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CompletedNCT00438594DenverY09Updated Jan 31, 2013

Age 9 Follow-up of Preventive Intervention (Denver)

An interventional study of home visitation in Child Rearing, Risk Reduction Behavior and Reproductive Behavior, sponsored by University of Colorado, Denver. Completed. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-31.

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

Phase
Not applicable
Study type
Interventional
Enrollment
584
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 9.

Read the detailed description

This project supports a 9-year follow-up of 650 children and their families who were enrolled in a randomized trial of prenatal and infancy home visiting by paraprofessionals and by nurses; participating families were assigned to control, paraprofessional-, or nurse-visited conditions. Earlier phases of assessment found significant benefits for nurse- and paraprofessional-visited families and children, although the nurse effects tended to be larger. The current phase of follow-up is designed to determine whether the effects of the nurse and paraprofessional programs endure and grow through the child age 9.5.

The project is organized around seven questions:

  1. Do the programs of nurse and paraprofessional home-visiting produce enduring effects on: a) mothers' life-course; b) qualities of care parents provide to their children; c) children's early-onset behavior problems; d) children's incoherence and aggression/destruction in response to story stems; e) children's executive, language, and intellectual functioning and school achievement?
  2. To what extent are the beneficial effects of the programs on parental care-giving and children's development concentrated on those born to mothers with few psychological resources?
  3. To what extent are the benefits of the programs on mothers and children equivalent for Mexican- Americans and European-Americans?
  4. To what extent are the effects of the programs on antisocial behavior concentrated on boys? 5. To what extent are program effects moderated by school and neighborhood contexts?
  1. To what extent are the effects of the programs on children's development explained by impacts of the programs on women's prenatal smoking, maternal life-course, qualities of parental caregiving, and children's earlier language development, executive functioning, and emotional regulation? 7. To what extent are the initial costs of the programs recovered in reduced expenditures for other government services during the first nine years of the first child's life?
02

Conditions studied

  • Child Rearing
  • Risk Reduction Behavior
  • Reproductive Behavior

Keywords

  • nurse
  • paraprofessional
  • 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 from 21 antepartum clinics serving low-income women in Denver recruited 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
584 participants (actual)

Study arms

  • No intervention
    Control group

    Control group

  • Experimental
    Paraprofessional home visits

    home visitation by Paraprofessional

    Behavioral: home visitation

  • Experimental
    Nurse home visits

    home visitation by Nurse

    Behavioral: home visitation

Interventions

  • Behavioralhome visitation

    Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.

06

What researchers measure

Primary outcomes

  1. fewer subsequent pregnancies

    Time frame: When first child is 9

  2. increased interval between the birth of the first and second child

    Time frame: When first child is 9

  3. reduced use of welfare

    Time frame: When first child is 9

  4. increased participation in the work force

    Time frame: When first child is 9

  5. reduced behavioral problems due to use of alcohol and drugs

    Time frame: When first child is 9

  6. fewer arrests

    Time frame: When first child is 9

  7. increased qualities of care parents provide to their children as reflected in fewer verified reports of child abuse and neglect and observations of coercive mother-child interaction.

    Time frame: When first child is 9

  8. children's early-onset behavior problems (both externalizing and internalizing) reported by parents and teachers at home, at school, and with peers.

    Time frame: At child age 9

  9. children's aggressive and destructive themes and narrative coherence in their responses to story stems.

    Time frame: At child age 9

  10. executive functions and school achievement.

    Time frame: At child age 9

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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, 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, 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00438594
Lead sponsor
University of Colorado, Denver
Collaborators
U.S. Department of Justice, National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Feb 22, 2007
Start date
Feb 2004
Completion
Apr 2006
Last update
Jan 31, 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 Jan 2013. You cannot join it, but the record below documents what was studied.

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