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

Not Applicable

• Conditions: Child Development
• Interventions: Behavioral: Home visiting without PCCSF (220 clusters); Behavioral: Home visiting intervention PCCSF (220 clusters)

• Registration Number: NCT02718287
• Lead Sponsor: Inter-American Development Bank

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.

Study Timeline

• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-24
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-30
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2520

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Home visiting without PCCSF (220 clusters)	Home visiting no PCCSF
Treatment:	Home visiting intervention PCCSF (220 clusters)	Home visiting with PCCSF

Primary Outcome Measures

Name	Time	Method
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