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临床试验/NCT02534597
NCT02534597已完成不适用

National Evaluation of Quality of Childcare (ENCCI)

Duke University1 个研究点 分布在 1 个国家目标入组 1,923 人开始时间: 2015年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,923
试验地点
1
主要终点
Children's developmental milestone achievement as measured by the Battelle Developmental Inventory, Second Edition (BDI-2).

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Months 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Children's developmental milestone achievement as measured by the Battelle Developmental Inventory, Second Edition (BDI-2).

时间窗: Four years

The BDI-2 Developmental Quotient has a mean of 100, standard deviation of 15, score range 40-160.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan Ostermann

Principal Investigator

Duke University

研究点 (1)

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