- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00336193
Competency Training, Staff Performance, & Family Outcomes
February 10, 2011 updated by: Centers for Disease Control and Prevention
University of Colorado Health Sciences Center: Competency Training, Staff Performance, & Family Outcomes
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.
Study Overview
Detailed Description
A two group experimental design will be used to examine the impact of an augmented competency-based curriculum for NFP home visitors and supervisors coupled with structured clinical consultation by NFP National Office professional development staff, as compared against the standard curriculum currently used, on quality of program implementation and family outcomes.
Study Type
Interventional
Enrollment (Anticipated)
1075
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Denver, Colorado, United States, 80262
- University of Colorado Denver Health Sciences Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- First time mothers (enrolled during pregnancy) and their children
Exclusion Criteria:
- See above. No other exclusion criteria will be used.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home visitation
In the intervention condition, nurse home visitors receive enhanced training to improve delivery of parenting interventions to mothers
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Home visitation to improve maternal health and well-being and parenting practices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessment of children's home environment
Time Frame: 12 and 24 months
|
12 and 24 months
|
|
Children's emergency room visits/hospitalizations
Time Frame: 6, 12, 18, and 24 months
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6, 12, 18, and 24 months
|
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Children's adjustment and behavior
Time Frame: 21-22 months
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21-22 months
|
|
Children's language development at 21 months
Time Frame: 21 months
|
21 months
|
|
Referrals to child protective services 6, 12, 18, and 24 months
Time Frame: 6, 12, 18, and 24 months
|
6, 12, 18, and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ruth A O'Brien, RN PhD, University of Colorado Denver Health Sciences Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
June 10, 2006
First Submitted That Met QC Criteria
June 10, 2006
First Posted (Estimate)
June 13, 2006
Study Record Updates
Last Update Posted (Estimate)
February 11, 2011
Last Update Submitted That Met QC Criteria
February 10, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- CDC-NCIPC-4537
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.