Behavior, AdaptiveNCT03079752
The Prenatal/Early Infancy Project: An Adolescent Follow-up
A study testing Developmental Screening, Screening plus Transportation and Screening, Transport, Prenatal Visits in people with Behavior, Adaptive, run by University of Colorado, Denver.
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… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior, Adaptive
- What is being tested?
- Developmental Screening, Screening plus Transportation and Screening, Transport, Prenatal Visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 629 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 1994to 30 Apr 1998
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
About this study
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.
Read the 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.
- Conditions
- Behavior, Adaptive
- Being tested
- Developmental Screening, Screening plus Transportation, Screening, Transport, Prenatal Visits, Screen, Transport, Prenatal/Inf Visits
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Developmental ScreeningBehavioural
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 TransportationBehavioural
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 VisitsBehavioural
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 VisitsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Developmental Screening | Active comparator | Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age. Receives: Behavioral: Developmental Screening |
| Screening plus Transportation | Active comparator | 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). Receives: Behavioral: Developmental Screening; Behavioral: Screening plus Transportation |
| Screening, Transport, Prenatal Visits | Active comparator | 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. Receives: Behavioral: Developmental Screening; Behavioral: Screening plus Transportation; Behavioral: Screening, Transport, Prenatal Visits |
| Screen, Transport, Prenatal/Inf Visits | Experimental | 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. Receives: Behavioral: Developmental Screening; Behavioral: Screening plus Transportation; Behavioral: Screening, Transport, Prenatal Visits; Behavioral: Screen, Transport, Prenatal/Inf Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing of Subsequent Births - Mothers
Interval in days between birth date of first child and first subsequent child (self-reported)
Measured: 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)
Measured: 15-year interval following birth of first child
Number of Months Employed - Mothers
Number of months employed (self-reported)
Measured: 15-year interval following birth of first child
Substance Abuse - Mothers
Count of behavioral impairments due to use of substances (self-reported)
Measured: 15-year period following birth of first child
Arrests - Mothers
Count of arrests (self-reported)
Measured: 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)
Measured: 15-year interval following birth of first child
Running Away from Home - Children
Count of times ran away from home - self-report
Measured: 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
Measured: 15-year period following their birth
Arrests - Children
Count of Arrests - self-report
Measured: 15-year period following birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start18 Mar 1994
- Primary completion12 Sep 1996
- Study completion30 Apr 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Behavior, AdaptiveStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University
- Responsible party
- Sponsor
- Investigators
- David Olds, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079752
- Sponsor's protocol ID
- UColorado
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2017
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 9272895Olds 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.
PubMed 9786373
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prenatal/Early Infancy Project: An Adolescent Follow-up
- ClinicalTrials.gov ID
- NCT03079752
- Acronym / sponsor ID
- UColorado
- Conditions
- Behavior, Adaptive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Cornell University
- Study start
- 18 Mar 1994 (actual)
- Primary completion
- 12 Sep 1996 (actual)
- Study completion
- 30 Apr 1998 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Developmental Screening | Active comparator | Behavioral: 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 Transportation | Active comparator | Behavioral: 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 Visits | Active comparator | Behavioral: 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 Visits | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Developmental ScreeningChild 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 | Behavioural | Developmental Screening, Screen, Transport, Prenatal/Inf Visits, Screening plus Transportation, Screening, Transport, Prenatal Visits |
| Screening plus TransportationChild 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. | Behavioural | Screen, Transport, Prenatal/Inf Visits, Screening plus Transportation, Screening, Transport, Prenatal Visits |
| Screening, Transport, Prenatal VisitsChild 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. | Behavioural | Screen, Transport, Prenatal/Inf Visits, Screening, Transport, Prenatal Visits |
| Screen, Transport, Prenatal/Inf VisitsChild 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. | Behavioural | Screen, Transport, Prenatal/Inf Visits |
Primary outcome
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)
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)
Number of Months Employed - Mothers
Time frame: 15-year interval following birth of first child
Number of months employed (self-reported)
Substance Abuse - Mothers
Time frame: 15-year period following birth of first child
Count of behavioral impairments due to use of substances (self-reported)
Arrests - Mothers
Time frame: 15-year interval following birth of first child
Count of arrests (self-reported)
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)
Running Away from Home - Children
Time frame: 15-year interval following birth of first child
Count of times ran away from home - self-report
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
Arrests - Children
Time frame: 15-year period following birth
Count of Arrests - self-report
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Results publication: PubMed 9272895Olds 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.
- Results publication: PubMed 9786373Olds 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Olds, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Developmental Screening, Screening plus Transportation and Screening, Transport, Prenatal Visits in people with Behavior, Adaptive, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing of Subsequent Births - Mothers (time frame: 15 years following birth of first child). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079752, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.