Child Development Clinical Trial
Official title:
Randomized Clinical 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. 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.
Status | Recruiting |
Enrollment | 880 |
Est. completion date | February 28, 2027 |
Est. primary completion date | February 28, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: 1. pregnant at 28 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 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 from our study because the community served by the two NFP delivery sites participating in our study is mostly English-speaking. However, those who don't speak English 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. |
Country | Name | City | State |
---|---|---|---|
United States | Nationwide Children's Hospital | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Nationwide Children's Hospital, University of Rochester |
United States,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of Pregnancy-related hypertension | High Blood Pressure associated with pregnancy | Birth of index child | |
Primary | Change in maternal tobacco use by cotinine | Measured by cotinine level in saliva | Less than 28 weeks gestation and 36 weeks gestation | |
Primary | Change in self reported maternal tobacco use | Measured by self-report (yes/no) | Less than 28 weeks gestation, 36 weeks gestation, index child age 6 months, 12 months, and 24 months. | |
Primary | Index child language development measured by the Bayley IV language subscale | Scaled, age-adjusted score from 1-19 with 19 being best outcome | Index child age 24 months | |
Primary | Index child language development measured by the MacArthur Bates CDI (Communicative Development Inventories) | Percentage out of 100; 100 being best outcome | Index child age 24 months | |
Secondary | Number of participants with infection during pregnancy based on medical record review | Receipt of screening for common infections; if positive, receipt of appropriate treatment | Index child age 1 month | |
Secondary | Number of infants born with weight less than 2500 grams per medical record review | Index child age 1 month | ||
Secondary | Number of infants born less than 34 weeks gestation per medical record review | Index child age 1 month | ||
Secondary | Change in self-reported maternal substance use | Past month use per self-report (yes/no) | Less than 28 weeks gestation, 36 weeks gestation, index child ages 6, 12, 18, 24 months | |
Secondary | Initiation and continuation of any breastfeeding per maternal report | Index child age 1 month, 6 months and 12 months | ||
Secondary | Percentage of well-child visits attended for index child per medical record review | Number out of 7 visits by 12 months | Index child age 18-24 months | |
Secondary | Index child immunization use per medical record review | Immunizations up-to-date for age at 18 months | Record review at index child age 18-24 months | |
Secondary | 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 | Index child age birth to 24 months, collected at 24 months | |
Secondary | Index child hospitalization for injuries | Number of days hospitalized for injury per medical record review | Record review at index child age 24 months | |
Secondary | 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 | 36 weeks gestation, index child age 18 months | |
Secondary | 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 | 36 weeks gestation, index child age 24 months | |
Secondary | 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. | Index child age 18 months | |
Secondary | Child's developmental index measured by Bayley IV developmental assessment | Scaled, age-adjusted score from 1-19 with 19 being best outcome | Index child age 24 months | |
Secondary | 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 | Index child age 24 months | |
Secondary | 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 | Index child age 24 months | |
Secondary | 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. | Less than 28 weeks gestation and index child age 6 months |
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