Cognitive Rehabilitation in Ugandan Children With HIV (HIV CCRT)
|ClinicalTrials.gov Identifier: NCT00926003|
Recruitment Status : Suspended (awaiting additional funding)
First Posted : June 23, 2009
Last Update Posted : June 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Computerized cognitive rehabilitation therapy (CCRT) Behavioral: control group||Phase 1|
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Aim 1. To evaluate the effectiveness of CCRT in improving cognitive performance outcomes in Ugandan children with HIV.
Hypothesis 1a: CCRT can improve short and long-term cognitive outcomes in children with HIV; Hypothesis 1b: Improvements in performance associated with CCRT are not solely due to increased computer exposure.
One-hundred and fifty school-age children with HIV in Kayunga District, Uganda, will undergo baseline neuropsychological testing using the Kaufman Assessment Battery for Children (KABC-2), the computerized Tests of Variables of Attention (TOVA: auditory and visual tests), the brief CogState computerized neuropsychological test battery (CogState), and the Bruininks-Oseretsky Tests of Motor Proficiency (2nd edition) (BOT-2). Cogstate is designed as a neuropsychological screening tool with minimal practice effects and suitable in a repeated measures design for monitoring the benefits of treatment on neurocognitive disability11. Children then will be randomized to either: CCRT intervention group (Captain's Log active rehabilitation), active control group (Captain's Log locked, non-rehabilitation mode), or passive control group (no computer intervention). CCRT or computer controls will be presented over 24 sessions (~ 45 min) for 8 weeks (3 sessions per week). After the 8-weeks, neurocognitive gains will be assessed with CogState and the KABC-2 working memory subscales (primary expected outcome measures). The full KABC-2, TOVA, CogState, and BOT-2 will be re-administered 3 months after the 8-week assessment. Thus, the full battery will be administered at enrollment and at 3-month follow-up, while the most strategic portions of the battery will be administered following the 8 weeks CCRT intervention period. The combined testing will allow us to assess both the short-term and longer-term neuropsychological benefits of CCRT.
Aim 2. To evaluate the effectiveness of CCRT in reducing psychiatric symptoms in Ugandan children with HIV.
Hypothesis 2: CCRT can reduce short- and long-term psychiatric symptoms in children with HIV.
Previously in cerebral malaria survivors, we demonstrated a significant reduction in short-term symptoms related to anxiety, depression, and somatic complaints as assessed by the Achenbach Child Behavior Checklist (CBCL) following CCRT intervention12. In this aim, caregiver-reported psychiatric symptoms on the CBCL will be assessed at enrollment, after the 8-week CCRT intervention period, and 3 months after enrollment. The CBCL assessment will also help us gauge the psychosocial benefits of the social attention and enrichment surrounding computer exposure in the active control condition, rather than the rehabilitative aspects of CCRT per se. This will be evident as we compare the active and passive control groups.
Aim 3. To evaluate how HIV subtype and the corresponding immunological status of the child modifies CCRT neuropsychological performance gains and psychiatric symptom reduction; .after controlling for quality of home environment, nutrition, and other risk factors of poverty.
Hypothesis 3: More aggressive HIV infection type accompanied by higher viral load and lower T-cell lymphocyte levels will decrease neural plasticity, as evidenced by lessened cognitive or psychiatric improvement after CCRT.
Our preliminary data indicates that specific HIV Subtype A in Ugandan children results in higher viral loads and lower T-lymphocyte levels in school-age children, as compared to Subtype D infection. These were associated with poorer neuropsychological outcomes. Likewise, in our preliminary HIV CCRT study Ugandan children with HIV, lower CD8 and CD4 activation levels in children receiving CCRT intervention resulted in less neuropsychological benefits from training. We will evaluate the moderating effects of HIV subtype, ART treatment, and corresponding immunological profile, on CCRT neuropsychological and psychiatric benefit. The moderating effects of HIV progressive encephalopathy on brain plasticity can also be monitored by CCRT training progress, measures by the Captain's Log Internal Evaluator (CLIE) feature of the program.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Factorial Assignment|
|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|
|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
- Neuropsychologcial Performance (CogState, KABC2, TOVA) [ Time Frame: 8 weeks intervention, pre- post-, and 3 mo follow-up assessments ]
- Psychiatric symptom reduction (CBCL) [ Time Frame: pre-intervention, post intervention, 3 mo follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926003
|Child Health Advocacy Interntional|
|Kayunga Town, Uganda|