Evaluation of the Home Visiting Pilot Program on Early Childhood Outcomes in Fortaleza Brazil

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Child Development

Intervention / Treatment
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* Behavioral: Home visiting intervention PCCSF (220 clusters)
* Behavioral: Home visiting without PCCSF (220 clusters)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Data will not be collected if parental consent not given.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment:<br>Home visiting with PCCSF | Behavioral: Home visiting intervention PCCSF (220 clusters)<br>* Low income mothers of children 0-2.5 years of age in the randomized treatment micro-areas will receive home visits by community health workers trained in the PCCSF curriculum in addition to the basic health curriculum. The community health workers are supervised by trained and experienced nurses.<br>|
| Experimental: Control<br>Home visiting no PCCSF | Behavioral: Home visiting without PCCSF (220 clusters)<br>* Low income mothers of children 0-2.5 years of age in the randomized control micro-areas will receive home visits by community health workers trained in the standard basic health curriculum (no PCCSF).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Denver Developmental Screening Test II- aggregate rating of language skills | language development | change from baseline to follow-up at 18 months | 
| Denver Developmental Screening Test II - aggregate rating of socioemotional skills | socioemotional development | change from baseline to follow-up at 18 months | 
| Denver Developmental Screening Test II -aggregate rating motor skills | motor development | change from baseline to follow-up at 18 months | 
| Denver Developmental Screening Test II -aggregate rating cognitive skills | cognitive development | change from baseline to follow-up at 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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language development, socio-emotional development, cognitive development, motor skills