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Computerized Cognitive Skills Training for Adolescents With Velocardiofacial Syndrome

Primary Purpose

Velocardiofacial Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Challenging Our Minds Program
Sponsored by
State University of New York - Upstate Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Velocardiofacial Syndrome focused on measuring VCFS, Chromosome 22q Deletion Syndrome, Learning Disorders

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Presence of psychotic symptoms

Sites / Locations

  • SUNY Upstate Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Computerized Cognitive Skills Training

Arm Description

Participants will receive the Challenging Our Minds intervention, delivered in-person in Phase 1 and remotely in Phases 2 and 3.

Outcomes

Primary Outcome Measures

The California Learning Test and the Visual Span Test

Secondary Outcome Measures

Performance on the Apartment Test

Full Information

First Posted
June 8, 2009
Last Updated
October 20, 2016
Sponsor
State University of New York - Upstate Medical University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00917189
Brief Title
Computerized Cognitive Skills Training for Adolescents With Velocardiofacial Syndrome
Official Title
Computer-Based Cognitive Remediation in Adolescents With VCFS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State University of New York - Upstate Medical University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Velocardiofacial Syndrome
Keywords
VCFS, Chromosome 22q Deletion Syndrome, Learning Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computerized Cognitive Skills Training
Arm Type
Experimental
Arm Description
Participants will receive the Challenging Our Minds intervention, delivered in-person in Phase 1 and remotely in Phases 2 and 3.
Intervention Type
Behavioral
Intervention Name(s)
Challenging Our Minds Program
Intervention Description
A computerized cognitive intervention that provides training in attention, memory, and executive function
Primary Outcome Measure Information:
Title
The California Learning Test and the Visual Span Test
Time Frame
Measured immediately following the intervention at each phase
Secondary Outcome Measure Information:
Title
Performance on the Apartment Test
Time Frame
Measured immediately following the intervention at each phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of velocardiofacial syndrome (VCFS) IQ score between 70 and 90 Exclusion Criteria: Presence of psychotic symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy R. Kates, PhD
Organizational Affiliation
State University of New York - Upstate Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27629273
Citation
Mariano MA, Tang K, Kurtz M, Kates WR. Examining the durability of a hybrid, remote and computer-based cognitive remediation intervention for adolescents with 22q11.2 deletion syndrome. Early Interv Psychiatry. 2018 Aug;12(4):686-693. doi: 10.1111/eip.12367. Epub 2016 Sep 15.
Results Reference
result
PubMed Identifier
26044111
Citation
Mariano MA, Tang K, Kurtz M, Kates WR. Cognitive remediation for adolescents with 22q11 deletion syndrome (22q11DS): a preliminary study examining effectiveness, feasibility, and fidelity of a hybrid strategy, remote and computer-based intervention. Schizophr Res. 2015 Aug;166(1-3):283-9. doi: 10.1016/j.schres.2015.05.030. Epub 2015 Jun 1.
Results Reference
result

Learn more about this trial

Computerized Cognitive Skills Training for Adolescents With Velocardiofacial Syndrome

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