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CompletedNCT00438282DenverY06Updated May 1, 2013

Age 6 Test of Home Visits by Nurses vs Paraprofessionals

An interventional study of home visitation in Child Rearing, Risk Reduction Behavior and Reproductive Behavior, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-01.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
604
Allocation
Randomized
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Child Rearing
  • Risk Reduction Behavior
  • Reproductive Behavior

Keywords

  • nurse
  • home visits
  • pregnancy
  • welfare
  • child development
03

In context

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
604 participants (actual)

Study arms

  • No intervention
    1

    Control group

  • Experimental
    2

    Paraprofessional home visits

    Behavioral: home visitation

  • Experimental
    3

    Nurse home visitation

    Behavioral: home visitation

Interventions

  • Behavioralhome visitation

    Home visitation from midway through pregnancy until child age 2. Group 2 is visitation by Paraprofessionals; group 3 is home visitation by Nurses.

06

What researchers measure

Primary outcomes

  1. increased interval between the birth of the first and second child;

    Time frame: When first child is 6

  2. increased cohabitation with the biological father of the child and the involvement of a supportive male partner;

    Time frame: When first child is 6

  3. 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

  4. 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

  5. children's compromised executive functions, language and intellectual skills

    Time frame: When child is 6

07

Study locations

1 site
  • University of Colorado Health Sciences Center
    Denver, Colorado 80218, United States
08

References and documents

Publications

  • 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. doi: 10.1542/peds.2004-0961. PubMed 15574615 ↗
  • 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. doi: 10.1542/peds.110.3.486. PubMed 12205249 ↗
  • Olds DL, Holmberg JR, Donelan-McCall N, Luckey DW, Knudtson MD, Robinson J. Effects of home visits by paraprofessionals and by nurses on children: follow-up of a randomized trial at ages 6 and 9 years. JAMA Pediatr. 2014 Feb;168(2):114-21. doi: 10.1001/jamapediatrics.2013.3817. PubMed 24296904 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00438282
Lead sponsor
University of Colorado, Denver
Collaborators
The Colorado Trust, National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Feb 22, 2007
Start date
Mar 2001
Primary completion
Jul 2005
Completion
Dec 2007
Last update
May 1, 2013

Study contacts

David L Olds, PhD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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