Nurse Family Partnership for Women With Previous Live Births

Not Applicable

Recruiting

• Conditions: Post Partum Depression; Pregnancy, High Risk; Child Development
• Interventions: Behavioral: Nurse Family Partnership

• Registration Number: NCT05887115
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2023-03-31
• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-26
• Primary Completion: 2027-02-28
• Study Completion: 2028-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (NFP)	Nurse Family Partnership	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.

Primary Outcome Measures

Name	Time	Method
Index child language development measured by the Bayley IV language subscale	Index child age 12 months	Scaled, age-adjusted score from 1-19 with 19 being best outcome
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 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months	Measured by self-report (yes/no)
Presence of Pregnancy-related hypertension	Birth of index child	High Blood Pressure associated with pregnancy
Index child language development measured by the Peabody Picture Vocabulary Test	Index child age 9 months	Percentage out of 100; 100 being best outcome
DNA methylation biomarkers	Within 6 weeks of index birth (postpartum) and child age 12 months	Epigenetic age and glucocorticoid-sensitive DNA methylation score from methylation array data

Secondary Outcome Measures

Name	Time	Method
Child's developmental index measured by Bayley IV developmental assessment	Index child age 12 months	Scaled, age-adjusted score from 1-19 with 19 being best outcome
Mother-child interaction measured by the Dyadic Assessment of Naturalistic Caregiver-child Experiences (DANCE)	Index child age 9 months	Video recorded interactions are scored by trained research assistants, for each behavior the frequency and proportion of time spent is recorded.
Initiation and continuation of any breastfeeding per maternal report	Index child age 1 month, 6 months	Maternal report of any breastfeeding
Index child immunization use per medical record review	Record review at index child age 9-12 months	Immunizations up-to-date for age at 9 months
Index child's social and emotional development measured by the Child Behavior Checklist (CBCL) (maternal report)	Index child age 6 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 36 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.
Change in self-reported maternal substance use	Less than 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months	Past month use per self-report (yes/no)
Index child emergency room visits for serious preventable injuries and sentinel injuries for child abuse.	Index child age birth to 9 months, Record review at index child age 9-12 months	Visit rate and reason for visit per medical record review
Index child hospitalization for injuries	Record review at index child age 9-12 months	Number of days hospitalized for injury per medical record review
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 quality of home environment measured by the CHAOS (Confusion, Hubbub and Order Scale) Scale	36 weeks gestation, index child age 6 months	On a scale of 1-15, The higher the score the higher the level of environmental chaos in the home
Index child's social and emotional development based on Bayley IV socio-emotional subscale	Index child age 12 months	Scaled, age-adjusted score from 1-19 with 19 being best outcome
Percentage of well-child visits attended for index child per medical record review	Index child age 9-12 months	Number out of 6 visits by 9 months
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 6 months	53 yes/no measures; score scaled based on child age, self-report and interviewer observation

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States