NCT00438282

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
604

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2001

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
1.6 years 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
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 1, 2013

Status Verified

February 1, 2013

Enrollment Period

4.3 years

First QC Date

February 20, 2007

Last Update Submit

April 30, 2013

Conditions

Child RearingRisk Reduction BehaviorReproductive Behavior

Keywords

nursehome visitspregnancywelfarechild development

Outcome Measures

Primary Outcomes (5)

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

    When first child is 6

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

    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.

    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

    When child is 6

  • children's compromised executive functions, language and intellectual skills

    When child is 6

Study Arms (3)

1

NO INTERVENTION

Control group

2

EXPERIMENTAL

Paraprofessional home visits

Behavioral: home visitation

3

EXPERIMENTAL

Nurse home visitation

Behavioral: home visitation

Interventions

home visitationBEHAVIORAL

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

23

Eligibility Criteria

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Health Sciences Center

Denver, Colorado, 80218, United States

Location

Related Publications (3)

  • 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, 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, 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

March 1, 2001

Primary Completion

July 1, 2005

Study Completion

December 1, 2007

Last Updated

May 1, 2013

Record last verified: 2013-02

Locations

US(1)