NCT04697134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
333

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2016

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

January 4, 2021

Last Update Submit

January 5, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Conscious Discipline Intervention Group

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants in this group did not receive the intervention.

Interventions

Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children.

Conscious Discipline Intervention Group

Eligibility Criteria

Age22 Months - 30 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants actively enrolled in the Roving Caregiver Program (0-2-year-olds living with parents in at-risk communities served by the RCP)

You may not qualify if:

  • Not enrolled in the Roving Caregiver Program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Windward Islands Research and Education Foundation

Saint George's, Grenada

Location

Related Publications (1)

  • Waechter R, Evans R, Fernandes M, Bailey B, Holmes S, Murray T, Isaac R, Punch B, Cudjoe N, Orlando L, Landon B. A Community-based Responsive Caregiving Program Improves Neurodevelopment in Two-year Old Children in a Middle-Income Country, Grenada, West Indies. Psychosoc Interv. 2022 May 13;31(2):97-107. doi: 10.5093/pi2022a6. eCollection 2022 May.

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Randall Waechter, PhD

    Windard Islands Research and Education Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Research

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

February 2, 2015

Primary Completion

August 18, 2016

Study Completion

August 18, 2016

Last Updated

January 7, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations