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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00438165
First Posted: February 22, 2007
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Colorado, Denver
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Age 12 Follow-up of Early Preventive Intervention

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 ]
  • 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 ]

Enrollment: 609
Study Start Date: September 2003
Study Completion Date: May 2012
Primary Completion Date: May 2012 (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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: David L Olds, PhD University of Colorado, Denver
  More Information

Publications:
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 ( U.S. NIH Grant/Contract )
First Submitted: February 20, 2007
First Posted: February 22, 2007
Last Update Posted: February 19, 2016
Last Verified: February 2016

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