Nurse Family Partnership for Pregnancies

Overseen By Natalie J Murphy

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Non-English/Spanish speakers, Under 16, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: Up to 24 months

500 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the Nurse-Family Partnership treatment?

Research shows that the Nurse-Family Partnership program, which involves nurses visiting first-time, low-income mothers at home, has been effective in improving pregnancy outcomes, child health and development, and increasing maternal economic self-sufficiency in the United States. However, its effectiveness in different settings, like Canada, still needs further evaluation. ^{1 2 3 4 5}

Is the Nurse-Family Partnership program safe for participants?

The Nurse-Family Partnership (NFP) program has been evaluated in multiple studies, primarily focusing on its effectiveness in improving health outcomes for mothers and children. While these studies do not specifically address safety concerns, the program involves home visits by trained nurses, which suggests a focus on supportive and safe interactions. ^{2 3 5 6 7}

How is the Nurse-Family Partnership treatment different from other treatments for supporting young, low-income, first-time mothers?

The Nurse-Family Partnership is unique because it involves public health nurses making regular home visits to support young, low-income, first-time mothers from early pregnancy until their child is two years old, focusing on improving pregnancy outcomes, child development, and maternal self-sufficiency. ^{1 2 3 5 7}

What is the purpose of this trial?

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.

Research Team

Deena Chisolm, PhD

Principal Investigator

Nationwide Children's Hospital

Mandy A Allison, MD, MSPH

Principal Investigator

University of Colorado School of Medicine

Eligibility Criteria

This trial is for pregnant women who are less than 28 weeks along, have had a previous live birth, and qualify for Medicaid. They must also meet one of these conditions: under 20 years old, no high school diploma, homeless, past low-weight or premature births, severe pregnancy complications before, got pregnant within 18 months after last pregnancy, use tobacco or marijuana currently or have a history of substance abuse.

Inclusion Criteria

Pregnant at 28 weeks EGA or less

History of previous live birth

Covered by Medicaid or Medicaid-eligible

Exclusion Criteria

I am younger than 16 years old.

Already enrolled in a home-visiting intervention with this pregnancy

Have previously been enrolled in NFP

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

1 visit (in-person)

Enrollment/Baseline

Data collection at study enrollment prior to 36 weeks gestation

1 week

1 visit (in-person or virtual)

Treatment

Participants receive the Nurse Family Partnership intervention or usual care

Up to 24 months

Weekly to bi-weekly visits (in-person or virtual)

Postpartum Data Collection

Data collection at 6 to 8 weeks postpartum

2 weeks

1 visit (in-person or virtual)

Child Development Follow-up

Data collection at child ages 6, 9, and 12 months

6 months

3 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nurse Family Partnership

Trial Overview The Nurse Family Partnership program is being tested to see if it helps reduce health problems in mothers with more than one child and improves the outcomes for their new baby as well as older siblings under six. The program involves home visits from nurses to provide support.

Participant Groups

Group I: Intervention (NFP) Active Control 1 Intervention

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.

Group II: Control Active Control 1 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.

Nurse Family Partnership is already approved in United States for the following indications:

Approved in United States as Nurse-Family Partnership for:

• Pregnancy support for low-income first-time mothers
• Maternal and child health improvement

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Nationwide Children's Hospital

Collaborator

Trials

354

Recruited

5,228,000+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

Findings from Research

The Nurse-Family Partnership Nurse Residency Program was well-attended, with over 92% attendance among participants, indicating strong engagement and interest in the program.

Participants reported high satisfaction with the program content and objectives, suggesting that it effectively supports the professional development of new nurses, despite no significant changes in workplace perception scores before and after the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Program implementation and outcomes from three cohorts of the nurse-family partnership nurse residency program. Harpin, SB., Artmann, ALA., Neal, M., et al.[2023]

The Nurse-Family Partnership (NFP) program significantly improved educational outcomes, with a 9.5 percentage point increase in high school diploma or GED attainment among mothers who initially had less than a high school education, compared to a reference group of 787 women.

NFP also enhanced employment outcomes, showing a 7.8 percentage point increase in employment status for mothers who were not employed at baseline, indicating the program's effectiveness in promoting economic self-sufficiency and reducing health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education and employment outcomes in clients of the Nurse-Family Partnership. Flowers, M., Sainer, S., Stoneburner, A., et al.[2021]

The Nurse-Family Partnership (NFP) program significantly reduced prenatal cannabis use and modestly decreased cigarette use among pregnant participants aged 14-24 from disadvantaged backgrounds, based on a study of 739 individuals.

While NFP did not show significant effects on reducing alcohol use or overall substance use rates, it demonstrates potential for improving maternal health by targeting specific substance use behaviors in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse home visiting and prenatal substance use in a socioeconomically disadvantaged population in British Columbia: analysis of prenatal secondary outcomes in an ongoing randomized controlled trial. Catherine, NLA., Boyle, M., Zheng, Y., et al.[2023]

Nurses in the Nurse Family Partnership (NFP) program play a crucial role in supporting first-time, low-income mothers by providing intensive home-visitation services aimed at improving maternal and child health outcomes.

To effectively address the significant psychosocial and mental health challenges faced by these families, nurses must adapt their approach from a traditional medical model to a more psychosocial model, emphasizing the importance of the nurse-client relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse home visiting: Perspectives from nurses. Zeanah, PD., Larrieu, JA., Boris, NW., et al.[2019]

The Nurse-Family Partnership (NFP) program, which has shown effectiveness in the U.S. for improving outcomes for disadvantaged mothers and their children, is being adapted for implementation in Canada, with initial pilot studies confirming its feasibility and acceptability.

The British Columbia Healthy Connections Project (BCHCP) will conduct a randomized controlled trial to evaluate the NFP's effectiveness in Canada, while also exploring biological mechanisms that may link the intervention to positive behavioral outcomes in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting, piloting and evaluating complex public health interventions: lessons learned from the Nurse-Family Partnership in Canadian public health settings. Jack, SM., Catherine, N., Gonzalez, A., et al.[2019]

Public health nurses in British Columbia recognized the importance of collaborating with child protection professionals to support families in need, highlighting a willingness to work together despite facing structural barriers.

The study identified four key themes regarding the nurses' experiences: understanding child protection perspectives, the desire for better collaboration, navigating uncertainties, and addressing the complexities of families and communities, indicating the need for improved integrated practices in health and child protection systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public health nurses' perceptions of their interactions with child protection services when supporting socioeconomically disadvantaged young mothers in British Columbia, Canada. Marcellus, L., Tonmyr, L., Jack, SM., et al.[2022]

Public health nurses (PHNs) reported high levels of job satisfaction and personal fulfillment from their relationships with clients in the Nurse-Family Partnership (NFP) program, highlighting the rewarding nature of their work with vulnerable, young mothers.

However, PHNs also faced significant stress due to workload and workplace factors, which could lead to burnout and compassion fatigue, indicating a need for strategies to support their well-being and improve program delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term home visiting with vulnerable young mothers: an interpretive description of the impact on public health nurses. Dmytryshyn, AL., Jack, SM., Ballantyne, M., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Program implementation and outcomes from three cohorts of the nurse-family partnership nurse residency program. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Education and employment outcomes in clients of the Nurse-Family Partnership. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Nurse home visiting and prenatal substance use in a socioeconomically disadvantaged population in British Columbia: analysis of prenatal secondary outcomes in an ongoing randomized controlled trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Nurse home visiting: Perspectives from nurses. [2019]

5. Canada pubmed.ncbi.nlm.nih.gov

Adapting, piloting and evaluating complex public health interventions: lessons learned from the Nurse-Family Partnership in Canadian public health settings. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Public health nurses' perceptions of their interactions with child protection services when supporting socioeconomically disadvantaged young mothers in British Columbia, Canada. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Long-term home visiting with vulnerable young mothers: an interpretive description of the impact on public health nurses. [2020]