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Clinical Trials/NCT02718287
NCT02718287
Unknown
Not Applicable

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 sites2,520 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Child Development
Sponsor
Inter-American Development Bank
Enrollment
2520
Primary Endpoint
Denver Developmental Screening Test II- aggregate rating of language skills
Last Updated
10 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
October 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Denver Developmental Screening Test II- aggregate rating of language skills

Time Frame: change from baseline to follow-up at 18 months

language development

Denver Developmental Screening Test II -aggregate rating cognitive skills

Time Frame: change from baseline to follow-up at 18 months

cognitive development

Denver Developmental Screening Test II - aggregate rating of socioemotional skills

Time Frame: change from baseline to follow-up at 18 months

socioemotional development

Denver Developmental Screening Test II -aggregate rating motor skills

Time Frame: change from baseline to follow-up at 18 months

motor development

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