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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Rochester
Emory University
University of Colorado, Boulder
RTI International
Yale University
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00708695
First received: May 27, 2008
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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 Intervention
Antisocial Behavior
Psychopathology
Substance Use
HIV Infections
Behavioral: Nurse Home Visitation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Age-17 Follow-up of Home Visiting Intervention

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • The program will continue to improve 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 ] [ Designated as safety issue: No ]
  • The program will improve the health and development of firstborn children who will exhibit better functioning, better mental health, and better behavior. [ Time Frame: at child age 17 ] [ Designated as safety issue: No ]
  • The program will reduce 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The program will reduce 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Spit samples will be taken.


Estimated Enrollment: 1340
Study Start Date: May 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Control
Received free transportation for scheduled prenatal care appointments and developmental screening and referral services at three time points.
Nurse
Received free transportation for scheduled prenatal care appointments and developmental screening and referral services at three time points, and nurse home visitation through pregnancy and infancy.
Behavioral: Nurse Home Visitation
Visits from nurses from mid-pregnancy to child age 2 years.

  Eligibility

Ages Eligible for Study:   17 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Colorado, Boulder
RTI International
Yale University
Investigators
Principal Investigator: David L Olds, PhD University of Colorado, Denver
  More Information

Additional Information:
Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00708695     History of Changes
Other Study ID Numbers: 08-0616, R01DA021624
Study First Received: May 27, 2008
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

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
Acquired Immunodeficiency Syndrome
Antisocial Personality Disorder
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Personality Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014