Longitudinal Follow Up of Subjects Enrolled in Randomized Trial of Prenatal and Infancy Home Visitation

Risk Reduction Behavior Clinical Trial

— ElmiraY19  

Official title:

Longitudinal Follow Up of Subjects Enrolled in Randomized Trials of Prenatal and Infancy Home Visitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443638
• Other study ID #: 98-0568
• Status: Completed
• Phase: N/A
• First received: March 2, 2007
• Last updated: January 29, 2013
• Start date: May 1998
• Est. completion date: April 2000

Study information

• Verified date: January 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: April 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Reproductive Behavior
• Risk Reduction Behavior

Intervention

Behavioral:
• nurse home visitation
Nurse home visitation

Locations

Country	Name	City	State
United States	CIDS	Elmira	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Smith-Richardson Foundation

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rates of pregnancy and out-of-wedlock child birth		At age 19	No
Primary	educational achievement, including graduation from high school and participation in various types of post-high school education		At age 19	No
Primary	participation in the work force, including enrollment in the armed services		At age 19	No
Primary	use of welfare		At age 19	No
Primary	use of substances (cigarettes, alcohol, and illegal drugs)		At age 19	No
Primary	involvement with the criminal justice system (arrests, convictions, incarcerations, etc.)		At age 19	No