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: September 9, 2014
Last verified: September 2014

January 29, 2013
September 9, 2014
October 2010
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Sustained attention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Sustained attention will be assessed using the Continuous Performance Test.
Complete list of historical versions of study NCT01781923 on ClinicalTrials.gov Archive Site
  • 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.
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.
Not Provided
Not Provided
 
Cognitive Remediation in 22q11DS
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • 22q11.2 Deletion Syndrome
  • Velo-Cardio-Facial Syndrome
  • 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.
  • 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.

    Interventions:
    • Behavioral: Cognitive remediation program
    • Behavioral: Small group social skills training
  • No Intervention: Control
    No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
11 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01781923
Pro00025985, R34MH091314
Yes
Duke University
Duke University
  • National Institute of Mental Health (NIMH)
  • Harvard University
  • University of Pittsburgh
Principal Investigator: Vandana Shashi, MD Duke University
Duke University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP