Trial record 20 of 61 for:    "Asperger syndrome"

Portable Visual Guidance System Phase II (PVGS-II)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by:
SymTrend Inc.
ClinicalTrials.gov Identifier:
NCT00848874
First received: April 25, 2008
Last updated: February 19, 2009
Last verified: February 2009
  Purpose

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 Intervention
Asperger Syndrome
High Functioning Autism
Behavioral: PVGS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SymTrend Inc.:

Primary Outcome Measures:
  • Students who use the PVGS will demonstrate improved classroom social pragmatics and executive functioning. [ Time Frame: Completion of intervention and three months hence ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PVGS User Behavioral: PVGS
Student use of SymTrend PVGS daily then tapering off for 14 weeks in conjunction to ratings by a coach.

  Eligibility

Ages Eligible for Study:   11 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848874

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

No publications provided

Responsible Party: Gary Mesibov, PhD, Dept of Psychiatry, UNC Medical School and Division TEACCH at UNC
ClinicalTrials.gov Identifier: NCT00848874     History of Changes
Other Study ID Numbers: 2R41MH75162, NIHM_2R41MH75162--02A1
Study First Received: April 25, 2008
Last Updated: February 19, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Autistic Disorder
Asperger Syndrome
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014