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

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 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.

Official Title
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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

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: 20 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 home visits biweekly. | Behavioral: Home visiting Program for Young Pregnant Women<br>* 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.<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: 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 | 

 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