Cognitive Remediation in 22q11DS
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|ClinicalTrials.gov Identifier: NCT01781923|
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : August 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|22q11.2 Deletion Syndrome Velo-Cardio-Facial Syndrome||Behavioral: Cognitive remediation program Behavioral: Small group social skills training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Remediation Program for Children at High-Risk of Schizophrenia: 22q11.2 Deletion Syndrome|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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.
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.
No Intervention: Control
- 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 ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781923
|United States, North Carolina|
|Duke University Health Systems|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Vandana Shashi, MD||Duke University|