The Prenatal/Early Infancy Project: An Adolescent Follow-up
1 other identifier
interventional
629
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 1994
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 1994
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 1996
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 1998
CompletedFirst Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
March 14, 2017
CompletedMarch 15, 2017
March 1, 2017
2.5 years
March 8, 2017
March 13, 2017
Conditions
Outcome Measures
Primary Outcomes (9)
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
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
Number of Months Employed - Mothers
Number of months employed (self-reported)
15-year interval following birth of first child
Substance Abuse - Mothers
Count of behavioral impairments due to use of substances (self-reported)
15-year period following birth of first child
Arrests - Mothers
Count of arrests (self-reported)
15-year interval following birth of first child
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
Running Away from Home - Children
Count of times ran away from home - self-report
15-year interval following birth of first child
Person in Need of Supervision (PIN) - Children
Self report of ever having been adjudicated as a PIN
15-year period following their birth
Arrests - Children
Count of Arrests - self-report
15-year period following birth
Study Arms (4)
Developmental Screening
ACTIVE COMPARATORParticipants 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 COMPARATORParticipants 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 COMPARATORParticipants 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
EXPERIMENTALParticipants 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.
Interventions
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
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.
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.
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Cornell Universitycollaborator
Related Publications (2)
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: 9272895RESULTOlds 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: 9786373RESULT
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Olds, MD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Assessors were not given access to the participants' original treatment assignments
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2017
First Posted
March 14, 2017
Study Start
March 18, 1994
Primary Completion
September 12, 1996
Study Completion
April 30, 1998
Last Updated
March 15, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
The investigators are in the process of archiving the primary data published for this trial with the University of Michigan Consortium for Political and Social Research.