Culture-Specific Neurodevelopmental Assessment of HIV-affected Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 599
- 试验地点
- 2
- 主要终点
- Kaufman Assessment Battery for Children 2nd Edition (KABC-II) Mental Processing Index (MPI)
研究概览
简要总结
The investigators will use Brain Power Games as a neurocognitive "stress test" or medical "challenge" test, in order to evaluate or improve brain/behavior functional integrity in HIV-affected children. This dual use of BPG is a key innovative feature. Each of the 5 core BPG games lasts 10 minutes and trains fine motor, monitoring/attention, visual/auditory working memory, spatial navigational learning.
The investigator's central hypothesis is that the BPG performance gains will be improved compared to waitlist control for children in Uganda and Malawi.
详细描述
We randomize equal numbers of each of three exposure groups of children (perinatally HIV infected, perinatally HIV-exposed but not infected, and unexposed/uninfected children) to one of two intervention arms. They are randomized to either the Brain Powered Games (BPG) intervention arm of 12 sessions of hour-long training (twice a day for several days weekly at the study clinic), or to the "wait-listed" arm of no BPG training sessions.
Separate analyses by country (Uganda and Malawi) are planned. HIV exposure status is used for balancing of randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HEU and HUU children at least 5 yrs of age and older from the PROMISE ND study (Uganda and Malawi)
- •HIV+ children from P1104s (Uganda and Malawi)
- •HUU children age-matched from PROMISE ND and P1104s study cohorts (Uganda and Malawi)
排除标准
- •Medical history of serious birth complications
- •Severe malnutrition
- •Bacterial meningitis
- •Encephalitis
- •Cerebral malaria
- •Other known brain injury or disorder requiring hospitalization
- •Seizures or other neurological disabilities
结局指标
主要结局
Kaufman Assessment Battery for Children 2nd Edition (KABC-II) Mental Processing Index (MPI)
时间窗: Month 2, month 6
The KABC mental processing index (MPI) is a summary score across domains. The normative mean 100 and standard deviation 15 are based on American norms. Range is 43 to 160. Higher score reflects better outcome.
次要结局
- Test of Variables of Attention (TOVA) Attention Deficit Hyperactivity Disorder (ADHD) Index(Month 2, month 6)
- Cognitive State (CogState) Correct Moves Per Second(Month 2, month 6)
研究者
Michael J. Boivin
Professor of Psychiatry and Neurology and Oftalmology
Michigan State University