Cognitive Remediation in 22q11DS
|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 ScienceBehavioral: 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.
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|