Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-31 @ 2:47 PM
Study NCT ID:
NCT05261451
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2022-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Occupational Therapy Trauma Informed Workshops and Consultations for Teachers at Head Start
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2022-02-14', 'studyFirstSubmitQcDate': '2022-02-28', 'lastUpdatePostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-Survey', 'timeFrame': 'Within 1 week after the consultations', 'description': 'knowledge and experience\n\nknowledge and experiences gained related to early childhood trauma. Higher scores indicate greater knowledge'}], 'secondaryOutcomes': [{'measure': 'Interview', 'timeFrame': 'Within 2 weeks after the consultations', 'description': 'Post interviews will be completed with participants who also complete the consultations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['occupational therapy', 'trauma informed care'], 'conditions': ['Trauma']}, 'descriptionModule': {'briefSummary': 'This study will utilize a pre/post mix method design\n\nQuantitative data will be gathered through surveys (including satisfaction questionnaires) administered pre/post workshops.\n\nQualitative data will be obtained through interviews post- workshop and consultations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Home Visitors or Teaching Staff at Head Start within San Bernardino County\n* Between 18-65 years of age\n* All genders\n* English Speaking\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT05261451', 'briefTitle': 'Occupational Therapy Trauma Informed Workshops and Consultations for Teachers at Head Start', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Effectiveness of Occupational Therapy Trauma Informed Workshops and Consultations for Teachers at Head Start', 'orgStudyIdInfo': {'id': '5210415'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Head Start Teachers', 'description': 'Participants will engage in three 1- hour workshops and optional consultations with an occupational therapist', 'interventionNames': ['Other: Workshop']}], 'interventions': [{'name': 'Workshop', 'type': 'OTHER', 'description': 'Participants will engage in three 1 hour workshops about trauma informed care. They will complete pre and post measure before engaging in the workshops', 'armGroupLabels': ['Head Start Teachers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Arezou Salamat', 'investigatorAffiliation': 'Loma Linda University'}}}}