Cognitive Remediation in 22q11DS

Overview

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.

Full Title of Study: “A Remediation Program for Children at High-Risk of Schizophrenia: 22q11.2 Deletion Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2015

Interventions

  • Behavioral: Cognitive remediation program
    • Subject plays for 30 minutes, 4 times per week, for 12 weeks.
  • Behavioral: Small group social skills training
    • Meet once per week for duration of 40 weeks.

Arms, Groups and Cohorts

  • 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.
  • No Intervention: Control
    • No intervention

Clinical Trial Outcome Measures

Primary 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 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 11 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Duke University
  • Collaborator
    • National Institute of Mental Health (NIMH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vandana Shashi, MD, Principal Investigator, Duke University

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