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Zika and Neurodevelopment Among Infants in Grenada

W

Windward Islands Research and Education Foundation

Status

Completed

Conditions

Development, Child
Neurocognitive Deficit
Neurodevelopmental Abnormality
Zika Virus Infection

Treatments

Behavioral: Conscious Discipline-Based Environmental Enrichment Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04697147
SGUZIKV

Details and patient eligibility

About

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

Full 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.

Enrollment

148 patients

Sex

All

Ages

24 to 30 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

148 participants in 2 patient groups

Intervention Group
Experimental group
Description:
Immediately randomized to receive the intervention for 12 weeks.
Treatment:
Behavioral: Conscious Discipline-Based Environmental Enrichment Intervention
Waitlist Control
No Intervention group
Description:
Randomized to receive the intervention post-study.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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