Clinical trial NCT02534597: National Evaluation of Quality of Childcare (C0682)
Official title: National Evaluation of Quality of Childcare (ENCCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Rearing
Mental Health Wellness 1
Health Behavior
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Whole Child International
name: University of South Carolina
name: University of Pittsburgh
First posted: 2015-08-27
Enrollment: 1923
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Children's developmental milestone achievement as measured by the Battelle Developmental Inventory, Second Edition (BDI-2).
timeFrame: Four years
Secondary outcomes:
Other outcomes:
Locations:
city: San Salvador
country: El Salvador
facility: Whole Child International
Study officials:
affiliation: Associate Research Professor
name: Jan Ostermann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor
name: Kathryn Whetten, PhD
role: PRINCIPAL_INVESTIGATOR
References: