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Age 9 Follow-up of Preventive Intervention (Denver) (DenverY09)

This study has been completed.
Sponsor:
Collaborators:
U.S. Department of Justice
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00438594
First received: February 20, 2007
Last updated: January 29, 2013
Last verified: January 2013

February 20, 2007
January 29, 2013
February 2004
Not Provided
  • fewer subsequent pregnancies [ Time Frame: When first child is 9 ] [ Designated as safety issue: No ]
  • increased interval between the birth of the first and second child [ Time Frame: When first child is 9 ] [ Designated as safety issue: No ]
  • reduced use of welfare [ Time Frame: When first child is 9 ] [ Designated as safety issue: No ]
  • increased participation in the work force [ Time Frame: When first child is 9 ] [ Designated as safety issue: No ]
  • reduced behavioral problems due to use of alcohol and drugs [ Time Frame: When first child is 9 ] [ Designated as safety issue: No ]
  • fewer arrests [ Time Frame: When first child is 9 ] [ Designated as safety issue: No ]
  • increased qualities of care parents provide to their children as reflected in fewer verified reports of child abuse and neglect and observations of coercive mother-child interaction. [ Time Frame: When first child is 9 ] [ Designated as safety issue: No ]
  • children's early-onset behavior problems (both externalizing and internalizing) reported by parents and teachers at home, at school, and with peers. [ Time Frame: At child age 9 ] [ Designated as safety issue: No ]
  • children's aggressive and destructive themes and narrative coherence in their responses to story stems. [ Time Frame: At child age 9 ] [ Designated as safety issue: No ]
  • executive functions and school achievement. [ Time Frame: At child age 9 ] [ Designated as safety issue: No ]
  • fewer subsequent pregnancies
  • increased interval between the birth of the first and second child
  • reduced use of welfare
  • increased participation in the work force
  • reduced behavioral problems due to use of alcohol and drugs
  • fewer arrests
  • increased qualities of care parents provide to their children as reflected in fewer verified reports of child abuse and neglect and observations of coercive mother-child interaction.
  • children’s early-onset behavior problems (both externalizing and internalizing) reported by parents and teachers at home, at school, and with peers.
  • children’s aggressive and destructive themes and narrative coherence in their responses to story stems.
  • executive functions and school achievement.
Complete list of historical versions of study NCT00438594 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Age 9 Follow-up of Preventive Intervention (Denver)
Age 9 Follow-up of Preventive Intervention

To examine the impact of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through 9.

This project supports a 9-year follow-up of 650 children and their families who were enrolled in a randomized trial of prenatal and infancy home visiting by paraprofessionals and by nurses; participating families were assigned to control, paraprofessional-, or nurse-visited conditions. Earlier phases of assessment found significant benefits for nurse- and paraprofessional-visited families and children, although the nurse effects tended to be larger. The current phase of follow-up is designed to determine whether the effects of the nurse and paraprofessional programs endure and grow through the child age 9.5.

The project is organized around seven questions:

  1. Do the programs of nurse and paraprofessional home-visiting produce enduring effects on: a) mothers' life-course; b) qualities of care parents provide to their children; c) children's early-onset behavior problems; d) children's incoherence and aggression/destruction in response to story stems; e) children's executive, language, and intellectual functioning and school achievement?
  2. To what extent are the beneficial effects of the programs on parental care-giving and children's development concentrated on those born to mothers with few psychological resources?
  3. To what extent are the benefits of the programs on mothers and children equivalent for Mexican- Americans and European-Americans?
  4. To what extent are the effects of the programs on antisocial behavior concentrated on boys? 5. To what extent are program effects moderated by school and neighborhood contexts?

6. To what extent are the effects of the programs on children's development explained by impacts of the programs on women's prenatal smoking, maternal life-course, qualities of parental caregiving, and children's earlier language development, executive functioning, and emotional regulation? 7. To what extent are the initial costs of the programs recovered in reduced expenditures for other government services during the first nine years of the first child's life?

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
  • Risk Reduction Behavior
  • Reproductive Behavior
Behavioral: home visitation
Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.
  • No Intervention: Control group
    Control group
  • Experimental: Paraprofessional home visits
    home visitation by Paraprofessional
    Intervention: Behavioral: home visitation
  • Experimental: Nurse home visits
    home visitation by Nurse
    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
584
April 2006
Not Provided

Inclusion Criteria:

  • Women from 21 antepartum clinics serving low-income women in Denver recruited if they had no previous live births and either qualified for Medicaid or had no private insurance.
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00438594
03-0776, R01MH069891
Yes
University of Colorado, Denver
University of Colorado, Denver
  • U.S. Department of Justice
  • National Institute of Mental Health (NIMH)
Principal Investigator: David L Olds, PhD University of Colorado, Denver
University of Colorado, Denver
January 2013

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