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The Prenatal/Early Infancy Project: An Adolescent Follow-up

NCT03079752 — Not applicable, Completed, 629 participants, University of Colorado, Denver

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RegistryNCT03079752
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, prevention
Enrollment629 (Actual)
SponsorUniversity of Colorado, Denver (Other); collaborators: Cornell University
ConditionsBehavior, Adaptive
InterventionsDevelopmental Screening, Screening plus Transportation, Screening, Transport, Prenatal Visits, Screen, Transport, Prenatal/Inf Visits (Behavioral)
Datesstart 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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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Developmental ScreeningActive comparatorBehavioral: Developmental ScreeningParticipants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age.
Screening plus TransportationActive comparatorBehavioral: Developmental Screening; Behavioral: Screening plus TransportationParticipants 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 VisitsActive comparatorBehavioral: Developmental Screening; Behavioral: Screening plus Transportation; Behavioral: Screening, Transport, Prenatal VisitsParticipants 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 VisitsExperimentalBehavioral: Developmental Screening; Behavioral: Screening plus Transportation; Behavioral: Screening, Transport, Prenatal Visits; Behavioral: Screen, Transport, Prenatal/Inf VisitsParticipants 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.
  • Developmental Screening (Behavioral): Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment of suspected problems at 12 and 24 months of age
  • Screening plus Transportation (Behavioral): Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment for suspected problems at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.
  • Screening, Transport, Prenatal Visits (Behavioral): Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment for suspected problems at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy.
  • Screen, Transport, Prenatal/Inf Visits (Behavioral): Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment for suspected problems at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy and 23 during the child's first two years of life.

+Outcome measures

Primary outcomes

  • Timing of Subsequent Births - Mothers [15 years following birth of first child]: Interval in days between birth date of first child and first subsequent child (self-reported)
  • Months Received Aid to Families with Dependent Children (AFDC) - Mothers [15-year interval following birth of first child]: Number of months mother received AFDC (self-reported)
  • Number of Months Employed - Mothers [15-year interval following birth of first child]: Number of months employed (self-reported)
  • Substance Abuse - Mothers [15-year period following birth of first child]: Count of behavioral impairments due to use of substances (self-reported)
  • Arrests - Mothers [15-year interval following birth of first child]: Count of arrests (self-reported)
  • Child Maltreatment Reports - Mothers [15-year interval following birth of first child]: Count of substantiated reports of child abuse and neglect in which mother was perpetrator (review of records)
  • Running Away from Home - Children [15-year interval following birth of first child]: Count of times ran away from home - self-report
  • Person in Need of Supervision (PIN) - Children [15-year period following their birth]: Self report of ever having been adjudicated as a PIN
  • Arrests - Children [15-year period following birth]: Count of Arrests - self-report

+Eligibility

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:

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+Publications

  • Results publication: 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. PMID 9272895
  • Results publication: 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. PMID 9786373

+Investigators

  • David Olds, MD, Principal investigator, University of Colorado, Denver

My Notes