Age 6 Test of Home Visits by Nurses vs Paraprofessionals

Risk Reduction Behavior Clinical Trial

— DenverY06  

Official title:

Age 6 Test of Home Visits by Nurses vs Paraprofessionals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438282
• Other study ID #: 00-0036
• Secondary ID: R01MH062485
• Status: Completed
• Phase: N/A
• First received: February 20, 2007
• Last updated: April 30, 2013
• Start date: March 2001
• Est. completion date: December 2007

Study information

• Verified date: February 2013
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT00053664

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: December 2007
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Child Rearing
• Reproductive Behavior
• Risk Reduction Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Mental Health (NIMH), The Colorado Trust

Country where clinical trial is conducted

United States, 

References & Publications (2)

Olds DL, Robinson J, O'Brien R, Luckey DW, Pettitt LM, Henderson CR Jr, Ng RK, Sheff KL, Korfmacher J, Hiatt S, Talmi A. Home visiting by paraprofessionals and by nurses: a randomized, controlled trial. Pediatrics. 2002 Sep;110(3):486-96. — View Citation

Olds DL, Robinson J, Pettitt L, Luckey DW, Holmberg J, Ng RK, Isacks K, Sheff K, Henderson CR Jr. Effects of home visits by paraprofessionals and by nurses: age 4 follow-up results of a randomized trial. Pediatrics. 2004 Dec;114(6):1560-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increased interval between the birth of the first and second child;		When first child is 6	No
Primary	increased cohabitation with the biological father of the child and the involvement of a supportive male partner;		When first child is 6	No
Primary	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.		When first child is 6	No
Primary	children's behavior problems and expressions of dysregulated aggressive and violent themes in their response to the MacArthur Story Stem Battery		When child is 6	No
Primary	children's compromised executive functions, language and intellectual skills		When child is 6	No