Velocardiofacial Syndrome Clinical Trial
Official title:
Computer-Based Cognitive Remediation in Adolescents With VCFS
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT00768820 -
The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome
|
Phase 4 | |
| Completed |
NCT00105274 -
Velocardiofacial (VCFS; 22q11.2; DiGeorge) Syndrome Study
|
N/A |