Clinical trial NCT02718287: Evaluation of the Home Visiting Pilot Program on Early Childhood Outcomes in Fortaleza Brazil
Official title: Evaluation of the Home Visiting Pilot Programa Cresça Com Seu Filho (PCCSF) on Early Childhood Outcomes: a Cluster-Randomized Trial in Fortaleza Brazil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Development
Keywords: language development
socio-emotional development
cognitive development
motor skills
Lead sponsor: Inter-American Development Bank
Sponsor class: OTHER
Collaborators: name: Municipal Secretary of Health, Fortaleza Brasil
name: Universidade Federal do Ceara
First posted: 2016-03-24
Enrollment: 2520
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Denver Developmental Screening Test II- aggregate rating of language skills
timeFrame: change from baseline to follow-up at 18 months
measure: Denver Developmental Screening Test II - aggregate rating of socioemotional skills
timeFrame: change from baseline to follow-up at 18 months
measure: Denver Developmental Screening Test II -aggregate rating motor skills
timeFrame: change from baseline to follow-up at 18 months
measure: Denver Developmental Screening Test II -aggregate rating cognitive skills
timeFrame: change from baseline to follow-up at 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Inter-American Development Bank
name: Florencia Lopez Boo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Secretaria Municipal de Saúde de Fortaleza
name: Cristiana Ferreira da Silva, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inter-American Development Bank
name: Marcia Rocha, M.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inter-American Development Bank
name: Suzanne Duryea, P.h.D.
role: PRINCIPAL_INVESTIGATOR
References: