NCT00336193

Brief Summary

This proposal examines the impact of an augmented competency based approach to training of home visitors and supervisors for delivery of the Nurse Family Partnership (NFP) on staff performance, fidelity to the program model, and family outcomes relative to child maltreatment and early behaviors associated with youth violence. The central premise underlying the proposed study is that the augmented competency based curriculum and clinical consultation to supervisors will improve nurses' knowledge and skills in working with families, which in turn, will lead to greater fidelity to the home visit guidelines (i.e., quality implementation), which in turn, will result in better maternal and child health outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,075

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2005

Typical duration for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

February 11, 2011

Status Verified

February 1, 2011

Enrollment Period

4.1 years

First QC Date

June 10, 2006

Last Update Submit

February 10, 2011

Conditions

Child Abuse

Keywords

home visitationfamily outcomescompetency training

Outcome Measures

Primary Outcomes (5)

  • Assessment of children's home environment

    12 and 24 months

  • Children's emergency room visits/hospitalizations

    6, 12, 18, and 24 months

  • Children's adjustment and behavior

    21-22 months

  • Children's language development at 21 months

    21 months

  • Referrals to child protective services 6, 12, 18, and 24 months

    6, 12, 18, and 24 months

Study Arms (1)

Home visitation

EXPERIMENTAL

In the intervention condition, nurse home visitors receive enhanced training to improve delivery of parenting interventions to mothers

Behavioral: Home visitation

Interventions

Home visitationBEHAVIORAL

Home visitation to improve maternal health and well-being and parenting practices

Home visitation

Eligibility Criteria

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

You may qualify if:

  • First time mothers (enrolled during pregnancy) and their children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver Health Sciences Center

Denver, Colorado, 80262, United States

Location

Study Officials

  • Ruth A O'Brien, RN PhD

    University of Colorado Denver Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

June 10, 2006

First Posted

June 13, 2006

Study Start

August 1, 2005

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

February 11, 2011

Record last verified: 2011-02

Locations

US(1)