Cognitive Remediation in 22q11DS

Study Overview
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Brief Summary
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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.

Official Title
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A Remediation Program for Children at High-Risk of Schizophrenia: 22q11.2 Deletion Syndrome

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

Intervention / Treatment
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* Behavioral: Cognitive remediation program
* Behavioral: Small group social skills training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: molecular/cytogenetic confirmation of 22q11DS Exclusion Criteria: Intelligence Quotient <60 diagnosis of psychosis pregnancy home location does not permit participation in small groups

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Remediation<br>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<br>* Subject plays for 30 minutes, 4 times per week, for 12 weeks.<br>* Other names: Posit Science;Behavioral: Small group social skills training<br>* Meet once per week for duration of 40 weeks.<br>|
| No Intervention: Control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive remediation, Social Cognition