NCT04697147

Zika and Neurodevelopment Among Infants in Grenada

Rescuing Neurodevelopment in Zika-Exposed Infants in Grenada

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Windward Islands Research and Education Foundation · Academic / Other
• Sex: All
• Age: 24 Months – 30 Months
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Conscious Discipline-Based Environmental Enrichment Intervention	Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children.

Timeline

• Start date: 2018-09-03
• Primary completion: 2020-02-22
• Completion: 2020-02-28
• First posted: 2021-01-06
• Last updated: 2021-01-07

Locations

1 site across 1 country: Grenada