Nurse-Family Partnership for Maternal Behavior

(NFP Trial)

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

5820 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. The study will be based in South Carolina, where a Medicaid waiver in combination with a pay-for-success contract will allow expansion of the program to women on Medicaid. The study plans to enroll 4000 low-income, first time mothers and their children into the intervention group, and another 2000 into the control group. The study will evaluate the program's impacts on outcomes using administrative records. This study aims to yield new evidence on the effect of NFP in a modern context, applied to a new population, across a broad range of outcomes, and financed by a novel public-private partnership based on accountability for outcomes.

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.

Is the Nurse-Family Partnership program safe for participants?

The Nurse-Family Partnership program has been studied extensively in various settings, including the United States, Canada, and England, and is generally considered safe for participants. It is a home-visit program aimed at supporting young, first-time mothers, and no significant safety concerns have been reported in the available research. ^{1 2 3 4 5}

How is the Nurse-Family Partnership treatment different from other treatments for maternal behavior?

The Nurse-Family Partnership is unique because it involves intensive home visits by nurses to support first-time, disadvantaged mothers from early pregnancy until their child's second birthday, focusing on improving maternal and child health, family environment, and maternal self-efficacy. Unlike other treatments, it is a preventive intervention that has been adapted for different cultural contexts and includes mental health augmentation to address issues like maternal depression and partner violence. ^{5 6 7 8 9}

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

The Nurse-Family Partnership (NFP) program is shown to be effective in supporting first-time, low-income mothers by improving maternal and child health outcomes. It also helps address mental health issues like depression and partner violence, which can affect the mother-child relationship. ^{5 10 11 12 13}

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

Live within an area serviced by a NFP Implementing Agency

Not currently enrolled in the study

Income level meets Medicaid eligibility criteria

Exclusion Criteria

Women whose income level does not meet Medicaid eligibility criteria

Women who have had a previous live birth

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

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]

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 (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. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of the mother-nurse partnership programme on mother and infant outcomes in paediatric cardiac intensive care unit. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Working in partnership with parents: the experience and challenge of practice innovation in child and family health nursing. [2012]

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

The process and promise of mental health augmentation of nurse home-visiting programs: Data from the Louisiana Nurse-Family Partnership. [2019]

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

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

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

Nurse home visiting: Perspectives from nurses. [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. 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]

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

Patterns of visit attendance in the nurse-family partnership program. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Evaluating the family nurse partnership in England: the Building Blocks trial. [2016]

10. Netherlands pubmed.ncbi.nlm.nih.gov

"This has changed me to be a better mum": A qualitative study exploring how the Australian Nurse-Family Partnership Program contributes to the development of First Nations women's self-efficacy. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of the Family Nurse Partnership (FNP) programme in England: Evidence from the building blocks trial. [2022]

12. Wales pubmed.ncbi.nlm.nih.gov

Evaluation of the effectiveness of the Family Nurse Partnership home visiting programme in first time young mothers in Scotland: a protocol for a natural experiment. [2022]

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

Effects of home visits by paraprofessionals and by nurses on children: follow-up of a randomized trial at ages 6 and 9 years. [2022]