Cognitive Remediation in 22q11DS

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Harvard University
University of Pittsburgh
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01781923
First received: January 29, 2013
Last updated: August 5, 2013
Last verified: August 2013
  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: 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 ] [ Designated as safety issue: No ]
    Sustained attention will be assessed using the Continuous Performance Test.

  • Change in executive function. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in verbal memory. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social skills [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The study will examine the impact of CCRP upon brain function and white matter structure in children with 22q11DS.


Estimated Enrollment: 36
Study Start Date: October 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • molecular/cytogenetic confirmation of 22q11DS

Exclusion Criteria:

  • IQ<60
  • diagnosis of psychosis
  • pregnancy
  • home location doesn't permit participation in small groups
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781923

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

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01781923     History of Changes
Other Study ID Numbers: Pro00025985, R34MH091314
Study First Received: January 29, 2013
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Cognitive remediation
Social Cognition

Additional relevant MeSH terms:
DiGeorge Syndrome
Facial Paralysis
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
Mouth Diseases
Stomatognathic Diseases
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014