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Cognitive Rehabilitation in Ugandan Children With HIV (HIV CCRT)

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ClinicalTrials.gov Identifier: NCT00926003
Recruitment Status : Suspended (awaiting additional funding)
First Posted : June 23, 2009
Last Update Posted : June 23, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
Research Topic: Over 110,000 HIV Ugandan children are at risk for neurocognitive disorders due to the progressive encephalopathy of CNS HIV infection. Even if clinically stable, these children can have motor, attention, memory, visual-spatial processing, and other executive function impairment. One-hundred and fifty school-age children with HIV in Kayunga District, Uganda, will serve as our participants. Fifty of these children will be randomly selected to receive 24 training sessions of a computerized cognitive rehabilitation therapy (CCRT) program called Captain's Log, marketed mostly for American children with attention or learning problems. A locked version of Captain's Log which does not direct the child's training in a progressive manner will be administered to a second "active control" group; while a third group will be a passive control group not receiving any computer training intervention. Study Aim 1: To compare the neuropsychological benefit of 24 training sessions of Captain's Log CCRT to the active and passive control groups over a 8-week period, and at 3-month follow-up. Study Aim 2: To compare the psychiatric benefit of 24 training sessions of Captain's Log CCRT to the active and passive control groups over an 8-week period, and at 3-month follow-up. Study Aim 3: To evaluate how HIV subtype, ART treatment status, and the corresponding clinical stability of the child modifies CCRT neuropsychological performance gains and psychiatric symptom reduction. Outcome Assessments: The Kaufman Assessment Battery for Children, 2nd ed. (KABC-2), Tests of Variables of Attention (TOVA) visual and auditory tests, CogState computerized neuropsychological screening test, Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), and Achenbach Child Behavior Checklist (CBCL) will be administered before and after the 8-week training period and at 3-month follow-up. We have previously used all these assessments with Ugandan children with HIV to effectively evaluate neuropsychological and psychiatric problems. Captain's Log has an internal evaluator feature which will help us monitor the specific training tasks to which the children best respond. Based on our prior research with Kayunga children with HIV, we anticipate that about 40% of our sample will be on ART at study enrollment, and about 20% will be Subtype D while 60% will be subtype A. We also observed that children with HIV Subtype A are at greater risk for neurocognitive deficits. Analyses: We will compare neuropsychological and psychiatric gains over the 8-week training period and at 3-mo follow-up for our three study groups, anticipating that they will be significantly greater for the CCRT intervention children (Study Aims 1 & 2). These neuropsychological gains will be associated with improved school performance over the long-term. Intervention children on ART will have greater gains than those not on ART, and HIV subtype D children will have lower viral loads and higher lymphocyte activation levels, resulting in greater gains from CCRT (Study Aim 3). Conclusion: CCRT will prove effective and sustainable in potentiating the neurocognitive benefit of ART in HIV children. It will prove viable for assessing and treating children in resource-poor settings.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Computerized cognitive rehabilitation therapy (CCRT) Behavioral: control group Phase 1

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Neuropsychological Benefits of Cognitive Training in Ugandan HIV Children
Study Start Date : October 2009
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : October 2012

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: CCRT intervention Behavioral: Computerized cognitive rehabilitation therapy (CCRT)
8 weeks of 3 times weekly intervention for 45 min per session with Captain's Log program
No Intervention: Control Behavioral: control group
no computer training


Outcome Measures

Primary Outcome Measures :
  1. Neuropsychologcial Performance (CogState, KABC2, TOVA) [ Time Frame: 8 weeks intervention, pre- post-, and 3 mo follow-up assessments ]

Secondary Outcome Measures :
  1. Psychiatric symptom reduction (CBCL) [ Time Frame: pre-intervention, post intervention, 3 mo follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV children 6 to 16 years of age and enrolled in the CAI program will be eligible should the parent or caregiver consent to participation in the study. They will all be confirmed HIV positive children (ELISA and Western blot). Only children with perinatally acquired HIV infection will be included.

Exclusion Criteria:

  • At pre-CCRT medical examination (see medical exam form in appendices) we will exclude children with a medical history of serious birth complications, severe malnutrition, bacterial meningitis, encephalitis, cerebral malaria, or other known brain injury or disorder requiring hospitalization. Also children with seizure or other neurological disability will be excluded. This will be screened using a brief medical history questionnaire and CAI medical chart review.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926003


Locations
Uganda
Child Health Advocacy Interntional
Kayunga Town, Uganda
Sponsors and Collaborators
Michigan State University
Makerere University
Child Health Advocacy International
University of Michigan
University of California, San Francisco
More Information

Responsible Party: Michael J. Boivin, Associate Professor of Neurology and of Psychiatry, Michigan State University
ClinicalTrials.gov Identifier: NCT00926003     History of Changes
Other Study ID Numbers: BIRB 07-709
R34MH085631
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: June 23, 2009
Last Verified: June 2009

Keywords provided by Michigan State University:
HIV
Children
Africa
Neuropsychology
cognitive rehabilitation
computers

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases