Computerized Cognitive Skills Training for Adolescents With Velocardiofacial Syndrome
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Computer-Based Cognitive Remediation in Adolescents With VCFS|
- The California Learning Test and the Visual Span Test [ Time Frame: Measured immediately following the intervention at each phase ] [ Designated as safety issue: No ]
- Performance on the Apartment Test [ Time Frame: Measured immediately following the intervention at each phase ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Computerized Cognitive Skills Training
Participants will receive the intervention, delivered in-person in Phase 1 and remotely in Phases 2 and 3.
Behavioral: Challenging Our Minds Program
A computerized cognitive intervention that provides training in attention, memory, and executive function
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917189
|United States, New York|
|SUNY Upstate Medical University|
|Syracuse, New York, United States, 13210|
|Principal Investigator:||Wendy R. Kates, PhD||State University of New York - Upstate Medical University|