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Completed

NCT Number: NCT04697147

Zika and Neurodevelopment Among Infants in Grenada

Implement a randomized controlled trial, evidence-based, culturally adapted, environmental enrichment intervention for the purpose of enhancing neurocognitive outcomes among Zika Exposed Children.

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Key information

Conditions

Zika Virus Infection Arbovirus Infections Development, Child Flaviviridae Infections Flavivirus Infections Infections Mosquito-Borne Diseases Neurocognitive Deficit Neurodevelopmental Abnormality RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

24 month–30 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Windward Islands Research and Education Foundation (WINDREF)

Saint George's, Grenada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The INTERGROWTH 21st Neurodevelopmental Assessment (INTER-NDA)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Windward Islands Research and Education Foundation

Other

Collaborators

  • National Institutes of Health (NIH)
  • St. George's University
  • Stanford University

Registry information

Official study title

Rescuing Neurodevelopment in Zika-Exposed Infants in Grenada

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2021
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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