Cognitive Remediation in 22q11DS

August 6, 2015 updated by: Duke University

A Remediation Program for Children at High-Risk of Schizophrenia: 22q11.2 Deletion Syndrome

The goal of this study is to collect preliminary data on the efficacy of a cognitive remediation program in improving the neurocognitive deficits in children with chromosome 22q11.2 deletion syndrome (22q11DS). This study involves a two part approaching including a computerized cognitive remediation program (CCRP, Posit Science, CA) in combination with a Social Cognitive Training (SCT) program. The computer-based training program has shown encouraging results in improving learning deficits in individuals with schizophrenia and we now seek to adapt them to children with 22q11DS, who have unique needs due to their lower IQ and high risk of psychosis in late adolescence and adulthood. The SCT is a small-group intervention program based on cognitive enhancement therapy, which has been shown to improve social cognition and functionality in adults with schizophrenia. A preliminary study will be performed using this two-pronged approach, to establish the feasibility and gather preliminary data on neurocognition before and after the intervention in these children; these data would enable a larger randomized controlled study to assess the efficacy of this approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • molecular/cytogenetic confirmation of 22q11DS

Exclusion Criteria:

  • Intelligence Quotient <60
  • diagnosis of psychosis
  • pregnancy
  • home location does not permit participation in small groups

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: Cognitive Remediation

12 week computer-based cognitive remediation program aimed to improve working memory, processing speed, and verbal learning/memory.

40 week small group social skills training sessions aimed to improve social skills and cognition.
Behavioral: Cognitive remediation program
Subject plays for 30 minutes, 4 times per week, for 12 weeks.
Other Names:
  • Posit Science
Behavioral: Small group social skills training
Meet once per week for duration of 40 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sustained attention
Time Frame: Baseline and 12 weeks
Sustained attention will be assessed using the Continuous Performance Test.
Baseline and 12 weeks
Change in executive function.
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in verbal memory.
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social skills
Time Frame: 40 weeks
Social skills will be measured using a parental survey called the Social Skills Rating System.
40 weeks
Change in brain function and white matter structure.
Time Frame: Baseline and 12 weeks
The study will examine the impact of CCRP upon brain function and white matter structure in children with 22q11DS.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Mental Health (NIMH)
University of Pittsburgh
Harvard University

Investigators

  • Principal Investigator: Vandana Shashi, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (Estimate)

February 1, 2013

Study Record Updates

Last Update Posted (Estimate)

August 10, 2015

Last Update Submitted That Met QC Criteria

August 6, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00025985
  • R34MH091314 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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