Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
Study NCT ID:
NCT04016766
Status:
UNKNOWN
Last Update Posted:
2021-08-17
First Post:
2019-07-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brief Mobile Intervention for Prepartying
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-15', 'studyFirstSubmitDate': '2019-07-10', 'studyFirstSubmitQcDate': '2019-07-10', 'lastUpdatePostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prepartying frequency', 'timeFrame': 'Past month (30 days)', 'description': 'Number of days reported prepartying on the timeline followback'}, {'measure': 'Drinks during prepartying', 'timeFrame': 'Past month (30 days)', 'description': 'Average number of drinks reported during prepartying on the timeline followback'}, {'measure': 'Drinking frequency', 'timeFrame': 'Past month (30 days)', 'description': 'Number of days reported any drinking on the timeline followback'}, {'measure': 'Drinks on drinking days', 'timeFrame': 'Past month (30 days)', 'description': 'Average number of drinks reported during drinking days on the timeline followback'}, {'measure': '21-item Brief Young Adult Alcohol Consequences Questionnaire', 'timeFrame': 'Past month (30 days)', 'description': 'Number of 21 assessed alcohol consequences experienced (yes/no). Yes responses are summed to yield a score on this measure. Higher scores indicate experience of a greater number of consequences. Scores range from 0 (no consequences) to 21 (experience of all 21 consequences)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heavy Drinking']}, 'referencesModule': {'references': [{'pmid': '37053413', 'type': 'DERIVED', 'citation': 'Pedersen ER, Hummer JF, Davis JP, Fitzke RE, Tran DD, Witkiewitz K, Clapp JD. A mobile-based pregaming drinking prevention intervention for college students: A pilot randomized controlled trial. Psychol Addict Behav. 2023 Nov;37(7):841-852. doi: 10.1037/adb0000925. Epub 2023 Apr 13.'}, {'pmid': '35717303', 'type': 'DERIVED', 'citation': 'Pedersen ER, Hummer JF, Davis JP, Fitzke RE, Christie NC, Witkiewitz K, Clapp JD. A mobile-based pregaming drinking prevention intervention for college students: study protocol for a randomized controlled trial. Addict Sci Clin Pract. 2022 Jun 18;17(1):31. doi: 10.1186/s13722-022-00314-5.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the research study is to develop and test a prepartying (aka "pregaming") specific brief mobile app intervention that is intended to help college students reduce their prepartying drinking behavior. Such behavior has been identified as a major contributor to alcohol-related negative consequences among young people. The investigators will first develop the intervention content based on theory and research supporting mechanisms of change in brief interventions with college students and document normative drinking information from 500 college students for inclusion in the intervention content. Investigators will then beta test the intervention with a sample of 14 heavy drinking college students. Focus group feasibility and acceptability feedback will inform the final intervention content. Investigators will then pilot test the mobile-based intervention in a randomized controlled trial of 500 college students who preparty frequently (n = 250 intervention, n = 250 attention control) and determine the efficacy of the intervention on (1) preventing heavy consumption levels during and after prepartying and on (2) reducing students\' global levels of heavy drinking and consequences one and three months post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* full time undergraduate college student\n* between the ages of 18 and 24\n* report typically prepartying at least once per week\n\nExclusion Criteria:\n\n* not meeting inclusion criteria'}, 'identificationModule': {'nctId': 'NCT04016766', 'briefTitle': 'Brief Mobile Intervention for Prepartying', 'organization': {'class': 'OTHER', 'fullName': 'RAND'}, 'officialTitle': 'Mobile Application Intervention Targeting the High Risk Drinking Practice of Prepartying', 'orgStudyIdInfo': {'id': 'R34AA025968', 'link': 'https://reporter.nih.gov/quickSearch/R34AA025968', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prepartying mobile app intervention', 'description': 'Mobile app intervention', 'interventionNames': ['Behavioral: Mobile app prepartying intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control participants receive a personalized attention control task (i.e., listing and ranking favorite movies, music, and books), which controls for the time needed by the intervention group to view the intervention material.'}], 'interventions': [{'name': 'Mobile app prepartying intervention', 'type': 'BEHAVIORAL', 'description': "The intervention is comprised of a theoretically-informed and empirically-supported, brief, accessible, and personalized intervention to address prepartying drinking. the prepartying intervention app will be tailored toward an individual's personal goals, beliefs (perceptions, expectancies, self-efficacy), and behavior (protective strategies), and focus on the core components of brief interventions that have been cited as constructs that mediate the effects of multiple component intervention programs (e.g., correcting perceived norms, use of protective behavioral strategies, increased self-efficacy, challenging expectancies, feedback on blood alcohol level).", 'armGroupLabels': ['Prepartying mobile app intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Pedersen, PhD', 'role': 'CONTACT', 'email': 'eric.pedersen@med.usc.edu', 'phone': '310-694-7255'}], 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Eric R Pedersen', 'role': 'CONTACT', 'email': 'ericp@rand.org', 'phone': '310-393-0411', 'phoneExt': '6078'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RAND', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern California', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}