Evaluation of the Home Visiting Pilot Program on Early Childhood Outcomes in Fortaleza Brazil
1 other identifier
interventional
2,520
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 9, 2016
CompletedFirst Posted
Study publicly available on registry
March 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedMarch 30, 2016
March 1, 2016
1.6 years
March 9, 2016
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Denver Developmental Screening Test II- aggregate rating of language skills
language development
change from baseline to follow-up at 18 months
Denver Developmental Screening Test II - aggregate rating of socioemotional skills
socioemotional development
change from baseline to follow-up at 18 months
Denver Developmental Screening Test II -aggregate rating motor skills
motor development
change from baseline to follow-up at 18 months
Denver Developmental Screening Test II -aggregate rating cognitive skills
cognitive development
change from baseline to follow-up at 18 months
Study Arms (2)
Treatment:
EXPERIMENTALHome visiting with PCCSF
Control
EXPERIMENTALHome visiting no PCCSF
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Data will not be collected if parental consent not given.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inter-American Development Banklead
- Municipal Secretary of Health, Fortaleza Brasilcollaborator
- Universidade Federal do Cearacollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2016
First Posted
March 24, 2016
Study Start
March 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
March 30, 2016
Record last verified: 2016-03