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Completed

NCT Number: NCT03878147

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

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.

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Key information

Conditions

BPG Intervention Control

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Research Project, Blantyre, Malawi

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About this 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.

Separate analyses by country (Uganda and Malawi) are planned. HIV exposure status is used for balancing of randomization.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Games Training

Behavioral

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.

Other names: Brain Powered Games, Village Builder

Primary outcomes

  1. Kaufman Assessment Battery for Children 2nd Edition (KABC-II) Mental Processing Index (MPI)

    Time frame: 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.

Secondary outcomes

  1. Test of Variables of Attention (TOVA) Attention Deficit Hyperactivity Disorder (ADHD) Index

    Time frame: Month 2, month 6

    TOVA is a computerized visual continuous performance test used in to screen, diagnose and monitor children and adults at risk for ADHD. TOVA consists of the rapid (tachistoscopic) presentation of a large geometric square on the computer screen with a smaller dark box either in the upper position (signal) or lower position (non-signal). The child is asked to press a switch in response to the signal (measuring vigilance attention), but to withhold responding to the non-signal (measuring impulsivity). The potential range of the TOVA ADHD index is from -10 to 10, higher score is better.

  2. Cognitive State (CogState) Correct Moves Per Second

    Time frame: Month 2, month 6

    CogState presents a 30-minute session that includes playing cards in a game-like manner to assess memory, attention, discrimination learning, and executive function that is non-language dependent. The number of correct moves per second during maze learning reflects executive functioning/planning. The range is from 0 to 5. Higher number reflects better outcome.

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Johns Hopkins University
  • Kamuzu University of Health Sciences
  • MU-JHU CARE
  • University of Michigan

Registry information

Official study title

Culture-Specific Neurodevelopmental Assessment of HIV-affected Children

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2019
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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