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临床试验/NCT01836965
NCT01836965已完成不适用

Replication of the The Multi-Media Social Skills Project for Adolescents With Autism Spectrum Disorders

Milton S. Hershey Medical Center2 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2013年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
155
试验地点
2
主要终点
Change from Baseline Social Responsiveness Scale Score after Intervention

研究概览

简要总结

The objective of this study is to validate a social skills training program manual for adolescents (ages 13-17) with Asperger's Syndrome or high functioning autism. Approximately 150 adolescents with autism spectrum disorders will participate in this study, in groups consisting of 6 adolescents and 6 peer volunteers. Participants will participate in both group therapy and peer generalization sessions (in the form of a photography class) once a week over the course of twelve weeks. Participants and their parents will complete paper and pencil, online, or phone measures and video-recordings to assess the participant's social skills prior to the intervention, at completion of the intervention and three months later.

详细描述

This study is a pre-test, post-test single group design with post test measures at one week after completion of intervention and follow-up at three months. Approximately 300 adolescents will participate in this study. The study will be conducted in ten cohorts of 12. Each cohort will have 6 participants and 6 adolescent volunteers (peers). Cohorts will be run in a time sequential manner with up to four cohorts running at a time. Participants and their parents will complete pre-test measures including both paper and pencil, online, or phone measures and a video-recording to assess the participant's social interaction skills and fluency. These adolescents will participate in both group therapy and peer generalization sessions once a week over the course of twelve weeks. Upon completion of the intervention, participants and parents will complete paper and pencil, online, or phone measures and video post-test measures. Participants will be encouraged to participate in a follow-up session where the paper and pencil and video measures will be completed again.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Between 13 and 17 years of age
  • Must be a Pennsylvania resident
  • A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the Checklist for Autism Spectrum Disorders (CASD; Mayes, 2012)
  • English as primary language spoken
  • Ability to fluently speak in full sentences
  • A verbal IQ of 85 or above on the Kaufman Brief Intelligence Test, Second Edition(KBIT-2; Kaufman & Kaufman, 1990)

排除标准

  • A significant language delay
  • Difficulty with aggression directed at peers
  • A primary thought disorder
  • A secondary disorder of anxiety or depression so severe as to prevent the individual's participation in the treatment
  • Low social motivation demonstrated through formalized assessment and/or by responses given to screening interviews assessing treatment goals

研究组 & 干预措施

Social Skills Intervention

Experimental

The intervention is a 12-week social skills training program that will consist of a 90 minute group therapy session followed by a 90 minute peer generalization session (in the form of a photography class with typically developing peers) meeting once per week. Each cohort will consist of 6 adolescents with Aspergers or high-functioning autism, who will be joined by 6 typically-developing peers for the photography class. During the group therapy session adolescents will discuss and watch video clips addressing social skills topics relevant to their age group. They will have a chance to practice these skills when paired with a typically developing peer for the photography class.

干预措施: Social Skills Intervention (Behavioral)

结局指标

主要结局

Change from Baseline Social Responsiveness Scale Score after Intervention

时间窗: One Week Post-Intervention

The Social Responsiveness Scale is a 65 - item survey designed to measure social competence.

Video recording of Social Interaction

时间窗: One Week Post-Intervention

Participants will be filmed in a brief interaction with a typically developing peer which will be coded to obtain social interaction skills and fluency scores.

次要结局

  • Change from Baseline Loneliness Scale after Intervention(One Week Post Intervention)
  • Change from Baseline Multidimensional Anxiety Scale for Children after Intervention(One Week Post-Intervention)
  • Change from Baseline Strengths and Difficulties Questionnaire at 3 month Follow Up(3 Month Follow Up)
  • Change from Baseline Strengths and Difficulties Questionnaire (SDQ) after Intervention(One Week Post-Intervention)
  • Change from Baseline Strengths and Difficulties Questionnaire (parent form)after Intervention(One Week Post-Intervention)
  • Change from Baseline Strengths and Difficulties Questionnaire (parent form)at 3 Month Follow Up(3 Month Follow Up)
  • Change from Baseline Loneliness Scale at 3-month Follow Up(3 Month Follow Up)
  • Change from Baseline Multidimensional Anxiety Scale for Children at 3 month Follow Up(3 Month Follow Up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Murray

MD

Milton S. Hershey Medical Center

研究点 (2)

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