Computerized Cognitive Skills Training for Adolescents With Velocardiofacial Syndrome

NCT ID: NCT00917189

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2015-04-30

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.

Conditions

Velocardiofacial Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Computerized Cognitive Skills Training

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

Group Type: EXPERIMENTAL

Challenging Our Minds Program

Intervention Type: BEHAVIORAL

A computerized cognitive intervention that provides training in attention, memory, and executive function

Interventions

Challenging Our Minds Program

A computerized cognitive intervention that provides training in attention, memory, and executive function

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Presence of psychotic symptoms

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy R. Kates, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

SUNY Upstate Medical University

Syracuse, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27629273 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26044111 (View on PubMed)

Other Identifiers

R33MH085901

Identifier Type: NIH

Identifier Source: secondary_id

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DDTR B4-TBI

Identifier Type: -

Identifier Source: secondary_id

R33MH085901

Identifier Type: NIH

Identifier Source: org_study_id

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