Nurse Family Partnership for Women With Previous Live Births

NCT05887115 | Terminated

• 1 other identifier: 20-0470
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Nurse Family Partnership; Home Visiting

Outcome Measures

Primary Outcomes (6)

• Presence of Pregnancy-related hypertension

  High Blood Pressure associated with pregnancy

  Birth of index child

• Change in maternal tobacco use by cotinine

  Measured by cotinine level in saliva

  Less than 28 weeks gestation and 36 weeks gestation

• Change in self reported maternal tobacco use

  Measured by self-report (yes/no)

  Less than 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months

• Index child language development measured by the Bayley IV language subscale

  Scaled, age-adjusted score from 1-19 with 19 being best outcome

  Index child age 12 months

• Index child language development measured by the Peabody Picture Vocabulary Test

  Percentage out of 100; 100 being best outcome

  Index child age 9 months

• DNA methylation biomarkers

  Epigenetic age and glucocorticoid-sensitive DNA methylation score from methylation array data

  Within 6 weeks of index birth (postpartum) and child age 12 months

Secondary Outcomes (16)

• Number of participants with infection during pregnancy based on medical record review

  Index child age 1 month

• Number of infants born with weight less than 2500 grams per medical record review

  Index child age 1 month

• Number of infants born less than 34 weeks gestation per medical record review

  Index child age 1 month

• Change in self-reported maternal substance use

  Less than 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months

• Initiation and continuation of any breastfeeding per maternal report

  Index child age 1 month, 6 months

Study Arms (2)

Intervention (NFP)

ACTIVE COMPARATOR

In the standard NFP intervention, low-income pregnant women are recruited to voluntarily join the program through their 28th week of pregnancy. Enrolled women receive home visits from a nurse. The visits can occur in-person or via telehealth. In-person visits can occur in the client's home or in another community location agreed upon by the client and the nurse (such as a library or coffee shop). The typical schedule for visits is weekly during the first month after enrollment, every two weeks until the birth of the infant, weekly during the post-partum period, then every two to four weeks until child age two.

Behavioral: Nurse Family Partnership

Control

NO INTERVENTION

The control group will receive usual care for pregnant people, which may include home visiting services from another source other than NFP. Participants who are randomly selected to receive other services will be given information about other services for which they may qualify and information about how to access those services.

Interventions

Nurse Family Partnership BEHAVIORAL

During NFP visits, the nurse: 1) engages in a therapeutic nurse-client relationship focused on promoting client abilities and behavior change to protect and promote her own health and child's health; 2) provides service coordination based on client's identified needs, referring to available community services; 3) follows NFP Visit Guidelines tailoring them to the strengths and challenges of each family; 4) works with client to support a healthy pregnancy by recognizing and reducing risk factors and promoting prenatal health care, healthy diet, exercise, and stress management; and 5) gathers data on program implementation and maternal and child health. The visits include content from six domains: personal health, environmental health, life-course, maternal role, family and friends, and health and human services. Nurses use educational materials to address the content from the six domains with their clients.

Intervention (NFP)

Eligibility Criteria

• Age: 16 Years - 46 Years
• Gender Eligibility Details: Participant must be pregnant to participate; can identify as any gender
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• pregnant at 32 weeks EGA or less
• history of previous live birth
• covered by Medicaid or Medicaid-eligible
• 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).

You may not qualify if:

• unable converse and demonstrate adequate understanding to provide consent for study participation in English or Spanish
• are already enrolled in a home-visiting intervention with this pregnancy
• have previously been enrolled in NFP
• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Nationwide Children's Hospital: collaborator
• University of Rochester: collaborator
• Columbia University: collaborator
• Yale University: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

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MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Mandy A Allison, MD, MSPH

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

• Deena Chisolm, PhD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Research assistants will not collect any NFP program data - only equivalent research data in both control and NFP groups. Research assistants will remind participants not to tell the researchers which group they are in prior to each research data collection. We will also record in our participant tracking database if a researcher is ever "unmasked" (e.g., saw the NFP folder/ materials/participant mentioned their NFP nurse during an interview). Similarly, the nurses providing NFP will not be aware of which of their clients are involved in the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: June 2, 2023
• Study Start: April 29, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available at the close of currently funded study (January 2027) and will be available for 10 years (through December 2036).
• Access Criteria: Criteria used in the review are as follows: 1. Proposal has reasonable scientific merit; allows data to be put to good scientific use. Proposal is both theoretically and empirically sound. 1. Statistical power is appropriate given level of project 2. Likely usefulness for investigator. 3. Likely to contribute to existing knowledge base 2. Investigator's collaborator should be associated with our team. They provide link to our team, may provide access to data or at least communicate what data are available. 3. Proposed analyses have not already been completed or proposed by other collaborators or members of the research team. 4. Demands on current staff time are minimal including: 1. Variable construction 2. Statistical consultation 3. Providing computer access/resources 4. Data cleaning 5. Providing access to data 6. Current load of staff, including existing outside projects

Locations

US (1)