跳至主要内容
临床试验/NCT00848874
NCT00848874已完成不适用

Phase II Study of a Portable Visual Guidance System for Use by AS/HFA Students in Inclusion Settings

Minna Levine, PhD2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2008年9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
发起方
入组人数
47
试验地点
2
主要终点
Students who use the PVGS will demonstrate improved classroom social pragmatics and executive functioning.

研究概览

简要总结

Abstract: In Phase I, we designed and tested a Portable Visual Guidance System (PVGS), which combines a PDA - for user guidance - and an Internet website - for linking the user to an educational support team. Use of the PVGS 1) significantly improved the in vivo social pragmatics of students diagnosed with Aspergers Syndrome/Higher Functioning Autism (AS/HFA); 2) revealed additional ways of improving social pragmatics; and 3) improved activity management in scheduling and vocational tasks.

In Phase II, we will focus on social pragmatics and two closely related skills: feelings management and assignment management. We aim to:

  1. Replicate Phase I success in the most educational setting for AS/HFA high school aged students: mainstream school inclusion classes.
  2. Replicate Phase I findings more efficiently, with a less highly trained, on-site coaching staff and with more distant (non-site) expert supervision of that staff.
  3. Contrast the outcomes of the curriculum with a diagnosis-matched wait-list control group.
  4. Develop and implement software that will enable on-site staff to create and modify individualized guidance and monitoring screens as needs arise.
  5. Design a commercially attractive package of software, video training, video-conferenced support, and manuals.
  6. Complete the translation of the SymTrend website and all the above tools into Spanish.

Significance: Successful completion of Phase II will:

  1. Provide a very effective and comprehensive system for teaching social pragmatics and related management skills to AS/HFA persons in an inclusion context.
  2. Provide a means of evaluating IEP effectiveness, thereby enabling a better use of special education funds and a reduction of litigation over IEP plan appropriateness and utility.
  3. Provide substantial support for our theoretical rationale for curriculum building in Special Education - a rationale that can guide the formulation of IEPs.
  4. Provide a theoretical rationale, an intervention framework, and intervention support technology that can be extended to cognitive behavioral treatment of other neuropsychiatric disorders and can be adapted for other forms of healthcare guidance.
  5. Provide an investigative system, as well as an intervention system, for tracking behavioral change in studies of frontal lobe and limbic neuroplasticity in neuropsychiatric disorders.

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
11 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 11-21
  • Diagnosis of AS/HFA
  • A student at participating high school and middle schools (Newton, MA; Brockton, MA; Veritas Christian Academy, Fletcher, NC; Durham, NC.

排除标准

  • Participating in another study

研究组 & 干预措施

PVGS User

Experimental

干预措施: PVGS (Behavioral)

结局指标

主要结局

Students who use the PVGS will demonstrate improved classroom social pragmatics and executive functioning.

时间窗: Completion of intervention and three months hence

次要结局

未报告次要终点

研究者

发起方
Minna Levine, PhD
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Minna Levine, PhD

Co-Invesetigator

SymTrend Inc.

研究点 (2)

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