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

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ClinicalTrials.gov Identifier: NCT02718287
Recruitment Status : Unknown
Verified March 2016 by Inter-American Development Bank.
Recruitment status was:  Enrolling by invitation
First Posted : March 24, 2016
Last Update Posted : March 30, 2016
Sponsor:
Collaborators:
Municipal Secretary of Health, Fortaleza Brasil
Universidade Federal do Ceara
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Child Development Behavioral: Home visiting intervention PCCSF (220 clusters) Behavioral: Home visiting without PCCSF (220 clusters) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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 Start Date : March 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment:
Home visiting with PCCSF
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.

Experimental: Control
Home visiting no PCCSF
Behavioral: 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).




Primary Outcome Measures :
  1. Denver Developmental Screening Test II- aggregate rating of language skills [ Time Frame: change from baseline to follow-up at 18 months ]
    language development

  2. Denver Developmental Screening Test II - aggregate rating of socioemotional skills [ Time Frame: change from baseline to follow-up at 18 months ]
    socioemotional development

  3. Denver Developmental Screening Test II -aggregate rating motor skills [ Time Frame: change from baseline to follow-up at 18 months ]
    motor development

  4. Denver Developmental Screening Test II -aggregate rating cognitive skills [ Time Frame: change from baseline to follow-up at 18 months ]
    cognitive development



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718287


Sponsors and Collaborators
Inter-American Development Bank
Municipal Secretary of Health, Fortaleza Brasil
Universidade Federal do Ceara
Investigators
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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

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Responsible Party: Inter-American Development Bank
ClinicalTrials.gov Identifier: NCT02718287     History of Changes
Other Study ID Numbers: IDB-2016-BR-1
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Keywords provided by Inter-American Development Bank:
language development
socio-emotional development
cognitive development
motor skills