| Descriptive Information Fields | |||||||||
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| Brief Title † | Follow-up Evaluation of Home Nurse Visitation Program for Socially Disadvantaged Women and Their Children | ||||||||
| Official Title † | 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 † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Economic productivity (e.g., unemployment, employment in jobs with limited opportunities for career growth, use of welfare, rates of out-of-wedlock births) [ Time Frame: Measured when child turns 27 years old ] [ Designated as safety issue: No ] Quality of partnered relationships (violence, commitment, and communication) [ Time Frame: Measured when child turns 27 years old ] [ Designated as safety issue: No ] Rates of child abuse and neglect [ Time Frame: Measured when child turns 27 years old ] [ Designated as safety issue: No ] Rates of criminal behavior, arrests, convictions, and imprisonment [ Time Frame: Measured when child turns 27 years old ] [ Designated as safety issue: No ] Mental health and abuse of substances [ Time Frame: Measured when child turns 27 years old ] [ Designated as safety issue: Yes ] Government expenditures and higher tax revenues [ Time Frame: Measured when child turns 27 years old ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | |||||||||
| Condition † | Risk Reduction Behavior | ||||||||
| Intervention † | Behavioral: Nurse home visitation Behavioral: Comparison services |
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| MEDLINE PMIDs | 16075193, 11771912, 10989400, 9272895, 8121734, 7510063, 8265329, 8433578, 3052116, 2425334 | ||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 345 | ||||||||
| Start Date † | September 2004 | ||||||||
| Completion Date | June 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
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| Gender | Female | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00443586 | ||||||||
| Organization ID | MH070761 | ||||||||
| Secondary IDs †† | DSIR 84-CTP | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | March 2, 2007 | ||||||||
| Last Updated Date | August 25, 2008 | ||||||||
