Development, Child, Neurocognitive Deficit, Neurodevelopmental Abnormality, Zika Virus Infection
Conditions
Brief summary
Implement a randomized controlled trial, evidence-based, culturally adapted, environmental enrichment intervention for the purpose of enhancing neurocognitive outcomes among Zika Exposed Children.
Detailed description
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.
Interventions
Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children.
Sponsors
St. George's University
Stanford University
National Institutes of Health (NIH)
Windward Islands Research and Education Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Neurocognitive assessors are blinded to which participants have received the intervention during their longitudinal visits.
Eligibility
Sex/Gender
ALL
Age
24 Months to 30 Months
Healthy volunteers
Yes
Inclusion criteria
* Must be actively enrolled in the pre-existing Zika Cohort Study * Infant must be alive and living with a parent/guardian at the time of recruitment * Infant must be between 24-27 months at the time of recruitment
Exclusion criteria
* Any infants older than 27 months * Persons not enrolled in the pre-existing Zika Cohort Study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The INTERGROWTH 21st Neurodevelopmental Assessment (INTER-NDA) | 22-30 months | 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. |
Countries
Grenada
Outcome results
None listed