Cognitive Remediation in 22q11DS

22q11.2 Deletion Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781923
• Other study ID #: Pro00025985
• Secondary ID: R34MH091314
• Status: Completed
• Phase: N/A
• First received: January 29, 2013
• Last updated: August 6, 2015
• Start date: October 2010
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• 22q11.2 Deletion Syndrome
• DiGeorge Syndrome
• Facial Paralysis
• Syndrome
• Velo-Cardio-Facial Syndrome

Intervention

Behavioral:
• Cognitive remediation program
Subject plays for 30 minutes, 4 times per week, for 12 weeks.
• Small group social skills training
Meet once per week for duration of 40 weeks.

Locations

Country	Name	City	State
United States	Duke University Health Systems	Durham	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	Harvard University, National Institute of Mental Health (NIMH), University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sustained attention	Sustained attention will be assessed using the Continuous Performance Test.	Baseline and 12 weeks	No
Primary	Change in executive function.		Baseline and 12 weeks	No
Primary	Change in verbal memory.		Baseline and 12 weeks	No
Secondary	Social skills	Social skills will be measured using a parental survey called the Social Skills Rating System.	40 weeks	No
Secondary	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	No