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

NCT ID: NCT02718287

Last Updated: 2016-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Child Development

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment:

Home visiting with PCCSF

Group Type EXPERIMENTAL

Home visiting intervention PCCSF (220 clusters)

Intervention Type BEHAVIORAL

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.

Control

Home visiting no PCCSF

Group Type EXPERIMENTAL

Home visiting without PCCSF (220 clusters)

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Municipal Secretary of Health, Fortaleza Brasil

UNKNOWN

Sponsor Role collaborator

Universidade Federal do Ceara

OTHER

Sponsor Role collaborator

Inter-American Development Bank

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Florencia Lopez Boo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Inter-American Development Bank

Cristiana Ferreira da Silva, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Secretaria Municipal de Saúde de Fortaleza

Marcia Rocha, M.A.

Role: PRINCIPAL_INVESTIGATOR

Inter-American Development Bank

Suzanne Duryea, P.h.D.

Role: PRINCIPAL_INVESTIGATOR

Inter-American Development Bank

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IDB-2016-BR-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.