Community-Based Conscious Discipline Program in Grenada

Sponsor

Windward Islands Research and Education Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT04697134

Collaborator

Grand Challenges Canada (Other), GRENCASE (Other), St. George's University (Other)

333

Enrollment

Location

Arms

18.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Behavior, Child Neurocognition, Child Development, Child	Behavioral: Conscious Discipline-Based Environmental Enrichment Intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

333 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Community-based Conscious Discipline Program to Reduce Corporal Punishment in the Caribbean

Actual Study Start Date :

Feb 2, 2015

Actual Primary Completion Date :

Aug 18, 2016

Actual Study Completion Date :

Aug 18, 2016

Arms and Interventions

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.	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.
No Intervention: Control Participants in this group did not receive the intervention.

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.

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.

No Intervention: Control

Participants in this group did not receive the intervention.

Outcome Measures

Primary Outcome Measures

INTERGROWTH 21st Neurodevelopment Assessment (INTER-NDA) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Months to 30 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Windward Islands Research and Education Foundation	Saint George's		Grenada

Sponsors and Collaborators

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

Investigators

Principal Investigator: Randall Waechter, PhD, Windard Islands Research and Education Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Randall Waechter, Associate Director of Research, Windward Islands Research and Education Foundation

ClinicalTrials.gov Identifier:

NCT04697134

Other Study ID Numbers:

SGUSavingBrainsI

First Posted:

Jan 6, 2021

Last Update Posted:

Jan 7, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 7, 2021