Cognitive Remediation in 22q11DS

N/ACompletedNCT01781923

Duke University38 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

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

Interventions

Cognitive remediation programBEHAVIORAL

Subject plays for 30 minutes, 4 times per week, for 12 weeks.

Small group social skills trainingBEHAVIORAL

Meet once per week for duration of 40 weeks.

Eligibility

Sex: ALLMin age: 11 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Health Systems

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Change in sustained attention

Sustained attention will be assessed using the Continuous Performance Test.

Time frame: Baseline and 12 weeks

Change in executive function.

Time frame: Baseline and 12 weeks

Change in verbal memory.

Time frame: Baseline and 12 weeks

Secondary Outcomes

Social skills

Social skills will be measured using a parental survey called the Social Skills Rating System.

Time frame: 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.

Time frame: Baseline and 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.