Portable Visual Guidance System Phase II

NCT00848874 | Completed

• 2 other identifiers: 2R41MH075162NIHM_2R41MH75162--02A1
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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. 1.Replicate Phase I success in the most educational setting for AS/HFA high school aged students: mainstream school inclusion classes.
2. 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. 3.Contrast the outcomes of the curriculum with a diagnosis-matched wait-list control group.
4. 4.Develop and implement software that will enable on-site staff to create and modify individualized guidance and monitoring screens as needs arise.
5. 5.Design a commercially attractive package of software, video training, video-conferenced support, and manuals.
6. 6.Complete the translation of the SymTrend website and all the above tools into Spanish.
7. 7.Provide a very effective and comprehensive system for teaching social pragmatics and related management skills to AS/HFA persons in an inclusion context.
8. 8.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.
9. 9.Provide substantial support for our theoretical rationale for curriculum building in Special Education - a rationale that can guide the formulation of IEPs.
10. 10.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.
11. 11.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.

Conditions

Asperger Syndrome; High Functioning Autism

Outcome Measures

Primary Outcomes (1)

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

  Completion of intervention and three months hence

Study Arms (1)

PVGS User

EXPERIMENTAL

Behavioral: PVGS

Interventions

PVGS BEHAVIORAL

Student use of SymTrend PVGS daily then tapering off for 14 weeks in conjunction to ratings by a coach.

PVGS User

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Participating in another study

Sponsors & Collaborators

• Minna Levine, PhD: lead
• SymTrend Inc.: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

SymTrend, Inc.

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Asperger Syndrome

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Gary Mesibov, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Minna Levine, PhD

  SymTrend Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Invesetigator

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: February 20, 2009
• Study Start: September 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

US (1)