Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT02586766
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
2015-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
University of Michigan Youth Violence Prevention Emergency Department Brief Intervention (Project Sync)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 409}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-22', 'studyFirstSubmitDate': '2015-10-09', 'studyFirstSubmitQcDate': '2015-10-22', 'lastUpdatePostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'violence behaviors as assessed with the combined modified Conflict Tactic Scale and the Conflict in Adolescent Dating Relationships Inventory to measure both peer and partner violence', 'timeFrame': 'past 2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Youth Violence'], 'conditions': ['Violence']}, 'referencesModule': {'references': [{'pmid': '27265097', 'type': 'DERIVED', 'citation': 'Carter PM, Walton MA, Zimmerman MA, Chermack ST, Roche JS, Cunningham RM. Efficacy of a Universal Brief Intervention for Violence Among Urban Emergency Department Youth. Acad Emerg Med. 2016 Sep;23(9):1061-70. doi: 10.1111/acem.13021. Epub 2016 Sep 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a brief motivational interviewing intervention given during emergency department care to 14-20 year olds seeking treatment, could reduce youth violence.', 'detailedDescription': 'This Emergency Department (ED) based study will test the effectiveness of a tailored therapist delivered motivational interviewing intervention, and an informational pamphlet control condition (IC) on reducing violence in 14-20 year olds who present to the Hurley Medical Center (HMC). Eligible adolescents at the Hurley Medical Center (HMC) emergency department (ED) (based on eligibility criteria) will complete a computerized online survey. The goal of the intervention was to examine ways 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. At 2-months following their ED visit, eligible adolescents (both from the intervention group and control group) will meet with a research assistant and self-administer an online computerized follow-up survey. An online survey tool will be used for baseline, follow up and post-test surveys. Participants will self-administer the survey at the time of follow up, post-test and baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. adolescents (ages 14-20) presenting to the Hurley Medical Center for a medical injury or illness (except exclusions noted below);\n2. adolescents will the ability to provide informed assent/consent depending on age;\n3. access to a parent or guardian in person or by telephone for parental consent for adolescents ages 14-17 (over 90% of adolescents had a parent/guardian present based on our prior work);\n4. currently residing in the intervention or control area;\n\nExclusion Criteria:\n\n1. adolescents who do not understand English;\n2. prisoners;\n3. adolescents with abnormal vital signs;\n4. adolescents deemed unable to provide informed consent by Emergency Department or research staff (e.g., intoxication, mental incompetence);\n5. adolescents treated in the Emergency Department for suicide attempts or sexual assault (because they present in high psychological distress requiring intensive attention and intervention by Emergency Department staff).'}, 'identificationModule': {'nctId': 'NCT02586766', 'briefTitle': 'University of Michigan Youth Violence Prevention Emergency Department Brief Intervention (Project Sync)', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'University of Michigan Youth Violence Prevention Emergency Department Brief Intervention', 'orgStudyIdInfo': {'id': '5U01CE001957-05', 'link': 'https://reporter.nih.gov/quickSearch/5U01CE001957-05', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral: Project Sync', 'description': 'Brief 30 minute on-on-one private motivation interviewing intervention during emergency department care', 'interventionNames': ['Behavioral: Project Sync']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison Group', 'description': 'This group did not receive an intervention, but did receive an informational pamphlet of resources in the area (enhanced usual care).'}], 'interventions': [{'name': 'Project Sync', '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': ['Behavioral: Project Sync']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rebecca Cunningham', 'investigatorAffiliation': 'University of Michigan'}}}}