An observational study in Antisocial Behavior, Psychopathology and Substance Use, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 17 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-04.
Sponsored by University of Colorado, Denver · Observational
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.
This study is a longitudinal follow-up of 670 primarily African-American women and their 18-year-old firstborn children enrolled since 1990 in a 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.1 This follow-up examines whether earlier program effects on maternal and child functioning 2-7 lead to less violent antisocial behavior, psychopathology, substance use and use-disorders, and risk for HIV; whether these effects are greater for those who carry genetic susceptibility to the environment and are at environmental risk; and whether program effects replicate those found with whites in an earlier trial.8-10 Results from earlier phases of follow-up from this trial found that the Memphis program affected women's prenatal health, fertility, partner relations, and use of welfare; children's injuries, cognition, language, achievement, conduct, depression/anxiety, and use of substances through child age 12.2-7 Program effects on maternal life-course were concentrated among mothers with higher psychological resources (better intellectual functioning, mental health, and sense of mastery), probably because higher-resource mothers could envision their success in the world of work, leading to better pregnancy planning and employment. Program effects on children were greater for those born to mothers with low psychological resources, because without help, low-resource mothers are especially challenged in the care of their children and their children function less well. Given the damaging effects of early stressors on developing neural circuitry, and given that many early neural developmental insults do not become fully evident until synaptic pruning is complete in late adolescence and early adulthood, there was reason to expect this early intervention would have enduring effects at youth age 18.
Hypotheses for Primary Grant
We specified hypotheses based upon the pattern of results found through child age 12, and separated them into primary and secondary hypotheses. Following the original formulation of hypotheses, we edited them to take into account results from the earlier Elmira trial10 that were analyzed following the submission of the proposal for the current phase of follow-up in Memphis. We had originally hypothesized that program effects would be more pronounced for mothers and children living in the most disadvantaged neighborhoods in Memphis, but realized as these data were being gathered that virtually all of the participants in the Memphis trial lived in neighborhoods that were so disadvantaged that there was little meaningful variation among neighborhoods, and therefore removed this aspect of our hypotheses. We also found that it was impossible to consistently gather information from children's school records on outcomes like conduct grades from hundreds of schools, so substituted high school graduation as a secondary outcome. These refined hypotheses were specified prior to the completion of data gathering and any analysis of treatment-control differences. We specify the original hypotheses and then indicate the revised hypotheses for maternal and child outcomes. Compared to control-group counterparts:
Original Maternal Outcomes Hypotheses
Revised Maternal Outcome Hypotheses
(Secondary) The program will reduce maternal substance use disorders (SUDs) and depression.
Original Child Outcomes Hypotheses
Revised Child Outcome Hypotheses 3. (Primary) The program will improve the health and development of firstborn children who will exhibit: a) superior cognitive, language, and academic functioning; b) less depression and anxiety; d) less gang membership, and fewer arrests, convictions, and self-reported antisocial behavior - especially for crimes involving interpersonal violence.
Maternal and Child Outcomes (Not Revised) 7. (Secondary) Program effects on mothers and youth, in preliminary analyses, will be more pronounced for those with genetic vulnerabilities:
Effects on child outcomes will be more pronounced among youth born to mothers with either 1) the S/S, S/LG and "LG/LG" (low-activity) genotypes of 5-HTTLPR (conferring susceptibility for depression under adversity) or 2) 2 copies of the high activity COMT Val158 allele (conferring susceptibility to compromised ECF and SUDs under conditions of adversity).
Examination of Intervention Effects on Subsequent Children With an administrative supplement, we addressed the following questions focused on subsequent children born within 5 years of the first child. Note that these questions were framed with no specific hypotheses about the degree to which particular subgroups would benefit from the intervention, given that intervention impact on pregnancy planning had been most pronounced on women with higher psychological resources.
Aims of the Benefit-Cost Analysis
With an administrative supplement, we conducted a benefit-cost analysis of NFP in Memphis. The benefit-cost study was designed to:
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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.
Exclusion Criteria:
The 514 families received: 1) free transportation for prenatal care; and 2) child developmental screening and referral services.
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.
Maternal life-course (reflected in reduced total public benefit expenditures for SNAP, AFDC/TANF, and Medicaid).
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.
Time frame: through first child age 18
Cognitive, language, and academic functioning among first-born children.
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.
Time frame: at youth age 18
Youth depression and anxiety
Measure of internalizing disorders based upon youth self-report.
Time frame: at youth age 18
Youth gang membership, arrests, convictions, and self-reported antisocial behavior, especially for crimes involving interpersonal violence.
Self-reported involvement with criminal justice system and antisocial behavior. Program effects on arrests and convictions hypothesized to be greater for females.
Time frame: at youth age 18
Youth risk for HIV infection, pregnancies, births, use of substances, and SUDs.
Outcomes based upon self-report and urine assays for STI's and substance use.
Time frame: at youth age 18.
Reduced maternal substance use disorders (SUDs) and depression.
Based upon maternal self-report of SUDs and depression.
Time frame: at youth age 18
Improved child executive cognitive functioning, and rates of high school graduation.
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.
Time frame: at youth age 18
Cumulative subsequent pregnancies - mothers
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.
Time frame: through youth age 18
Pregnancies - youth
Self-reported pregnancies and pregnancy outcomes.
Time frame: through youth age 18
Relationship with Current Partner
Self-reported duration and quality of relationship, cohabitation, marriage, partner employment, and relationship to first-born child
Time frame: at youth age 18
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified individual participant data (including data dictionaries) will be made available in addition to study protocols, the statistical analysis plan, and the informed consent form. The data will be made available on publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.
Supporting information: Study protocol, Sap, Icf
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University of Colorado, Denver