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临床试验/NCT06342583
NCT06342583Unknown不适用

Advanced Social Relations Training for Children and Young People 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 30 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form)

研究概览

简要总结

Advanced social relations protocol is aimed at young people with autism aged 9-12 years with an intelligence quotient (IQ) ≥ 80. There will be an experimental group in which technology will be used and a control group in which activities will be carried out in the traditional way. The protocol will be carried out once a week for a duration of 45 minutes. The aim is to enhance communication and social skills within the group. A total of 23 sessions are planned. From the first to the third session the participants will acquire skills for communicating and conversing in an appropriate way. Thereafter from the fourth to the eleventh session social stories illustrating scenes from everyday life will be shown, with the aim of learning and managing the dynamics in which they find themselves on a daily basis. At the end of each story shown they will be asked to impersonate the protagonists depicted in the stories, each participant involved in turn will play all the roles shown in the stories, thus working in the mode of role playing.

The last part, which includes sessions from the twelfth to the twenty-third, will be dedicated to the correct and conscious use of social networks with a focus on the risks that can be encountered and the correct ways to make good use of them.

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
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • diagnosis of autism
  • intelligence quotient ≥ 80

排除标准

  • presence of other medical disorders

结局指标

主要结局

Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form)

时间窗: the administration of the Vineland-II takes approximately 20-60 minutes

The Vineland-II, a revision of the Vineland Adaptive Behavior Scales (Vineland ABS), assess adaptive behavior (AB), i.e., the activities that the individual habitually performs to meet the expectations of personal autonomy and social responsibility characteristic of people of the same age and cultural background. Specifically, they aim to measure AB in the domains Communication, Skills of Daily Living, Socialization (in individuals from 0 to 90 years of age) and Motor Skills (in individuals from 0 to 7 years of age and 56 to 90 years of age). Assessment of AB is necessary for diagnosis of intellectual disability disorder and, in accordance with Diagnostic and Statistical Manual of Mental Disorders (DSM-5), for assessment of the level of severity of the disorder. The Vineland-IIs consist of 4 scales divided into 11 subscales. They also provide an overall AB index.

Eye contact

时间窗: the administration of the test takes approximately 10 minutes

Unit of measurement: Number of visual contacts observed during social interaction. Rating scale: 0 to 10, where 0 indicates no eye contact and 10 indicates constant eye contact

Approval/sharing gestures

时间窗: the administration of the test takes approximately 10 minutes

Unit of measurement: Number of approval or sharing gestures observed during social interaction. Rating scale: 0 to 10, where 0 indicates no approval/sharing gestures and 10 indicates a high frequency of such gestures.

Smile in relation to group members' expressions

时间窗: the administration of the test takes approximately 10 minutes

Unit of measurement: Number of smiles observed in relation to group members' expressions. Rating scale: 0 to 10, where 0 represents no smiles and 10 indicates constant smiling in response to others' expression Unit of measurement: Number of greetings performed during social interaction. Rating scale: 0 to 10, where 0 indicates absence of greetings and 10 indicates a high number of greetings

Greeting

时间窗: the administration of the test takes approximately 10 minutes

Unit of measurement: Number of greetings performed during social interaction. Rating scale: 0 to 10, where 0 indicates absence of greetings and 10 indicates a high number of greetings

Taking verbal initiative

时间窗: the administration of the test takes approximately 10 minutes

Unit of measurement: Number of times verbal initiative is taken during social interaction. Rating scale: 0 to 10, where 0 indicates no verbal initiative and 10 indicates high verbal initiative

Asking a question

时间窗: the administration of the test takes approximately 10 minutes

Unit of measurement: Number of questions asked during social interaction. Rating scale: 0 to 10, where 0 indicates no questions and 10 indicates a high number of questions

Proposing an idea or activity to be carried out

时间窗: the administration of the test takes approximately 10 minutes

Unit of measurement: Number of ideas or activities proposed during social interaction. Rating scale: 0 to 10, where 0 indicates no proposals and 10 indicates a high number of proposals

Answering a question

时间窗: the administration of the test takes approximately 10 minutes

Unit of measurement: Percentage of questions answered during social interaction. Rating scale: From 0% (no response) to 100% (response to all questions)

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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