Overview

This trial is active, not recruiting.

Condition velocardiofacial syndrome
Treatment challenging our minds program
Sponsor State University of New York - Upstate Medical University
Collaborator National Institute of Mental Health (NIMH)
Start date September 2009
End date February 2014
Trial size 35 participants
Trial identifier NCT00917189, DDTR B4-TBI, R33 MH085901, R33MH085901

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will receive the intervention, delivered in-person in Phase 1 and remotely in Phases 2 and 3.
challenging our minds program
A computerized cognitive intervention that provides training in attention, memory, and executive function

Primary Outcomes

Measure
The California Learning Test and the Visual Span Test
time frame: Measured immediately following the intervention at each phase

Secondary Outcomes

Measure
Performance on the Apartment Test
time frame: Measured immediately following the intervention at each phase

Eligibility Criteria

Male or female participants from 12 years up to 16 years old.

Inclusion Criteria: - Diagnosis of velocardiofacial syndrome (VCFS) - IQ score between 70 and 90 Exclusion Criteria: - Presence of psychotic symptoms

Additional Information

Official title Computer-Based Cognitive Remediation in Adolescents With VCFS
Principal investigator Wendy R. Kates, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by State University of New York - Upstate Medical University.