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

Child Development Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02718287
• Other study ID #: IDB-2016-BR-1
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 9, 2016
• Last updated: March 29, 2016
• Start date: March 2016
• Est. completion date: October 2017

Study information

• Verified date: March 2016
• Source: Inter-American Development Bank
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2520
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Child Development

Intervention

Behavioral:
• 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.
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Inter-American Development Bank	Municipal Secretary of Health, Fortaleza Brasil, Universidade Federal do Ceara

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Denver Developmental Screening Test II- aggregate rating of language skills	language development	change from baseline to follow-up at 18 months	No
Primary	Denver Developmental Screening Test II - aggregate rating of socioemotional skills	socioemotional development	change from baseline to follow-up at 18 months	No
Primary	Denver Developmental Screening Test II -aggregate rating motor skills	motor development	change from baseline to follow-up at 18 months	No
Primary	Denver Developmental Screening Test II -aggregate rating cognitive skills	cognitive development	change from baseline to follow-up at 18 months	No