National Evaluation of Quality of Childcare (ENCCI)

April 5, 2021 updated by: Jan Ostermann, Duke University

National Evaluation of Quality of Childcare (ENCCI)

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1923

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • San Salvador, El Salvador
        • Whole Child International

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pctm
Receives the earliest Promotores training, followed by direct caregiver training, materials support, and technical assistance.
Experimental: p_ctm
Receives the earliest Promotores training, followed by delayed caregiver training, delayed materials support, and delayed technical assistance.
Experimental: _pmt
Receives the delayed Promotores training, followed by receipt of materials support and technical assistance.
Experimental: _p_mt
Receives the delayed Promotores training, followed by delayed receipt of materials support and technical assistance.
Experimental: _pct
Receives the delayed Promotores training, followed by caregiver training and technical assistance.
Experimental: _p_ct
Receives the delayed Promotores training, followed by delayed caregiver training and technical assistance.
Experimental: _pt
Receives the delayed Promotores training, followed by technical assistance.
Experimental: _p_t
Receives the delayed Promotores training, followed by delayed technical assistance.
Experimental: _pc
Receives the delayed Promotores training, followed by a full caregiver training only.
Experimental: _p_c
Receives the delayed Promotores training, followed by delayed caregiver training.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Jan Ostermann, PhD, Associate Research Professor
  • Principal Investigator: Kathryn Whetten, PhD, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

June 30, 2016

Study Registration Dates

First Submitted

August 21, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • C0682

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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