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

NCT02807818 | Unknown DMC

• 1 other identifier: 0722-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development

Keywords

Child development; Infant; Mother-Child Relations

Outcome Measures

Primary Outcomes (1)

• Change in neuropsychomotor development during first year of life

  Complete child assessment with the Bayley Scale of Infant Development at 3, 6 and 12 months of age.

  From 3 to 12 months of age

Secondary Outcomes (2)

• Change in child brain maturation

  At 6 and 12 months

• Mother-child attachment biomarker

  At 6 and 12 months

Study Arms (2)

Nurse home visits

EXPERIMENTAL

Nurse biweekly home visit.

Behavioral: Home visiting Program for Young Pregnant Women

Usual care

NO INTERVENTION

Usual care.

Interventions

Home visiting Program for Young Pregnant Women BEHAVIORAL

Nurse home visits

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Low socioeconomic status
• Mother's age between 14-19
• Mother being a primapara
• Gestation between the 8th and 16th week

You may not qualify if:

• High-risk gestation
• Mother's Intellectual, visual or auditory disability

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403010, Brazil

Location

Related Publications (5)

• da Silva LA, Siqueira LD, Oliveira LGF, Miguel Filho EC, Polanczyk GV, Fracolli LA. The impact of a home visiting program on the care environment of Brazilian adolescent mothers - an descriptive exploratory study. Front Glob Womens Health. 2025 Apr 25;6:1530351. doi: 10.3389/fgwh.2025.1530351. eCollection 2025.

  PMID: 40351759 DERIVED

• 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.

  PMID: 35256034 DERIVED

• 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.

  PMID: 34257407 DERIVED

• 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.

  PMID: 33844435 DERIVED

• 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.

  PMID: 32720906 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 21, 2016
• Study Start: June 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

BR (1)