NCT03878147

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

Culture-Specific Neurodevelopmental Assessment of HIV-affected Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 599 (actual)
• Sponsor: Michigan State University · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• BPG Intervention
• Control

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Games Training	Brain Powered Games (BPG) uses games for neurocognitive assessment and training, using images and sounds more familiar to African children. As a computerized cognitive rehabilitation training (CCRT) program designed for Sub-Saharan African school-age children, it can help children infected affected directly or indirectly by HIV. BPG consists of 5 core games evaluating different cognitive abilities (learning, memory, language, attention). Each game includes a visual tutorial, several adjustable settings on the administrative side (Admin), and records game play data for research purposes. Village Builder (VB) is a pro-social reasoning/planning world building strategy type game intended to evaluate frontal lobe executive functions in a culture-friendly and enjoyable game manner. It consists of many of the village artistic components as used in BPG but orchestrated into a village setting where children must gather resources and protect them in order to expand the capacity of the village.

Timeline

• Start date: 2020-03-30
• Primary completion: 2024-02-29
• Completion: 2024-12-23
• First posted: 2019-03-18
• Last updated: 2025-04-20
• Results posted: 2025-04-20

Locations

2 sites across 2 countries: Malawi, Uganda