ClinicalTrials.gg
Status unknownNCT02718287Updated Mar 30, 2016

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

An interventional study of Home visiting intervention PCCSF (220 clusters) and Home visiting without PCCSF (220 clusters) in Child Development, sponsored by Inter-American Development Bank. Status unknown. Open to participants aged 1 Day to 28 Months. Per ClinicalTrials.gov, last updated 2016-03-30.

Sponsored by Inter-American Development Bank · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
2,520
Allocation
Randomized
Ages
1 Day to 28 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Child Development

Keywords

  • language development
  • socio-emotional development
  • cognitive development
  • motor skills
03

In context

Lead sponsor

Inter-American Development Bank is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 28 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Data will not be collected if parental consent not given.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
2,520 participants (estimated)

Study arms

  • Experimental
    Treatment:

    Home visiting with PCCSF

    Behavioral: Home visiting intervention PCCSF (220 clusters)

  • Experimental
    Control

    Home visiting no PCCSF

    Behavioral: Home visiting without PCCSF (220 clusters)

Interventions

  • BehavioralHome 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.

  • BehavioralHome 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).

06

What researchers measure

Primary outcomes

  1. Denver Developmental Screening Test II- aggregate rating of language skills

    language development

    Time frame: change from baseline to follow-up at 18 months

  2. Denver Developmental Screening Test II - aggregate rating of socioemotional skills

    socioemotional development

    Time frame: change from baseline to follow-up at 18 months

  3. Denver Developmental Screening Test II -aggregate rating motor skills

    motor development

    Time frame: change from baseline to follow-up at 18 months

  4. Denver Developmental Screening Test II -aggregate rating cognitive skills

    cognitive development

    Time frame: change from baseline to follow-up at 18 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02718287
Lead sponsor
Inter-American Development Bank
Collaborators
Municipal Secretary of Health, Fortaleza Brasil, Universidade Federal do Ceara
Responsible party
Sponsor
First posted
Mar 24, 2016
Start date
Mar 2016
Primary completion
Oct 2017 (estimated)
Completion
Oct 2017 (estimated)
Last update
Mar 30, 2016

Study contacts

Florencia Lopez Boo, Ph.D.
principal investigator · Inter-American Development Bank
Cristiana Ferreira da Silva, Ph.D.
principal investigator · Secretaria Municipal de Saúde de Fortaleza
Marcia Rocha, M.A.
principal investigator · Inter-American Development Bank
Suzanne Duryea, P.h.D.
principal investigator · Inter-American Development Bank

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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