Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-25 @ 1:38 PM
Study NCT ID:
NCT02923492
Status:
COMPLETED
Last Update Posted:
2018-08-27
First Post:
2016-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Translation of an Intervention for Violence Among Adolescents in Emergency Departments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-24', 'studyFirstSubmitDate': '2016-10-03', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peer violence behaviors', 'timeFrame': 'Change from baseline to 3 months', 'description': 'as assessed with the modified Conflict Tactic Scale'}, {'measure': 'Violence Consequences', 'timeFrame': 'Change from baseline to 3 months', 'description': 'as assessment with a scale developed in the original SafERteens study'}], 'secondaryOutcomes': [{'measure': 'Self-Efficacy for non-violence', 'timeFrame': 'Change from baseline to 3 months', 'description': 'As assessed with the Teen Conflict Survey'}, {'measure': 'Attitude towards viiolence', 'timeFrame': 'Change from baseline to 3 months', 'description': 'as assessed with the Attitudes Towards Violence Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Violence']}, 'descriptionModule': {'briefSummary': 'The translation study aims to refine and package intervention and training materials essential to translating an efficacious Emergency Department (ED) based Brief Intervention (BI) for violence (SafERteens) for two delivery methods: by ED staff on site or by therapist remotely. The study will take place in two phases. During the Effectiveness phase, we will determine the effectiveness of the interventions \\[on-site therapist delivered BI + text messages (n=133); remote therapy delivered BI + text messages (n=133)\\], as compared to a usual care control (brochure; n=133), on violence outcomes at 3 months. Note that tailored text messages will be delivered daily for the first month post-discharge, and three times per week in the second month post-discharge to the BI groups. During the Implementation phase, components of the RE-AIM model will be assessed over a 4-month period.', 'detailedDescription': 'Participants who screen positive for the study during the effectiveness phase, will be randomized to either the therapy or control at a rate of 2:1. Whether the participant receives the on-site therapist or the remote therapist will depend on day of week or shift. Over the course of the study, the proportion of shifts covered by on-site verses remote therapists will be balanced for seasonality and time of day (evening vs. day time).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* youth (ages 14-18) presenting to the Hurley Medical Center (HMC) ED who are medically stable. Patients classified by medical staff as having unstable vital signs or "Level 1" trauma (e.g., unconscious, in need of immediate lifesaving procedures such as surgery), will be approached during their inpatient stay after stabilization (4% based on prior work);\n* access to a parent or guardian for consent among adolescents ages 14-17 (over 90% based on our prior work).\n* Positive past 3 month violence screen criteria: Youth will be eligible for the study if they endorse on self-report computer survey past three month violence perpetration\n\nExclusion Criteria:\n\n* youth who do not understand English\n* youth deemed unable to provide informed assent/consent by ED or research staff\n* prisoners at time of ED presentation.\n* youth who present to the ED as victims of sexual abuse or child abuse'}, 'identificationModule': {'nctId': 'NCT02923492', 'briefTitle': 'Translation of an Intervention for Violence Among Adolescents in Emergency Departments', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Translation of an Intervention for Violence Among Adolescents in Emergency Departments', 'orgStudyIdInfo': {'id': 'R49CE002099', 'link': 'https://reporter.nih.gov/quickSearch/R49CE002099', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'In-person Therapy by ED Staff', 'description': 'Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered by ED staff in-person.', 'interventionNames': ['Behavioral: SafERteens']}, {'type': 'EXPERIMENTAL', 'label': 'Remote Therapy by Research Staff', 'description': 'Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care delivered remotely (over video) by research staff.', 'interventionNames': ['Behavioral: SafERteens']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison Group', 'description': 'This group will not receive an intervention, but did receive an informational pamphlet of resources in the area (enhanced usual care).'}], 'interventions': [{'name': 'SafERteens', 'type': 'BEHAVIORAL', 'description': 'A 30 minute private on-on-one brief motivational interviewing intervention given during emergency department care. The goal of the intervention was to reduce and prevention youth violence using techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This one-on one counseling approach emphasizes individual choice and responsibility and differentiates between future goals/values and current behavior', 'armGroupLabels': ['In-person Therapy by ED Staff', 'Remote Therapy by Research Staff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48503', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hurley Medical Center Emergency Department', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry', 'investigatorFullName': 'Maureen A Walton', 'investigatorAffiliation': 'University of Michigan'}}}}