National Evaluation of Quality of Childcare

Health Behavior Clinical Trial

— ENCCI  

Official title:

National Evaluation of Quality of Childcare (ENCCI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534597
• Other study ID #: C0682
• Status: Completed
• Phase: N/A
• Start date: March 1, 2015
• Est. completion date: June 30, 2016

Study information

• Verified date: April 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This evaluation seeks to assess the impact of a training program on childcare center environments and child/caregiver wellbeing in El Salvador. Through a longitudinal, randomized control trial, over 200 childcare centers participating in the program will be assigned to various treatment arms receiving different components of the program. A community comparison cohort will also be enrolled.

Description:

Whole Child International (WCI) is a U.S.-based non-governmental organization. Its focus is on improving the caregiving environments for vulnerable children by effecting changes within child care centers and orphanages.

This evaluation will assess the impact of an educational training and technical assistance program offered by WCI in collaboration with the El Salvadoran government. The program consists of a series of educational trainings (for local government officials, directors of childcare and residential centers, and center caregivers) and technical assistance including infrastructural changes within centers.

To evaluate this intervention, a longitudinal, randomized controlled trial will be used to assign participating centers to one of seven treatment arms that will receive different components of the intervention. A community comparison cohort will also be enrolled to identify selection effects as well as local norms and standards. The central research question is, "Does providing training for institution providers and caregivers improve child outcomes?"

Ethnographic research will also explore local cultural norms regarding child caregiving, and seek to understand how the intervention is received within communities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1923
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 4 Years

Eligibility

Inclusion Criteria:

• Children between the ages of 6 months-4 years old at baseline, who are currently attending government-run childcare centers in El Salvador, will be eligible for enrollment in this study. One parent/guardian and center caregiver for an enrolled child will also complete assessments.

• In the comparison group, for every 5th center-attending child enrolled, the nearest neighboring child between the ages of 6 months and 4 years at enrollment, and who does not attend the center, will be eligible for enrollment. One parent/guardian of the comparison child will also complete assessments.

Exclusion Criteria:

• Children with known disabilities, who are unlikely to show developmental changes over time, may be excluded from the study.

Related Conditions & MeSH terms

• Child Rearing
• Health Behavior
• Mental Health Wellness 1

Intervention

Behavioral:
• Promotores Training

• Delayed Promotores training

• Caregiver training

• Delayed caregiver training

• Materials support

• Delayed materials support

• Technical assistance

• Delayed technical assistance

Locations

Country	Name	City	State
El Salvador	Whole Child International	San Salvador

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	University of Pittsburgh, University of South Carolina, Whole Child International

Country where clinical trial is conducted

El Salvador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's developmental milestone achievement as measured by the Battelle Developmental Inventory, Second Edition (BDI-2).	The BDI-2 Developmental Quotient has a mean of 100, standard deviation of 15, score range 40-160.	Four years