Competency Training, Staff Performance, & Family Outcomes

This study has been completed.

Sponsor:

Information provided by:

Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT00336193

First received: June 10, 2006

Last updated: February 10, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 10, 2006

Last Updated Date

February 10, 2011

Start Date ^ICMJE

August 2005

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assessment of children's home environment [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Children's emergency room visits/hospitalizations [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
Children's adjustment and behavior [ Time Frame: 21-22 months ] [ Designated as safety issue: No ]
Children's language development at 21 months [ Time Frame: 21 months ] [ Designated as safety issue: No ]
Referrals to child protective services 6, 12, 18, and 24 months [ Time Frame: 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Assessment of children's home environment at 12 and 24 months
Children's emergency room visits/hospitalizations at 6, 12, 18, and 24 months
Children's adjustment and behavior at 21-22 months
Children's language development at 21 months
Referrals to child protective services at 6, 12, 18, and 24 months

Change History

Complete list of historical versions of study NCT00336193 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Competency Training, Staff Performance, & Family Outcomes

Official Title ^ICMJE

University of Colorado Health Sciences Center: Competency Training, Staff Performance, & Family Outcomes

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.

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention

Condition ^ICMJE

Child Abuse

Intervention ^ICMJE

Behavioral: Home visitation

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

Study Arm (s)

Experimental: Home visitation

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

Intervention: Behavioral: Home visitation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1075

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

First time mothers (enrolled during pregnancy) and their children

Exclusion Criteria:

See above. No other exclusion criteria will be used.

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00336193

Other Study ID Numbers ^ICMJE

CDC-NCIPC-4537

Has Data Monitoring Committee

Responsible Party

Ruth O'Brien, University of Colorado Health Sciences Center

Study Sponsor ^ICMJE

Centers for Disease Control and Prevention

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ruth A O'Brien, RN PhD

University of Colorado Denver Health Sciences Center

Information Provided By

Centers for Disease Control and Prevention

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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