Portable Visual Guidance System Phase II (PVGS-II)
Primary Purpose
Asperger Syndrome, High Functioning Autism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PVGS
Sponsored by
About this trial
This is an interventional treatment trial for Asperger Syndrome
Eligibility 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
Sites / Locations
- SymTrend, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PVGS User
Arm Description
Outcomes
Primary Outcome Measures
Students who use the PVGS will demonstrate improved classroom social pragmatics and executive functioning.
Secondary Outcome Measures
Full Information
NCT ID
NCT00848874
First Posted
April 25, 2008
Last Updated
October 5, 2018
Sponsor
Minna Levine, PhD
Collaborators
SymTrend Inc., University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT00848874
Brief Title
Portable Visual Guidance System Phase II
Acronym
PVGS-II
Official Title
Phase II Study of a Portable Visual Guidance System for Use by AS/HFA Students in Inclusion Settings
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Minna Levine, PhD
Collaborators
SymTrend Inc., University of North Carolina, Chapel Hill
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Replicate Phase I success in the most educational setting for AS/HFA high school aged students: mainstream school inclusion classes.
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.
Contrast the outcomes of the curriculum with a diagnosis-matched wait-list control group.
Develop and implement software that will enable on-site staff to create and modify individualized guidance and monitoring screens as needs arise.
Design a commercially attractive package of software, video training, video-conferenced support, and manuals.
Complete the translation of the SymTrend website and all the above tools into Spanish.
Significance: Successful completion of Phase II will:
Provide a very effective and comprehensive system for teaching social pragmatics and related management skills to AS/HFA persons in an inclusion context.
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.
Provide substantial support for our theoretical rationale for curriculum building in Special Education - a rationale that can guide the formulation of IEPs.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asperger Syndrome, High Functioning Autism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PVGS User
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
PVGS
Intervention Description
Student use of SymTrend PVGS daily then tapering off for 14 weeks in conjunction to ratings by a coach.
Primary Outcome Measure Information:
Title
Students who use the PVGS will demonstrate improved classroom social pragmatics and executive functioning.
Time Frame
Completion of intervention and three months hence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Mesibov, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Minna Levine, PhD
Organizational Affiliation
SymTrend Inc.
Official's Role
Study Director
Facility Information:
Facility Name
SymTrend, Inc.
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Portable Visual Guidance System Phase II
We'll reach out to this number within 24 hrs