Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 11:48 AM
Study NCT ID:
NCT04147520
Status:
UNKNOWN
Last Update Posted:
2021-08-02
First Post:
2019-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Hazardous Alcohol Use in Social Networks Using Targeted Intervention: 21 Rising
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1475}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-29', 'studyFirstSubmitDate': '2019-10-23', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol use', 'timeFrame': 'At each follow up, measure average drinks per week in the past 30 days', 'description': 'Average number of drinks per week in the past 30 days'}, {'measure': 'Average number of alcohol consequences in the past 30 days', 'timeFrame': 'At each follow up, measure count of alcohol consequences in the past 30 days', 'description': 'Count of alcohol consequences in the past 30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Drinking', 'Alcohol; Harmful Use']}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to determine whether change in alcohol use among college students can be transmitted through social network ties to other members in the network. Members of one college class at a northeastern university will be enrolled in a longitudinal study in which they will provide self-reported behavioral information and information about their social ties to others in their college class. A subset of heavy drinking participants will be asked to meet in person to complete an interview about their alcohol use - called a Brief Motivational Interview. There is evidence that this sort of interview can reduce harmful alcohol use. The investigators expect that following the Brief Motivational Interview others in their friendship clusters will show reduced harm associated with alcohol use as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Must be a member of the class of 2021 or 2021.5 at the site university\n\nExclusion Criteria:\n\n• None'}, 'identificationModule': {'nctId': 'NCT04147520', 'briefTitle': 'Reducing Hazardous Alcohol Use in Social Networks Using Targeted Intervention: 21 Rising', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Reducing Hazardous Alcohol Use in Social Networks Using Targeted Intervention: 21 Rising', 'orgStudyIdInfo': {'id': '1810002247'}, 'secondaryIdInfos': [{'id': '2R01AA023522', 'link': 'https://reporter.nih.gov/quickSearch/2R01AA023522', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Brief Motivational Interview', 'description': 'Single-session in person conversation focusing on risks associated with alcohol use.', 'interventionNames': ['Behavioral: Brief Motivational Interview']}, {'type': 'NO_INTERVENTION', 'label': 'Natural History Control', 'description': 'No contact.'}], 'interventions': [{'name': 'Brief Motivational Interview', 'type': 'BEHAVIORAL', 'description': 'Single (60 min) session discussion of alcohol use and associated experiences.', 'armGroupLabels': ['Brief Motivational Interview']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02912', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Nancy Barnett, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is concern that with information in the dataset, including social ties, individuals could be re-identified.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}