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

Child Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04362098
• Other study ID #: 2016/22455-8
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 13, 2018
• Est. completion date: June 2022

Study information

• Verified date: April 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 167
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Development

Intervention

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.

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in Child Brain Maturation	Assessment of brain wave patterns (alpha, gamma and theta frequencies) via electroencephalography (EEG).	At 6 and 12 months
Secondary	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