ElmiraY19: Longitudinal Follow Up of Subjects Enrolled in Randomized Trial of Prenatal and Infancy Home Visitation
Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT00443638
Collaborator
Smith-Richardson Foundation (Other)
320
1
3
23
13.9
Study Details
Study Description
Brief Summary
The Elmira follow-up study is designed to assess the extent to which prenatal and infancy home visitation by nurses affects the life-course development of 19-year-old youth whose mothers received those services during pregnancy and the first two years of the child's life.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Longitudinal Follow Up of Subjects Enrolled in Randomized Trials of Prenatal and Infancy Home Visitation
Study Start Date
:
May 1, 1998
Actual Study Completion Date
:
Apr 1, 2000
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Group Control Group |
|
| Experimental: Home visitation through pregnancy Nurse home visitation through pregnancy |
Behavioral: nurse home visitation
Nurse home visitation
|
| Experimental: Home visitation through age 2 Nurse home visitation through child age 2. |
Behavioral: nurse home visitation
Nurse home visitation
|
Outcome Measures
Primary Outcome Measures
- rates of pregnancy and out-of-wedlock child birth [At age 19]
- educational achievement, including graduation from high school and participation in various types of post-high school education [At age 19]
- participation in the work force, including enrollment in the armed services [At age 19]
- use of welfare [At age 19]
- use of substances (cigarettes, alcohol, and illegal drugs) [At age 19]
- involvement with the criminal justice system (arrests, convictions, incarcerations, etc.) [At age 19]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Pregnant women prior to the 25th week of gestation
-
no previous live births
-
one of the following sociodemographic risk characteristics:
-
young age (< 19 years at registration);
-
unmarried
-
low socioeconomic status (Medicaid status or no private insurance)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CIDS | Elmira | New York | United States | 14901 |
Sponsors and Collaborators
- University of Colorado, Denver
- Smith-Richardson Foundation
Investigators
- Principal Investigator: David Olds, PhD, University of Colorado, Denver
Study Documents (Full-Text)
None provided.More Information
Publications
- Eckenrode J, Ganzel B, Henderson CR Jr, Smith E, Olds DL, Powers J, Cole R, Kitzman H, Sidora K. Preventing child abuse and neglect with a program of nurse home visitation: the limiting effects of domestic violence. JAMA. 2000 Sep 20;284(11):1385-91.
- Eckenrode J, Zielinski D, Smith E, Marcynyszyn LA, Henderson CR Jr, Kitzman H, Cole R, Powers J, Olds DL. Child maltreatment and the early onset of problem behaviors: can a program of nurse home visitation break the link? Dev Psychopathol. 2001 Fall;13(4):873-90.
- Izzo CV, Eckenrode JJ, Smith EG, Henderson CR, Cole R, Kitzman H, Olds DL. Reducing the impact of uncontrollable stressful life events through a program of nurse home visitation for new parents. Prev Sci. 2005 Dec;6(4):269-74.
- Olds DL, Eckenrode J, Henderson CR Jr, Kitzman H, Powers J, Cole R, Sidora K, Morris P, Pettitt LM, Luckey D. Long-term effects of home visitation on maternal life course and child abuse and neglect. Fifteen-year follow-up of a randomized trial. JAMA. 1997 Aug 27;278(8):637-43.
- Olds DL, Henderson CR Jr, Chamberlin R, Tatelbaum R. Preventing child abuse and neglect: a randomized trial of nurse home visitation. Pediatrics. 1986 Jul;78(1):65-78.
- Olds DL, Henderson CR Jr, Kitzman H. Does prenatal and infancy nurse home visitation have enduring effects on qualities of parental caregiving and child health at 25 to 50 months of life? Pediatrics. 1994 Jan;93(1):89-98.
- Olds DL, Henderson CR Jr, Phelps C, Kitzman H, Hanks C. Effect of prenatal and infancy nurse home visitation on government spending. Med Care. 1993 Feb;31(2):155-74.
- Olds DL, Henderson CR Jr, Tatelbaum R, Chamberlin R. Improving the life-course development of socially disadvantaged mothers: a randomized trial of nurse home visitation. Am J Public Health. 1988 Nov;78(11):1436-45.
- Olds DL, Henderson CR Jr, Tatelbaum R. Intellectual impairment in children of women who smoke cigarettes during pregnancy. Pediatrics. 1994 Feb;93(2):221-7. Erratum in: Pediatrics 1994 Jun;93(6 Pt 1):973.
- Olds DL, Henderson CR Jr, Tatelbaum R. Prevention of intellectual impairment in children of women who smoke cigarettes during pregnancy. Pediatrics. 1994 Feb;93(2):228-33. Erratum in: Pediatrics 1994 Jun;93(6 Pt 1):973.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00443638
Other Study ID Numbers:
- 98-0568
First Posted:
Mar 6, 2007
Last Update Posted:
Jan 31, 2013
Last Verified:
Jan 1, 2013