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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00926003 |
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Date of registration:
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22/06/2009 |
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Primary sponsor: |
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Public title:
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Cognitive Rehabilitation in Ugandan Children With HIV
HIV CCRT |
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Scientific title:
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Neuropsychological Benefits of Cognitive Training in Ugandan HIV Children |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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60 |
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Recruitment status: |
Suspended |
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URL:
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http://clinicaltrials.gov/show/NCT00926003 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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Uganda
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Key inclusion & exclusion criteria
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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.
Age minimum:
6 Years
Age maximum:
16 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Intervention(s)
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Behavioral: Computerized cognitive rehabilitation therapy (CCRT)
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Behavioral: control group
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Primary Outcome(s)
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Neuropsychologcial Performance (CogState, KABC2, TOVA)
[Time Frame: 8 weeks intervention, pre- post-, and 3 mo follow-up assessments]
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Secondary Outcome(s)
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Psychiatric symptom reduction (CBCL)
[Time Frame: pre-intervention, post intervention, 3 mo follow-up]
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Secondary ID(s)
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BIRB 07-709
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R34MH085631
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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