| Registry | NCT03079752 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Enrollment | 629 (Actual) |
| Sponsor | University of Colorado, Denver (Other); collaborators: Cornell University |
| Conditions | Behavior, Adaptive |
| Interventions | Developmental Screening, Screening plus Transportation, Screening, Transport, Prenatal Visits, Screen, Transport, Prenatal/Inf Visits (Behavioral) |
| Dates | start 1994-03-18, primary completion 1996-09-12, completion 1998-04-30, first posted 2017-03-14, last updated 2017-03-15 |
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The Nurse-Family Partnership, a program of prenatal and infancy home visiting by nurses, has been examined in a series of 3 randomized trials since 1977. It has received considerable attention in the scientific and public policy communities for its replicated effects on a variety of maternal and child health outcomes across these 3 trials, including prenatal health, childhood injuries, rates of subsequent pregnancies, inter-birth intervals, as well as its long-term effects on maternal life-course, criminal behavior, and 15-year-olds' criminal and antisocial behavior in the first trial of the program conducted in Elmira, New York.
Although this program produced positive effects on maternal and child health from pregnancy through the child's fourth year of life, its long-term effects remain unexamined. The current study was conducted to determine the extent to which the beneficial effects of the program set in motion early in the life cycle altered the life-course trajectories of the mothers and the children's adaptive functioning through the first child's 15th birthday. This study examines the long-term effects of the program on two domains of maternal functioning: 1) maternal life course (subsequent children, use of welfare, employment, substance abuse, and encounters with the criminal justice system); and 2) perpetration of child abuse and neglect; and two domains of the children's behavior: 1) their functioning in schools, and 2) their criminal and antisocial behavior. The investigators hypothesized that the program effects in these domains of maternal and child functioning, as in earlier phases of the study, would be greater for families in which the mothers experienced a larger number of chronic stressors and had fewer resources to manage the challenges of living in poverty and being a parent.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Developmental Screening | Active comparator | Behavioral: Developmental Screening | Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age. |
| Screening plus Transportation | Active comparator | Behavioral: Developmental Screening; Behavioral: Screening plus Transportation | Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two). |
| Screening, Transport, Prenatal Visits | Active comparator | Behavioral: Developmental Screening; Behavioral: Screening plus Transportation; Behavioral: Screening, Transport, Prenatal Visits | Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two), plus nurse home visiting during pregnancy. |
| Screen, Transport, Prenatal/Inf Visits | Experimental | Behavioral: Developmental Screening; Behavioral: Screening plus Transportation; Behavioral: Screening, Transport, Prenatal Visits; Behavioral: Screen, Transport, Prenatal/Inf Visits | Participants received regular sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two), plus nurse home visiting during pregnancy and through child age two. |
Sex: All, ages: 15 Years to any, accepts healthy volunteers
Inclusion Criteria: Must be offspring of mothers who enrolled in Elmira randomized clinical trial of the Nurse-Family Partnership (known as the Prenatal Early Infancy Project) - Exclusion Criteria: \-