Nurse Family Partnership for Women With Previous Live Births

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT05887115

Collaborator

Nationwide Children's Hospital (Other), University of Rochester (Other)

880

Enrollment

Location

Arms

Anticipated Duration (Months)

18.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy, High Risk Child Development Post Partum Depression	Behavioral: Nurse Family Partnership	N/A

Detailed Description

The proposed study will be conducted in partnership with two or more NFP sites in Columbus and Dayton, Ohio. Investigators will work with the prenatal care clinics and pregnancy resource referral centers to identify a process that fits into each site's flow for identifying and recruiting eligible multiparous pregnant women at 28 weeks EGA (estimated gestational age) or less to participate in the study. The study will recruit 800 women to participate. Half will be randomized to receive NFP and half will be randomized to receive any other community services available outside of NFP. Researchers will compare the intervention group with the control group to test the effects described in the Aims above (as outlined in the following hypotheses).

Hypothesis 1-Compared to multiparous women who receive usual care, women who receive NFP will have reductions in pregnancy-related hypertension and tobacco use.

Hypothesis 2-Compared to children of women who receive usual care, those whose mothers receive NFP will have improved language development.

Women will be asked to participate in seven data collection episodes at study enrollment/baseline, 36 to 40 weeks pregnancy, 6 to 8 weeks postpartum, and child ages 6, 12, 18, and 24 months.

Researchers will use the following data sources for this study: 1) data routinely collected by the NFP team to determine enrollment and engagement in the NFP program of study participants randomized to NFP; 2) self-administered and interview surveys of study participants collected by the research assistant; 3) formal observation-based assessment tools (such as the Bayley assessment of child development) administered by the research assistant; 4) videos of parent-child interactions recorded by the research assistant and coded by parenting experts; 5) saliva samples (mothers) collected by the research assistant or self-collected by the participant with guidance from the research assistant; 6) data from medical record review of mothers and their children; and 7) birth certificate data.

The research assistants will conduct all the primary data collection from mother-child dyads who have agreed to participate in the trial, and primary data collection will be separate from NFP program delivery which will be conducted by the NFP nurses. Primary data collection will occur at 7 time points as described above. Primary data collection will occur in the participants' homes or at another location where the participant and research assistant feel comfortable (such as a meeting room in a public library). The majority of measures could be collected in a variety of settings with the exception of the video-taped interactions between parents and children which would ideally occur in the child's natural environment. The postpartum and 12 month visits only involve maternal report measures and can be conducted by telephone/video using online surveys.

The research assistant will record where each data collection episode occurred. The research assistant will also record all attempts made to contact study participants for data collection and missed episodes of data collection (i.e., if a visit were arranged and the participant were not available). The research assistant will be trained regarding appropriate collection, transport, and storage procedures for biologic samples and will be trained to conduct the Bayley assessment of child development.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

880 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Masking Description:

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.

Primary Purpose:

Health Services Research

Official Title:

Randomized Clinical Trial of Nurse Family Partnership for Women With Previous Live Births

Actual Study Start Date :

Mar 31, 2023

Anticipated Primary Completion Date :

Feb 28, 2026

Anticipated Study Completion Date :

Feb 28, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention (NFP) 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 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.
No Intervention: Control 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.

Arm

Intervention/Treatment

Active Comparator: Intervention (NFP)

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

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.

No Intervention: Control

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.

Outcome Measures

Primary Outcome Measures

Presence of Pregnancy-related hypertension [Birth of index child]
High Blood Pressure associated with pregnancy
Change in maternal tobacco use by cotinine [Less than 28 weeks gestation and 36 weeks gestation]
Measured by cotinine level in saliva
Change in self reported maternal tobacco use [Less than 28 weeks gestation, 36 weeks gestation, index child age 6 months, 12 months, and 24 months.]
Measured by self-report (yes/no)
Index child language development measured by the Bayley IV language subscale [Index child age 24 months]
Scaled, age-adjusted score from 1-19 with 19 being best outcome
Index child language development measured by the MacArthur Bates CDI (Communicative Development Inventories) [Index child age 24 months]
Percentage out of 100; 100 being best outcome

Secondary Outcome Measures

Number of participants with infection during pregnancy based on medical record review [Index child age 1 month]
Receipt of screening for common infections; if positive, receipt of appropriate treatment
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 28 weeks gestation, 36 weeks gestation, index child ages 6, 12, 18, 24 months]
Past month use per self-report (yes/no)
Initiation and continuation of any breastfeeding per maternal report [Index child age 1 month, 6 months and 12 months]
Percentage of well-child visits attended for index child per medical record review [Index child age 18-24 months]
Number out of 7 visits by 12 months
Index child immunization use per medical record review [Record review at index child age 18-24 months]
Immunizations up-to-date for age at 18 months
Index child emergency room visits for serious preventable injuries and sentinel injuries for child abuse. [Index child age birth to 24 months, collected at 24 months]
Visit rate and reason for visit per medical record review
Index child hospitalization for injuries [Record review at index child age 24 months]
Number of days hospitalized for injury per medical record review
Change in quality of home environment measured by the HOME (Home Observation Measurement of the Environment) Inventory short form [36 weeks gestation, index child age 18 months]
53 yes/no measures; score scaled based on child age, self-report and interviewer observation
Change in quality of home environment measured by the CHAOS (Confusion, Hubbub and Order Scale) Scale [36 weeks gestation, index child age 24 months]
On a scale of 1-15, The higher the score the higher the level of environmental chaos in the home
Mother-child interaction measured by the Dyadic Assessment of Naturalistic Caregiver-child Experiences (DANCE) [Index child age 18 months]
Video recorded interactions are scored by trained research assistants, for each behavior the frequency and proportion of time spent is recorded.
Child's developmental index measured by Bayley IV developmental assessment [Index child age 24 months]
Scaled, age-adjusted score from 1-19 with 19 being best outcome
Index child's social and emotional development based on Bayley IV socio-emotional subscale [Index child age 24 months]
Scaled, age-adjusted score from 1-19 with 19 being best outcome
Index child's social and emotional development measured by the Child Behavior Checklist (CBCL) (maternal report) [Index child age 24 months]
54 question scored on a scale of 0-2; lower scores are more emotionally regulated children
Change in maternal perceived stress measured by Perceived Stress Scale (maternal report) [Less than 28 weeks gestation and index child age 6 months]
Scale of 0-40 based on 10 questions; 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

pregnant at 28 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).

Exclusion Criteria:

unable converse and demonstrate adequate understanding to provide consent for study participation in English
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 from our study because the community served by the two NFP delivery sites participating in our study is mostly English-speaking. However, those who don't speak English 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

University of Colorado, Denver
Nationwide Children's Hospital
University of Rochester

Investigators

Principal Investigator: Mandy A Allison, MD, MSPH, University of Colorado School of Medicine
Principal Investigator: Deena Chisolm, PhD, Nationwide Children's Hospital

Study Documents (Full-Text)

Informed Consent Form - Feb 21, 2023

More Information

Additional Information:

Publications

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT05887115

Other Study ID Numbers:

20-0470

First Posted:

Jun 2, 2023

Last Update Posted:

Jun 2, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Colorado, Denver

Nurse Family Partnership

Home Visiting

Additional relevant MeSH terms:

Depression, Postpartum

Study Results

No Results Posted as of Jun 2, 2023