A Remediation Program for Children at High-Risk of Schizophrenia: 22q11.2 Deletion Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Change in sustained attention
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 11 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Social skills(40 weeks)
- Change in brain function and white matter structure.(Baseline and 12 weeks)