Neurodevelopmental Assessment of Children in Uganda and Malawi Using a Software Package

  • STATUS
    Recruiting
  • End date
    Dec 23, 2024
  • participants needed
    600
  • sponsor
    Michigan State University
Updated on 5 May 2022
HIV Vaccine

Summary

The investigators will use Brain Power Games or Village Builder, two different MSU-developed computer-based learning games for children on Tablets, as a neurocognitive "stress test" or medical "challenge" test, in order to evaluate 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. Village Builder (VB) uses similar graphics as BPG, but is a pro-social "world-building" game where children gather and protect resources to build a village. thus VB emphasizes planning/reasoning (executive function or EF) neurocognitive abilities, while BPG emphasizes attention, memory, and learning tasks. In As an African child plays with BPG or VB on a touch-screen tablet, we will use games as a dynamic window into the child's developing brain and EF-based frontal lobe development Aim 1. Evaluate concurrent and predictive validity of BPG static (baseline) and dynamic (during 12 training sessions) cognitive assessments Aim 2. Compare the validity of BPG static and dynamic assessments Aim 3. Test the sensitivity of dynamic assessment to learning loss over time by evaluating how much BPG and/or VB performance gains diminish during a 6-month absence of training The investigator's central hypothesis is that the BPG and VB performance gains (dynamic assessment) will explain the additional variation in the gold-standard measures at time points after static (baseline) assessment, and more effectively capture the effects of HIV/ARV exposure and treatment across HIV affected cohorts (HIV, HEU, HUU) of children in Uganda and Malawi.

Description

In Phase I of the study 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. In phase II of the protocol (after pretesting, 2 months of waiting followed by post-training testing and then 6-month follow-up testing for both immediate and wait-listed BPG training arms - the wait-listed children will all undergo 12 sessions of village Builder which is a pro-social reasoning/planning strategy game newly developed by our Games for Entertainment and Learning (GEL) lab at Michigan State University (MSU). In Phase II for the Village Builder children, all children will also undergo neuropsychological testing before and after the 12 training sessions, as well as neuropsychological assessment at six-month follow-up post training.

Details
Condition HIV Infections, HIV Exposed Uninfected, HUU Unexposed Uninfected
Treatment Brain Powered Games, Cognitive Games Training
Clinical Study IdentifierNCT03878147
SponsorMichigan State University
Last Modified on5 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
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