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Completed

NCT Number: NCT02534597

National Evaluation of Quality of Childcare (C0682)

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.

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Key information

Age range

6 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Whole Child International

San Salvador, El Salvador

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Promotores Training

Behavioral

Delayed Promotores training

Behavioral

Caregiver training

Behavioral

Delayed caregiver training

Behavioral

Materials support

Behavioral

Delayed materials support

Behavioral

Technical assistance

Behavioral

Delayed technical assistance

Behavioral

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of Pittsburgh
  • University of South Carolina
  • Whole Child International

Registry information

Official study title

National Evaluation of Quality of Childcare (ENCCI)

Acronym: ENCCI

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 27, 2015
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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