Cognitive Remediation in 22q11DS

Not Applicable

Completed

• Conditions: Velo-Cardio-Facial Syndrome; 22q11.2 Deletion Syndrome
• Interventions: Behavioral: Cognitive remediation program; Behavioral: Small group social skills training

• Registration Number: NCT01781923
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-02-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-06
• Last Update Posted: 2015-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• molecular/cytogenetic confirmation of 22q11DS

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Exclusion Criteria

• Intelligence Quotient <60
• diagnosis of psychosis
• pregnancy
• home location does not permit participation in small groups

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Remediation	Cognitive remediation program	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.
Cognitive Remediation	Small group social skills training	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.

Primary Outcome Measures

Name	Time	Method
Change in executive function.	Baseline and 12 weeks
Change in verbal memory.	Baseline and 12 weeks
Change in sustained attention	Baseline and 12 weeks	Sustained attention will be assessed using the Continuous Performance Test.

Secondary Outcome Measures

Name	Time	Method
Social skills	40 weeks	Social skills will be measured using a parental survey called the Social Skills Rating System.
Change in brain function and white matter structure.	Baseline and 12 weeks	The study will examine the impact of CCRP upon brain function and white matter structure in children with 22q11DS.

Trial Locations

Locations (1)

Duke University Health Systems; 🇺🇸 Durham, North Carolina, United States