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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 : October 24, 2018
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

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 Visiting

  Show Detailed Description

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

Group/Cohort Intervention/treatment
Free Transportation
The 166 families in this treatment condition received free transportation for scheduled prenatal care appointments. This group did not receive any postpartum services or assessments.
Transportation, Child Screening/Referral
The 514 families received: 1) free transportation for prenatal care; and 2) child developmental screening and referral services.
Behavioral: Nurse Home Visiting
Visits from nurses from mid-pregnancy to child age 2 years.

Prenatal Nurse Home-Visiting
The 230 families received: 1) free transportation for prenatal care; and 2) nurse home-visiting during pregnancy and postpartum (one visit).
Nurse Home Visiting through Age 2
The 228 families: 1) free transportation for prenatal care; 2) nurse home-visiting during pregnancy and through child's second birthday; and 3) child developmental screening and referral.
Behavioral: Nurse Home Visiting
Visits from nurses from mid-pregnancy to child age 2 years.




Primary Outcome Measures :
  1. Maternal life-course (reflected in reduced total public benefit expenditures for SNAP, AFDC/TANF, and Medicaid). [ Time Frame: through first child age 18 ]
    Public benefit expenditures estimated from review of state administrative records and maternal report of all children's birth dates. Program effects on public-benefit expenditures hypothesized to be especially pronounced for mothers with higher psychological resources.

  2. Cognitive, language, and academic functioning among first-born children. [ Time Frame: at youth age 18 ]
    Direct tests of youth cognitive, language, and academic functioning. Program effects in this domain hypothesized to be most pronounced for children born to mothers with low psychological resources.

  3. Youth depression and anxiety [ Time Frame: at youth age 18 ]
    Measure of internalizing disorders based upon youth self-report.

  4. Youth gang membership, arrests, convictions, and self-reported antisocial behavior, especially for crimes involving interpersonal violence. [ Time Frame: at youth age 18 ]
    Self-reported involvement with criminal justice system and antisocial behavior. Program effects on arrests and convictions hypothesized to be greater for females.

  5. Youth risk for HIV infection, pregnancies, births, use of substances, and SUDs. [ Time Frame: at youth age 18. ]
    Outcomes based upon self-report and urine assays for STI's and substance use.


Secondary Outcome Measures :
  1. Reduced maternal substance use disorders (SUDs) and depression. [ Time Frame: at youth age 18 ]
    Based upon maternal self-report of SUDs and depression.

  2. Improved child executive cognitive functioning, and rates of high school graduation. [ Time Frame: at youth age 18 ]
    Based upon direct tests of risky decision making, impulsivity, facial recognition, verbal working memory) and records of high school graduation. Program effects in this domain hypothesized to be more pronounced for children born to mothers with low psychological resources.


Other Outcome Measures:
  1. Cumulative subsequent pregnancies - mothers [ Time Frame: through youth age 18 ]
    Self-reported number of subsequent pregnancies, pregnancy outcomes, live births, low-birth weight newborns, and birth dates. Program effects on cumulative pregnancies and births hypothesized to be more pronounced among mothers with high psychological resources.

  2. Pregnancies - youth [ Time Frame: through youth age 18 ]
    Self-reported pregnancies and pregnancy outcomes.

  3. Relationship with Current Partner [ Time Frame: at youth age 18 ]
    Self-reported duration and quality of relationship, cohabitation, marriage, partner employment, and relationship to first-born child


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


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Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Very low-income African-Americans living in a major urban area. In this trial, 1,138 low-income pregnant women (98% unmarried, 67% <19 years old, 92% African-American) were randomly assigned to experimental or comparison services; 742 were followed after delivery. The sample resided in extraordinarily stressful neighborhoods and endured extreme poverty. At registration, 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.

Information from the National Library of Medicine

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

Additional Information:
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: October 24, 2018
Last Verified: October 2018

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