NCT01781923

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 10, 2015

Status Verified

August 1, 2015

Enrollment Period

4.7 years

First QC Date

January 29, 2013

Last Update Submit

August 6, 2015

Conditions

22q11.2 Deletion SyndromeVelo-Cardio-Facial Syndrome

Keywords

Cognitive remediationSocial Cognition

Outcome Measures

Primary Outcomes (3)

  • Change in sustained attention

    Sustained attention will be assessed using the Continuous Performance Test.

    Baseline and 12 weeks

  • Change in executive function.

    Baseline and 12 weeks

  • Change in verbal memory.

    Baseline and 12 weeks

Secondary Outcomes (2)

  • Social skills

    40 weeks

  • Change in brain function and white matter structure.

    Baseline and 12 weeks

Study Arms (2)

Cognitive Remediation

EXPERIMENTAL

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.

Behavioral: Cognitive remediation programBehavioral: Small group social skills training

Control

NO INTERVENTION

No intervention

Interventions

Cognitive remediation programBEHAVIORAL

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

Also known as: Posit Science
Cognitive Remediation
Small group social skills trainingBEHAVIORAL

Meet once per week for duration of 40 weeks.

Cognitive Remediation

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • molecular/cytogenetic confirmation of 22q11DS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health Systems

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

DiGeorge Syndrome

Condition Hierarchy (Ancestors)

22q11 Deletion SyndromeCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesLymphatic AbnormalitiesLymphatic DiseasesHemic and Lymphatic DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornHypoparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Vandana Shashi, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 1, 2013

Study Start

October 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 10, 2015

Record last verified: 2015-08

Locations

US(1)