Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-27 @ 7:06 PM
Study NCT ID:
NCT05443750
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-15
First Post:
2022-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Motivational Behavioral Economic Intervention to Reduce Risky Drinking Among Community-Dwelling Emerging Adults
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All study procedures are web-based so delivery of intervention or control materials are fully automated, as are the outcomes assessments. The consent form informs participants they will be assigned to either a brief intervention focused on reducing risks of drinking and promoting healthy futures or an alcohol and health education intervention; they may be able to discern which condition they received upon implementation. Of necessity, the investigators know which condition they receive to initiate the proper web-based program.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'brief web-based motivational behavioral economic alcohol intervention compared to web-based health education control materials'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 806}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2022-06-16', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Timeline Followback (TLFB) at 6 months post-baseline', 'timeFrame': '6 months post-baseline', 'description': 'At each assessment point, participants will complete an online TLFB concerning their daily drinking during the past month, an interval found sufficiently long to characterize drinking patterns. Using a calendar that covers the 30-day recall interval, participants record how many standard drinks of beer, wine, or liquor they consumed each day. Drinks per week will be calculated for tests of study hypotheses along with other metrics for descriptive purposes (frequency of gender adjusted heavy and high intensity drinking days).The TLFB is considered the "gold standard" for obtaining reliable and accurate reports of alcohol consumption using a variety of assessment modalities (e.g., interview, online, phone) and is accepted by the FDA for use as an efficacy endpoint of percentage of heavy drinking days in clinical trials.'}, {'measure': 'Change from baseline Timeline Followback (TLFB) at 12 months post-baseline', 'timeFrame': '12 months post-baseline', 'description': 'At each assessment point, participants will complete an online TLFB concerning their daily drinking during the past month, an interval found sufficiently long to characterize drinking patterns. Using a calendar that covers the 30-day recall interval, participants record how many standard drinks of beer, wine, or liquor they consumed each day. Drinks per week will be calculated for tests of study hypotheses along with other metrics for descriptive purposes (frequency of gender adjusted heavy and high intensity drinking days).The TLFB is considered the "gold standard" for obtaining reliable and accurate reports of alcohol consumption using a variety of assessment modalities (e.g., interview, online, phone) and is accepted by the FDA for use as an efficacy endpoint of percentage of heavy drinking days in clinical trials.'}, {'measure': 'Change from baseline Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) at 6 months post-baseline', 'timeFrame': '6 months post-baseline', 'description': 'The Brief Young Adult Alcohol Consequences Questionnaire asks about 24 negative events during the past month (e.g., neglected obligations, driving after drinking) and includes common and less severe consequences suitable for use with younger populations. The B-YAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences. Scores, ranging from 0-24, are predicted by typical drinking as well as by BE-relevant indices of impulsivity and poor self-regulation. Higher scores indicate participants are experiencing more negative events associated with their drinking.'}, {'measure': 'Change from baseline Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) scores at 12 months post-baseline', 'timeFrame': '12 months post-baseline', 'description': 'The Brief Young Adult Alcohol Consequences Questionnaire asks about 24 negative events during the past month (e.g., neglected obligations, driving after drinking) and includes common and less severe consequences suitable for use with younger populations. The B-YAACQ is reliable yet sensitive to changes in alcohol use, has high internal consistency, and includes common but less severe consequences. Scores, ranging from 0-24, are predicted by typical drinking as well as by BE-relevant indices of impulsivity and poor self-regulation. Higher scores indicate participants are experiencing more negative events associated with their drinking.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline Adolescent Reinforcement Survey Schedule-Substance Use Version (ARSS-SUV) at 6 months post-baseline', 'timeFrame': '6 months post-baseline', 'description': 'Participants report past month frequency and rate the enjoyment of 36 activities that are substance free vs. substance involved. Frequency and enjoyment ratings are multiplied to obtain a cross-product that reflects reinforcement derived from the activity, and the relative reinforcement value of alcohol (R-ratio) is computed for analysis \\[(alcohol-related total/(alcohol-free total + alcohol- related total)\\]. Participants also report the number of hours spent engaging in several activity categories during a typical week in the past month (work, exercise, drinking, recreation).'}, {'measure': 'Change from baseline Adolescent Reinforcement Survey Schedule-Substance Use Version (ARSS-SUV) at 12 months post-baseline', 'timeFrame': '12 months post-baseline', 'description': 'Participants report past month frequency and rate the enjoyment of 36 activities that are substance free vs. substance involved. Frequency and enjoyment ratings are multiplied to obtain a cross-product that reflects reinforcement derived from the activity, and the relative reinforcement value of alcohol (R-ratio) is computed for analysis \\[(alcohol-related total/(alcohol-free total + alcohol- related total)\\]. Participants also report the number of hours spent engaging in several activity categories during a typical week in the past month (work, exercise, drinking, recreation).'}, {'measure': 'Change from baseline Minute Discounting Task at 6 months post-baseline', 'timeFrame': '6 months post-baseline', 'description': "This adjusting delay discounting task yields accurate discount rates in less than one minute. Values are well correlated with the established longer adjusting amount delay discounting procedure. Delays are adjusted based on participants' responses in a series of 5 trials in which a hypothetical monetary reward amount is held constant. The task directly measures ED50, which is the delay at which the current reward value is half its nominal dollar amount. Outcomes will not be incentivized because hypothetical and real money generate equivalent measures."}, {'measure': 'Change from baseline Minute Discounting Task at 12 months post-baseline', 'timeFrame': '12 months post-baseline', 'description': "This adjusting delay discounting task yields accurate discount rates in less than one minute. Values are well correlated with the established longer adjusting amount delay discounting procedure. Delays are adjusted based on participants' responses in a series of 5 trials in which a hypothetical monetary reward amount is held constant. The task directly measures ED50, which is the delay at which the current reward value is half its nominal dollar amount. Outcomes will not be incentivized because hypothetical and real money generate equivalent measures."}, {'measure': 'Change from baseline Alcohol Purchase Task (APT) at 6 months post-baseline', 'timeFrame': '6 months post-baseline', 'description': 'This questionnaire asks participants to report how many standard drinks they would consume across 20 prices ($0 to $40) in an imaginary drinking setting, which yields multiple observed and derived indices reflecting sensitivity to price changes that correspond with actual alcohol use. Elasticity of demand and intensity (consumption at $0) will be used for analysis. Relative insensitivity to price changes ("inelastic" demand) is related to risky drinking and alcohol problems, and intensity has incremental utility to predict alcohol use disorder symptoms beyond drinking practices.'}, {'measure': 'Change from baseline Alcohol Purchase Task (APT) at 12 months post-baseline', 'timeFrame': '12 months post-baseline', 'description': 'This questionnaire asks participants to report how many standard drinks they would consume across 20 prices ($0 to $40) in an imaginary drinking setting, which yields multiple observed and derived indices reflecting sensitivity to price changes that correspond with actual alcohol use. Elasticity of demand and intensity (consumption at $0) will be used for analysis. Relative insensitivity to price changes ("inelastic" demand) is related to risky drinking and alcohol problems, and intensity has incremental utility to predict alcohol use disorder symptoms beyond drinking practices.'}, {'measure': 'Change from baseline Relative Discretionary Expenditures on Alcohol (RDEA) at 6 months post-baseline', 'timeFrame': '6 months post-baseline', 'description': 'The RDEA index reflects strength of preference for alcohol in relation to other discretionary commodities common in the personal economies of younger adults and predicts alcohol problems and outcomes. It is based on participant reports of money spent during the past month on nonessential items (e.g., clothing, music, recreation) and on alcoholic beverages, regardless of whether the alcohol was consumed. Participants also report dollars saved voluntarily, which reflects resource allocation for future goals. Lower RDEA values and proportionately greater allocation to savings than alcohol predict positive drinking outcomes.'}, {'measure': 'Change from baseline Relative Discretionary Expenditures on Alcohol (RDEA) at 12 months post-baseline', 'timeFrame': '12 months post-baseline', 'description': 'The RDEA index reflects strength of preference for alcohol in relation to other discretionary commodities common in the personal economies of younger adults and predicts alcohol problems and outcomes. It is based on participant reports of money spent during the past month on nonessential items (e.g., clothing, music, recreation) and on alcoholic beverages, regardless of whether the alcohol was consumed. Participants also report dollars saved voluntarily, which reflects resource allocation for future goals. Lower RDEA values and proportionately greater allocation to savings than alcohol predict positive drinking outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['risky drinking reduction, emerging adults, social networks'], 'conditions': ['Alcohol Drinking']}, 'referencesModule': {'references': [{'pmid': '10842426', 'type': 'BACKGROUND', 'citation': 'Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.'}, {'type': 'BACKGROUND', 'citation': 'Arnett, J. J. The developmental context of substance use in emerging adulthood. Journal of Drug Issues, 2005;35(2): 235-254.'}, {'pmid': '22846248', 'type': 'BACKGROUND', 'citation': 'Bauermeister JA, Zimmerman MA, Johns MM, Glowacki P, Stoddard S, Volz E. 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Social Network Drinking Feedback is Associated with Use of Protective Behavioral Strategies and Drinking-Related Outcomes in Emerging Adult Risky Drinkers. J Stud Alcohol Drugs. 2022 Jan;83(1):64-73. doi: 10.15288/jsad.2022.83.64.'}, {'type': 'BACKGROUND', 'citation': 'Tucker, JA, Cheong, J, & Chandler, SD. Selecting communication channels for substance misuse prevention with at-risk emerging adults living in the Southern United States. Journal of Child and Adolescent Substance Abuse, 2016(25): 539-545.'}, {'pmid': '31526051', 'type': 'BACKGROUND', 'citation': 'Tucker JA, Chandler SD, Cheong J. Predicting HIV testing in low threshold community contexts among young African American women living in the Southern United States. AIDS Care. 2020 Feb;32(2):175-181. doi: 10.1080/09540121.2019.1668522. Epub 2019 Sep 16.'}, {'pmid': '33630617', 'type': 'BACKGROUND', 'citation': 'Tucker JA, Lindstrom K, Chandler SD, Bacon JP, Cheong J. Behavioral economic indicators of risky drinking among community-dwelling emerging adults. Psychol Addict Behav. 2021 Jun;35(4):415-423. doi: 10.1037/adb0000686. Epub 2021 Feb 25.'}, {'pmid': '26054041', 'type': 'BACKGROUND', 'citation': 'Tucker JA, Cheong J, Chandler SD, Crawford SM, Simpson CA. Social networks and substance use among at-risk emerging adults living in disadvantaged urban areas in the southern United States: a cross-sectional naturalistic study. Addiction. 2015 Sep;110(9):1524-32. doi: 10.1111/add.13010. Epub 2015 Jul 14.'}, {'pmid': '19309182', 'type': 'BACKGROUND', 'citation': 'Tucker JA, Roth DL, Vignolo MJ, Westfall AO. A behavioral economic reward index predicts drinking resolutions: moderation revisited and compared with other outcomes. J Consult Clin Psychol. 2009 Apr;77(2):219-28. doi: 10.1037/a0014968.'}, {'pmid': '27763465', 'type': 'BACKGROUND', 'citation': 'Tucker JA, Simpson CA, Chandler SD, Borch CA, Davies SL, Kerbawy SJ, Lewis TH, Crawford MS, Cheong J, Michael M. Utility of Respondent Driven Sampling to Reach Disadvantaged Emerging Adults for Assessment of Substance Use, Weight, and Sexual Behaviors. J Health Care Poor Underserved. 2016;27(1):194-208. doi: 10.1353/hpu.2016.0006.'}, {'type': 'BACKGROUND', 'citation': 'U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. National Survey on Drug Use and Health 2018. 2019.'}, {'type': 'BACKGROUND', 'citation': 'U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. National Survey on Drug Use and Health 2020. 2022.'}, {'pmid': '17784893', 'type': 'BACKGROUND', 'citation': 'Valente TW, Ritt-Olson A, Stacy A, Unger JB, Okamoto J, Sussman S. Peer acceleration: effects of a social network tailored substance abuse prevention program among high-risk adolescents. Addiction. 2007 Nov;102(11):1804-15. doi: 10.1111/j.1360-0443.2007.01992.x. Epub 2007 Sep 3.'}, {'type': 'BACKGROUND', 'citation': 'Vuchinich, RE & Tucker, JA. Alcoholic relapse, life events, and behavioral theories of choice: A prospective analysis. Experimental and Clinical Psychopharmacology, 1996;4(1): 19-28.'}, {'type': 'BACKGROUND', 'citation': 'Wejnert C, Heckathorn DD. Web-based network sampling: efficiency and efficacy of respondent-driven sampling for online research. Sociological Methods & Research, 2008;37(1): 105- 134.'}, {'type': 'BACKGROUND', 'citation': 'White, H, Labouvie, E., Papadaratsakis, V. Changes in substance use during the transition to adulthood: A comparison of college students and their noncollege age peers. Journal of Drug Issues, 2005;35(2): 281-306.'}, {'pmid': '26112433', 'type': 'BACKGROUND', 'citation': 'White RG, Hakim AJ, Salganik MJ, Spiller MW, Johnston LG, Kerr L, Kendall C, Drake A, Wilson D, Orroth K, Egger M, Hladik W. Strengthening the Reporting of Observational Studies in Epidemiology for respondent-driven sampling studies: "STROBE-RDS" statement. J Clin Epidemiol. 2015 Dec;68(12):1463-71. doi: 10.1016/j.jclinepi.2015.04.002. Epub 2015 May 1.'}, {'type': 'BACKGROUND', 'citation': 'Zimbardo PG, Boyd JN. Putting time in perspective: a valid reliable individual-differences metric. Journal of Personality and Social Psychology, 1999;77(6): 1271-1288.'}], 'seeAlsoLinks': [{'url': 'http://sourceforge.net/projects/egonet/', 'label': 'Link to access the Egonet software (McCarty \\& Smith, 2014)'}, {'url': 'http://www.niaaa.nih.gov/publications', 'label': 'Link to access the NIAAA\'s "Helping patients who drink too much: A clinician\'s guide."'}, {'url': 'https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHDetailedTabs2018R2/NSDUHDetailedTabs2018.pdf', 'label': 'Link to access National Survey on Drug Use and Health 2018'}, {'url': 'https://www.samhsa.gov/data/report/2020-nsduh-detailed-tables', 'label': 'Link to access National Survey on Drug Use and Health 2020'}, {'url': 'http://my.ireta.org/sites/ireta.org/files/USAUDIT-Guide_2016_final.pdf', 'label': 'Link to access the US-AUDIT'}]}, 'descriptionModule': {'briefSummary': 'Emerging adult risky drinkers living in disadvantaged communities often have limited access to rewarding activities and adult roles that offer alternatives to heavy drinking. Guided by behavioral economics, this cluster randomized controlled trial will evaluate a brief behavioral intervention aimed at increasing future orientation and engaging pro-social alternatives to drinking delivered using a peer-driven sampling method and digital platform well suited for accessing their social networks.', 'detailedDescription': 'Brief motivational interventions (BMIs) to reduce risky drinking in college students are well established as beneficial, but the needs of emerging adult (EA) risky drinkers who live in disadvantaged communities and are not fulltime college students have been neglected. They tend to have more constrained access to rewarding opportunities, adult roles, and activities that present pro-social alternatives to heavy drinking. When coupled with the foreshortened time horizons typical of many EAs, this suggests the need for interventions that not only enhance motivation to reduce drinking, but guide EAs to engage in alternatives to heavy drinking and orient their behavior toward longer-term positive goals. Guided by behavioral economics (BE), this study will disseminate and evaluate a brief motivational BE intervention that combines BMI elements with the Substance Free Activity Session shown to reduce drinking by increasing future orientation and engagement in pro-social alternatives. The intervention will be delivered using a digital platform appropriate for EAs whose social networks operate through such communications. Because peers influence substance use, a peer-driven sampling method (Respondent Driven Sampling \\[RDS\\]) will be used to recruit 500 community-dwelling EAs ages 18-28 for a cluster randomized controlled trial that compares the intervention with a health education control condition. Additional EA target population members ("seed" participants, n = 250) will start RDS recruitment but are not part of the intervention evaluation sample. The evaluation study will assess participants\' drinking practices and problems, BE outcome predictors, and social networks at enrollment and at 1, 6, and 12-month follow-ups. Intervention efficacy and behavior change mechanisms will be examined. Reduced alcohol demand and delay discounting and favorable post-intervention shifts in future orientation, substance-free vs. substance-involved activities, and use of protective behavioral strategies to reduce drinking-related harms are predicted to mediate intervention effects. Social network analysis will assess whether the intervention attenuates network promotion of individual drinking. The study will be the first to test a web-based alcohol reduction intervention focused on BE principles and to use digital RDS to reach community-dwelling EAs for intervention. The study will translate and test BE mediators and moderators of change, and the digital intervention has high potential for reach and scalability with under-served community risk groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females ages 18-28 who are not enrolled fulltime in 4-year colleges/universities and who reside in disadvantaged North and Central Florida communities\n* Past 30-day alcohol use exceeding NIAAA (2005) single day limits for lower risk drinking (4 drinks for males; 3 drinks for women) and one or more alcohol-related negative consequences in the past 90 days\n* Web access via smartphone or computer; and (4) minimum 8th grade education, the level necessary to use study materials.\n\nExclusion Criteria:\n\n* Age out of range\n* Blood relatives of previously enrolled participants\n* Invalid enrollment referral number\n* Fulltime college students\n* Absence of above drinking risk indicators\n* Lack of smartphone or computer availability\n* Education less than 8th grade'}, 'identificationModule': {'nctId': 'NCT05443750', 'acronym': 'Horizons', 'briefTitle': 'Digital Motivational Behavioral Economic Intervention to Reduce Risky Drinking Among Community-Dwelling Emerging Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Digital Motivational Behavioral Economic Intervention to Reduce Risky Drinking Among Community-Dwelling Emerging Adults', 'orgStudyIdInfo': {'id': 'IRB202201411'}, 'secondaryIdInfos': [{'id': '1R01AA028230-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01AA028230-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational Behavioral Economic Intervention', 'description': 'Web-based alcohol risk reduction brief intervention', 'interventionNames': ['Behavioral: Motivational Behavioral Economic Alcohol Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Health Education', 'description': 'Web-based health education material', 'interventionNames': ['Behavioral: Health Education']}], 'interventions': [{'name': 'Motivational Behavioral Economic Alcohol Intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention combines an alcohol brief motivational intervention (US-THRIVE \\[Tertiary Health Research Intervention via Email\\]) with the Substance-Free Activity Session (SFAS), shown to reduce drinking and related negative consequences by increasing future orientation and engagement in pro-social alternatives to drinking. The intervention will be delivered using a web-based platform appropriate for the young adult target population whose social networks operate through such communications.', 'armGroupLabels': ['Motivational Behavioral Economic Intervention']}, {'name': 'Health Education', 'type': 'BEHAVIORAL', 'description': 'Participants view web-based health educational material about alcohol, sleep, and nutrition of a similar length and style to the experimental intervention materials.', 'armGroupLabels': ['Health Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida College of Health & Human Performance', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Jalie A Tucker, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'url': 'https://nda.nih.gov/niaaa/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data availability and duration of availability governed by NDA policies and procedures for data sharing.', 'ipdSharing': 'YES', 'description': 'Project data will be submitted as required to the National Institute on Alcohol Abuse and Alcoholism Data Archive (NDA), which is a data repository that houses and shares human subjects data generated by NIAAA-funded research. Sharing individual participant data (IPD) is governed by the NDA data sharing terms and conditions. When data are uploaded, each participant has an associated Global Unique ID, or GUID.', 'accessCriteria': 'General scientific community with access to the NDA'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}