Computerized Cognitive Skills Training for Adolescents With Velocardiofacial Syndrome

Velocardiofacial Syndrome Clinical Trial

Official title:

Computer-Based Cognitive Remediation in Adolescents With VCFS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917189
• Other study ID #: R33MH085901
• Secondary ID: R33MH085901DDTR
• Status: Completed
• Phase: N/A
• First received: June 8, 2009
• Last updated: October 20, 2016
• Start date: September 2009
• Est. completion date: April 2015

Study information

• Verified date: October 2016
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

Inclusion Criteria:

• Diagnosis of velocardiofacial syndrome (VCFS)

• IQ score between 70 and 90

Exclusion Criteria:

• Presence of psychotic symptoms

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• DiGeorge Syndrome
• Syndrome
• Velocardiofacial Syndrome

Intervention

Behavioral:
• Challenging Our Minds Program
A computerized cognitive intervention that provides training in attention, memory, and executive function

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Schiz — View 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. 2016 Sep 15. doi: 10.1111/eip.12367. [Epub a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The California Learning Test and the Visual Span Test		Measured immediately following the intervention at each phase	No
Secondary	Performance on the Apartment Test		Measured immediately following the intervention at each phase	No