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Behavioral Intervention

Nurse-Family Partnership for Maternal Behavior (NFP Trial)

Q: Are recruiting efforts underway for this experiment?

According to official information hosted on clinicaltrials.gov, the specified trial is no longer accepting patients. This research was first posted in April 2016 and updated as of January 2022; 282 other trials are still actively looking for participants, however.

Q: What is the overarching aim of this experiment?

This medical trial will measure its success over a 24 month period postpartum and aim to reduce inter-birth intervals below 21 months. The secondary outcomes that are being assessed include small for gestational age (SGA), very low birth weight, and severe acute maternal morbidity as defined by the Centers for Disease Control and Prevention.

Q: Is participation in this medical experiment open to the public?

This experiment is looking for 5820 individuals who have experienced premature births and are between 15-55 years old. To apply, these conditions must first be met.

Q: Are there any locations in North America that have implemented this medical investigation?

This study is currently being conducted at 9 sites, including Anderson, Orangeburg and Spartanberg. Other cities are also offering participation in the trial - it's suggested to pick a clinic close by so as to reduce travel needs should you decide to join.

Q: Does this trial offer the opportunity for those over 20 to participate?

As per the criteria for participation in this trial, potential enrollees must be between 15 and 55 years old.

N/A

Waitlist Available

Led By Margaret McConnell, PhD

Research Sponsored by Harvard School of Public Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 15-55

Gestation period less than 28 weeks (i.e. less than or equal to 27 weeks, 6 days) at time of recruitment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years postpartum; medicaid claims, hospital discharge

Awards & highlights

NFP Trial Summary

This trial will test if the Nurse Family Partnership (NFP) program, which provides home visits to low-income first-time mothers, improves maternal and child health outcomes. The study will enroll 4000 mothers in the intervention group and 2000 in the control group, and compare health outcomes using administrative records.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves educational and support services rather than medical treatments, traditional side effects are not applicable. However, participants may experience varying levels of emotional or psychological impact from their involvement.

NFP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 15 and 55 years old.

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I am less than 28 weeks pregnant.

NFP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year postpartum; mortality records

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year postpartum; mortality records

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year postpartum; mortality records for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite birth outcome

Inter-birth interval of < 21 months

Major injury or concern for abuse or neglect

Secondary outcome measures

Adequate prenatal care

Antidepressant prescription

Any emergency department visit for child

+51 more

NFP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment-NFPExperimental Treatment1 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: ControlActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Harvard School of Public HealthLead Sponsor

122 Previous Clinical Trials

1,929,870 Total Patients Enrolled

1 Trials studying Premature Birth

8,468 Patients Enrolled for Premature Birth

Abdul Latif Jameel Poverty Action LabOTHER

27 Previous Clinical Trials

176,722 Total Patients Enrolled

Harvard School of Public Health (HSPH)Lead Sponsor

272 Previous Clinical Trials

16,299,192 Total Patients Enrolled

5 Trials studying Premature Birth

14,356 Patients Enrolled for Premature Birth

Media Library

Nurse-Family Partnership (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03360539 — N/A

Premature Birth Clinical Trial 2023: Nurse-Family Partnership Highlights & Side Effects. Trial Name: NCT03360539 — N/A

Nurse-Family Partnership (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03360539 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruiting efforts underway for this experiment?

"According to official information hosted on clinicaltrials.gov, the specified trial is no longer accepting patients. This research was first posted in April 2016 and updated as of January 2022; 282 other trials are still actively looking for participants, however."

Answered by AI

What is the overarching aim of this experiment?

"This medical trial will measure its success over a 24 month period postpartum and aim to reduce inter-birth intervals below 21 months. The secondary outcomes that are being assessed include small for gestational age (SGA), very low birth weight, and severe acute maternal morbidity as defined by the Centers for Disease Control and Prevention."

Answered by AI

Is participation in this medical experiment open to the public?

"This experiment is looking for 5820 individuals who have experienced premature births and are between 15-55 years old. To apply, these conditions must first be met."

Answered by AI

Are there any locations in North America that have implemented this medical investigation?

"This study is currently being conducted at 9 sites, including Anderson, Orangeburg and Spartanberg. Other cities are also offering participation in the trial - it's suggested to pick a clinic close by so as to reduce travel needs should you decide to join."

Answered by AI