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A Home Visiting Program for Pregnant Youth to Promote Early Brain Development

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02807818
Enrollment
80
Registered
2016-06-21
Start date
2015-06-30
Completion date
2018-12-31
Last updated
2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development

Keywords

Child development, Infant, Mother-Child Relations

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.

Interventions

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 19 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in neuropsychomotor development during first year of lifeFrom 3 to 12 months of ageComplete child assessment with the Bayley Scale of Infant Development at 3, 6 and 12 months of age.

Secondary

MeasureTime frameDescription
Change in child brain maturationAt 6 and 12 monthsAssessment of brain wave patterns (alpha, gamma and theta frequencies) via electroencephalography (EEG).
Mother-child attachment biomarkerAt 6 and 12 monthsAssessment of event-related potential associated with child face recognition of the mother via electroencephalography (EEG).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026