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Alcohol DrinkingHorizonsNCT05443750

Digital Motivational Behavioral Economic Intervention to Reduce Risky Drinking Among Community-Dwelling Emerging Adults

A study testing Motivational Behavioral Economic Alcohol Intervention and Health Education in people with Alcohol Drinking, run by University of Florida at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 28 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Drinking
What is being tested?
Motivational Behavioral Economic Alcohol Intervention and Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
806 participants
Where
1 siteUnited States
Study dates
9 Jan 2023to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 28 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
  • 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
  • Web access via smartphone or computer; and (4) minimum 8th grade education, the level necessary to use study materials.

Who cannot join

  • Age out of range
  • Blood relatives of previously enrolled participants
  • Invalid enrollment referral number
  • Fulltime college students
  • Absence of above drinking risk indicators
  • Lack of smartphone or computer availability
  • Education less than 8th grade

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Florida College of Health & Human Performance

    Gainesville, Florida, 32611

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Motivational Behavioral Economic Alcohol Intervention, Health Education
Keywords
risky drinking reduction, emerging adults, social networks
Medical subject headings
Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational Behavioral Economic Alcohol InterventionBehavioural

    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.

  • Health EducationBehavioural

    Participants view web-based health educational material about alcohol, sleep, and nutrition of a similar length and style to the experimental intervention materials.

Study groups in NCT05443750
Study groupRoleWhat they receive
Motivational Behavioral Economic InterventionExperimentalWeb-based alcohol risk reduction brief intervention
Receives: Behavioral: Motivational Behavioral Economic Alcohol Intervention
Health EducationActive comparatorWeb-based health education material
Receives: Behavioral: Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline Timeline Followback (TLFB) at 6 months post-baseline

    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.

    Measured: 6 months post-baseline

  2. Change from baseline Timeline Followback (TLFB) at 12 months post-baseline

    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.

    Measured: 12 months post-baseline

  3. Change from baseline Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) at 6 months post-baseline

    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.

    Measured: 6 months post-baseline

  4. Change from baseline Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ) scores at 12 months post-baseline

    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.

    Measured: 12 months post-baseline

Secondary outcomes (8)
  1. Change from baseline Adolescent Reinforcement Survey Schedule-Substance Use Version (ARSS-SUV) at 6 months post-baseline

    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).

    Measured: 6 months post-baseline

  2. Change from baseline Adolescent Reinforcement Survey Schedule-Substance Use Version (ARSS-SUV) at 12 months post-baseline

    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).

    Measured: 12 months post-baseline

  3. Change from baseline Minute Discounting Task at 6 months post-baseline

    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.

    Measured: 6 months post-baseline

  4. Change from baseline Minute Discounting Task at 12 months post-baseline

    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.

    Measured: 12 months post-baseline

  5. Change from baseline Alcohol Purchase Task (APT) at 6 months post-baseline

    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.

    Measured: 6 months post-baseline

  6. Change from baseline Alcohol Purchase Task (APT) at 12 months post-baseline

    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.

    Measured: 12 months post-baseline

  7. Change from baseline Relative Discretionary Expenditures on Alcohol (RDEA) at 6 months post-baseline

    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.

    Measured: 6 months post-baseline

  8. Change from baseline Relative Discretionary Expenditures on Alcohol (RDEA) at 12 months post-baseline

    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.

    Measured: 12 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2022
  2. Study start9 Jan 2023
  3. Primary completion2 Jun 2026
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
brief web-based motivational behavioral economic alcohol intervention compared to web-based health education control materials
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
806 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443750
Sponsor's protocol ID
IRB202201411
Other IDs
1R01AA028230-01A1
Acronym
Horizons
Status last verified
Jun 2026
First submitted
16 Jun 2022
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.

    PubMed 10842426
  • Arnett, J. J. The developmental context of substance use in emerging adulthood. Journal of Drug Issues, 2005;35(2): 235-254.

  • Bauermeister JA, Zimmerman MA, Johns MM, Glowacki P, Stoddard S, Volz E. Innovative recruitment using online networks: lessons learned from an online study of alcohol and other drug use utilizing a web-based, respondent-driven sampling (webRDS) strategy. J Stud Alcohol Drugs. 2012 Sep;73(5):834-8. doi: 10.15288/jsad.2012.73.834.

    PubMed 22846248
  • Babor TF, Higgins-Biddle JC, Robaina, K. USAUDIT: The Alcohol Use Disorder Identification Test, adapted for use in the United States: A guide for primary care practitioners. Substance Abuse and Mental Health Services Administration. 2016.

  • Broz D, Wejnert C, Pham HT, DiNenno E, Heffelfinger JD, Cribbin M, Krishna N, Teshale EH, Paz-Bailey G; National HIV Behavioral Surveillance System Study Group. HIV infection and risk, prevention, and testing behaviors among injecting drug users -- National HIV Behavioral Surveillance System, 20 U.S. cities, 2009. MMWR Surveill Summ. 2014 Jul 4;63(6):1-51.

    PubMed 24990587
  • Buscemi J, Murphy JG, Martens MP, McDevitt-Murphy ME, Dennhardt AA, Skidmore JR. Help-seeking for alcohol-related problems in college students: correlates and preferred resources. Psychol Addict Behav. 2010 Dec;24(4):571-80. doi: 10.1037/a0021122.

    PubMed 21198220
  • Call KT, Davern M, Boudreaux M, Johnson PJ, Nelson J. Bias in telephone surveys that do not sample cell phones: uses and limits of poststratification adjustments. Med Care. 2011 Apr;49(4):355-64. doi: 10.1097/MLR.0b013e3182028ac7.

    PubMed 21407032
  • Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661. No abstract available.

    PubMed 22951546
  • Carter AC, Brandon KO, Goldman MS. The college and noncollege experience: a review of the factors that influence drinking behavior in young adulthood. J Stud Alcohol Drugs. 2010 Sep;71(5):742-50. doi: 10.15288/jsad.2010.71.742.

    PubMed 20731981
  • Cheong J, Lindstrom K, Chandler SD, Bacon JP, Tucker JA. Social Network Feedback and Drinking Outcomes among Emerging Adult Risky Drinkers Living in Urban Communities. Subst Use Misuse. 2021;56(13):1989-1996. doi: 10.1080/10826084.2021.1963985. Epub 2021 Aug 25.

    PubMed 34429032
  • Cheong J, Tucker JA, Simpson CA, Chandler SD. Time horizons and substance use among African American youths living in disadvantaged urban areas. Addict Behav. 2014 Apr;39(4):818-23. doi: 10.1016/j.addbeh.2013.12.016. Epub 2014 Jan 7.

    PubMed 24531637
  • Cheong J, Tucker JA, Chandler SD. Reasons for Accepting and Declining Free HIV Testing and Counseling Among Young African American Women Living in Disadvantaged Southern Urban Communities. AIDS Patient Care STDS. 2019 Jan;33(1):25-31. doi: 10.1089/apc.2018.0090. Epub 2018 Oct 17.

    PubMed 30328693
  • Cheong J, Tucker JA, Chandler SD. Time Horizons, Drug Use, and Risky Sex in Young Women from Poor Urban Areas. Sucht. 2022 Apr;68(2):75-82. doi: 10.1024/0939-5911/a000758. Epub 2022 Apr 13.

    PubMed 35502297
  • Chen CM, Dufour, MC, Yi, HY. Alcohol consumption among young adults ages 18-24 in the United States: Results from the 2001-2002 NESARC survey. Alcohol Research & Health, 2004;28(4): 269-280.

  • Cook SH, Bauermeister JA, Gordon-Messer D, Zimmerman MA. Online network influences on emerging adults' alcohol and drug use. J Youth Adolesc. 2013 Nov;42(11):1674-86. doi: 10.1007/s10964-012-9869-1. Epub 2012 Dec 2.

    PubMed 23212348

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Behavioral Economic Alcohol Intervention and Health Education in people with Alcohol Drinking, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Timeline Followback (TLFB) at 6 months post-baseline (time frame: 6 months post-baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05443750, which also lists 69 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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