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Home Visiting Programs to Improve Early Childhood Development and Maternal Mental Health

NCT02704000 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 826

Last updated 2023-11-30

No results posted yet for this study

Summary

This study evaluates the efficacy and cost-effectiveness of two platforms for delivering home visiting programs in the poor urban setting of Sao Paulo's western region: a program delivered by a newly trained cadre of Child Development Agents, and a program delivered by Community Health Agents employed by the government as part of the Family Health Strategy (ESF). The program will randomly select 400 mother-child dyads to follow a curriculum that is currently being adapted to the local context. The primary outcome of the program will be cognitive development for children aged 9 to 15 months old at baseline (21-27 months at endline) The secondary outcomes will include child physical development as well as maternal mental health.

Conditions

  • Child Development
  • Mental Health Wellness 1

Interventions

BEHAVIORAL

Home visiting program (Jamaica curriculum)

Agents will deliver bi-weekly home-visits following the curriculum developed for the Jamaica intervention study by Susan Walker and colleagues. This curriculum foresees age-appropriate tasks assigned to the caregiver during each visit.

Sponsors & Collaborators

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Alexandra VM Brentani, PhD · Universidade de São Paulo, Faculdade de Medicina USP

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
17 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-10-31
Completion
2019-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02704000 on ClinicalTrials.gov