Zika Virus InfectionNCT04697147
Zika and Neurodevelopment Among Infants in Grenada
A study testing Conscious Discipline-Based Environmental Enrichment Intervention in people with Zika Virus Infection and Neurocognitive Deficit, run by Windward Islands Research and Education Foundation at 1 site in Grenada.
Trial summary
Implement a randomized controlled trial, evidence-based, culturally adapted, environmental enrichment intervention for the purpose of enhancing neurocognitive outcomes among Zika Exposed Children. Read more about this study
- Who is it for?
- Ages 24 to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Zika Virus Infection, Neurocognitive Deficit, Development, Child
- What is being tested?
- Conscious Discipline-Based Environmental Enrichment Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteGrenada
- Study dates
- 3 Sep 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Any infants older than 27 months
- Persons not enrolled in the pre-existing Zika Cohort Study
Trial locations and contacts
1 site in 1 country.
Grenada1 site
Windward Islands Research and Education Foundation (WINDREF)
Saint George's
About this study
Official title: Rescuing Neurodevelopment in Zika-Exposed 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.
Read the 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.
- Conditions
- Zika Virus Infection, Neurocognitive Deficit, Development, Child, Neurodevelopmental Abnormality
- Being tested
- Conscious Discipline-Based Environmental Enrichment Intervention
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conscious Discipline-Based Environmental Enrichment InterventionBehavioural
Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Immediately randomized to receive the intervention for 12 weeks. Receives: Behavioral: Conscious Discipline-Based Environmental Enrichment Intervention |
| Waitlist Control | No intervention | Randomized to receive the intervention post-study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 22-30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start3 Sep 2018
- Primary completion22 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Zika Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Windward Islands Research and Education Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- St. George's University, Stanford University, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Dr. Randall Waechter, Windward Islands Research and Education Foundation
- Investigators
- Randall Waechter, PhD, Principal investigator, Windward Islands Research and Education Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697147
- Sponsor's protocol ID
- SGUZIKV
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 7 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35259172
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescuing Neurodevelopment in Zika-Exposed Infants in Grenada
- ClinicalTrials.gov ID
- NCT04697147
- Acronym / sponsor ID
- SGUZIKV
- Conditions
- Zika Virus Infection, Neurocognitive Deficit, Development, Child, Neurodevelopmental Abnormality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Windward Islands Research and Education FoundationUniversity, hospital or other
- Collaborators
- St. George's University, Stanford University, National Institutes of Health (NIH)
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 22 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Conscious Discipline-Based Environmental Enrichment InterventionImmediately randomized to receive the intervention for 12 weeks. |
| Waitlist Control | No intervention | –Randomized to receive the intervention post-study. |
Who may qualify
- Ages
- 24 to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Any infants older than 27 months
- Persons not enrolled in the pre-existing Zika Cohort Study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conscious Discipline-Based Environmental Enrichment InterventionConscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children. | Behavioural | Intervention Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Derived from this study: PubMed 35259172Waechter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall Waechter, PhD principal investigator
Windward Islands Research and Education Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conscious Discipline-Based Environmental Enrichment Intervention in people with Zika Virus Infection and Neurocognitive Deficit, run by Windward Islands Research and Education Foundation at 1 site in Grenada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Grenada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The INTERGROWTH 21st Neurodevelopmental Assessment (INTER-NDA) (time frame: 22-30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04697147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.