Clinical trial NCT05887115: Nurse Family Partnership for Women With Previous Live Births
Official title: Trial of Nurse Family Partnership for Women With Previous Live Births
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy, High Risk
Child Development
Post Partum Depression
Keywords: Nurse Family Partnership
Home Visiting
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
name: University of Rochester
name: Columbia University
name: Yale University
First posted: 2023-06-02
Enrollment: 500
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

A supplemental study to this study, led by investigators at Yale and Columbia, includes the following Aims:

Aim 1: Test whether the NFP causes variation in DNAm at Glucocorticoid-sensitive sites in infants over the first year of life.

Aim 2: Determine whether NFP causes differences in epigenetic age in infants over the first year of life.

Aim 3: Evaluate DNAm signatures as predictors of infant development at 12 months of age.

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 pregnancy resource referral centers to identify a process that fits into each site's flow for identifying and recruiting eligible multiparous pregnant women at 32 weeks EGA (estimated gestational age) or less to participate in the study. The study will recruit 500 women to participate. Half will be receiving NFP and half will be receiving 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.

Supplemental study hypotheses:

Hypothesis 1: maternal NFP participation causes DNAm variation at glucocorticoid-sensitive sites across the genome at birth, controlling for genetic ancestry

Hypothesis 2: NFP participation reduces DNAm age acceleration from birth to 12 months of age, controlling for genetic variation.

Hypothesis 3: Glucocorticoid-sensitive DNAm and epigenetic aging in offspring measured across infancy (birth to 12 months) will correlate with infant development at 12 months.

Women will be asked to participate in four data collection episodes at study enrollment/baseline (prior to 36 weeks gestation), 6 to 8 weeks postpartum, and child ages 6 and 9 months, and (if consented), to an additional visit at child age 12 months for the supplemental DNAm study.

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) data from medical record review of mothers and their children; 6) birth certificate data; 7) buccal cell samples (infants) collected by the research assistant or self-collected by the participant with guidance from the research assistant.

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 4 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 post partum and 6 month visits only involve maternal report measures and can be conducted by telephone/video using online surveys, unless the participant consents to the cheek swab at the post partum visit, which would be collected in-person.

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.

Eligibility criteria: Inclusion Criteria:

1. pregnant at 32 weeks EGA or less
2. history of previous live birth
3. covered by Medicaid or Medicaid-eligible
4. 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:

1. unable converse and demonstrate adequate understanding to provide consent for study participation in English or Spanish
2. are already enrolled in a home-visiting intervention with this pregnancy
3. have previously been enrolled in NFP
4. under the age of 16 years. Note that we propose to exclude those who don't speak English or Spanish from our study because the community served by the two NFP delivery sites participating in our study is mostly English-speaking with some Spanish-speaking. However, those who don't speak English or Spanish 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.

Primary outcomes:
measure: Presence of Pregnancy-related hypertension
timeFrame: Birth of index child
measure: Change in maternal tobacco use by cotinine
timeFrame: Less than 28 weeks gestation and 36 weeks gestation
measure: Change in self reported maternal tobacco use
timeFrame: Less than 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months
measure: Index child language development measured by the Bayley IV language subscale
timeFrame: Index child age 12 months
measure: Index child language development measured by the Peabody Picture Vocabulary Test
timeFrame: Index child age 9 months
measure: DNA methylation biomarkers
timeFrame: Within 6 weeks of index birth (postpartum) and child age 12 months
Secondary outcomes:
measure: Number of participants with infection during pregnancy based on medical record review
timeFrame: Index child age 1 month
measure: Number of infants born with weight less than 2500 grams per medical record review
timeFrame: Index child age 1 month
measure: Number of infants born less than 34 weeks gestation per medical record review
timeFrame: Index child age 1 month
measure: Change in self-reported maternal substance use
timeFrame: Less than 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months
measure: Initiation and continuation of any breastfeeding per maternal report
timeFrame: Index child age 1 month, 6 months
measure: Percentage of well-child visits attended for index child per medical record review
timeFrame: Index child age 9-12 months
measure: Index child immunization use per medical record review
timeFrame: Record review at index child age 9-12 months
measure: Index child emergency room visits for serious preventable injuries and sentinel injuries for child abuse.
timeFrame: Index child age birth to 9 months, Record review at index child age 9-12 months
measure: Index child hospitalization for injuries
timeFrame: Record review at index child age 9-12 months
measure: Change in quality of home environment measured by the HOME (Home Observation Measurement of the Environment) Inventory short form
timeFrame: 36 weeks gestation, index child age 6 months
measure: Change in quality of home environment measured by the CHAOS (Confusion, Hubbub and Order Scale) Scale
timeFrame: 36 weeks gestation, index child age 6 months
measure: Mother-child interaction measured by the Dyadic Assessment of Naturalistic Caregiver-child Experiences (DANCE)
timeFrame: Index child age 9 months
measure: Child's developmental index measured by Bayley IV developmental assessment
timeFrame: Index child age 12 months
measure: Index child's social and emotional development based on Bayley IV socio-emotional subscale
timeFrame: Index child age 12 months
measure: Index child's social and emotional development measured by the Child Behavior Checklist (CBCL) (maternal report)
timeFrame: Index child age 6 months
measure: Change in maternal perceived stress measured by Perceived Stress Scale (maternal report)
timeFrame: Less than 36 weeks gestation and index child age 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: University of Colorado School of Medicine
name: Mandy A Allison, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Nationwide Children's Hospital
name: Deena Chisolm, PhD
role: PRINCIPAL_INVESTIGATOR
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