Age-17 Follow-up of Home Visiting Intervention (MemphisY17)
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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 |
- 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 ]
- 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 |
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.
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00708695
| United States, Tennessee | |
| Memphis Study Office | |
| Memphis, Tennessee, United States, 38111 | |
| Principal Investigator: | David L Olds, PhD | University of Colorado, Denver |
More Information
Additional Information:
Publications:
Additional 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 |
| 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 |
ClinicalTrials.gov processed this record on March 03, 2015