Cognitive Remediation in 22q11DS
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Purpose
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.
| Condition | Intervention |
|---|---|
|
22q11.2 Deletion Syndrome Velo-Cardio-Facial Syndrome |
Behavioral: Cognitive remediation program Behavioral: Small group social skills training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A Remediation Program for Children at High-Risk of Schizophrenia: 22q11.2 Deletion Syndrome |
- Sustained attention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Sustained attention will be assessed using the Continuous Performance Test.
- 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.
| Estimated Enrollment: | 36 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
No intervention
|
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- molecular/cytogenetic confirmation of 22q11DS
Exclusion Criteria:
- IQ<60
- diagnosis of psychosis
- pregnancy
- home location doesn't permit participation in small groups
Contacts and Locations| Contact: Vandana Shashi, MD | 919-681-2772 | vandana.shashi@duke.edu |
| United States, North Carolina | |
| Duke University Health Systems | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Kelly Schoch, MS 919-681-2772 kelly.schoch@duke.edu | |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01781923 History of Changes |
| Other Study ID Numbers: | Pro00025985, R34MH091314 |
| Study First Received: | January 29, 2013 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Cognitive remediation Social Cognition |
Additional relevant MeSH terms:
|
DiGeorge Syndrome Facial Paralysis 22q11 Deletion Syndrome Craniofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Lymphatic Abnormalities Lymphatic Diseases Abnormalities, Multiple |
Congenital Abnormalities Chromosome Disorders Genetic Diseases, Inborn Hypoparathyroidism Parathyroid Diseases Endocrine System Diseases Mouth Diseases Stomatognathic Diseases Paralysis Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013