Cognitive Remediation in 22q11DS

Brief Title

Cognitive Remediation in 22q11DS

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.
    



Study Type

Interventional


Primary Outcome

Change in sustained attention

Secondary Outcome

 Social skills

Condition

22q11.2 Deletion Syndrome

Intervention

Cognitive remediation program

Study Arms / Comparison Groups

 Cognitive Remediation
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

38

Start Date

October 2010

Completion Date

June 2015

Primary Completion Date

June 2015

Eligibility 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
      

Gender

All

Ages

11 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Vandana Shashi, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01781923

Organization ID

Pro00025985

Secondary IDs

R34MH091314

Responsible Party

Sponsor

Study Sponsor

Duke University

Collaborators

 National Institute of Mental Health (NIMH)

Study Sponsor

Vandana Shashi, MD, Principal Investigator, Duke University


Verification Date

August 2015