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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04697134
Other study ID # SGUSavingBrainsI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2015
Est. completion date August 18, 2016

Study information

Verified date January 2021
Source Windward Islands Research and Education Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To improve neurocognitive outcomes in 2-year-old children by implementing a community-based intervention program that follows the principles of Conscious Discipline.


Description:

We aimed to introduce Conscious Discipline (CD) in Grenada as a means of improving neurodevelopment in 2-year-old children. The CD intervention promotes improved social-emotional connections between parents/guardians and children that reduces harsh discipline and corporal punishment and provides an ideal environment for the development of higher cognitive functioning (e.g. working memory, inhibition, emotional regulation). The intervention is implemented by using a distributed local, train-the-trainer model in partnership with the Grenada Roving Caregiver Program, managed by GRENCASE. CD training was provided to 85 existing Roving Caregivers, 70 of whom were certified as Conscious Discipline Paraprofessionals (CDPPs). Certified CDPPs traveled out to communities and villages throughout Grenada, to impart knowledge and skills to new and expecting parents. Following the intervention, parents who received CD training were assessed in their ability to implement CD skills with their child(ren). Neurocognition was assessed in children post-intervention using the INTERGROWTH 21st Neurodevelopmental Assessment (INTERNDA). Neurocognitive outcomes were compared between the intervention arm and the waitlist control arm of the study.


Recruitment information / eligibility

Status Completed
Enrollment 333
Est. completion date August 18, 2016
Est. primary completion date August 18, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Months to 30 Months
Eligibility Inclusion Criteria: - Participants actively enrolled in the Roving Caregiver Program (0-2-year-olds living with parents in at-risk communities served by the RCP) Exclusion Criteria: - Not enrolled in the Roving Caregiver Program

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Grenada Windward Islands Research and Education Foundation Saint George's

Sponsors (4)

Lead Sponsor Collaborator
Windward Islands Research and Education Foundation Grand Challenges Canada, GRENCASE, St. George's University

Country where clinical trial is conducted

Grenada, 

Outcome

Type Measure Description Time frame Safety issue
Primary INTERGROWTH 21st Neurodevelopment 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
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