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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH091314 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Harvard University | OTHER |
| University of Pittsburgh | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Remediation | Experimental | 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. |
|
| Control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive remediation program | Behavioral | Subject plays for 30 minutes, 4 times per week, for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in sustained attention | Sustained attention will be assessed using the Continuous Performance Test. | Baseline and 12 weeks |
| Change in executive function. | Baseline and 12 weeks | |
| Change in verbal memory. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Social skills | Social skills will be measured using a parental survey called the Social Skills Rating System. | 40 weeks |
| Change in brain function and white matter structure. | The study will examine the impact of CCRP upon brain function and white matter structure in children with 22q11DS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vandana Shashi, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health Systems | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D004062 | DiGeorge Syndrome |
| ID | Term |
|---|---|
| D058165 | 22q11 Deletion Syndrome |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
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| Small group social skills training | Behavioral | Meet once per week for duration of 40 weeks. |
|
| Baseline and 12 weeks |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D044148 | Lymphatic Abnormalities |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D007011 | Hypoparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |