Computerized Cognitive Rehabilitation in Ugandan Children With HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Full Computerized cognitive training; Limited computerized cognitive training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 weeks of 3 times weekly intervention for 60 min per session with the full titrating version of Captain's Log program (3 games for attention, 3 games for visual spatial working memory, 3 games for reasoning/planning; Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training. 8 weeks of 3 times weekly intervention for 60 min per session with the non-titrating version of Captain's Log program (3 games for attention, 3 games for visual spatial working memory, 3 games for reasoning/planning).
Other intervention name(s): computerized cognitive games; computerized cognitive rehabilitation therapy (CCRT); computerized cognitive rehabilitation therapy (CCRT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Children; Africa; Neuropsychology; cognitive rehabilitation; computers