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

NCT04362098 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2020-04-24

No results posted yet for this study

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.

Conditions

  • Child Development

Interventions

BEHAVIORAL

Home visiting Program for Young Pregnant Women

The visitation program was elaborated based in the following theoretical principles: a) Albert Bandura's self-efficacy theory; b) Urie Brofenbrenner's bioecological theory, which recognizes the importance of the insertion of individuals in families in varied contexts of life in society; c) John Bowlby and Mary Ainsworth's attachment theory. The basic premises of the intervention are health care, environmental health, life course development, development of parenting ability, relationship with friends and family, and social service support.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Guilherme V Polanczyk, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-13
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04362098 on ClinicalTrials.gov