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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Child Development

Intervention / Treatment
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* Behavioral: Home visiting Program for Young Pregnant Women


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse home visits<br>Nurse biweekly home visit. | Behavioral: Home visiting Program for Young Pregnant Women<br> <br> |
| No Intervention: Usual care<br>Usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child development, Infant, Mother-Child Relations