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
  Purpose

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


Condition Intervention
Child Rearing
Risk Reduction Behavior
Reproductive 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 9 Follow-up of Preventive Intervention

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Enrollment: 584
Study Start Date: February 2004
Study Completion Date: April 2006
Arms Assigned Interventions
No Intervention: Control group
Control group
Experimental: Paraprofessional home visits
home visitation by Paraprofessional
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.
Experimental: Nurse home visits
home visitation by Nurse
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.

Detailed Description:

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?

  Eligibility

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

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00438594

Sponsors and Collaborators
University of Colorado, Denver
U.S. Department of Justice
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: NCT00438594     History of Changes
Other Study ID Numbers: 03-0776, R01MH069891
Study First Received: February 20, 2007
Last Updated: January 29, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 18, 2014