Clinical trial NCT04362098: A Home Visiting Program for Pregnant Youth to Promote Early Brain Development II
Official title: The Effects Over Early Brain Development of a Nurse Home Visitation Program for Pregnant Youth and Their Families Living in a Poor Urban Area in São Paulo, Brazil II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Development
Keywords: Child Development
Infant
Mother-Child Relations
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 167
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Neuropsychomotor Development During First Year of Life: Cognition
timeFrame: From 3 to 12 months of age
measure: Change in Neuropsychomotor Development During First Year of Life: Receptive Language
timeFrame: From 3 to 12 months of age
measure: Change in Neuropsychomotor Development During First Year of Life: Expressive Language
timeFrame: From 3 to 12 months of age
measure: Change in Neuropsychomotor Development During First Year of Life: Fine Motor
timeFrame: From 3 to 12 months of age
measure: Change in Neuropsychomotor Development During First Year of Life: Gross Motor
timeFrame: From 3 to 12 months of age
Secondary outcomes:
measure: Change in Child Brain Maturation
timeFrame: At 6 and 12 months
measure: Mother-child Attachment Biomarker
timeFrame: At 6 and 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Guilherme V Polanczyk, PhD
role: STUDY_CHAIR
References: