Portable Visual Guidance System Phase II (PVGS-II)
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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:
- 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.
| 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 |
- 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 |
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| United States, Massachusetts | |
| SymTrend, Inc. | |
| Belmont, Massachusetts, United States, 02478 | |
| 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 June 18, 2013