Trial of Nurse Family Partnership for Women With Previous Live Births
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Index child language development measured by the Bayley IV language subscale
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 16 Years 至 46 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant at 32 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).
排除标准
- •unable converse and demonstrate adequate understanding to provide consent for study participation in English or Spanish
- •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 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.
结局指标
主要结局
Index child language development measured by the Bayley IV language subscale
时间窗: Index child age 12 months
Scaled, age-adjusted score from 1-19 with 19 being best outcome
Change in maternal tobacco use by cotinine
时间窗: Less than 28 weeks gestation and 36 weeks gestation
Measured by cotinine level in saliva
Change in self reported maternal tobacco use
时间窗: 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
时间窗: Birth of index child
High Blood Pressure associated with pregnancy
Index child language development measured by the Peabody Picture Vocabulary Test
时间窗: Index child age 9 months
Percentage out of 100; 100 being best outcome
DNA methylation biomarkers
时间窗: Within 6 weeks of index birth (postpartum) and child age 12 months
Epigenetic age and glucocorticoid-sensitive DNA methylation score from methylation array data
次要结局
- Child's developmental index measured by Bayley IV developmental assessment(Index child age 12 months)
- Mother-child interaction measured by the Dyadic Assessment of Naturalistic Caregiver-child Experiences (DANCE)(Index child age 9 months)
- Initiation and continuation of any breastfeeding per maternal report(Index child age 1 month, 6 months)
- Index child immunization use per medical record review(Record review at index child age 9-12 months)
- Index child's social and emotional development measured by the Child Behavior Checklist (CBCL) (maternal report)(Index child age 6 months)
- Change in maternal perceived stress measured by Perceived Stress Scale (maternal report)(Less than 36 weeks gestation and index child age 6 months)
- 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)
- 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)
- Index child hospitalization for injuries(Record review at index child age 9-12 months)
- Number of participants with infection during pregnancy based on medical record review(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 quality of home environment measured by the CHAOS (Confusion, Hubbub and Order Scale) Scale(36 weeks gestation, index child age 6 months)
- Index child's social and emotional development based on Bayley IV socio-emotional subscale(Index child age 12 months)
- Percentage of well-child visits attended for index child per medical record review(Index child age 9-12 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)