Nurse Family Partnership for Women With Previous Live Births

Child Development Clinical Trial

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

Status Recruiting

Clinical 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.

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Child Development
• Depression, Postpartum
• Post Partum Depression
• Pregnancy, High Risk

• NCT number: NCT05887115
• Study type: Interventional
• Source: University of Colorado, Denver
• Contact: Natalie J Murphy
• Phone: 7206722402
• Email: natalie.murphy@cuanschutz.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2023
• Completion date: February 28, 2027