Age 12 Follow-up of Early Preventive Intervention (Memphis) (MemphisY12)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00438165
First received: February 20, 2007
Last updated: February 5, 2013
Last verified: December 2007
  Purpose

To examine the impact of prenatal and infancy home visiting by nurses from child age 2 through 12.


Condition Intervention
Child Rearing
Reproductive Behavior
Risk Reduction Behavior
Behavioral: home visitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Age 12 Follow-up of Early Preventive Intervention

Resource links provided by NLM:


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

Primary Outcome Measures:
  • the number and spacing of subsequent pregnancies and births [ Time Frame: When first child is 12 ] [ Designated as safety issue: No ]
  • the rates of marriage and cohabitation with the father of the child [ Time Frame: When first child is 12 ] [ Designated as safety issue: No ]
  • mothers' employment, career growth, economic self-sufficiency, and welfare dependence [ Time Frame: When first child is 12 ] [ Designated as safety issue: No ]
  • mothers' behavioral problems due to substance abuse [ Time Frame: When first child is 12 ] [ Designated as safety issue: No ]
  • children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement [ Time Frame: At age 12 ] [ Designated as safety issue: No ]
  • rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children [ Time Frame: At age 12 ] [ Designated as safety issue: No ]
  • mothers' arrests for serious misdemeanors and felonies [ Time Frame: When first child is 12 ] [ Designated as safety issue: No ]

Enrollment: 609
Study Start Date: September 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Control group
Experimental: 2
Nurse home visits
Behavioral: home visitation
Home visitation by nurses from midway through pregnancy until child age 2

Detailed Description:

This study is a longitudinal follow-up of 679 low-income women (89% African American) and their firstborn and subsequent children who have participated in a randomized trial of prenatal and infancy home visiting by nurses in Memphis, Tennessee since 1988. The study was conducted when the first-born children completed sixth grade, at around their 12th birthday.

The current follow-up was designed to determine whether: a) nurse-visited women differ from comparison group women in their life-course outcomes (the number and spacing of subsequent pregnancies and births; the rates of marriage and cohabitation with the father of the child; their employment, career growth, economic self-sufficiency, and welfare dependence; and behavioral problems due to substance abuse; arrests for serious misdemeanors and felonies); b) children of nurse-visited women differ from comparison-children in their academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement; c) there are lower rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children born to nurse-visited women; d) nurse-visited families have fewer government expenditures and higher taxes paid; e) the effects of the program on child outcomes are concentrated on children born to women with low psychological resources; f) the effects of the program on maternal life course and government costs are concentrated on women with high psychological resources; g) the effects of the program on children are greater in schools and neighborhoods that contain greater risks for academic and behavioral problems; h) the effect of the program on children's disruptive behavior problems is explained by the combined effects of the program on maternal life-course, qualities of parental care-giving, and children's sequential processing skills, and aggressive and violent themes, reliance on adults, and story incoherence in their responses to the McArthur Story Stem Battery at earlier assessments. Data will be derived from maternal interviews and reviews of state administrative and school records. Results from this trial will provide policy makers with an estimate of likely long-term effects of this program when it is conducted in close to real-life conditions.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women <29 weeks gestation, with no previous live births, and with at least 2 socio-demographic risk characteristics (unmarried, <12 years of education, unemployed)
  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: NCT00438165

Locations
United States, New York
University of Rochester School of Nursing
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: David L Olds, PhD University of Colorado, Denver
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00438165     History of Changes
Other Study ID Numbers: 02-0683, R01MH068790
Study First Received: February 20, 2007
Last Updated: February 5, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Denver:
nurse
home visits
pregnancy
welfare
child development

ClinicalTrials.gov processed this record on September 22, 2014