A Home Visiting Program for Pregnant Youth to Promote Early Brain Development II
- Conditions
- Child Development
- Interventions
- Behavioral: Home visiting Program for Young Pregnant Women
- Registration Number
- NCT04362098
- Lead Sponsor
- University of Sao Paulo
- 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 21 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, 12 and 24 months using the Bayley Scale of Infant Development. Brain development will be assessed via electroencephalography at 6, 12 and 24 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 167
- Low socioeconomic status
- Mother's age between 14-19
- Mother being a primapara
- Gestation between the 8th and 16th week
- High-risk gestation
- Mother's Intellectual, visual or auditory disability
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nurse home visits Home visiting Program for Young Pregnant Women Nurse home visits biweekly.
- Primary Outcome Measures
Name Time Method Change in Neuropsychomotor Development During First Year of Life: Receptive Language From 3 to 12 months of age Child assessment with the Bayley Scale of Infant Development.
Change in Neuropsychomotor Development During First Year of Life: Expressive Language From 3 to 12 months of age Child assessment with the Bayley Scale of Infant Development
Change in Neuropsychomotor Development During First Year of Life: Fine Motor From 3 to 12 months of age Child assessment with the Bayley Scale of Infant Development, fine motor scale.
Change in Neuropsychomotor Development During First Year of Life: Cognition 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.
Change in Neuropsychomotor Development During First Year of Life: Gross Motor From 3 to 12 months of age Child assessment with the Bayley Scale of Infant Development
- Secondary Outcome Measures
Name Time Method Change in Child Brain Maturation At 6 and 12 months Assessment of brain wave patterns (alpha, gamma and theta frequencies) via electroencephalography (EEG).
Mother-child Attachment Biomarker At 6 and 12 months Assessment of event-related potential associated with child face recognition of the mother via electroencephalography (EEG).
Trial Locations
- Locations (1)
Faculdade de Medicina da Universidade de São Paulo
🇧🇷São Paulo, Brazil