Age-17 Follow-up of Home Visiting Intervention - Full Text View

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:

MedlinePlus related topics: HIV/AIDS HIV/AIDS and Pregnancy

U.S. FDA Resources

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

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples With DNA

Spit samples will be taken.


Enrollment:	1138
Study Start Date:	May 2008
Study Completion Date:	October 2015
Primary Completion Date:	October 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.	Behavioral: Nurse Home Visitation Visits from nurses from mid-pregnancy to child age 2 years.
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.	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 (Child, Adult)
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

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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Kitzman H, Olds DL, Henderson CR Jr, Hanks C, Cole R, Tatelbaum R, McConnochie KM, Sidora K, Luckey DW, Shaver D, Engelhardt K, James D, Barnard K. Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing. A randomized controlled trial. JAMA. 1997 Aug 27;278(8):644-52.

Kitzman H, Olds DL, Sidora K, Henderson CR Jr, Hanks C, Cole R, Luckey DW, Bondy J, Cole K, Glazner J. Enduring effects of nurse home visitation on maternal life course: a 3-year follow-up of a randomized trial. JAMA. 2000 Apr 19;283(15):1983-9.

Olds DL, Kitzman H, Cole R, Robinson J, Sidora K, Luckey DW, Henderson CR Jr, Hanks C, Bondy J, Holmberg J. Effects of nurse home-visiting on maternal life course and child development: age 6 follow-up results of a randomized trial. Pediatrics. 2004 Dec;114(6):1550-9.

Olds DL, Kitzman H, Hanks C, Cole R, Anson E, Sidora-Arcoleo K, Luckey DW, Henderson CR Jr, Holmberg J, Tutt RA, Stevenson AJ, Bondy J. Effects of nurse home visiting on maternal and child functioning: age-9 follow-up of a randomized trial. Pediatrics. 2007 Oct;120(4):e832-45.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Olds DL, Kitzman H, Knudtson MD, Anson E, Smith JA, Cole R. Effect of home visiting by nurses on maternal and child mortality: results of a 2-decade follow-up of a randomized clinical trial. JAMA Pediatr. 2014 Sep;168(9):800-6. doi: 10.1001/jamapediatrics.2014.472.


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:	March 1, 2016
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2016

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