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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02718287

Enrollment

2520

Registered

2016-03-24

Start date

2016-03-31

Completion date

2017-10-31

Last updated

2016-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development

Keywords

language development, socio-emotional development, cognitive development, motor skills

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.

Interventions

BEHAVIORALHome 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.

BEHAVIORALHome 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Months

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026