Pregnancy, High RiskNCT05887115
Nurse Family Partnership for Women With Previous Live Births
A study testing Nurse Family Partnership in people with Pregnancy, High Risk and Child Development, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, High Risk, Child Development, Post Partum Depression
- What is being tested?
- Nurse Family Partnership
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 31 Jan 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 46 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Trial of Nurse Family Partnership for Women With Previous Live Births
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.
Read more
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.
Read the 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.
- Being tested
- Nurse Family Partnership
- Keywords
- Nurse Family Partnership, Home Visiting
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Family PartnershipBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (NFP) | Active comparator | 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. Receives: Behavioral: Nurse Family Partnership |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Presence of Pregnancy-related hypertension
High Blood Pressure associated with pregnancy
Measured: Birth of index child
Change in maternal tobacco use by cotinine
Measured by cotinine level in saliva
Measured: Less than 28 weeks gestation and 36 weeks gestation
Change in self reported maternal tobacco use
Measured by self-report (yes/no)
Measured: Less than 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months
Index child language development measured by the Bayley IV language subscale
Scaled, age-adjusted score from 1-19 with 19 being best outcome
Measured: Index child age 12 months
Index child language development measured by the Peabody Picture Vocabulary Test
Percentage out of 100; 100 being best outcome
Measured: Index child age 9 months
DNA methylation biomarkers
Epigenetic age and glucocorticoid-sensitive DNA methylation score from methylation array data
Measured: Within 6 weeks of index birth (postpartum) and child age 12 months
Secondary outcomes (16)
Number of participants with infection during pregnancy based on medical record review
Receipt of screening for common infections; if positive, receipt of appropriate treatment
Measured: Index child age 1 month
Number of infants born with weight less than 2500 grams per medical record review
Measured: Index child age 1 month
Number of infants born less than 34 weeks gestation per medical record review
Measured: Index child age 1 month
Change in self-reported maternal substance use
Past month use per self-report (yes/no)
Measured: Less than 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months
Initiation and continuation of any breastfeeding per maternal report
Maternal report of any breastfeeding
Measured: Index child age 1 month, 6 months
Percentage of well-child visits attended for index child per medical record review
Number out of 6 visits by 9 months
Measured: Index child age 9-12 months
Index child immunization use per medical record review
Immunizations up-to-date for age at 9 months
Measured: Record review at index child age 9-12 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
Measured: Index child age birth to 9 months, Record review at index child age 9-12 months
Index child hospitalization for injuries
Number of days hospitalized for injury per medical record review
Measured: Record review at 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
53 yes/no measures; score scaled based on child age, self-report and interviewer observation
Measured: 36 weeks gestation, index child age 6 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
Measured: 36 weeks gestation, index child age 6 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.
Measured: Index child age 9 months
Child's developmental index measured by Bayley IV developmental assessment
Scaled, age-adjusted score from 1-19 with 19 being best outcome
Measured: Index child age 12 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
Measured: Index child age 12 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
Measured: Index child age 6 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.
Measured: Less than 36 weeks gestation and index child age 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start29 Apr 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Why it stopped: Recruitment milestones not met; funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, High RiskStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital, University of Rochester, Columbia University, Yale University
- Responsible party
- Sponsor
- Investigators
- Mandy A Allison, MD, MSPH, Principal investigator, University of Colorado School of MedicineDeena Chisolm, PhD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887115
- Sponsor's protocol ID
- 20-0470
- Status last verified
- Aug 2025
- First submitted
- 27 Apr 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified individual participant data with researchers who desire to conduct additional analyses. Investigators who are interested in accessing de-identified individual participant data should e-mail the Prevention Research Center for Family and Child Health (FamilyChildPRC@cuanschutz.edu) to request an application for data use. The leadership team at the PRC (Prevention Research Center for Family and Child Health) will review the application and determine whether to grant access. The criteria are listed below under 'Access Criteria'.
Publications
Bor J, Cohen GH, Galea S. Population health in an era of rising income inequality: USA, 1980-2015. Lancet. 2017 Apr 8;389(10077):1475-1490. doi: 10.1016/S0140-6736(17)30571-8.
PubMed 28402829Freudenberg N, Ruglis J. Reframing school dropout as a public health issue. Prev Chronic Dis. 2007 Oct;4(4):A107. Epub 2007 Sep 15.
PubMed 17875251Petersen EE, Davis NL, Goodman D, Cox S, Mayes N, Johnston E, Syverson C, Seed K, Shapiro-Mendoza CK, Callaghan WM, Barfield W. Vital Signs: Pregnancy-Related Deaths, United States, 2011-2015, and Strategies for Prevention, 13 States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2019 May 10;68(18):423-429. doi: 10.15585/mmwr.mm6818e1.
PubMed 31071074Wang E, Glazer KB, Howell EA, Janevic TM. Social Determinants of Pregnancy-Related Mortality and Morbidity in the United States: A Systematic Review. Obstet Gynecol. 2020 Apr;135(4):896-915. doi: 10.1097/AOG.0000000000003762.
PubMed 32168209Cheng TL, Johnson SB, Goodman E. Breaking the Intergenerational Cycle of Disadvantage: The Three Generation Approach. Pediatrics. 2016 Jun;137(6):e20152467. doi: 10.1542/peds.2015-2467. Epub 2016 May 9.
PubMed 27244844National Research Council (US) and Institute of Medicine (US) Committee on Integrating the Science of Early Childhood Development; Shonkoff JP, Phillips DA, editors. From Neurons to Neighborhoods: The Science of Early Childhood Development. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225557/
PubMed 25077268Noble KG, Houston SM, Brito NH, Bartsch H, Kan E, Kuperman JM, Akshoomoff N, Amaral DG, Bloss CS, Libiger O, Schork NJ, Murray SS, Casey BJ, Chang L, Ernst TM, Frazier JA, Gruen JR, Kennedy DN, Van Zijl P, Mostofsky S, Kaufmann WE, Kenet T, Dale AM, Jernigan TL, Sowell ER. Family income, parental education and brain structure in children and adolescents. Nat Neurosci. 2015 May;18(5):773-8. doi: 10.1038/nn.3983. Epub 2015 Mar 30.
PubMed 25821911Noble KG, Engelhardt LE, Brito NH, Mack LJ, Nail EJ, Angal J, Barr R, Fifer WP, Elliott AJ; PASS Network. Socioeconomic disparities in neurocognitive development in the first two years of life. Dev Psychobiol. 2015 Jul;57(5):535-51. doi: 10.1002/dev.21303. Epub 2015 Mar 30.
PubMed 25828052Brito NH, Noble KG. Socioeconomic status and structural brain development. Front Neurosci. 2014 Sep 4;8:276. doi: 10.3389/fnins.2014.00276. eCollection 2014.
PubMed 25249931Bradley RH, Corwyn RF. Socioeconomic status and child development. Annu Rev Psychol. 2002;53:371-99. doi: 10.1146/annurev.psych.53.100901.135233.
PubMed 11752490Duncan GJ, Dowsett CJ, Claessens A, Magnuson K, Huston AC, Klebanov P, Pagani LS, Feinstein L, Engel M, Brooks-Gunn J, Sexton H, Duckworth K, Japel C. School readiness and later achievement. Dev Psychol. 2007 Nov;43(6):1428-1446. doi: 10.1037/0012-1649.43.6.1428.
PubMed 18020822Uchino BN. Social support and health: a review of physiological processes potentially underlying links to disease outcomes. J Behav Med. 2006 Aug;29(4):377-87. doi: 10.1007/s10865-006-9056-5. Epub 2006 Jun 7.
PubMed 16758315Falk-Rafael A. Advancing nursing theory through theory-guided practice: the emergence of a critical caring perspective. ANS Adv Nurs Sci. 2005 Jan-Mar;28(1):38-49. doi: 10.1097/00012272-200501000-00005.
PubMed 15718937Olds DL, Henderson CR Jr, Tatelbaum R, Chamberlin R. Improving the delivery of prenatal care and outcomes of pregnancy: a randomized trial of nurse home visitation. Pediatrics. 1986 Jan;77(1):16-28.
PubMed 3510017Olds DL, Henderson CR Jr, Chamberlin R, Tatelbaum R. Preventing child abuse and neglect: a randomized trial of nurse home visitation. Pediatrics. 1986 Jul;78(1):65-78.
PubMed 2425334