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| Name | Class |
|---|---|
| St. George's University | UNKNOWN |
| Stanford University | OTHER |
| National Institutes of Health (NIH) | NIH |
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Implement a randomized controlled trial, evidence-based, culturally adapted, environmental enrichment intervention for the purpose of enhancing neurocognitive outcomes among Zika Exposed Children.
The intervention group received up to twelve 1-hour weekly visits by trained and experienced Grenadian parent and infant relationship specialists who provided home-based interventions as part of the Saving Brains Grenada project.
The environmental enrichment intervention is a brain-based program that teaches parents about brain development in young infants and skills for building a strong social-emotional connection that stimulates brain development and maximizes neurocognitive function. A detailed intervention manual was developed and used as a guide for the intervention specialists. Neurocognitive outcomes in the intervention and control group were assessed pre and post intervention by a separate and blinded assessment team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Immediately randomized to receive the intervention for 12 weeks. |
|
| Waitlist Control | No Intervention | Randomized to receive the intervention post-study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conscious Discipline-Based Environmental Enrichment Intervention | Behavioral | Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children. |
| Measure | Description | Time Frame |
|---|---|---|
| The INTERGROWTH 21st Neurodevelopmental Assessment (INTER-NDA) | The INTER-NDA is a measure of cognition, motor skills (fine and gross motor), language (expressive and receptive), behavior, executive function, attention and social-emotional reactivity for 2-year-olds. The measure is comprised of 30 items scored across a spectrum, with higher scores indicating better outcomes. | 22-30 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall Waechter, PhD | Windward Islands Research and Education Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Windward Islands Research and Education Foundation (WINDREF) | Saint George's | Grenada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35259172 | Derived | Waechter R, Burgen KS, Punch B, Evans R, Blackmon K, Noel T, Fernandes M, Landon B. Improving neurodevelopment in Zika-exposed children: A randomized controlled trial. PLoS Negl Trop Dis. 2022 Mar 8;16(3):e0010263. doi: 10.1371/journal.pntd.0010263. eCollection 2022 Mar. |
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| ID | Term |
|---|---|
| D000071243 | Zika Virus Infection |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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Neurocognitive assessors are blinded to which participants have received the intervention during their longitudinal visits.
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |