Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 20, 2007
February 5, 2013
September 2003
December 2006   (final data collection date for primary outcome measure)
  • 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 ]
  • the number and spacing of subsequent pregnancies and births
  • the rates of marriage and cohabitation with the father of the child
  • mothers' employment, career growth, economic self-sufficiency, and welfare dependence
  • mothers' behavioral problems due to substance abuse
  • children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement
  • rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children
  • mothers' arrests for serious misdemeanors and felonies
Complete list of historical versions of study NCT00438165 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Age 12 Follow-up of Early Preventive Intervention (Memphis)
Age 12 Follow-up of Early Preventive Intervention

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
  • Child Rearing
  • Reproductive Behavior
  • Risk Reduction Behavior
Behavioral: home visitation
Home visitation by nurses from midway through pregnancy until child age 2
  • No Intervention: 1
    Control group
  • Experimental: 2
    Nurse home visits
    Intervention: Behavioral: home visitation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
609
December 2006
December 2006   (final data collection date for primary outcome measure)

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)
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00438165
02-0683, R01MH068790
Yes
University of Colorado, Denver
University of Colorado, Denver
National Institute of Mental Health (NIMH)
Principal Investigator: David L Olds, PhD University of Colorado, Denver
University of Colorado, Denver
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP