Theory of Mind Skills in Children With Autism Spectrum Disorder.

Istituto per la Ricerca e l'Innovazione Biomedica2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月16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
40
试验地点
2
主要终点
NEuroPSYcology second edition (NEPSY-II) evaluations

研究概览

简要总结

The project involves the participation of 40 children with Autism Spectrum Disorder of both sexes, aged between 6 and 10 years. The subjects will undergo a pre-intervention evaluation phase, which will consist of administering the Theory of Mind (ToM) test present in the NEuroPSYcology second edition (NEPSY) battery, part A. The same test will be administered again at the end of the intervention. Once the inclusion criteria have been met and following the randomization of the sample, divided into Experimental Group (EG n=20) and Control Group (CG n=20), the administration of the search task will proceed. The study involves 12 sessions, one per week, lasting 45 minutes. The EG will view twelve social scenes created through a tablet. In the scenario, the depictions will be presented in color. Guided by the narrating voice of QT Robot, they will have to choose between two or three alternatives the one that represents the appropriate mental state by selecting it on the tablet. Consequently, an audio-visual feedback will be provided, through the robot, to give the subject information about the accuracy of their response. In both groups, a simple instruction will be given to the child, telling them to pay attention to the story that will be narrated and then answer simple questions. In the EG, QT robot will speak, while in the CG it will be the operator. The prompts will be related to the accuracy of the response or they will rather be aimed at encouraging the child to give the correct answer.

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
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Proven diagnosis of autism
  • QS ≥ 75 assessed by administration of the GRIFFITHS scales
  • Passing the emotional recognition test of the NEPSY II battery

排除标准

  • presence of other medical disorders

结局指标

主要结局

NEuroPSYcology second edition (NEPSY-II) evaluations

时间窗: The tests will be scheduled pre intervention (T0), at 6 months (T1) and at the study conclusion, about 1 year (T2).The test needs about 120-180 minutes.

NEuroPSYcology second edition (NEPSY-II) is the most internationally known battery for assessing neuropsychological development in developmental age. Each NEPSY-II test provides raw scores that must be converted into scalar scores (min 1 - max 19) or percentile scores (min \<2% - max \>75%) according to the conversion tables in the manual. For each sub-scale higher scores correspond to better performance. NESPY's Theory of Mind (ToM) sub test, section A is used in this protocol. Assesses the ability to decode and interpret others' intentions and life points and understand how they influence behavior. the test will be given to children pre- and post-intervention. The ToM test is divided into verbal: the child is read scenarios or shown figures and asked questions that require understanding of the other's point of view; nonverbal: the child is asked to choose the emotional expression appropriate to the mood of a character depicted in certain contexts.

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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