Cognitive Remediation in 22q11DS

This study is currently recruiting participants.

Verified January 2013 by Duke University

Sponsor:

Collaborators:

National Institute of Mental Health (NIMH)

Harvard University

University of Pittsburgh

Information provided by (Responsible Party):

Duke University

ClinicalTrials.gov Identifier:

NCT01781923

First received: January 29, 2013

Last updated: January 30, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 29, 2013

Last Updated Date

January 30, 2013

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sustained attention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Sustained attention will be assessed using the Continuous Performance Test.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01781923 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cognitive Remediation in 22q11DS

Official Title ^ICMJE

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 Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

22q11.2 Deletion Syndrome
Velo-Cardio-Facial Syndrome

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2014

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

molecular/cytogenetic confirmation of 22q11DS

Exclusion Criteria:

IQ<60
diagnosis of psychosis
pregnancy
home location doesn't permit participation in small groups

Gender

Both

Ages

12 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Vandana Shashi, MD

919-681-2772

vandana.shashi@duke.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01781923

Other Study ID Numbers ^ICMJE

Pro00025985, R34MH091314

Has Data Monitoring Committee

Yes

Responsible Party

Duke University

Study Sponsor ^ICMJE

Duke University

Collaborators ^ICMJE

National Institute of Mental Health (NIMH)
Harvard University
University of Pittsburgh

Investigators ^ICMJE

Not Provided

Information Provided By

Duke University

Verification Date

January 2013

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

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