Survive and Thrive Boa Vista Early Childhood Program

NCT03386747 | Unknown

• 1 other identifier: TTS180818280
• Study Type: interventional
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed project will tackle the two most salient problems for children under 5 in Brazil: the continued high rates of neonatal mortality, and the large disparities in early childhood development. We propose to extend and scale up previously tested and validated home visiting programs to the city of Boa Vista in the north region of Brazil. The core intervention of the program will be home visits or group meetings to mothers and caregivers by trained child development agents. At the core of the program is a detailed curriculum, which contains gestation and age-specific topics of child health and development to be discussed with caregivers at each encounter.

Conditions

Neonatal Death; Mental Competency

Keywords

child development; neonatal mortality

Outcome Measures

Primary Outcomes (1)

• Overall child development - PRIDI score

  Children's overall development will be assessed using the PRIDI child development assessment tool.

  Age 2 - year 3 of the study

Secondary Outcomes (1)

• Neonatal mortality

  3 years

Study Arms (3)

Home Visiting Group

EXPERIMENTAL

Intervention: Home visits to improve parenting behaviors

Behavioral: Home visits to improve parenting behaviors

Center based parenting group

EXPERIMENTAL

Intervention: Center based parenting groups

Behavioral: Center based parenting groups

control group

NO INTERVENTION

The rest of pregnant women and their children who will not receive the intervention

Interventions

Home visits to improve parenting behaviors BEHAVIORAL

Caregivers will be visited twice per month starting from the third trimester in pregnancy up to age three to discuss important health and development behaviors.

Home Visiting Group

Center based parenting groups BEHAVIORAL

Caregivers will be invited to early childhood development groups. Groups will meet at nearby centers twice per month. Caregivers will be invited to participate starting from the third trimester up to age 3 of the child.

Center based parenting group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- pregnant women living in the urban area of Boa Vista
• at LEAST ONE of the following vulnerability criteria
• bolsa família or other social cash transfer program recipient
• household income per capita less than half of minimum wage
• previous exposure to domestic or sexual violence before.

You may not qualify if:

• women living outside of Boa Vista urban area
• women not meeting social vulnerability criteria above

Sponsors & Collaborators

• University of Sao Paulo: lead
• The University of The West Indies: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• Inter-American Development Bank: collaborator
• Swiss Tropical & Public Health Institute: collaborator

Study Sites (1)

Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, 01246903, Brazil

Location

Related Publications (1)

• Brentani A, Ferrer APS, Bessa L, Chang S, Walker S, Powell C, Hamadani J, Grisi S, Fink G. Survive and Thrive in Brazil: The Boa Vista Early Childhood Program: study protocol of a stepped-wedge, randomized controlled trial. Trials. 2020 May 7;21(1):390. doi: 10.1186/s13063-020-4217-3.

  PMID: 32381097 DERIVED

MeSH Terms

Conditions

Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra Brentani, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Treatment requires active participation and will be revealed immediately.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 29, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: December 29, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)