Clinical trial NCT02807818: A Home Visiting Program for Pregnant Youth to Promote Early Brain Development
Official title: 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
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: 2016-06-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
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 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.


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
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:
References:
citation: Euclydes VLV, Gastaldi VD, Feltrin AS, Hoffman DJ, Gouveia G, Cogo H, Felipe-Silva A, Vieira RP, Miguel EC, Polanczyk GV, Chiesa A, Fracolli L, Matijasevich A, Ferraro A, Argeu A, Maschietto M, Brentani HP. DNA methylation mediates a randomized controlled trial home-visiting intervention during pregnancy and the Bayley infant's cognitive scores at 12 months of age. J Dev Orig Health Dis. 2022 Oct;13(5):556-565. doi: 10.1017/S2040174421000738. Epub 2022 Mar 8.
citation: Fatori D, Fonseca Zuccolo P, Shephard E, Brentani H, Matijasevich A, Archanjo Ferraro A, Aparecida Fracolli L, Chiesa AM, Leckman J, Constantino Miguel E, V Polanczyk G. A randomized controlled trial testing the efficacy of a Nurse Home Visiting Program for Pregnant Adolescents. Sci Rep. 2021 Jul 13;11(1):14432. doi: 10.1038/s41598-021-93938-7.
citation: Alarcao FSP, Shephard E, Fatori D, Amavel R, Chiesa A, Fracolli L, Matijasevich A, Brentani H, Nelson CA, Leckman J, Miguel EC, Polanczyk GV. Promoting mother-infant relationships and underlying neural correlates: Results from a randomized controlled trial of a home-visiting program for adolescent mothers in Brazil. Dev Sci. 2021 Nov;24(6):e13113. doi: 10.1111/desc.13113. Epub 2021 Apr 12.
citation: Fatori D, Argeu A, Brentani H, Chiesa A, Fracolli L, Matijasevich A, Miguel EC, Polanczyk G. Maternal Parenting Electronic Diary in the Context of a Home Visit Intervention for Adolescent Mothers in an Urban Deprived Area of Sao Paulo, Brazil: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 28;8(7):e13686. doi: 10.2196/13686.