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

NCT04362098 | Unknown DMC

• 1 other identifier: 2016/22455-8
• Study Type: interventional
• Target: 167
• 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 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

Keywords

Child Development; Infant; Mother-Child Relations

Outcome Measures

Primary Outcomes (5)

• Change in Neuropsychomotor Development During First Year of Life: Cognition

  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

• Change in Neuropsychomotor Development During First Year of Life: Receptive Language

  Child assessment with the Bayley Scale of Infant Development.

  From 3 to 12 months of age

• Change in Neuropsychomotor Development During First Year of Life: Expressive Language

  Child assessment with the Bayley Scale of Infant Development

  From 3 to 12 months of age

• Change in Neuropsychomotor Development During First Year of Life: Fine Motor

  Child assessment with the Bayley Scale of Infant Development, fine motor scale.

  From 3 to 12 months of age

• Change in Neuropsychomotor Development During First Year of Life: Gross Motor

  Child assessment with the Bayley Scale of Infant Development

  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 home visits biweekly.

Behavioral: Home visiting Program for Young Pregnant Women

Usual care

NO INTERVENTION

Usual care.

Interventions

Home visiting Program for Young Pregnant Women BEHAVIORAL

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.

Nurse home visits

Eligibility Criteria

• Age: 14 Years - 20 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

Study Officials

• Guilherme V Polanczyk, PhD

  University of Sao Paulo

  STUDY CHAIR

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: April 22, 2020
• First Posted: April 24, 2020
• Study Start: June 13, 2018
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

BR (1)