Ignite Creation Date:
2024-05-06 @ 12:53 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03878147
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2019-03-12
Brief Title:
Neurodevelopmental Assessment of Children in Uganda and Malawi Using a Software Package
Sponsor:
Michigan State University
Organization:
Michigan State University
Study Overview
Official Title:
Culture-Specific Neurodevelopmental Assessment of HIV-affected Children
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will use Brain Power Games or Village Builder two different MSU-developed computer-based learning games for children on Tablets as a neurocognitive stress test or medical challenge test in order to evaluate brainbehavior 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 monitoringattention visualauditory working memory spatial navigational learning Village Builder VB uses similar graphics as BPG but is a pro-social world-building game where children gather and protect resources to build a village thus VB emphasizes planningreasoning executive function or EF neurocognitive abilities while BPG emphasizes attention memory and learning tasks In As an African child plays with BPG or VB on a touch-screen tablet we will use games as a dynamic window into the childs developing brain and EF-based frontal lobe development Aim 1 Evaluate concurrent and predictive validity of BPG static baseline and dynamic during 12 training sessions cognitive assessments Aim 2 Compare the validity of BPG static and dynamic assessments Aim 3 Test the sensitivity of dynamic assessment to learning loss over time by evaluating how much BPG andor VB performance gains diminish during a 6-month absence of training The investigators central hypothesis is that the BPG and VB performance gains dynamic assessment will explain the additional variation in the gold-standard measures at time points after static baseline assessment and more effectively capture the effects of HIVARV exposure and treatment across HIV affected cohorts HIV HEU HUU of children in Uganda and Malawi
Detailed Description:
In Phase I of the study we randomize equal numbers of each of three exposure groups of children perinatally HIV infected perinatally HIV-exposed but not infected and unexposeduninfected 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 In phase II of the protocol after pretesting 2 months of waiting followed by post-training testing and then 6-month follow-up testing for both immediate and wait-listed BPG training arms - the wait-listed children will all undergo 12 sessions of village Builder which is a pro-social reasoningplanning strategy game newly developed by our Games for Entertainment and Learning GEL lab at Michigan State University MSU In Phase II for the Village Builder children all children will also undergo neuropsychological testing before and after the 12 training sessions as well as neuropsychological assessment at six-month follow-up post training
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD098027 | NIH | None | httpsreporternihgovquickSearchR01HD098027 |