Zika and Neurodevelopment Among Infants in Grenada

NCT04697147 | Completed

• 1 other identifier: SGUZIKV
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Immediately randomized to receive the intervention for 12 weeks.

Behavioral: Conscious Discipline-Based Environmental Enrichment Intervention

Waitlist Control

NO INTERVENTION

Randomized to receive the intervention post-study.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 24 Months - 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Any infants older than 27 months
• Persons not enrolled in the pre-existing Zika Cohort Study

Sponsors & Collaborators

• Windward Islands Research and Education Foundation: lead
• St. George's University: collaborator
• Stanford University: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Windward Islands Research and Education Foundation (WINDREF)

Saint George's, Grenada

Location

Related Publications (1)

• Waechter R, Burgen KS, Punch B, Evans R, Blackmon K, Noel T, Fernandes M, Landon B. Improving neurodevelopment in Zika-exposed children: A randomized controlled trial. PLoS Negl Trop Dis. 2022 Mar 8;16(3):e0010263. doi: 10.1371/journal.pntd.0010263. eCollection 2022 Mar.

  PMID: 35259172 DERIVED

MeSH Terms

Conditions

Zika Virus Infection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Randall Waechter, PhD

  Windward Islands Research and Education Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Neurocognitive assessors are blinded to which participants have received the intervention during their longitudinal visits.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Research

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: September 3, 2018
• Primary Completion: February 22, 2020
• Study Completion: February 28, 2020
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)