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临床试验/NCT02382172
NCT02382172已完成不适用

Social Cognition and Interaction Training for Autism (SCIT-A)

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Change in visual attention from baseline as measured by the Tobii Eye Tracking Paradigm

研究概览

简要总结

Purpose: To collect outcome measures such as eye tracking and questionnaire data prior to and following a group based clinical therapy program to determine the effectiveness of the therapy approach. The therapy program is aimed at improving social cognitions and skills of individuals who find social situations difficult, stressful and/or uncomfortable and with a desire to enhance skills required for social interactions.

Participants: Cohorts of individuals aged 10-69 years old with symptoms of a neurodevelopment disorder, who have general difficulty with social interactions.

Procedures: Participants enrolled in a clinical therapy program for improvement of social cognitions and skills will complete eye tracking tasks, several questionnaires and rating scales, and a diagnostic interview prior to and following the 8 week therapy program. The post treatment assessments will be conducted within a week of the therapy completion and then again approximately 2 months after the last therapy session. The entire study duration is expected to be approximately 17 weeks. These outcome measures will measure the effectiveness of the treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
10 Years 至 69 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 13-
  • Symptoms of a neurodevelopmental disorder.
  • English as primary language and ability to speak in fluent, full length sentences: Treatment will be conducted in a group setting in English.

排除标准

  • Inability to speak English fluently.

结局指标

主要结局

Change in visual attention from baseline as measured by the Tobii Eye Tracking Paradigm

时间窗: The pre-treatment assessment will take place within a week of beginning the social skills group. Immediately after the 8-week clinic, there will be another assessment and then a final assessment 2 months following completion of the therapy.

Participants will complete an eyetracking task both before and after the Social Skills training clinic. The eyetracking task will be presented on a Tobii 1750 eyetracker integrated with a 17" display monitor (Tobii Technology, Stockholm, Sweden). The task will be an interactive visual exploration task that is a validated measure of social attention. It's a 15-minute eye tracking task, which is non-invasive and completely safe. During the task, participants will be asked to look at two children playing together. The Tobii eyetracker will record where the participants focus their gaze and for how long.

次要结局

  • Change in patient social cognition as measured by the Hinting Task(The pre-treatment assessment will take place within a week of beginning the social skills group. Immediately after the 8-week clinic, there will be another assessment and then a final assessment 2 months following completion of the therapy.)
  • Change in patient social skills as measured by the Social Responsiveness Scale (SRS)(The pre-treatment assessment will take place within a week of beginning the social skills group. Immediately after the 8-week clinic, there will be another assessment and then a final assessment 2 months following completion of the therapy.)
  • Change in patient social cognition as measured by the Penn Emotion Recognition Task-40 (ER40)(The pre-treatment assessment will take place within a week of beginning the social skills group. Immediately after the 8-week clinic, there will be another assessment and then a final assessment 2 months following completion of the therapy.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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