Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT00336193
Status:
COMPLETED
Last Update Posted:
2011-02-11
First Post:
2006-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Competency Training, Staff Performance, & Family Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1075}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-10', 'studyFirstSubmitDate': '2006-06-10', 'studyFirstSubmitQcDate': '2006-06-10', 'lastUpdatePostDateStruct': {'date': '2011-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Assessment of children's home environment", 'timeFrame': '12 and 24 months'}, {'measure': "Children's emergency room visits/hospitalizations", 'timeFrame': '6, 12, 18, and 24 months'}, {'measure': "Children's adjustment and behavior", 'timeFrame': '21-22 months'}, {'measure': "Children's language development at 21 months", 'timeFrame': '21 months'}, {'measure': 'Referrals to child protective services 6, 12, 18, and 24 months', 'timeFrame': '6, 12, 18, and 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['home visitation', 'family outcomes', 'competency training'], 'conditions': ['Child Abuse']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First time mothers (enrolled during pregnancy) and their children\n\nExclusion Criteria:\n\n* See above. No other exclusion criteria will be used.'}, 'identificationModule': {'nctId': 'NCT00336193', 'briefTitle': 'Competency Training, Staff Performance, & Family Outcomes', 'organization': {'class': 'FED', 'fullName': 'Centers for Disease Control and Prevention'}, 'officialTitle': 'University of Colorado Health Sciences Center: Competency Training, Staff Performance, & Family Outcomes', 'orgStudyIdInfo': {'id': 'CDC-NCIPC-4537'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home visitation', 'description': 'In the intervention condition, nurse home visitors receive enhanced training to improve delivery of parenting interventions to mothers', 'interventionNames': ['Behavioral: Home visitation']}], 'interventions': [{'name': 'Home visitation', 'type': 'BEHAVIORAL', 'description': 'Home visitation to improve maternal health and well-being and parenting practices', 'armGroupLabels': ['Home visitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver Health Sciences Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': "Ruth A O'Brien, RN PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado Denver Health Sciences Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': "Ruth O'Brien", 'oldOrganization': 'University of Colorado Health Sciences Center'}}}}