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

U

University of Sao Paulo

Status

Unknown

Conditions

Child Development

Treatments

Behavioral: Home visiting Program for Young Pregnant Women

Study type

Interventional

Funder types

Other

Identifiers

NCT04362098
2016/22455-8

Details and patient eligibility

About

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.

Enrollment

167 patients

Sex

Female

Ages

14 to 20 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

167 participants in 2 patient groups

Nurse home visits
Experimental group
Description:
Nurse home visits biweekly.
Treatment:
Behavioral: Home visiting Program for Young Pregnant Women
Usual care
No Intervention group
Description:
Usual care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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