This trial is active, not recruiting.

Condition child development
Treatment home visiting program for young pregnant women
Sponsor University of Sao Paulo
Start date June 2015
End date May 2017
Trial size 80 participants
Trial identifier NCT02807818, 0722-03


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Nurse biweekly home visit.
home visiting program for young pregnant women
(No Intervention)
Usual care.

Primary Outcomes

Change in neuropsychomotor development during first year of life
time frame: From 3 to 12 months of age

Secondary Outcomes

Change in child brain maturation
time frame: At 6 and 12 months
Mother-child attachment biomarker
time frame: At 6 and 12 months

Eligibility Criteria

Female participants from 14 years up to 19 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Sao Paulo.