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Cognitive Remediation in 22q11DS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781923
First Posted: February 1, 2013
Last Update Posted: August 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
Harvard University
University of Pittsburgh
Information provided by (Responsible Party):
Duke University
  Purpose
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.

Condition Intervention
22q11.2 Deletion Syndrome Velo-Cardio-Facial Syndrome Behavioral: Cognitive remediation program Behavioral: Small group social skills training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Remediation Program for Children at High-Risk of Schizophrenia: 22q11.2 Deletion Syndrome

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in sustained attention [ Time Frame: Baseline and 12 weeks ]
    Sustained attention will be assessed using the Continuous Performance Test.

  • Change in executive function. [ Time Frame: Baseline and 12 weeks ]
  • Change in verbal memory. [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures:
  • Social skills [ Time Frame: 40 weeks ]
    Social skills will be measured using a parental survey called the Social Skills Rating System.

  • 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.


Enrollment: 38
Study Start Date: October 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Posit Science
Behavioral: Small group social skills training
Meet once per week for duration of 40 weeks.
No Intervention: Control
No intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781923


Locations
United States, North Carolina
Duke University Health Systems
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
Harvard University
University of Pittsburgh
Investigators
Principal Investigator: Vandana Shashi, MD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01781923     History of Changes
Other Study ID Numbers: Pro00025985
R34MH091314 ( U.S. NIH Grant/Contract )
First Submitted: January 29, 2013
First Posted: February 1, 2013
Last Update Posted: August 10, 2015
Last Verified: August 2015

Keywords provided by Duke University:
Cognitive remediation
Social Cognition

Additional relevant MeSH terms:
Syndrome
DiGeorge Syndrome
Disease
Pathologic Processes
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