Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-29 @ 10:49 AM
Study NCT ID:
NCT04579068
Status:
WITHDRAWN
Last Update Posted:
2022-08-19
First Post:
2020-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decreasing Alcohol Use Through Student Peer Leaders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}, {'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study not funded', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-08-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2026-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2020-10-01', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use Using the RAPS4-QF Instrument', 'timeFrame': '15 minutes', 'description': 'Following the RAPS4-QF screening by AAPL, we anticipate that we will detect a 30% detection of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use.'}, {'measure': 'Detection of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use based on adverse life experiences Using the RAPS4-QF Instrument', 'timeFrame': '15 minutes', 'description': 'Following the RAPS4-QF screening by AAPL, we anticipate that AAPLs with adverse life experiences will have a 40% detection rate of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use.'}, {'measure': 'Detection of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use based on Race/Ethnicity Using the RAPS4-QF Instrument', 'timeFrame': '15 minutes', 'description': 'Following the RAPS4-QF screening by AAPL, we anticipate that AAPLs with matching race/ethnicity will have a 30% detection rate of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use.'}, {'measure': 'Detection of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use based on drinking status Using the RAPS4-QF Instrument', 'timeFrame': '15 minutes', 'description': 'Following the RAPS4-QF screening by AAPL, we anticipate that AAPLs that are alcohol non-abstainers will have a 30% detection rate of problematic alcohol use (i.e. HED or AUD) and at-risk alcohol use.'}, {'measure': 'Percentage of Participants Achieving Decreased Levels of Alcohol Risk Using the SBIRT Intervention', 'timeFrame': 'Intervention: 15 minutes; Follow-up Point: 6 months post-intervention', 'description': 'By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 30% change in alcohol risk.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alcohol'], 'conditions': ['Alcohol Abuse', 'Alcohol Drinking', 'Alcohol Use Disorder', 'Alcohol Problem']}, 'descriptionModule': {'briefSummary': 'Problematic alcohol use can lead to worse social and health related consequences for underserved minorities, requiring urgent intervention. By training underserved minority health professional students, this proposed project will develop and test the feasibility of an innovative and culturally tailored intervention for adults studying at a minority institution, with specific focus on alcohol screening, brief intervention, and referral of treatment (SBIRT). This proposal is expected to have a positive impact on alcohol reduction and prevention for minority communities', 'detailedDescription': 'Problematic alcohol use, including alcohol use disorders (AUD) and high episodic drinking (HED), remains a public health crisis among college students, particularly those from underserved minority groups. Less likely to disclose alcohol use, underserved minority college students participate in riskier drinking, attributed to multiple social factors, including racial/ethnic discrimination, financial strain, and neighborhood disadvantage. Faced with worse alcohol health-related consequences, effective interventions to reduce alcohol use among this population is critically needed. To reduce alcohol-related health disparities, the investigators aim to develop a public health-based, comprehensive program (Alcohol Awareness Peer Leaders) that will train underserved minority non-traditional health professional students to conduct alcohol screening, brief intervention, and referral to treatment (SBIRT) by using a culturally sensitive approach and screening tool (Rapid Alcohol Problems Screen - RAPS4-QF). By utilizing a culturally adapted SBIRT curriculum, AAPLs will be able to deliver alcohol education and messaging to motivate alcohol risk reduction and decrease in consumption for non-traditional college students studying at a predominantly minority academic institution in an underserved area. The Andersen Healthcare Utilization Model will be utilized to guide this intervention. This theoretically and culturally tailored proposed project is evidence-informed and promising for underserved minority college students and will be advanced through the following three aims: 1) Using an explanatory-sequential mixed methods design, examine a) alcohol consumption and HED patterns, b) attitudes toward alcohol use, c) social and environmental factors, and d) alcohol-related consequences among minority health professional students, 2) Through training of minority health professional students as Alcohol Awareness Peer Leaders (AAPLs), assess the acceptability and relevance of a peer-based SBIRT that was culturally-tailored based on Aim 1 findings, and 3) To compare the feasibility and effectiveness of delivering a culturally-tailored SBIRT using RAPS4-QF by AAPLs by race/ethnicity, drinking status (abstainer vs. drinker), and adverse life experiences. These outcomes will result in the training of 208 underserved minority AAPLs who will conduct culturally competent and evidence-based alcohol screening, brief intervention, and treatment referral for over 2000 students. The result of this innovative proposal will produce future healthcare professionals who will be a valuable community resource for underserved areas as they can continue to decrease alcohol health disparities for underrepresented minority populations, inducing sustainability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* enrolled student at CDU\n* age 18 or older\n* Speak and understand English\n\nExclusion Criteria:\n\n* not enrolled as a student at CDU\n* Under the age of 18\n* Unable to speak English'}, 'identificationModule': {'nctId': 'NCT04579068', 'briefTitle': 'Decreasing Alcohol Use Through Student Peer Leaders', 'organization': {'class': 'OTHER', 'fullName': 'Charles Drew University of Medicine and Science'}, 'officialTitle': 'Alcohol Awareness Peer Leaders (AAPL): A Multidisciplinary, Culturally Based Training Program for Underserved Minority Health Professional Students to Increase Alcohol Screening and Intervention', 'orgStudyIdInfo': {'id': 'AAPLCDU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Screening and Brief Intervention of Problematic Alcohol Use', 'description': "We plan to test the feasibility and effectiveness of the delivery of the peer-based SBIRT using the RAPS4-QF screening tool with CDU students. Furthermore, we will compare delivery by AAPLs' race/ethnicity, drinking status (abstainer vs. non-abstainer), and adverse life experiences. Following the screening by AAPLs, we expect a 30% detection of problematic alcohol use (i.e. high episodic drinking \\[HED\\] or AUD) and at-risk alcohol use. Participants that screen positive will receive brief motivational interviewing and referral to treatment and will be contacted 6 months following the SBIRT to assess their drinking behaviors. We expect that participants will decrease their alcohol consumption or drinking risk at the 6-month follow up.", 'interventionNames': ['Behavioral: Screening and Brief Intervention of Problematic Alcohol Use']}], 'interventions': [{'name': 'Screening and Brief Intervention of Problematic Alcohol Use', 'type': 'BEHAVIORAL', 'description': 'Provide/enhance knowledge, screening and detection, modify attitudes, motivate and provide skills and resources to reduce alcohol related risk and consumption.', 'armGroupLabels': ['Screening and Brief Intervention of Problematic Alcohol Use']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sharon Cobb, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles R. Drew University of Medicine & Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles Drew University of Medicine and Science', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}