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

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

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.

Study Overview

• Status: Unknown
• Conditions: Child Development
• Intervention / Treatment: Behavioral: Home visiting Program for Young Pregnant Women

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403010
    • Faculdade de Medicina da Universidade de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 20 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nurse home visits; Nurse home visits biweekly.	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.
NO_INTERVENTION: Usual care; Usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Child Brain Maturation	Assessment of brain wave patterns (alpha, gamma and theta frequencies) via electroencephalography (EEG).	At 6 and 12 months
Mother-child Attachment Biomarker	Assessment of event-related potential associated with child face recognition of the mother via electroencephalography (EEG).	At 6 and 12 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Chair: Guilherme V Polanczyk, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 13, 2018
• Primary Completion (ANTICIPATED): June 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (ACTUAL): April 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Child Development; Infant; Mother-Child Relations
• Other Study ID Numbers: 2016/22455-8

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No