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

March 29, 2016 updated by: Inter-American Development Bank

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2520

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment:
Home visiting with PCCSF
Behavioral: Home visiting intervention PCCSF (220 clusters)
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.
Experimental: Control
Home visiting no PCCSF
Behavioral: Home visiting without PCCSF (220 clusters)
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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inter-American Development Bank

Collaborators

Universidade Federal do Ceará
Municipal Secretary of Health, Fortaleza Brasil

Investigators

  • Principal Investigator: Florencia Lopez Boo, Ph.D., Inter-American Development Bank
  • Principal Investigator: Cristiana Ferreira da Silva, Ph.D., Secretaria Municipal de Saúde de Fortaleza
  • Principal Investigator: Marcia Rocha, M.A., Inter-American Development Bank
  • Principal Investigator: Suzanne Duryea, P.h.D., Inter-American Development Bank

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IDB-2016-BR-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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