Asperger SyndromePVGS-IINCT00848874
Portable Visual Guidance System Phase II
A study testing PVGS in people with Asperger Syndrome and High Functioning Autism, run by Minna Levine, PhD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 21 years
- Conditions the study is for
- Asperger Syndrome, High Functioning Autism
- What is being tested?
- PVGS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Participating in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of a Portable Visual Guidance System for Use by AS/HFA Students in Inclusion Settings
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:
Read more
- 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.
- Conditions
- Asperger Syndrome, High Functioning Autism
- Being tested
- PVGS
- Medical subject headings
- Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVGSBehavioural
Student use of SymTrend PVGS daily then tapering off for 14 weeks in conjunction to ratings by a coach.
| Study group | Role | What they receive |
|---|---|---|
| PVGS User | Experimental | Not described Receives: Behavioral: PVGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Students who use the PVGS will demonstrate improved classroom social pragmatics and executive functioning.
Measured: Completion of intervention and three months hence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asperger SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minna Levine, PhD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SymTrend Inc., University of North Carolina, Chapel Hill
- Responsible party
- Sponsor-investigator, Minna Levine, PhD, SymTrend Inc.
- Investigators
- Gary Mesibov, PhD, Principal investigator, University of North Carolina, Chapel HillMinna Levine, PhD, Study director, SymTrend Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848874
- Sponsor's protocol ID
- 2R41MH075162
- Other IDs
- NIHM_2R41MH75162--02A1
- Acronym
- PVGS-II
- Status last verified
- Oct 2018
- First submitted
- 25 Apr 2008
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of a Portable Visual Guidance System for Use by AS/HFA Students in Inclusion Settings
- ClinicalTrials.gov ID
- NCT00848874
- Acronym / sponsor ID
- PVGS-II / 2R41MH075162
- Conditions
- Asperger Syndrome, High Functioning Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Minna Levine, PhDIndustry (pharma, biotech, devices)
- Collaborators
- SymTrend Inc., University of North Carolina, Chapel Hill
- Study start
- Sep 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PVGS User | Experimental | Behavioral: PVGS |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participating in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVGSStudent use of SymTrend PVGS daily then tapering off for 14 weeks in conjunction to ratings by a coach. | Behavioural | PVGS User |
Primary outcome
Students who use the PVGS will demonstrate improved classroom social pragmatics and executive functioning.
Time frame: Completion of intervention and three months hence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Mesibov, PhD principal investigator
University of North Carolina, Chapel Hill
Minna Levine, PhD study director
SymTrend Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVGS in people with Asperger Syndrome and High Functioning Autism, run by Minna Levine, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Students who use the PVGS will demonstrate improved classroom social pragmatics and executive functioning. (time frame: Completion of intervention and three months hence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.