Viewing Study NCT00438282



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Last Modification Date: 2024-10-26 @ 9:31 AM
Study NCT ID: NCT00438282
Status: COMPLETED
Last Update Posted: 2013-05-01
First Post: 2007-02-20

Brief Title: Age 6 Test of Home Visits by Nurses vs Paraprofessionals
Sponsor: University of Colorado Denver
Organization: University of Colorado Denver

Study Overview

Official Title: Age 6 Test of Home Visits by Nurses vs Paraprofessionals
Status: COMPLETED
Status Verified Date: 2013-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DenverY06
Brief Summary: To examine the impact of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through 6
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 AmericanAsian 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 womens 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 childrens completion of kindergarten at age six and whether beneficial effects emerge at this later time period for families visited by paraprofessionals

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01MH062485 NIH None httpsreporternihgovquickSearchR01MH062485