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

NCT03878147 | Completed Results

• 2 other identifiers: 2191R01HD098027
• Study Type: interventional
• Target: 599
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

BPG Intervention; Control

Keywords

cognitive games, attention, memory, learning, reasoning, planning, HIV, African, children

Outcome Measures

Primary Outcomes (1)

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

  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.

  Month 2, month 6

Secondary Outcomes (2)

• 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

Study Arms (4)

BPG, Uganda

EXPERIMENTAL

Children in Uganda randomized to BPG

Behavioral: Cognitive Games Training

Waitlist control, Uganda

NO INTERVENTION

Children in Uganda randomized to waitlist control

BPG, Malawi

EXPERIMENTAL

Children in Malawi randomized to BPG

Behavioral: Cognitive Games Training

Waitlist control, Malawi

NO INTERVENTION

Children in Malawi randomized to waitlist control

Interventions

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.

Also known as: Brain Powered Games, Village Builder

BPG, Malawi; BPG, Uganda

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Johns Hopkins Research Project

Blantyre, Malawi

Location

Makerere University Johns Hopkins University Research Collaboration

Kampala, Uganda

Location

Limitations and Caveats

There were multiple secondary outcomes with no formal adjustment for the level of significance. The results for the primary outcome should be given greatest strength of the interpretation.

Results Point of Contact

• Title: Michael J. Boivin
• Organization: Michigan State University

boivin@msu.edu

+15178840281

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Neurology and Oftalmology

Model Details: The subject population for this proposal will consist of 600 children roughly equally divided between males and females and between HIV exposed uninfected and HIV unexposed and uninfected. These are Ugandan and Malawian children 5-12 years of age at study initiation who live in Uganda or Malawi.

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 18, 2019
• Study Start: March 30, 2020
• Primary Completion: February 29, 2024
• Study Completion: December 23, 2024
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1); MA (1)