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

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ClinicalTrials.gov Identifier: NCT00438165
Recruitment Status : Completed
First Posted : February 22, 2007
Last Update Posted : February 19, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE February 20, 2007
First Posted Date  ICMJE February 22, 2007
Last Update Posted Date February 19, 2016
Study Start Date  ICMJE September 2003
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2007)
  • the number and spacing of subsequent pregnancies and births [ Time Frame: When first child is 12 ]
  • the rates of marriage and cohabitation with the father of the child [ Time Frame: When first child is 12 ]
  • mothers' employment, career growth, economic self-sufficiency, and welfare dependence [ Time Frame: When first child is 12 ]
  • mothers' behavioral problems due to substance abuse [ Time Frame: When first child is 12 ]
  • children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement [ Time Frame: At age 12 ]
  • rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children [ Time Frame: At age 12 ]
  • mothers' arrests for serious misdemeanors and felonies [ Time Frame: When first child is 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2007)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Age 12 Follow-up of Early Preventive Intervention (Memphis)
Official Title  ICMJE Age 12 Follow-up of Early Preventive Intervention
Brief Summary To examine the impact of prenatal and infancy home visiting by nurses from child age 2 through 12.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Child Rearing
  • Reproductive Behavior
  • Risk Reduction Behavior
Intervention  ICMJE Behavioral: home visitation
Home visitation by nurses from midway through pregnancy until child age 12
Study Arms  ICMJE
  • No Intervention: 1
    Control group
  • Experimental: 2
    Nurse home visits
    Intervention: Behavioral: home visitation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2007)
609
Original Enrollment  ICMJE
 (submitted: February 21, 2007)
679
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women <29 weeks gestation
  • No previous live births
  • At least 2 socio-demographic risk characteristics; e.g. unmarried, <12 years of education, unemployed.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00438165
Other Study ID Numbers  ICMJE 02-0683
R01MH068790 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: David L Olds, PhD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date February 2016

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