- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03079752
The Prenatal/Early Infancy Project: An Adolescent Follow-up
March 13, 2017 updated by: University of Colorado, Denver
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
629
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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
|
Active Comparator: 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).
|
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.
|
Active Comparator: 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.
|
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.
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timing of Subsequent Births - Mothers
Time Frame: 15 years following birth of first child
|
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
Time Frame: 15-year interval following birth of first child
|
Number of months mother received AFDC (self-reported)
|
15-year interval following birth of first child
|
Number of Months Employed - Mothers
Time Frame: 15-year interval following birth of first child
|
Number of months employed (self-reported)
|
15-year interval following birth of first child
|
Substance Abuse - Mothers
Time Frame: 15-year period following birth of first child
|
Count of behavioral impairments due to use of substances (self-reported)
|
15-year period following birth of first child
|
Arrests - Mothers
Time Frame: 15-year interval following birth of first child
|
Count of arrests (self-reported)
|
15-year interval following birth of first child
|
Child Maltreatment Reports - Mothers
Time Frame: 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)
|
15-year interval following birth of first child
|
Running Away from Home - Children
Time Frame: 15-year interval following birth of first child
|
Count of times ran away from home - self-report
|
15-year interval following birth of first child
|
Person in Need of Supervision (PIN) - Children
Time Frame: 15-year period following their birth
|
Self report of ever having been adjudicated as a PIN
|
15-year period following their birth
|
Arrests - Children
Time Frame: 15-year period following birth
|
Count of Arrests - self-report
|
15-year period following birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David Olds, MD, University of Colorado, Denver
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 1994
Primary Completion (Actual)
September 12, 1996
Study Completion (Actual)
April 30, 1998
Study Registration Dates
First Submitted
March 8, 2017
First Submitted That Met QC Criteria
March 8, 2017
First Posted (Actual)
March 14, 2017
Study Record Updates
Last Update Posted (Actual)
March 15, 2017
Last Update Submitted That Met QC Criteria
March 13, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- UColorado
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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