NCT00438594

Brief Summary

To examine the impact of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through 9.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
584

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2004

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

First QC Date

February 20, 2007

Last Update Submit

January 29, 2013

Conditions

Child RearingRisk Reduction BehaviorReproductive Behavior

Keywords

nurseparaprofessionalhome visitspregnancywelfarechild development

Outcome Measures

Primary Outcomes (10)

  • fewer subsequent pregnancies

    When first child is 9

  • increased interval between the birth of the first and second child

    When first child is 9

  • reduced use of welfare

    When first child is 9

  • increased participation in the work force

    When first child is 9

  • reduced behavioral problems due to use of alcohol and drugs

    When first child is 9

  • fewer arrests

    When first child is 9

  • 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.

    When first child is 9

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

    At child age 9

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

    At child age 9

  • executive functions and school achievement.

    At child age 9

Study Arms (3)

Control group

NO INTERVENTION

Control group

Paraprofessional home visits

EXPERIMENTAL

home visitation by Paraprofessional

Behavioral: home visitation

Nurse home visits

EXPERIMENTAL

home visitation by Nurse

Behavioral: home visitation

Interventions

home visitationBEHAVIORAL

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

Nurse home visitsParaprofessional home visits

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 12205249BACKGROUND

  • 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.

    PMID: 15574615BACKGROUND

  • 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.

    PMID: 24296904DERIVED

MeSH Terms

Conditions

Risk Reduction BehaviorReproductive Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • David L Olds, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

February 1, 2004

Study Completion

April 1, 2006

Last Updated

January 31, 2013

Record last verified: 2013-01