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Zika and Neurodevelopment Among Infants in Grenada

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04697147
Recruitment Status : Completed
First Posted : January 6, 2021
Last Update Posted : January 7, 2021
Sponsor:
Collaborators:
St. George's University
Stanford University
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Dr. Randall Waechter, Windward Islands Research and Education Foundation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Zika Virus Infection Neurocognitive Deficit Development, Child Neurodevelopmental Abnormality Behavioral: Conscious Discipline-Based Environmental Enrichment Intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Neurocognitive assessors are blinded to which participants have received the intervention during their longitudinal visits.
Primary Purpose: Treatment
Official Title: Rescuing Neurodevelopment in Zika-Exposed Infants in Grenada
Actual Study Start Date : September 3, 2018
Actual Primary Completion Date : February 22, 2020
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Group
Immediately randomized to receive the intervention for 12 weeks.
 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.
No Intervention: Waitlist Control
Randomized to receive the intervention post-study.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   24 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04697147


Locations
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Grenada
Windward Islands Research and Education Foundation (WINDREF)
Saint George's, Grenada
Sponsors and Collaborators
Windward Islands Research and Education Foundation
St. George's University
Stanford University
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Randall Waechter, PhD Windward Islands Research and Education Foundation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Randall Waechter, Associate Director of Research, Windward Islands Research and Education Foundation
ClinicalTrials.gov Identifier: NCT04697147    
Other Study ID Numbers: SGUZIKV
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Zika Virus Infection
Virus Diseases
Infections
Arbovirus Infections
 Vector Borne Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections