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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

599 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2024-12-23

Brief Summary

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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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Detailed Description

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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

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BPG Intervention Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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BPG, Uganda

Children in Uganda randomized to BPG

Group Type EXPERIMENTAL

Cognitive Games Training

Intervention Type 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.

Waitlist control, Uganda

Children in Uganda randomized to waitlist control

Group Type NO_INTERVENTION

No interventions assigned to this group

BPG, Malawi

Children in Malawi randomized to BPG

Group Type EXPERIMENTAL

Cognitive Games Training

Intervention Type 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.

Waitlist control, Malawi

Children in Malawi randomized to waitlist control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Brain Powered Games Village Builder

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No