Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-22 @ 10:11 AM
Study NCT ID:
NCT04026633
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2019-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attitudes & College Experiences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-03', 'studyFirstSubmitDate': '2019-07-11', 'studyFirstSubmitQcDate': '2019-07-17', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Alcohol Consumption from Baseline to 1-Month', 'timeFrame': '1 month after baseline', 'description': 'Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.'}, {'measure': 'Change in Alcohol-related consequences from Baseline to 1- and 3-Months', 'timeFrame': '1 month and 3 months after baseline', 'description': 'The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) (Kahler et al., 2005) is a 24-item self-administered checklist of problems related to drinking; responses are dichotomous (yes/no) and refer to the past month which was collected at baseline and 5-months. The BYAACQ demonstrates strong psychometric properties and is free of gender bias (Kahler et al., 2005).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alcohol Intervention', 'College Students'], 'conditions': ['Alcohol Abuse']}, 'descriptionModule': {'briefSummary': 'High volume drinking by young adults has proven resistant to long term change, so new approaches are needed. Given strong associations between alcohol-related attitudes and drinking behavior, the investigators adapt a theory-based attitude change strategy for use in alcohol prevention. This research tests the impact of a brief counter attitudinal advocacy activity on subsequent drinking and negative consequences.', 'detailedDescription': 'The persistence of risky drinking among young adults in college calls for continued efforts to prevent harms related to alcohol. Current prevention interventions have achieved some success, but rely on a single mechanism of change: correcting exaggerated drinking norms. The investigators propose to test a novel prevention strategy targeting another mechanism of change: creating attitude-behavior dissonance. To date, changing alcohol-related attitudes and the resulting attitude-behavior discrepancy has been underutilized as a behavior change strategy for alcohol abuse prevention. Informed by an extensive literature showing strong and consistent associations between alcohol attitudes and drinking behavior, the investigators adapted a brief counter-attitudinal advocacy (CAA) manipulation to the alcohol prevention context.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-24 years of age\n* Enrolled in the university's undergraduate four-year degree program\n* Past month heavy episodic drinking (for men, \\>5 drinks in one day, for women \\>4 drinks in one day)\n* At least two self-reported negative consequence from drinking in the past month\n\nExclusion Criteria:\n\n• Status as a graduating senior"}, 'identificationModule': {'nctId': 'NCT04026633', 'acronym': 'ACE', 'briefTitle': 'Attitudes & College Experiences', 'organization': {'class': 'OTHER', 'fullName': 'Brooklyn College of the City University of New York'}, 'officialTitle': 'Using Counter Attitudinal Advocacy to Change Drinking Behavior & Related Problems', 'orgStudyIdInfo': {'id': 'R21AA025676', 'link': 'https://reporter.nih.gov/quickSearch/R21AA025676', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Enhanced Intervention', 'description': 'Participants assigned to this arm will complete a personal writing task about alcohol use.', 'interventionNames': ['Behavioral: CAA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'description': 'Participants assigned to this arm will complete a personal writing task about eating behaviors.', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'CAA', 'type': 'BEHAVIORAL', 'description': 'Participants will write about the use of PBS and alcohol use.', 'armGroupLabels': ['Experimental: Enhanced Intervention']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Participants will write about eating and exercise.', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11210', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Brooklyn College', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Within one year of study completion', 'ipdSharing': 'YES', 'description': 'After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.', 'accessCriteria': 'To be determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brooklyn College of the City University of New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Angelo DiBello', 'investigatorAffiliation': 'Brooklyn College of the City University of New York'}}}}