- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04697134
Community-Based Conscious Discipline Program in Grenada
A Community-based Conscious Discipline Program to Reduce Corporal Punishment in the Caribbean
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Saint George's, Grenada
- Windward Islands Research and Education Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Conscious Discipline Intervention Group
Participants in this group received one-on-one Conscious Discipline classes with a Roving Caregiver.
These classes consisted of the dissemination of Conscious Discipline Skills and fun songs, games, and activities to foster connections between the infant and caregiver.
Both the infant and caregiver received the intervention simultaneously.
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Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children.
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No Intervention: Control
Participants in this group did not receive the intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
INTERGROWTH 21st Neurodevelopment Assessment (INTER-NDA)
Time Frame: 22-30 Months
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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.
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22-30 Months
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Collaborators and Investigators
Investigators
- Principal Investigator: Randall Waechter, PhD, Windard Islands Research and Education Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SGUSavingBrainsI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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