Portable Visual Guidance System Phase II (PVGS-II)
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|ClinicalTrials.gov Identifier: NCT00848874|
Recruitment Status : Unknown
Verified February 2009 by SymTrend Inc..
Recruitment status was: Enrolling by invitation
First Posted : February 20, 2009
Last Update Posted : February 20, 2009
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 or disease||Intervention/treatment||Phase|
|Asperger Syndrome High Functioning Autism||Behavioral: PVGS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of a Portable Visual Guidance System for Use by AS/HFA Students in Inclusion Settings|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||June 2009|
|Estimated Study Completion Date :||April 2010|
|Experimental: PVGS User||
Student use of SymTrend PVGS daily then tapering off for 14 weeks in conjunction to ratings by a coach.
- Students who use the PVGS will demonstrate improved classroom social pragmatics and executive functioning. [ Time Frame: Completion of intervention and three months hence ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848874
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Principal Investigator:||Gary Mesibov, PhD||University of North Carolina, Chapel Hill|
|Study Director:||Minna Levine, PhD||SymTrend Inc.|