Zika and Neurodevelopment Among Infants in Grenada

Not Applicable

Completed

• Conditions: Zika Virus Infection; Neurocognitive Deficit; Development, Child; Neurodevelopmental Abnormality
• Interventions: Behavioral: Conscious Discipline-Based Environmental Enrichment Intervention

• Registration Number: NCT04697147
• Lead Sponsor: Windward Islands Research and Education Foundation

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.

Study Timeline

• Study Start: 2018-09-03
• Primary Completion: 2020-02-22
• Study Completion: 2020-02-28
• Status Verified: 2021-01
• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Study First Posted: 2021-01-06
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Conscious Discipline-Based Environmental Enrichment Intervention	Immediately randomized to receive the intervention for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Windward Islands Research and Education Foundation (WINDREF); 🇬🇩 Saint George's, Grenada