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

Behavior, Adaptive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079752
• Other study ID #: UColorado
• Status: Completed
• Phase: N/A
• First received: March 8, 2017
• Last updated: March 13, 2017
• Start date: March 18, 1994
• Est. completion date: April 30, 1998

Study information

• Verified date: March 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 629
• Est. completion date: April 30, 1998
• Est. primary completion date: September 12, 1996
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Behavior, Adaptive

Intervention

Behavioral:
• Developmental Screening
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
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
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Cornell University

References & Publications (2)

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 — View 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. 199 — View Citation

Outcome

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