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

Michigan State University

Status: Completed

Conditions: BPG Intervention; Control

Treatments: Behavioral: Cognitive Games Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03878147

2191

R01HD098027 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 599 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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599 participants in 4 patient groups

BPG, Uganda

Experimental group

Description:

Children in Uganda randomized to BPG

Treatment:

Behavioral: Cognitive Games Training

Waitlist control, Uganda

No Intervention group

Description:

Children in Uganda randomized to waitlist control

BPG, Malawi

Experimental group

Description:

Children in Malawi randomized to BPG

Treatment:

Behavioral: Cognitive Games Training

Waitlist control, Malawi

No Intervention group

Description:

Children in Malawi randomized to waitlist control