Computerized Cognitive Skills Training for Adolescents With Velocardiofacial Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00917189
First received: June 8, 2009
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Velocardiofacial Syndrome
Behavioral: Challenging Our Minds Program

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • The California Learning Test and the Visual Span Test [ Time Frame: Measured immediately following the intervention at each phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Performance on the Apartment Test [ Time Frame: Measured immediately following the intervention at each phase ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of velocardiofacial syndrome (VCFS)
  • IQ score between 70 and 90

Exclusion Criteria:

  • Presence of psychotic symptoms
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917189

Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Wendy R. Kates, PhD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00917189     History of Changes
Other Study ID Numbers: R33 MH085901, R33MH085901, DDTR B4-TBI
Study First Received: June 8, 2009
Last Updated: February 4, 2014
Health Authority: United States: Federal Government

Keywords provided by State University of New York - Upstate Medical University:
VCFS
Chromosome 22q Deletion Syndrome
Learning Disorders

Additional relevant MeSH terms:
DiGeorge Syndrome
22q11 Deletion Syndrome
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Lymphatic Abnormalities
Lymphatic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 28, 2014