N/A N=599 Randomized Diagnostic

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

BPG Intervention · Control

Bottom Line

View on ClinicalTrials.gov: NCT03878147 ↗

Enrolled (actual)

599

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcome: Primary: Kaufman Assessment Battery for Children 2nd Edition (KABC-II) Mental Processing Index (MPI) — 77.18; 74.79; 71.79; 73.72 units on a scale — p=<.01

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cognitive Games Training (Behavioral)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: Michigan State University
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Kaufman Assessment Battery for Children 2nd Edition (KABC-II) Mental Processing Index (MPI)	77.18; 74.79; 71.79; 73.72; 77.27; 76.46	<.01 sig
SECONDARY Test of Variables of Attention (TOVA) Attention Deficit Hyperactivity Disorder (ADHD) Index	-1.21; -1.08; -2.63; -2.35; -0.81; -0.83	.65
SECONDARY Cognitive State (CogState) Correct Moves Per Second	0.23; 0.21; 0.20; 0.18; 0.27; 0.25	.01 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03878147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.