Nurse Family Partnership for Women With Previous Live Births

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pregnancy, High Risk, Child Development, Post Partum Depression

Intervention / Treatment
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* Behavioral: Nurse Family Partnership


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention (NFP)<br>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<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nurse Family Partnership, Home Visiting