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Completed

NCT Number: NCT01781923

Cognitive Remediation in 22q11DS

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.

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Key information

Conditions

22q11.2 Deletion Syndrome 22q11 Deletion Syndrome Abnormalities, Multiple Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities DiGeorge Syndrome Endocrine System Diseases Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Hemic and Lymphatic Diseases Hypoparathyroidism Lymphatic Abnormalities Lymphatic Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Parathyroid Diseases Velo-Cardio-Facial Syndrome

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health Systems

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive remediation program

Behavioral

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

Other names: Posit Science

Small group social skills training

Behavioral

Meet once per week for duration of 40 weeks.

Primary outcomes

  1. Change in sustained attention

    Time frame: Baseline and 12 weeks

    Sustained attention will be assessed using the Continuous Performance Test.

  2. Change in executive function.

    Time frame: Baseline and 12 weeks

  3. Change in verbal memory.

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Social skills

    Time frame: 40 weeks

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

  2. Change in brain function and white matter structure.

    Time frame: Baseline and 12 weeks

    The study will examine the impact of CCRP upon brain function and white matter structure in children with 22q11DS.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Harvard University
  • National Institute of Mental Health (NIMH)
  • University of Pittsburgh

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2013
Registry last updated
Aug 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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