Computerized Cognitive Skills Training for Adolescents With Velocardiofacial Syndrome

Brief Title

Computerized Cognitive Skills Training for Adolescents With Velocardiofacial Syndrome

Official Title

Computer-Based Cognitive Remediation in Adolescents With VCFS

Brief Summary

      This study will test a computer-based treatment for youth with the genetic disorder
      velocardiofacial syndrome (VCFS) to help them improve skills in memory, attention, and
      executive functioning.
    

Detailed Description

      Velocardiofacial syndrome (VCFS) is a genetic condition caused by deletion of a segment of
      the 22nd chromosome at the location 22q11.2. VCFS is characterized by a combination of
      medical problems related to the palate (velo) and the heart (cardio) and by a distinct facial
      appearance. Also common in people with VCFS, among other problems, are learning and speech
      difficulties. These difficulties are specifically categorized as deficits in attention,
      working memory, and executive functioning. This study will develop and test a computer-based
      intervention for adolescents with VCFS that will teach them cognitive skills to lessen these
      deficits.

      This study will have three phases. In the first phase, the intervention will be pilot tested
      with an in-person coach. In the second phase, the intervention will be pilot tested remotely
      with a video-conferencing coach. In the third phase, the intervention will be delivered
      remotely, and testing will be expanded to include more participants and a longer assessment
      period. Information on participant drop-out and level of difficulty will be gathered and used
      to refine the treatment between phases.

      Participation in Phase 1 will last 6 months. At study entry, participants will complete
      baseline measures that involve a structured diagnostic interview to assess behavioral or
      emotional difficulties and cognitive testing to assess intellectual functioning. Then they
      will meet with a study training coach three times a week at their homes. During these
      sessions, participants will complete exercises in the Challenging our Minds program, a
      computer-based system designed to improve learning. Exercises will develop skills in seven
      domains: attention, decision making, memory, understanding relationships between objects,
      problem solving, communication, and social perception.

      Participation in Phase 2 will last 6 to 9 months. Participants in this phase will complete
      the same baseline measures that occurred at study entry and then complete exercises in
      Challenging our Minds three times a week. Instead of having a training coach come to their
      homes, participants in Phase 2 will work with a training coach via video-conferencing
      software.

      Participation in Phase 3 will last 2 years. Participants will undergo assessments at four
      points: at baseline, after 9 months, after 18 months, and after 27 months. These assessments
      will include the baseline measures from the previous phases as well as a virtual reality
      computer task. Between their visits at 9 and 18 months, participants will work with a
      training coach via video conferencing three times a week to complete the Challenging our
      Minds exercises.
    


Study Type

Interventional


Primary Outcome

The California Learning Test and the Visual Span Test

Secondary Outcome

 Performance on the Apartment Test

Condition

Velocardiofacial Syndrome

Intervention

Challenging Our Minds Program

Study Arms / Comparison Groups

 Computerized Cognitive Skills Training
Description:  Participants will receive the Challenging Our Minds intervention, delivered in-person in Phase 1 and remotely in Phases 2 and 3.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

37

Start Date

September 2009

Completion Date

April 2015

Primary Completion Date

April 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of velocardiofacial syndrome (VCFS)

          -  IQ score between 70 and 90

        Exclusion Criteria:

          -  Presence of psychotic symptoms
      

Gender

All

Ages

12 Years - 16 Years

Accepts Healthy Volunteers

No

Contacts

Wendy R. Kates, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00917189

Organization ID

R33MH085901

Secondary IDs

R33MH085901

Responsible Party

Sponsor

Study Sponsor

State University of New York - Upstate Medical University

Collaborators

 National Institute of Mental Health (NIMH)

Study Sponsor

Wendy R. Kates, PhD, Principal Investigator, State University of New York - Upstate Medical University


Verification Date

October 2016