Clinical Trial: Cognitive Remediation in 22q11DS

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Duke University

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Sustained attention [ Time Frame: 12 weeks ]

Sustained attention will be assessed using the Continuous Performance Test.


Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Social skills [ Time Frame: 40 weeks ]

Social skills will be measured using a parental survey called the Social Skills Rating System.


Information By: Duke University

Dates:
Date Received: January 29, 2013
Date Started: October 2010
Date Completion:
Last Updated: August 6, 2015
Last Verified: August 2015