Nurse Family Partnership for Women With Previous Live Births

Description

The goal of this clinical trial is to test the Nurse Family Partnership (NFP) in mothers with previous live births (multiparous or multip individuals). The main aims are: Specific Aim 1-Determine the effectiveness of NFP among multiparous women for reducing maternal morbidity and improving pregnancy outcomes. Specific Aim 2-Determine the effectiveness of NFP among index children (child from pregnancy when mother was enrolled) of multiparous women for improving child outcomes. Specific Aim 3 (Exploratory)-In preparation for a future study of the effects of preventive home-visiting programs on mother-index child-sibling triads, describe siblings (characteristics, role, influence) in the context of nurse home-visiting and evaluate the effectiveness of NFP on outcomes for prior-born siblings younger than 6 years old living in the home, including cognitive development, socioemotional development, and identification and referral to needed services. A supplemental study to this study, led by investigators at Yale and Columbia, includes the following Aims: Aim 1: Test whether the NFP causes variation in DNAm at Glucocorticoid-sensitive sites in infants over the first year of life. Aim 2: Determine whether NFP causes differences in epigenetic age in infants over the first year of life. Aim 3: Evaluate DNAm signatures as predictors of infant development at 12 months of age.

Conditions

Pregnancy, High Risk, Child Development, Post Partum Depression

Talk to us

Study Overview

On this page

Study Details

Study overview

The goal of this clinical trial is to test the Nurse Family Partnership (NFP) in mothers with previous live births (multiparous or multip individuals). The main aims are: Specific Aim 1-Determine the effectiveness of NFP among multiparous women for reducing maternal morbidity and improving pregnancy outcomes. Specific Aim 2-Determine the effectiveness of NFP among index children (child from pregnancy when mother was enrolled) of multiparous women for improving child outcomes. Specific Aim 3 (Exploratory)-In preparation for a future study of the effects of preventive home-visiting programs on mother-index child-sibling triads, describe siblings (characteristics, role, influence) in the context of nurse home-visiting and evaluate the effectiveness of NFP on outcomes for prior-born siblings younger than 6 years old living in the home, including cognitive development, socioemotional development, and identification and referral to needed services. A supplemental study to this study, led by investigators at Yale and Columbia, includes the following Aims: Aim 1: Test whether the NFP causes variation in DNAm at Glucocorticoid-sensitive sites in infants over the first year of life. Aim 2: Determine whether NFP causes differences in epigenetic age in infants over the first year of life. Aim 3: Evaluate DNAm signatures as predictors of infant development at 12 months of age.

Trial of Nurse Family Partnership for Women With Previous Live Births

Nurse Family Partnership for Women With Previous Live Births

Condition
Pregnancy, High Risk
Intervention / Treatment

-

Contacts and Locations

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. pregnant at 32 weeks EGA or less
  • 2. history of previous live birth
  • 3. covered by Medicaid or Medicaid-eligible
  • 4. at least one of the following risks or adversities -age 19 or younger, no high school degree or equivalent, homeless (using a standardized definition), previous birth with low birth weight or prematurity, previous pregnancy with severe morbidity based on Centers for Disease Control definition, current pregnancy within 18 months of previous pregnancy, currently using tobacco or marijuana, history of substance use disorder, and self-identification as Black/African American (as a marker of facing the adversity of structural racism).
  • 1. unable converse and demonstrate adequate understanding to provide consent for study participation in English or Spanish
  • 2. are already enrolled in a home-visiting intervention with this pregnancy
  • 3. have previously been enrolled in NFP
  • 4. under the age of 16 years. Note that we propose to exclude those who don't speak English or Spanish from our study because the community served by the two NFP delivery sites participating in our study is mostly English-speaking with some Spanish-speaking. However, those who don't speak English or Spanish are not excluded from participation in NFP, and NFP routinely provides services to all eligible families regardless of language spoken using bilingual/multilingual nurses when available or using interpretation services. NFP materials for nurses to use with families, known as 'facilitators', are available in several languages. In the rare circumstance that a pregnant woman is excluded from participating in our study based on language, they will not be excluded from receiving NFP.

Ages Eligible for Study

16 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Colorado, Denver,

Mandy A Allison, MD, MSPH, PRINCIPAL_INVESTIGATOR, University of Colorado School of Medicine

Deena Chisolm, PhD, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

2028-02-28