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Age-17 Follow-up of Home Visiting Intervention (MemphisY17)

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ClinicalTrials.gov Identifier: NCT00708695
Recruitment Status : Completed
First Posted : July 2, 2008
Last Update Posted : March 3, 2016
Sponsor:
Collaborators:
University of Rochester
Emory University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Colorado, Boulder
RTI International
National Institute on Drug Abuse (NIDA)
Yale University
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study is a longitudinal follow-up of 670 primarily African-American women and their 17-year-old firstborn children enrolled since 1990 in a highly significant randomized controlled trial (RCT) of prenatal and infancy home visiting by nurses. Nurses in this program are charged with improving pregnancy outcomes, child health and development, and maternal economic self-sufficiency. This follow-up examines whether earlier program effects on maternal and child functioning lead to less violent antisocial behavior, psychopathology, substance use and use-disorders, and risk for HIV; whether these effects are greater for those at both genetic and environmental risk; and whether program effects replicate those found with whites in an earlier trial.

Condition or disease Intervention/treatment
Antisocial Behavior Psychopathology Substance Use HIV Infections Behavioral: Nurse Home Visitation

Study Design
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Study Type : Observational
Actual Enrollment : 1138 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Age-17 Follow-up of Home Visiting Intervention
Study Start Date : May 2008
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
Free Transportation
The 166 families in this treatment condition received free round-trip taxicab transportation for scheduled prenatal care appointments. This group did not receive any postpartum services or assessments.
Free Transportation, Screening/Referral Service
The 514 families in this group received: 1) free transportation for scheduled prenatal care; and 2) developmental screening and referral services for the child at the 6th, 12th, and 24th months of the child's life.
 Behavioral: Nurse Home Visitation
Visits from nurses from mid-pregnancy to child age 2 years.
Free Transportation, home-visit, postpartum visit
The 230 families in this treatment condition received: 1) free transportation for scheduled prenatal care; and 2) intensive nurse home-visitation services during pregnancy and one postpartum visit in the hospital before discharge and one postpartum visit in the home. This group did not receive any postpartum services or assessments.
Free Transportation, home-visit, Screening/Referral Service
The 228 families in this condition received: 1) free transportation for scheduled prenatal care; 2) intensive nurse home-visitation services during pregnancy and through the child's second birthday; and 3) developmental screening and referral services for the child at the 6th, 12th, and 24th months of the child's life.
 Behavioral: Nurse Home Visitation
Visits from nurses from mid-pregnancy to child age 2 years.


Outcome Measures
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Primary Outcome Measures :
  1. Improvement of maternal life-course (fewer short inter-birth intervals, less use of welfare, more stable partner relations), especially for mothers with higher psychological resources. [ Time Frame: when first child is 17 ]
  2. Improvement of the health and development of firstborn children who will exhibit better functioning, better mental health, and better behavior. [ Time Frame: at child age 17 ]
  3. Reduction of children's risk for HIV infection, including a) use of substances and SUDs; b) risky sexual behaviors; c) sexually transmitted infections (STIs) and d) pregnancies. [ Time Frame: at child age 17 ]
  4. Program effects on children will be more pronounced for a) males, b) those born to low-resource mothers, and c) those living in the most disadvantaged neighborhoods at registration. [ Time Frame: at child age 17 ]

Secondary Outcome Measures :
  1. Reduction of maternal substance use disorders (SUDs) and depression, effects that will be more pronounced for a) mothers with low psychological resources, and b) those living in the most disadvantaged neighborhoods at registration. [ Time Frame: when first child is 17 ]
  2. Program effects on mothers and children, in preliminary analyses, will be more pronounced for those with genetic vulnerabilities. [ Time Frame: when first child is 17 ]
  3. Program effects on adolescent functioning will be explained by its improvement in prenatal health, early care of the child, maternal life-course, and earlier child academic and behavioral functioning. [ Time Frame: at child age 17 ]

Biospecimen Retention:   Samples With DNA
Spit samples will be taken.

Eligibility Criteria
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Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The Memphis trial was designed to test the effects of the program with a large sample of very low-income African-Americans living in a major urban area, when the program was administered through a local health department, and the program developers had limited involvement in its implementation. In this trial, 1,139 low-income pregnant women (98% unmarried, 67% <19 years old, 92% African-American) were randomly assigned to experimental or comparison services; 743 were followed after delivery. The sample has resided in extraordinarily stressful neighborhoods and has endured extreme poverty. At registration, the mean level of neighborhood disorganization (assessed by census tract data at the block group and using the Lauritsen scale) was 3.43 SD above the national mean, i.e., the average level of adversity in the sample neighborhoods was among the worst in the nation (in the top 1000th). 85% of the sample had incomes below the federal poverty guidelines.
Criteria

Inclusion Criteria:

  • Women who were enrolled in the New Mothers Study and their children as described in Study Population Description.

Exclusion Criteria:

  • Women who were not enrolled in the New Mothers Study and their children as described in the Study Population Description.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00708695


Locations
United States, Tennessee
Memphis Study Office
Memphis, Tennessee, United States, 38111
Sponsors and Collaborators
University of Colorado, Denver
University of Rochester
Emory University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Colorado, Boulder
RTI International
National Institute on Drug Abuse (NIDA)
Yale University
Investigators
Principal Investigator: David L Olds, PhD University of Colorado, Denver
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00708695     History of Changes
Other Study ID Numbers: 08-0616
R01DA021624 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2008    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016

Keywords provided by University of Colorado, Denver:
nurse
home visits
pregnancy
welfare
 child development
Child Rearing
Reproductive Behavior
Risk Reduction Behavior

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases