Age 6 Test of Home Visits by Nurses vs Paraprofessionals (DenverY06)

This study has been completed.
Sponsor:
Collaborators:
The Colorado Trust
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00438282
First received: February 20, 2007
Last updated: April 30, 2013
Last verified: February 2013
  Purpose

To examine the impact of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through 6.


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 6 Test of Home Visits by Nurses vs Paraprofessionals

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

Primary Outcome Measures:
  • increased interval between the birth of the first and second child; [ Time Frame: When first child is 6 ] [ Designated as safety issue: No ]
  • increased cohabitation with the biological father of the child and the involvement of a supportive male partner; [ Time Frame: When first child is 6 ] [ Designated as safety issue: No ]
  • increase parents' competent care of their children, as reflected in greater involvement and monitoring of their children's behavior, more consistent discipline, and greater investment in their children's educational achievement. [ Time Frame: When first child is 6 ] [ Designated as safety issue: No ]
  • children's behavior problems and expressions of dysregulated aggressive and violent themes in their response to the MacArthur Story Stem Battery [ Time Frame: When child is 6 ] [ Designated as safety issue: No ]
  • children's compromised executive functions, language and intellectual skills [ Time Frame: When child is 6 ] [ Designated as safety issue: No ]

Enrollment: 604
Study Start Date: March 2001
Study Completion Date: December 2007
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Control group
Experimental: 2
Paraprofessional home visits
Behavioral: home visitation
Home visitation from midway through pregnancy until child age 2. Group 2 is visitation by Paraprofessionals; group 3 is home visitation by Nurses.
Experimental: 3
Nurse home visitation
Behavioral: home visitation
Home visitation from midway through pregnancy until child age 2. Group 2 is visitation by Paraprofessionals; group 3 is home visitation by Nurses.

Detailed Description:

This project supports an age-six assessment of 669 children and their families who were enrolled in a randomized trail that compared prenatal and infancy home visiting by nurses versus paraprofessionals. Both groups of visitors in each study employed essentially the same program model. The program model has proven to be effective using nurses when focused on European-American and African Americans in earlier trails conducted over the past 20 years. Paraprofessional visitors in the current trail share many of the social characteristics of the families they visited. The current study also allows us to examine the extent to which these different visitor types produce effects with Mexican Americans that are similar to those achieved with European-Americans and African Americans in previous trails of this program using nurse home visitors. The sample is composed of low-income women who had no previous live births and who were substantially ethnic minorities (46 percent Mexican American, 16 percent African American, and 3 percent Native American/Asian), unmarried (87 percent), and less than 19 years of age (58 percent) at the time of registration during pregnancy.

In earlier phases of assessment, the nurse-visitor program was found to reduce women's use of tobacco during pregnancy; to improve the home environments and quality of care that mothers provided to their children; to improve the language and mental development of children born to mothers with low psychological resources (where psychological resources were defined as high rates of mental disorder symptoms, limited intellectual functioning, and little belief in their control over their life circumstances); and to improve maternal life-course, as reflected in fewer subsequent pregnancies and increases in employment. The paraprofessional program produced smaller, mostly non-significant and inconsistent effects while the program was in operation, but recent evidence from a 4-year follow up of the sample now suggests that paraprofessional program effects on parental caregiving and child development may be increasing as the children mature. The current proposal seeks support to determine whether the beneficial effects of the nurse home visiting program endure through the children's completion of kindergarten at age six, and whether beneficial effects emerge at this later time period for families visited by paraprofessionals.

  Eligibility

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

Inclusion Criteria:

  • Women were recruited from 21 antepartum clinics serving low-income women in Denver 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: NCT00438282

Locations
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80218
Sponsors and Collaborators
University of Colorado, Denver
The Colorado Trust
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: NCT00438282     History of Changes
Obsolete Identifiers: NCT00053664
Other Study ID Numbers: 00-0036, R01MH062485
Study First Received: February 20, 2007
Last Updated: April 30, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 20, 2014