Trial record 7 of 73 for:    "Asperger syndrome"

Portable Visual Guidance System Phase II (PVGS-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00848874
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : October 9, 2018
SymTrend Inc.
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Minna Levine, PhD, SymTrend Inc.

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Asperger Syndrome High Functioning Autism Behavioral: PVGS Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of a Portable Visual Guidance System for Use by AS/HFA Students in Inclusion Settings
Study Start Date : September 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: PVGS User Behavioral: PVGS
Student use of SymTrend PVGS daily then tapering off for 14 weeks in conjunction to ratings by a coach.

Primary Outcome Measures :
  1. Students who use the PVGS will demonstrate improved classroom social pragmatics and executive functioning. [ Time Frame: Completion of intervention and three months hence ]

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Ages Eligible for Study:   11 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Participating in another study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00848874

United States, Massachusetts
SymTrend, Inc.
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Minna Levine, PhD
SymTrend Inc.
University of North Carolina, Chapel Hill
Principal Investigator: Gary Mesibov, PhD University of North Carolina, Chapel Hill
Study Director: Minna Levine, PhD SymTrend Inc.

Responsible Party: Minna Levine, PhD, Co-Invesetigator, SymTrend Inc. Identifier: NCT00848874     History of Changes
Other Study ID Numbers: 2R41MH075162 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Asperger Syndrome
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders