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

February 20, 2007
April 30, 2013
March 2001
July 2005   (final data collection date for primary outcome measure)
  • 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 ]
  • increased interval between the birth of the first and second child;
  • increased cohabitation with the biological father of the child and the involvement of a supportive male partner;
  • 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.
  • children’s behavior problems and expressions of dysregulated aggressive and violent themes in their response to the MacArthur Story Stem Battery
  • children's compromised executive functions, language and intellectual skills
  • fewer subsequent pregnancies;
Complete list of historical versions of study NCT00438282 on ClinicalTrials.gov Archive Site
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Age 6 Test of Home Visits by Nurses vs Paraprofessionals
Age 6 Test of Home Visits by Nurses vs Paraprofessionals

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

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.

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 visitation from midway through pregnancy until child age 2. Group 2 is visitation by Paraprofessionals; group 3 is home visitation by Nurses.
  • No Intervention: 1
    Control group
  • Experimental: 2
    Paraprofessional home visits
    Intervention: Behavioral: home visitation
  • Experimental: 3
    Nurse home visitation
    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
604
December 2007
July 2005   (final data collection date for primary outcome measure)

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.
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00438282
00-0036, R01MH062485
Yes
University of Colorado, Denver
University of Colorado, Denver
  • The Colorado Trust
  • National Institute of Mental Health (NIMH)
Principal Investigator: David L Olds, PhD University of Colorado, Denver
University of Colorado, Denver
February 2013

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