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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD098027 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| Johns Hopkins University | OTHER |
| MU-JHU CARE | OTHER |
| Kamuzu University of Health Sciences |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPG, Uganda | Experimental | Children in Uganda randomized to BPG |
|
| Waitlist control, Uganda | No Intervention | Children in Uganda randomized to waitlist control | |
| BPG, Malawi | Experimental | Children in Malawi randomized to BPG |
|
| Waitlist control, Malawi | No Intervention | Children in Malawi randomized to waitlist control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Test of Variables of Attention (TOVA) Attention Deficit Hyperactivity Disorder (ADHD) Index | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Research Project | Blantyre | Malawi | ||||
| Makerere University Johns Hopkins University Research Collaboration |
No individual-level data will be made available to other researchers
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Waitlist Control, Uganda | Children in Uganda randomized to waitlist control |
| FG002 | 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. |
| FG003 | Waitlist Control, Malawi | Children in Malawi randomized to waitlist control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Children In Uganda or Malawi aged 5-12 years
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Child age in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Children in Uganda and Malawi | Posted | Least Squares Mean | Standard Error | units on a scale | Month 2, month 6 |
|
Adverse even data were collected over 6 months of study participation for all children.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael J. Boivin | Michigan State University | +15178840281 | boivin@msu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 8, 2019 | Mar 8, 2025 | Prot_SAP_ICF_000.pdf |
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| OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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.
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|
|
| Month 2, month 6 |
| Cognitive State (CogState) Correct Moves Per Second | 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. | Month 2, month 6 |
| Kampala |
| Uganda |
| BG001 | Waitlist Control, Uganda | Children in Uganda randomized to waitlist control |
| BG002 | 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. |
| BG003 | Waitlist Control, Malawi | Children in Malawi randomized to waitlist control |
| BG004 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HIV status | Count of Participants | Participants |
|
| 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 of 100 and standard deviation of 15 are based on American norms. Higher score is better. | Mean | Standard Deviation | units on a scale |
|
| Test of Variables of Attention (TOVA) attention deficit hyperactivity disorder (ADHD) index | 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. | Mean | Standard Deviation | units on a scale |
|
| Cognitive State (CogState) correct moves per second | CogState presents a 30-min 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. Higher number reflects better outcome. | Mean | Standard Deviation | number of moves per second |
|
| OG001 | Waitlist Control, Uganda | Children in Uganda randomized to waitlist control |
| OG002 | 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. |
| OG003 | Waitlist Control, Malawi | Children in Malawi randomized to waitlist control |
|
|
|
| Secondary | Test of Variables of Attention (TOVA) Attention Deficit Hyperactivity Disorder (ADHD) Index | 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. | Children in Uganda and Malawi. | Posted | Least Squares Mean | Standard Error | units on a scale | Month 2, month 6 |
|
|
|
|
| Secondary | Cognitive State (CogState) Correct Moves Per Second | 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. | Children in Uganda and Malawi. | Posted | Least Squares Mean | Standard Error | moves per second | Month 2, month 6 |
|
|
|
|
| 0 |
| 149 |
| 0 |
| 149 |
| 0 |
| 149 |
| EG001 | Waitlist Control, Uganda | Children in Uganda randomized to waitlist control | 0 | 150 | 0 | 150 | 0 | 150 |
| EG002 | 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. | 0 | 149 | 0 | 149 | 0 | 149 |
| EG003 | Waitlist Control, Malawi | Children in Malawi randomized to waitlist control | 0 | 151 | 0 | 151 | 0 | 151 |
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| Month 6 |
|
BPG minus waitlist control.
| Superiority |
The key parameter was difference between least square means of trial arms at month 2. |
| The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance. | Mixed Models Analysis | Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates. | .95 | P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05. | Median Difference (Final Values) | 0.02 | Standard Error of the Mean | 0.29 | 2-Sided | 95 | -0.54 | 0.58 | BPG minus waitlist control. | Superiority | The key parameter was difference between least square means of trial arms at month 6. |
| The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance. | Mixed Models Analysis | Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates. | .34 | P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05. | Median Difference (Final Values) | -0.39 | Standard Error of the Mean | 0.27 | 2-Sided | 95 | -0.92 | 0.13 | BPG minus waitlist control. | Superiority | The key parameter was difference between least square means of trial arms at month 2. |
| The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance. | Mixed Models Analysis | Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates. | .81 | P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05. | Mean Difference (Final Values) | -0.08 | Standard Error of the Mean | 0.33 | 2-Sided | 95 | -0.73 | 0.58 | BPG minus waitlist control. | Superiority | The key parameter was difference between least square means of trial arms at month 6. |
| Month 6 |
|
BPG minus waitlist control
| Superiority |
The key parameter was difference between least square means of trial arms at month 2. |
| The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance. | Mixed Models Analysis | Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates. | .02 | P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05. | Mean Difference (Final Values) | 0.02 | Standard Error of the Mean | 0.01 | 2-Sided | 95 | 0.003 | 0.040 | BPG minus waitlist control | Superiority | The key parameter was difference between least square means of trial arms at month 6. |
| The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance. | Mixed Models Analysis | Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates. | .19 | P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05. | Mean Difference (Final Values) | 0.02 | Standard Error of the Mean | 0.01 | 2-Sided | 95 | -0.01 | 0.05 | BPG minus waitlist control. | Superiority | The key parameter was difference between least square means of trial arms at month 2. |
| The null hypothesis was that the means of two arms were equal. The alternative hypothesis was that means of two arms were not equal. With this sample size, differences between arms corresponding to the unadjusted effect size Cohen's d=0.33 would be detectable as statistically significant with power of .80 in two-sided tests at .05 level of significance. | Mixed Models Analysis | Baseline value of the outcome, child's age, sex, and HIV exposure status were included as covariates. | .19 | P-value was not adjusted for multiple comparisons. A priori threshold for statistical significance was .05. | Mean Difference (Final Values) | 0.02 | Standard Error of the Mean | 0.01 | 2-Sided | 95 | -0.01 | 0.04 | BPG minus waitlist control. | Superiority | The key parameter was difference between least square means of trial arms at month 2. |