Trial Outcomes & Findings for Neurodevelopmental Assessment of Children in Uganda and Malawi Using a Software Package (NCT NCT03878147)
NCT ID: NCT03878147
Last Updated: 2025-04-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
599 participants
Primary outcome timeframe
Month 2, month 6
Results posted on
2025-04-20
Participant Flow
Randomization was stratified by HIV exposure status (infected, exposed uninfected, unexposed uninfected) to ensure the same distribution of HIV exposure by trial arm (BPG or waitlist control). The study hypotheses were based on comparisons of BPG versus waitlist control arm across all children separately in Uganda and Malawi.
Participant milestones
| Measure |
BPG, Uganda
Children in Uganda randomized to BPG
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.
|
Waitlist Control, Uganda
Children in Uganda randomized to waitlist control
|
BPG, Malawi
Children in Malawi randomized to BPG
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.
|
Waitlist Control, Malawi
Children in Malawi randomized to waitlist control
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
149
|
150
|
149
|
151
|
|
Overall Study
COMPLETED
|
146
|
146
|
147
|
149
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neurodevelopmental Assessment of Children in Uganda and Malawi Using a Software Package
Baseline characteristics by cohort
| Measure |
BPG, Uganda
n=149 Participants
Children in Uganda randomized to BPG
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.
|
Waitlist Control, Uganda
n=150 Participants
Children in Uganda randomized to waitlist control
|
BPG, Malawi
n=149 Participants
Children in Malawi randomized to BPG
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.
|
Waitlist Control, Malawi
n=151 Participants
Children in Malawi randomized to waitlist control
|
Total
n=599 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.71 years
STANDARD_DEVIATION 2.41 • n=93 Participants
|
9.01 years
STANDARD_DEVIATION 2.33 • n=4 Participants
|
8.87 years
STANDARD_DEVIATION 2.12 • n=27 Participants
|
9.03 years
STANDARD_DEVIATION 2.30 • n=483 Participants
|
8.95 years
STANDARD_DEVIATION 2.21 • n=36 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
75 Participants
n=483 Participants
|
304 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
76 Participants
n=483 Participants
|
295 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
149 Participants
n=93 Participants
|
150 Participants
n=4 Participants
|
149 Participants
n=27 Participants
|
151 Participants
n=483 Participants
|
599 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
Malawi
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
149 participants
n=27 Participants
|
151 participants
n=483 Participants
|
300 participants
n=36 Participants
|
|
Region of Enrollment
Uganda
|
149 participants
n=93 Participants
|
150 participants
n=4 Participants
|
0 participants
n=27 Participants
|
0 participants
n=483 Participants
|
299 participants
n=36 Participants
|
|
HIV status
HIV unexposed uninfected
|
59 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
59 Participants
n=483 Participants
|
240 Participants
n=36 Participants
|
|
HIV status
HIV exposed uninfected
|
60 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
239 Participants
n=36 Participants
|
|
HIV status
HIV infected
|
30 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
120 Participants
n=36 Participants
|
|
Kaufman Assessment Battery for Children 2nd Edition (KABC-II) Mental Processing Index (MPI)
|
71.54 units on a scale
STANDARD_DEVIATION 9.83 • n=93 Participants
|
71.65 units on a scale
STANDARD_DEVIATION 11.05 • n=4 Participants
|
70.47 units on a scale
STANDARD_DEVIATION 10.03 • n=27 Participants
|
68.82 units on a scale
STANDARD_DEVIATION 11.59 • n=483 Participants
|
69.64 units on a scale
STANDARD_DEVIATION 10.86 • n=36 Participants
|
|
Test of Variables of Attention (TOVA) attention deficit hyperactivity disorder (ADHD) index
|
-1.72 units on a scale
STANDARD_DEVIATION 3.12 • n=93 Participants
|
-1.50 units on a scale
STANDARD_DEVIATION 2.96 • n=4 Participants
|
-3.14 units on a scale
STANDARD_DEVIATION 3.30 • n=27 Participants
|
-3.16 units on a scale
STANDARD_DEVIATION 3.10 • n=483 Participants
|
-3.15 units on a scale
STANDARD_DEVIATION 3.20 • n=36 Participants
|
|
Cognitive State (CogState) correct moves per second
|
0.13 number of moves per second
STANDARD_DEVIATION 0.10 • n=93 Participants
|
0.15 number of moves per second
STANDARD_DEVIATION 0.09 • n=4 Participants
|
0.14 number of moves per second
STANDARD_DEVIATION 0.17 • n=27 Participants
|
0.16 number of moves per second
STANDARD_DEVIATION 0.20 • n=483 Participants
|
0.15 number of moves per second
STANDARD_DEVIATION 0.18 • n=36 Participants
|
PRIMARY outcome
Timeframe: Month 2, month 6Population: Children in Uganda and Malawi
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.
Outcome measures
| Measure |
BPG, Uganda
n=149 Participants
Children in Uganda randomized to BPG
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.
|
Waitlist Control, Uganda
n=150 Participants
Children in Uganda randomized to waitlist control
|
BPG, Malawi
n=149 Participants
Children in Malawi randomized to BPG
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.
|
Waitlist Control, Malawi
n=151 Participants
Children in Malawi randomized to waitlist control
|
|---|---|---|---|---|
|
Kaufman Assessment Battery for Children 2nd Edition (KABC-II) Mental Processing Index (MPI)
Month 2
|
77.18 units on a scale
Standard Error 0.60
|
74.79 units on a scale
Standard Error 0.61
|
71.79 units on a scale
Standard Error 0.71
|
73.72 units on a scale
Standard Error 0.72
|
|
Kaufman Assessment Battery for Children 2nd Edition (KABC-II) Mental Processing Index (MPI)
Month 6
|
77.27 units on a scale
Standard Error 0.60
|
76.46 units on a scale
Standard Error 0.61
|
73.40 units on a scale
Standard Error 0.69
|
73.61 units on a scale
Standard Error 0.70
|
SECONDARY outcome
Timeframe: Month 2, month 6Population: Children in Uganda and Malawi.
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.
Outcome measures
| Measure |
BPG, Uganda
n=149 Participants
Children in Uganda randomized to BPG
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.
|
Waitlist Control, Uganda
n=150 Participants
Children in Uganda randomized to waitlist control
|
BPG, Malawi
n=149 Participants
Children in Malawi randomized to BPG
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.
|
Waitlist Control, Malawi
n=151 Participants
Children in Malawi randomized to waitlist control
|
|---|---|---|---|---|
|
Test of Variables of Attention (TOVA) Attention Deficit Hyperactivity Disorder (ADHD) Index
Month 2
|
-1.21 units on a scale
Standard Error 0.21
|
-1.08 units on a scale
Standard Error 0.21
|
-2.63 units on a scale
Standard Error 0.25
|
-2.35 units on a scale
Standard Error 0.25
|
|
Test of Variables of Attention (TOVA) Attention Deficit Hyperactivity Disorder (ADHD) Index
Month 6
|
-0.81 units on a scale
Standard Error 0.21
|
-0.83 units on a scale
Standard Error 0.21
|
-2.23 units on a scale
Standard Error 0.24
|
-2.15 units on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Month 2, month 6Population: Children in Uganda and Malawi.
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.
Outcome measures
| Measure |
BPG, Uganda
n=149 Participants
Children in Uganda randomized to BPG
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.
|
Waitlist Control, Uganda
n=150 Participants
Children in Uganda randomized to waitlist control
|
BPG, Malawi
n=149 Participants
Children in Malawi randomized to BPG
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.
|
Waitlist Control, Malawi
n=151 Participants
Children in Malawi randomized to waitlist control
|
|---|---|---|---|---|
|
Cognitive State (CogState) Correct Moves Per Second
Month 2
|
0.23 moves per second
Standard Error 0.01
|
0.21 moves per second
Standard Error 0.01
|
0.20 moves per second
Standard Error 0.01
|
0.18 moves per second
Standard Error 0.01
|
|
Cognitive State (CogState) Correct Moves Per Second
Month 6
|
0.27 moves per second
Standard Error 0.01
|
0.25 moves per second
Standard Error 0.01
|
0.23 moves per second
Standard Error 0.01
|
0.22 moves per second
Standard Error 0.01
|
Adverse Events
BPG, Uganda
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control, Uganda
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BPG, Malawi
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Waitlist Control, Malawi
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place