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临床试验/NCT02718287
NCT02718287Unknown不适用

Evaluation of the Home Visiting Pilot Programa Cresça Com Seu Filho (PCCSF) on Early Childhood Outcomes: a Cluster-Randomized Trial in Fortaleza Brazil

Inter-American Development Bank0 个研究点目标入组 2,520 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,520
主要终点
Denver Developmental Screening Test II- aggregate rating of language skills

研究概览

简要总结

This is a cluster-randomized study of a home visiting program targeting mothers of children 0 to 2.5 years of age with the objective of improving global child development. The program, Programa Cresça com Seu Filho (PCCSF), will be randomized across 220 microareas in the poorest Region (V) of the state of Fortaleza, Brazil.

详细描述

This is an evaluation of pilot program, Programa Cresça com Seu Filho (PCCSF) which is publically funded and, developed in a partnership between the Ministry of Health (MoH) of Brazil and the municipal government of Fortaleza. The program targets low-income mothers of children 0 to 2.5 years old, living in low-income neighborhoods in Fortaleza Brazil. The home visits are carried out by community health workers (CHW), who currently work for the Ministry of Health as part of the program Programa Saúde da Família. The CHWs will be trained on the PCCSF curriculum in order to provide 1-hour visits with the early stimulation package during two years. The PCCSF home visiting program is planned to begin implementation the week of March 15, 2016 for half of the community health workers and April 15, 2016 for the other half.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
1 Day 至 28 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Mothers of children ages 0-2.5 years of age
  • Included in the poverty registry CadastroUnico
  • Residents of specific 440 poor microareas of Region V of Fortaleza

排除标准

  • Data will not be collected if parental consent not given.

结局指标

主要结局

Denver Developmental Screening Test II- aggregate rating of language skills

时间窗: change from baseline to follow-up at 18 months

language development

Denver Developmental Screening Test II -aggregate rating cognitive skills

时间窗: change from baseline to follow-up at 18 months

cognitive development

Denver Developmental Screening Test II - aggregate rating of socioemotional skills

时间窗: change from baseline to follow-up at 18 months

socioemotional development

Denver Developmental Screening Test II -aggregate rating motor skills

时间窗: change from baseline to follow-up at 18 months

motor development

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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