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

April 30, 2013 updated by: University of Colorado, Denver
To examine the impact of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through 6.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

604

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • University of Colorado Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
increased interval between the birth of the first and second child;
Time Frame: When first child is 6
When first child is 6
increased cohabitation with the biological father of the child and the involvement of a supportive male partner;
Time Frame: When first child is 6
When first child is 6
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
When first child is 6
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
When child is 6
children's compromised executive functions, language and intellectual skills
Time Frame: When child is 6
When child is 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Mental Health (NIMH)
The Colorado Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 20, 2007

First Submitted That Met QC Criteria

February 21, 2007

First Posted (Estimate)

February 22, 2007

Study Record Updates

Last Update Posted (Estimate)

May 1, 2013

Last Update Submitted That Met QC Criteria

April 30, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 00-0036
  • R01MH062485 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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