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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 2, 2007 | ||||||||
| Last Updated Date | August 25, 2008 | ||||||||
| Start Date ICMJE | September 2004 | ||||||||
| Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00443586 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Follow-up Evaluation of Home Nurse Visitation Program for Socially Disadvantaged Women and Their Children | ||||||||
| Official Title ICMJE | Age-27 Follow-up of Early Preventive Intervention | ||||||||
| Brief Summary | This study will evaluate the long-term effects of a prenatal and early childhood home nurse visitation program for socially disadvantaged women and their children. |
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| Detailed Description | Nearly half a million children are born each year to single, low-income mothers. Children born to socially disadvantaged mothers are more likely to experience chronic health problems, encounter child abuse and neglect, and receive insufficient health care. Home visitation by nurses during pregnancy and early childhood may prevent a wide range of health and developmental problems in children born to women who are either teenagers, unmarried, or of low economic status. This study is associated with a home nurse visitation program that first began with 400 socially disadvantaged pregnant women between the years of 1977 and 1980 in an upstate New York semi-rural county. Participants in the original study were randomly assigned to participate in the home nurse visitation program or receive comparison services from pregnancy until the child's second birthday. Participants assigned to receive comparison services were provided with free transportation for prenatal and child care, as well as sensory and developmental screening for the child. Participants assigned to the home nurse visitation program were visited at home by a nurse 9 times during pregnancy and 23 times during the child's first 2 years of life. A follow-up study concluded that the home nurse visitation program reduced the number subsequent pregnancies, use of welfare, child abuse and neglect, and criminal behavior on the part of the socially disadvantaged mothers for up to 15 years after the birth of their first child. This follow-up study will determine whether a home nurse visitation program has continued long-term effects on a child's health and development, 27 years later. Specifically, this study will evaluate whether the nurse-visited young adult offspring differ from the comparison group in their economic productivity; rates of child abuse and neglect; criminal behavior; mental health; abuse of substances; use of welfare, foster care, and healthcare in relation to government expenditures; and quality of their partnered relationships. Participants within the nurse-visited program group will be compared with each other to determine whether certain characteristics or factors, such as genetic vulnerabilities, environmental risks, or a history of child abuse, make someone less likely to benefit from a home nurse visitation program. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Risk Reduction Behavior | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 345 | ||||||||
| Estimated Completion Date | June 2009 | ||||||||
| Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00443586 | ||||||||
| Responsible Party | David Olds, University of Colorado Denver | ||||||||
| Study ID Numbers ICMJE | MH070761, DSIR 84-CTP | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | August 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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