Portable Visual Guidance System Phase II

Asperger Syndrome Clinical Trial

— PVGS-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848874
• Other study ID #: 2R41MH075162
• Secondary ID: NIHM_2R41MH75162
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: March 2010

Study information

• Verified date: October 2018
• Source: SymTrend Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Asperger Syndrome
• High Functioning Autism

Intervention

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

Locations

Country	Name	City	State
United States	SymTrend, Inc.	Belmont	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Minna Levine, PhD	SymTrend Inc., University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Students who use the PVGS will demonstrate improved classroom social pragmatics and executive functioning.		Completion of intervention and three months hence