Zika and Neurodevelopment Among Infants in Grenada

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Rescuing Neurodevelopment in Zika-Exposed Infants in Grenada

Conditions
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Zika Virus Infection, Neurocognitive Deficit, Development, Child, Neurodevelopmental Abnormality

Intervention / Treatment
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* Behavioral: Conscious Discipline-Based Environmental Enrichment Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 30 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Immediately randomized to receive the intervention for 12 weeks. | Behavioral: Conscious Discipline-Based Environmental Enrichment Intervention<br>* Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children.<br>|
| No Intervention: Waitlist Control<br>Randomized to receive the intervention post-study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |