HIV Infections Clinical Trial
Official title:
Neuropsychological Benefits of Cognitive Training in Ugandan HIV Children
One-hundred and fifty-nine school-age children with HIV in Kayunga District, Uganda were randomized to one of 3 treatment arms: 24 training sessions of a computerized cognitive rehabilitation therapy (CCRT) program called Captain's Log; 24 sessions of Captain's Log not titrated to child's performance; or no 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 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 post training. Captain's Log has an internal evaluator feature which will help us monitor the specific training tasks to which the children best respond. 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 clinically stable on ART will have greater gains than those not stable or virally suppressed on ART. Conclusion: CCRT will prove effective and sustainable for enhancing neurocognitive status in HIV children. Futher work will prove this approach viable for assessing and treating children in resource-poor settings.
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 ARV treatment status and clinical response along with 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: Children virally suppressed on ART treatment with a history of fewer
opportunistic illnesses and better CD4 counts will have better neuropsychological outcomes in
response to CCRT training.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 CCRT program.
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