Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00708695
First received: May 27, 2008
Last updated: March 1, 2016
Last verified: March 2016

May 27, 2008
March 1, 2016
May 2008
October 2015   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ 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 ]
  • 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 ]
Complete list of historical versions of study NCT00708695 on ClinicalTrials.gov Archive Site
  • 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 ] [ 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 ]
  • 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 ]
Not Provided
Not Provided
 
Age-17 Follow-up of Home Visiting Intervention
Age-17 Follow-up of Home Visiting Intervention
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:
Spit samples will be taken.
Probability Sample
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.
  • Antisocial Behavior
  • Psychopathology
  • Substance Use
  • HIV Infections
Behavioral: Nurse Home Visitation
Visits from nurses from mid-pregnancy to child age 2 years.
  • 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.
    Intervention: Behavioral: Nurse Home Visitation
  • 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.
    Intervention: Behavioral: Nurse Home Visitation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1138
October 2015
October 2015   (final data collection date for primary outcome measure)

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.
Both
17 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00708695
08-0616, R01DA021624
Yes
Not Provided
Not Provided
University of Colorado, Denver
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
Principal Investigator: David L Olds, PhD University of Colorado, Denver
University of Colorado, Denver
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP