Nurse-Family Partnership for Maternal Behavior

(NFP Trial)

Not currently recruiting at 8 trial locations

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Harvard School of Public Health

Disqualifiers: Men, Previous births, Not pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Nurse-Family Partnership (NFP), a program where nurses visit first-time, low-income mothers at home to provide support and guidance from pregnancy until the child reaches two years of age. The goal is to evaluate how this program affects various outcomes for mothers and their children using data from official records. Participants will either join the NFP program or receive standard community care. This trial targets first-time pregnant women who are less than 28 weeks into their pregnancy, meet Medicaid income criteria, and live in areas where the program operates. As an unphased trial, this study offers a unique opportunity to enhance understanding of the benefits of supportive care for new mothers and their children.

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 prior data suggests that the Nurse-Family Partnership is safe for maternal behavior?

Research shows that the Nurse-Family Partnership (NFP) program is generally safe and well-received. Studies indicate that while the program does not significantly change birth outcomes, it does not increase the risk of harm either. For instance, one study found that 26.9% of participants in the NFP group experienced adverse birth events, similar to those not in the program. The NFP program focuses on improving prenatal care and early childhood outcomes through regular home visits by nurses. These visits have been shown to aid child language development and enhance mothers' mental health. Overall, evidence suggests that joining the NFP is safe and can positively affect both mothers and children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nurse-Family Partnership program because it offers a proactive, personalized approach to supporting low-income, first-time mothers. Unlike traditional care options that may focus primarily on medical check-ups and community services, this program involves registered nurses visiting mothers regularly from early pregnancy until the child is two years old. This consistent support helps mothers make informed decisions and build strong, healthy family dynamics. By fostering a close, ongoing relationship, the program aims to improve maternal behavior and child outcomes significantly, which could lead to long-term benefits for families.

What evidence suggests that the Nurse-Family Partnership is effective for maternal behavior?

Research has shown that the Nurse-Family Partnership (NFP) program, which participants in this trial may receive, positively impacts several areas. Studies indicate that NFP can enhance children's health and cognitive skills, with improvements in thinking skills observed by age two. Evidence also suggests that mothers in the program are less likely to have another baby within 18 months. Although NFP does not significantly reduce child injuries or pregnancies beyond this period, it improves mothers' reports of their children's language and mental health. Overall, these findings suggest that NFP can lead to better outcomes for both mothers and their children. ^{1 2 3 5 6}

Who Is on the Research Team?

Margaret McConnell, PhD

Principal Investigator

Harvard School of Public Health (HSPH)

Are You a Good Fit for This Trial?

This trial is for low-income, first-time mothers aged 15-55 who are currently pregnant with gestation less than 28 weeks. Participants must live in areas served by the Nurse-Family Partnership (NFP) agencies, meet Medicaid eligibility criteria, and not be incarcerated or enrolled in this study already.

Inclusion Criteria

Income level meets Medicaid eligibility criteria

Live within an area serviced by a NFP Implementing Agency

Not currently enrolled in the study

Exclusion Criteria

Women who have had a previous live birth

Women whose income level does not meet Medicaid eligibility criteria

I am at least 28 weeks pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Nurses visit low-income, first-time mothers regularly from early pregnancy until the child is two years old

Up to 24 months

Regular home visits

Follow-up

Participants are monitored for maternal and child outcomes using administrative data

24 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Nurse-Family Partnership

Trial Overview The effects of the Nurse-Family Partnership program on preventing premature births and improving maternal behavior are being tested. The trial randomly assigns eligible women to either receive NFP services or to a control group, comparing outcomes using administrative records.

How Is the Trial Designed?

Group I: Treatment-NFP Experimental Treatment 1 Intervention

NFP is a prenatal and infancy home visiting program for low-income, first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, helping the mother-to-be make informed choices. The nurses continue visiting regularly until the child is two years old.

Group II: Control Active Control 1 Intervention

Control group members have access to the standard of care and whatever other programs and services are available in the community.

Who Is Running the Clinical Trial?

Harvard School of Public Health

Lead Sponsor

Trials

123

Recruited

1,938,000+

Harvard School of Public Health (HSPH)

Lead Sponsor

Trials

283

Recruited

17,030,000+

Abdul Latif Jameel Poverty Action Lab

Collaborator

Trials

31

Recruited

273,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4512284/

Projected Outcomes of Nurse-Family Partnership Home ... We assumed effectiveness in replication declined by 21.8%, proportionally with the decline in mean visits per family from trials to operational programs.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0145213425003564

Effectiveness of Nurse-Family Partnership on child ... Results from a US NFP trial conducted in Colorado analyzed available child data (29 % attrition in NFP arm) and reported higher cognition at age two years for ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38784984

Evaluating the real-world implementation of the Family ... Maternal outcomes: There was some evidence that Family Nurse Partnership mothers were less likely to have a subsequent delivery within 18 months of the index ...

4. nfpinternational.org nfpinternational.org/research/

NFP Research - Nurse-Family Partnership (NFP) International Three randomized, controlled trials demonstrate that Nurse-Family Partnership delivers against its goals of better pregnancy outcomes, improved child health and ...

5. acamh.onlinelibrary.wiley.com acamh.onlinelibrary.wiley.com/doi/abs/10.1111/jcpp.13846

Effectiveness of nurse‐home visiting in improving child and ... NFP did not reduce child injuries or subsequent maternal pregnancies but did improve maternal-reported child language and mental health (problem ...

6. hsph.harvard.edu hsph.harvard.edu/news/new-research-on-intensive-nurse-home-visiting-program-shows-no-impact-on-birth-outcomes-study-is-ongoing/

New research on intensive nurse home visiting program ... Researchers found that individuals randomized to receive NFP services experienced adverse birth events at a rate of 26.9 percent, compared to a ...