Portable Visual Guidance System Phase II (PVGS-II)

October 5, 2018 updated by: Minna Levine, PhD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • SymTrend, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minna Levine, PhD

Collaborators

University of North Carolina, Chapel Hill
SymTrend Inc.

Investigators

  • Principal Investigator: Gary Mesibov, PhD, University of North Carolina, Chapel Hill
  • Study Director: Minna Levine, PhD, SymTrend Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

April 25, 2008

First Submitted That Met QC Criteria

February 19, 2009

First Posted (ESTIMATE)

February 20, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2R41MH075162 (NIH)
  • NIHM_2R41MH75162--02A1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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