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OpenTrials
Completed

NCT Number: NCT00848874

Portable Visual Guidance System Phase II

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.

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Key information

Age range

11 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SymTrend, Inc.

Belmont, Massachusetts, 02478, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PVGS

Behavioral

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

Primary outcomes

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

    Time frame: Completion of intervention and three months hence

Sponsors and collaborators

Lead sponsor

Minna Levine, PhD

Industry

Collaborators

  • SymTrend Inc.
  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Acronym: PVGS-II

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 20, 2009
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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