An interventional study of Mobile-delivered personalized feedback in Youth Drinking and Alcohol Drinking, sponsored by Brown University. Completed at 1 site in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Brown University · Not applicable, Interventional, and Prevention
The investigators propose to examine mornings after drinking as an optimal time to provide repeated, personalized feedback, with the goal of reducing hazardous drinking. Specifically, the investigators will further develop and pilot test a novel theory-based personalized feedback intervention (PFI) for heavy drinking young adults. Intervention strategies include personalized feedback (e.g., feedback on prior night blood alcohol concentration, consequences) contrasted with both drinking goals set at baseline and corrective normative feedback (e.g., how last night's drinking compares to peers). Up to 170 participants (50% non-college) will be randomized to one of three groups: PFI with monetary incentives for daily surveys, PFI without monetary incentives, or survey assessment only. The investigators will examine recruitment rates, retention rates, confirmation of intervention content delivery/intake, response rates to daily surveys, data quality, and ratings of intervention value. Investigators will test whether these indicators of engagement differ between those who do and do not receive monetary incentives for daily surveys. Further, baseline, post-test, and 3-month follow-up assessments will allow us to examine differences in drinking behavior between PFI and control. The results of the proposed research will result in a novel and scalable intervention for alcohol misuse among young adults, with potential to have an important impact on the public health problem of high-risk drinking.
The investigators will recruit up to 170 participants for a small randomized controlled trial. Participants will be randomized to four weeks of intervention with or without daily incentives for completing surveys, or assessment-only control, to test feasibility, acceptability, and initial evidence of efficacy.
44 studies on the registry are indexed under Underage Drinking; 13 are open to participants now.
This study's enrollment of 152 is below the median of 360 across 43 interventional studies indexed under Underage Drinking.
Browse Underage Drinking studies →Brown University is the lead sponsor of 290 studies on the registry; 40 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided. Participants in this group will receive $1 per day for submitting their daily survey.
Behavioral: Mobile-delivered personalized feedback
Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided. Participants in this group will NOT receive $1 per day for submitting their daily survey.
Behavioral: Mobile-delivered personalized feedback
Participants in this arm will only complete baseline and follow-up surveys.
Following each daily survey on which a participant indicates prior day drinking, personalized feedback will be provided on how their most recent behavior (e.g., drinks last night, drinking days so far this week) compare/contrast with personal goals. Participants will then choose whether to receive additional feedback in any of 7 areas: blood alcohol concentrate on, high risk behaviors, consequences of drinking, caloric intake, spending, how drinking compares to peers, and safe drinking strategies. All participants will receive feedback on drinks consumed, and then be asked to choose at least one additional topic for feedback (following each drinking day). In addition to day-level feedback, an aggregate feedback report on drinking patterns and related behaviors will be delivered twice, once at the end of each 2-week period. Once again, they will have the option to view feedback across the range of topics noted above.
Drinks Per Week Post-test
drinks per week in the past 30 days
Time frame: post-test (1 month following baseline; end of intervention period for those in intervention groups)
Heavy Drinking Frequency Post-test
Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days
Time frame: post-test (end of 4-week intervention for those in intervention groups, and 1 month after baseline)
Negative Alcohol Consequences Post-test
Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
Time frame: post-test (end of 4-week intervention)
Drinks Per Week 3-month Follow-up
drinks per week in the past 30 days
Time frame: 3 month follow-up (4 months following baseline)
Heavy Drinking Frequency 3-month Follow-up
Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days
Time frame: 3 month follow-up (4 months post-baseline)
Negative Alcohol Consequences 3-month Follow-up
Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
Time frame: 3-month follow-up (3 months after end of intervention; 4 months after baseline
Participants were recruited via social media advertisements, outreach to participants from prior studies with documented interest in future studies, and a university listserv. Recruitment occurred between August 2024 and June 2025.
| Milestone | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control |
|---|---|---|---|
| Started | 54 | 52 | 46 |
| Completed | 54 | 49 | 46 |
| Not completed | 0 | 3 | 0 |
| Withdrew: 3 withdrawn from no incentives group due to ineligibility becoming clear after enrollment | 0 | 3 | 0 |
drinks per week in the past 30 days
| drinks per week | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control |
|---|---|---|---|
| Drinks Per Week Post-test | 15.28 ± 12.01 | 12.76 ± 10.66 | 11.48 ± 7.93 |
Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days
| number of heavy drinking days | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control |
|---|---|---|---|
| Heavy Drinking Frequency Post-test | 5.75 ± 5.80 | 4.91 ± 4.80 | 4.16 ± 4.57 |
Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
| negative consequences | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control |
|---|---|---|---|
| Negative Alcohol Consequences Post-test | 6.28 ± 4.46 | 6.82 ± 4.72 | 6.11 ± 4.55 |
drinks per week in the past 30 days
| drinks per week | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control |
|---|---|---|---|
| Drinks Per Week 3-month Follow-up | 11.20 ± 9.62 | 9.85 ± 9.15 | 10.18 ± 7.51 |
Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days
| number of heavy drinking days | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control |
|---|---|---|---|
| Heavy Drinking Frequency 3-month Follow-up | 3.78 ± 4.26 | 3.80 ± 4.11 | 4.02 ± 4.00 |
Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)
| negative consequences | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control |
|---|---|---|---|
| Negative Alcohol Consequences 3-month Follow-up | 6.49 ± 5.42 | 4.91 ± 4.47 | 5.33 ± 4.65 |
Collected over From enrollment to end of follow-up (4 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Personalized Feedback Plus Incentive | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
| Personalized Feedback Without Incentive | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Control | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Age, Continuous(Years) | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control | Total |
|---|---|---|---|---|
| Mean | 23.28 ± 2.92 | 23.86 ± 3.29 | 23.22 ± 2.72 | 23.45 ± 2.98 |
| Sex: Female, Male(Participants) | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control | Total |
|---|---|---|---|---|
| Female | 32 | 29 | 19 | 80 |
| Male | 22 | 20 | 27 | 69 |
| Race (NIH/OMB)(Participants) | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 12 | 7 | 8 | 27 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 2 | 4 | 10 |
| White | 32 | 34 | 30 | 96 |
| More than one race | 4 | 5 | 4 | 13 |
| Unknown or Not Reported | 2 | 1 | 0 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control | Total |
|---|---|---|---|---|
| Hispanic or Latino | 4 | 8 | 7 | 19 |
| Not Hispanic or Latino | 50 | 41 | 39 | 130 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| drinks per week(drinks per week) | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control | Total |
|---|---|---|---|---|
| Mean | 18.47 ± 13.67 | 17.22 ± 11.13 | 15.24 ± 10.06 | 17.06 ± 11.82 |
| heavy drinking frequency(days) | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control | Total |
|---|---|---|---|---|
| Mean | 6.96 ± 5.92 | 7.06 ± 4.05 | 6.30 ± 4.86 | 6.79 ± 5.02 |
| negative consequences(consequences) | Personalized Feedback Plus Incentive | Personalized Feedback Without Incentive | Control | Total |
|---|---|---|---|---|
| Mean | 8.52 ± 3.89 | 9.67 ± 4.90 | 7.33 ± 3.68 | 8.53 ± 4.27 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — This study will submit and share data with NIAAA Data Archive, a data repository housed within the National Institute of Mental Health Data Archive (NDA). Participants complete a baseline survey of participant characteristics and drinking behavior and related constructs, a post-test survey, and a 3-month follow-up assessment to measure drinking behavior post-intervention. Data from these 3 surveys will be shared.
Time frame: Data will be shared on or before the NDA submission due dates (April 1 and October 1 each year). It will remain in the archive as per the archive regulations.
Ran from Aug 2024 to primary completion in Oct 2025, 14 months.
Results were first posted in Jun 2026, 7 months after primary completion.
Of 34 non-industry interventional studies with no phase under Underage Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's 14 months is below that.
Counting every sponsor, half of 36 studies reached it within 24 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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