Clinical trial NCT03079752: The Prenatal/Early Infancy Project: An Adolescent Follow-up
Official title: The Prenatal/Early Infancy Project: An Adolescent Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Adaptive
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Cornell University
First posted: 2017-03-14
Enrollment: 629
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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:

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Primary outcomes:
measure: Timing of Subsequent Births - Mothers
timeFrame: 15 years following birth of first child
measure: Months Received Aid to Families with Dependent Children (AFDC) - Mothers
timeFrame: 15-year interval following birth of first child
measure: Number of Months Employed - Mothers
timeFrame: 15-year interval following birth of first child
measure: Substance Abuse - Mothers
timeFrame: 15-year period following birth of first child
measure: Arrests - Mothers
timeFrame: 15-year interval following birth of first child
measure: Child Maltreatment Reports - Mothers
timeFrame: 15-year interval following birth of first child
measure: Running Away from Home - Children
timeFrame: 15-year interval following birth of first child
measure: Person in Need of Supervision (PIN) - Children
timeFrame: 15-year period following their birth
measure: Arrests - Children
timeFrame: 15-year period following birth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: David Olds, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olds DL, Eckenrode J, Henderson CR Jr, Kitzman H, Powers J, Cole R, Sidora K, Morris P, Pettitt LM, Luckey D. Long-term effects of home visitation on maternal life course and child abuse and neglect. Fifteen-year follow-up of a randomized trial. JAMA. 1997 Aug 27;278(8):637-43.
citation: Olds D, Henderson CR Jr, Cole R, Eckenrode J, Kitzman H, Luckey D, Pettitt L, Sidora K, Morris P, Powers J. Long-term effects of nurse home visitation on children's criminal and antisocial behavior: 15-year follow-up of a randomized controlled trial. JAMA. 1998 Oct 14;280(14):1238-44. doi: 10.1001/jama.280.14.1238.