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Cognitive Remediation in 22q11DS

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01781923
Enrollment
38
Registered
2013-02-01
Start date
2010-10-31
Completion date
2015-06-30
Last updated
2015-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Cognitive remediation, Social Cognition

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.

Interventions

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

BEHAVIORALSmall group social skills training

Meet once per week for duration of 40 weeks.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Harvard University
CollaboratorOTHER
University of Pittsburgh
CollaboratorOTHER
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 17 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in sustained attentionBaseline and 12 weeksSustained attention will be assessed using the Continuous Performance Test.
Change in executive function.Baseline and 12 weeks
Change in verbal memory.Baseline and 12 weeks

Secondary

MeasureTime frameDescription
Social skills40 weeksSocial 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 weeksThe study will examine the impact of CCRP upon brain function and white matter structure in children with 22q11DS.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026