Survive and Thrive Boa Vista Early Childhood Program (STBV)
Primary Purpose
Neonatal Death, Mental Competency
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Home visits to improve parenting behaviors
Center based parenting groups
Sponsored by
About this trial
This is an interventional health services research trial for Neonatal Death focused on measuring child development, neonatal mortality
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- women living outside of Boa Vista urban area
- women not meeting social vulnerability criteria above
Sites / Locations
- Faculdade de Medicina da Universidade de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Home Visiting Group
Center based parenting group
control group
Arm Description
Intervention: Home visits to improve parenting behaviors
Intervention: Center based parenting groups
The rest of pregnant women and their children who will not receive the intervention
Outcomes
Primary Outcome Measures
Overall child development - PRIDI score
Children's overall development will be assessed using the PRIDI child development assessment tool.
Secondary Outcome Measures
Neonatal mortality
Probability of death between day 0 and day 27 after birth
Full Information
NCT ID
NCT03386747
First Posted
December 13, 2017
Last Updated
December 20, 2017
Sponsor
University of Sao Paulo
Collaborators
The University of The West Indies, International Centre for Diarrhoeal Disease Research, Bangladesh, Inter-American Development Bank, Swiss Tropical & Public Health Institute
1. Study Identification
Unique Protocol Identification Number
NCT03386747
Brief Title
Survive and Thrive Boa Vista Early Childhood Program
Acronym
STBV
Official Title
Survive and Thrive in Brazil: Boa Vista Early Childhood Program
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
The University of The West Indies, International Centre for Diarrhoeal Disease Research, Bangladesh, Inter-American Development Bank, Swiss Tropical & Public Health Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Even though much progress has been achieved in child mortality globally, relatively minor improvements have been realized in the first four weeks of children's life generally referred to as the neonatal period. Each year, four million infants die within the first 28 days of their life globally. As pointed out in the Lancet's neonatal survival series, 3 million neonatal deaths could be prevented each year by low-cost interventions. In Brazil, more than 25,000 newborns die each year within the first 28 days of their life, with a majority of deaths occurring in the first week. Previous studies suggest that one of the most effective ways to prevent such deaths are home visiting programs, which support mothers in the first weeks of infant's lives, promote breastfeeding and kangaroo mother care, and ensure appropriate medical care when needed. From a child health and child development perspective, optimal outcomes appear only feasible if continued support is provided to mothers from pregnancy throughout the first years of children's life. Home-based visits and support have become increasingly recognized as a both crucial and highly cost-effective strategy to achieve such outcomes.
The objective of this project is to extend and scale up the previously tested and validated home visiting programs to the city of Boa Vista. At the core of this program is a detailed curriculum, which contains gestation and age-specific topics of child health and development to be discussed with caregivers at each home visit. The intervention package will start in the third trimester of pregnancy and feature to sessions per month up to age 3 years.
This curriculum will be delivered through two separate - and randomly assigned - platforms: home visits through trained Child Development Agents (CDAs), and center-based delivery of the same delivery to groups of caregivers. The pilot study in Sao Paulo suggests that each CDA can handle approximately 40 families, visiting each caregiver twice per month. Visits will be initiated during the second trimester of pregnancy. The visits during pregnancy will not be a substitute for prenatal care but are designed to prepare mothers for babies and set up a relationship for a closer follow-up after birth. In Brazil, as well as globally, the numbers of pre-term deliveries and stillbirth is rather large, 20% of mature stillbirths (more than 37 weeks of gestation, more than 2.5 Kg) so the pre-natal care can be improved clearly. The visits would also occur during the neonatal period, when the largest proportional of under 5 mortality happens. This would be the first component of the program, addressing maternal and perinatal/neonatal mortality. Particular attention will be given to mothers after birth, with two special visits scheduled for the first week after birth focusing on maternal mental health; breastfeeding as well as kangaroo mother care when appropriate. Such visitation programs have been successfully tested within the family health strategy, and will be further reinforced and complemented by the new visitation program.
The city of Boa Vista has a population of approximately 330,000 people, with, 22,377 families (~30%) currently receiving social cash transfers under the bolsa familia program. The city is comparable to the national average in terms of the observed poverty rates, and roughly average in terms of its size. Infant mortality rate is estimated at 14.2 per 1000 live births, with 21% of births given by teenage mothers and 15% of infants born preterm.
The proposed project will exclusively target the most vulnerable households currently supported by the bolsa familia social cash transfer program. According to municipality estimates, about 5000 children are born each year in eligible households.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Death, Mental Competency
Keywords
child development, neonatal mortality
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Treatment requires active participation and will be revealed immediately.
Allocation
Randomized
Enrollment
15000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home Visiting Group
Arm Type
Experimental
Arm Description
Intervention: Home visits to improve parenting behaviors
Arm Title
Center based parenting group
Arm Type
Experimental
Arm Description
Intervention: Center based parenting groups
Arm Title
control group
Arm Type
No Intervention
Arm Description
The rest of pregnant women and their children who will not receive the intervention
Intervention Type
Behavioral
Intervention Name(s)
Home visits to improve parenting behaviors
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Center based parenting groups
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall child development - PRIDI score
Description
Children's overall development will be assessed using the PRIDI child development assessment tool.
Time Frame
Age 2 - year 3 of the study
Secondary Outcome Measure Information:
Title
Neonatal mortality
Description
Probability of death between day 0 and day 27 after birth
Time Frame
3 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
women living outside of Boa Vista urban area
women not meeting social vulnerability criteria above
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Brentani, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32381097
Citation
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.
Results Reference
derived
Learn more about this trial
Survive and Thrive Boa Vista Early Childhood Program
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