Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT05846269
Status:
UNKNOWN
Last Update Posted:
2023-05-06
First Post:
2022-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Resiliency and TIC Intervention for PMHNP Specialty DNP Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2022-12-12', 'studyFirstSubmitQcDate': '2023-04-26', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trauma informed care knowledge questionnaire', 'timeFrame': '2023 Academic Year', 'description': "An original online survey designed by the investigators to align with objectives of intervention and to measure participants' knowledge and confidence related to trauma informed care principles. Composed of 12 items, all open-ended or Likert scale responses."}, {'measure': 'Resiliency knowledge and skills questionnaire', 'timeFrame': '2023 Academic Year', 'description': "An original online survey designed by the investigators to align with objectives of intervention and to measure participants' knowledge and confidence related to trauma informed care principles. Composed of 12 items, all open-ended or Likert scale responses."}], 'secondaryOutcomes': [{'measure': 'Maslach Burnout Inventory Scale questionnaire', 'timeFrame': '2023 Academic Year', 'description': 'Min value=0, max value=132, higher score indicates more professional burnout (worse outcome)'}, {'measure': 'Connor-Davison Resilience Scale 25 (CD-RISC-25) questionnaire', 'timeFrame': '2023 Academic Year', 'description': 'Min value=0, max value=100, higher score indicates better resiliency (better outcome)'}, {'measure': 'Perceived Stress Scale questionnaire', 'timeFrame': '2023 Academic Year', 'description': 'Min value=0, max value=40, higher score indicates higher perceived stress (worse outcome)'}, {'measure': 'Adverse Childhood Experiences (ACEs) questionnaire', 'timeFrame': 'Spring 2023', 'description': 'Min value=0, max value=10, higher score indicates more negative childhood experiences related to physical and mental health issues later in life (worse outcome)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Graduate nursing students', 'Resiliency', 'Trauma informed care'], 'conditions': ['Stress', 'Trauma']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to explore the impact of a resiliency and trauma informed care educational intervention for Psychiatric Mental Health Nurse Practitioner (PMHNP) students at the University of Arizona College of Nursing during the final, clinical year of the program. Specifically, the investigators will examine if the educational intervention is feasible, acceptable and helpful to students, and can decrease burnout and increase resiliency.', 'detailedDescription': 'Students in the Doctor of Nursing Practice (DNP) and certificate programs during their final, clinical year of the program will be asked to complete anonymous online surveys before each semester (Spring, Summer, and Fall) that measure levels of burnout, resiliency, Adverse Childhood Experiences (ACEs), perceived stress, and knowledge related to trauma-informed care principles and ways to promote their resiliency. Students in the Psychiatric Mental Health Nurse Practitioner (PMHNP) specialty will receive an educational intervention related to trauma-informed care and resiliency during an in-person clinical immersion in January, May, and August 2023; after each session, they will be asked to complete an anonymous online post-intervention survey. Each survey includes a disclosure statement and list of University and national mental health resources in case participants experience any emotional distress related to the topics/questions related to the survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The inclusion criteria will be Doctor of Nursing Practice and Post-Masters certificate students at the University of Arizona College of Nursing. All study participants will be over age 18. The investigators will include participants of all genders and ethnicities that meet our inclusion criteria for the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Doctor of Nursing Practice (DNP) and post-Masters certificate students at the University of Arizona College of Nursing in the final, clinical year of their program.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT05846269', 'briefTitle': 'A Resiliency and TIC Intervention for PMHNP Specialty DNP Students', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'A Resiliency and Trauma-Informed Care Intervention for Psychiatric Mental Health Nurse Practitioner Specialty Doctor of Nursing Practice Students', 'orgStudyIdInfo': {'id': 'STUDY00002213'}}, 'armsInterventionsModule': {'armGroups': [{'label': '2023 Clinical Cohort', 'description': 'Students in the Doctor of Nursing Practice (DNP) nurse practitioner specialties and certificate programs in the clinical year of their programs during 2023.', 'interventionNames': ['Other: Educational Intervention']}], 'interventions': [{'name': 'Educational Intervention', 'type': 'OTHER', 'description': 'Educational intervention addressing trauma-informed care and resiliency.', 'armGroupLabels': ['2023 Clinical Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85721', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lindsay A Bouchard, DNP', 'role': 'CONTACT', 'email': 'labouchard@arizona.edu', 'phone': '520-815-9065'}, {'name': 'Jessica Rainbow, PhD', 'role': 'CONTACT', 'email': 'jrainbow@arizona.edu', 'phone': '520-626-3233'}, {'name': 'Lindsay A Bouchard, DNP', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jessica Rainbow, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Janay Young, DNP', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'centralContacts': [{'name': 'Lindsay A Bouchard, DNP', 'role': 'CONTACT', 'email': 'labouchard@arizona.edu', 'phone': '520-815-9065'}, {'name': 'Jessica Rainbow, PhD', 'role': 'CONTACT', 'email': 'jrainbow@arizona.edu', 'phone': '520-626-3233'}], 'overallOfficials': [{'name': 'Lindsay Bouchard, DNP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}