The Effects on Early Brain Development of a Nurse Home Visitation Program for Pregnant Youth and Their Families Living in a Poor Urban Area in Sao Paulo, Brazil
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Sao Paulo
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Change in neuropsychomotor development during first year of life
Study Overview
Brief Summary
Home visiting programs for pregnant women aiming to improve mother-infant relationship has received worldwide attention in the past 30 years. These programs are considered an important strategy to improve women's health during pregnancy, aside from improving child's birthing conditions and allowing parents access to tools which will nurture and properly stimulate their baby, thus promoting emotional and cognitive development. Objectives: The "Nurse home visitation program for pregnant youth" aims to promote infant´s healthy development, from pregnancy to the first months of life, in a high-risk population. Methods: Eighty young pregnant women aged between 14 and 20 years were randomly allocated to the intervention or to usual prenatal care program. The "Nurse home visitation program for pregnant youth" was developed based on Albert Bandura's theory of self-efficacy, on Urie Bronfenbrenner´s bioecological model, which recognizes the importance of individual and family inclusion in various contexts of social life, on John Bowlby and Mary Ainsworth evolutionary theories of attachment, which involves the care practitioner addressing issues such as environmental health, life course and parenting, bond between mother and infant, and infant´s social and cognitive development. Neuropsychomotor development will be assessed at 3, 6 and 12 months using the Bayley Scale of Infant Development. Brain development will be assessed via electroencephalography at 6 and 12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to 19 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Low socioeconomic status
- •Mother's age between 14-19
- •Mother being a primapara
- •Gestation between the 8th and 16th week
Exclusion Criteria
- •High-risk gestation
- •Mother's Intellectual, visual or auditory disability
Arms & Interventions
Nurse home visits
Nurse biweekly home visit.
Intervention: Home visiting Program for Young Pregnant Women (Behavioral)
Usual care
Usual care.
Outcomes
Primary Outcomes
Change in neuropsychomotor development during first year of life
Time Frame: From 3 to 12 months of age
Complete child assessment with the Bayley Scale of Infant Development at 3, 6 and 12 months of age.
Secondary Outcomes
- Change in child brain maturation(At 6 and 12 months)
- Mother-child attachment biomarker(At 6 and 12 months)
Investigators
Guilherme Vanoni Polanczyk
Professor
University of Sao Paulo