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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34AA029733-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized feedback plus incentive | Experimental | 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. |
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| Personalized feedback without incentive | Experimental | 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. |
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| Control | No Intervention | Participants in this arm will only complete baseline and follow-up surveys. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile-delivered personalized feedback | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Drinks Per Week Post-test | drinks per week in the past 30 days | 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 | 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) | post-test (end of 4-week intervention) |
| Drinks Per Week 3-month Follow-up | drinks per week in the past 30 days | 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 | 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) | 3-month follow-up (3 months after end of intervention; 4 months after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer E Merrill, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02903 | United States |
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.
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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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Personalized Feedback Plus Incentive | 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. |
| FG001 | Personalized Feedback Without Incentive | 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. |
| FG002 | Control | Participants in this arm will only complete baseline and follow-up surveys. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Personalized Feedback Plus Incentive | 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. |
| BG001 | Personalized Feedback Without Incentive |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Drinks Per Week Post-test | drinks per week in the past 30 days | The number of participants who completed post-test is slightly lower in Groups 1 and 2 than at baseline. | Posted | Mean | Standard Deviation | drinks per week | post-test (1 month following baseline; end of intervention period for those in intervention groups) |
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From enrollment to end of follow-up (4 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Personalized Feedback Plus Incentive | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Merrill | Brown University | 401-863-5165 | jennifer_merrill@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2026 | Mar 27, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2026 | Mar 27, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 30, 2024 | Mar 20, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000066608 | Underage Drinking |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| D001519 | Behavior |
| D004327 | Drinking Behavior |
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Participants are randomized to one of three conditions: (1) daily surveys plus personalized feedback about yesterday's drinking, with a monetary incentive for survey completion, (2) daily surveys plus personalized feedback about yesterday's drinking, with no monetary incentive, or (3) survey assessment (baseline and follow-up) only
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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. |
| BG002 | Control | Participants in this arm will only complete baseline and follow-up surveys. |
| BG003 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| drinks per week | Drinks per typical week in past 30 days | Mean | Standard Deviation | drinks per week |
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| heavy drinking frequency | number of heavy drinking days in past 30 days | Mean | Standard Deviation | days |
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| negative consequences | Number of negative consequences in the past 30 days were measured with the Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ; Kahler et al 2005). Scores range from 0-24 for a count of different consequences (e.g., embarrassing oneself, hangover). | Mean | Standard Deviation | consequences |
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| OG002 | Control | Participants in this arm will only complete baseline and follow-up surveys. |
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| Primary | Heavy Drinking Frequency Post-test | Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days | Number completing post-test was slightly lower than baseline. | Posted | Mean | Standard Deviation | number of heavy drinking days | post-test (end of 4-week intervention for those in intervention groups, and 1 month after baseline) |
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| Primary | Negative Alcohol Consequences Post-test | Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) | Number completing post-test was slightly lower than baseline | Posted | Mean | Standard Deviation | negative consequences | post-test (end of 4-week intervention) |
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| Primary | Drinks Per Week 3-month Follow-up | drinks per week in the past 30 days | Number of participants completing 3 month follow-up was slightly lower than at baseline | Posted | Mean | Standard Deviation | drinks per week | 3 month follow-up (4 months following baseline) |
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| Primary | Heavy Drinking Frequency 3-month Follow-up | Number of days drinking 4+ drinks (women) or 5+ drinks (men) in the past 30 days | Number completing post-test was slightly lower than baseline. | Posted | Mean | Standard Deviation | number of heavy drinking days | 3 month follow-up (4 months post-baseline) |
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| Primary | Negative Alcohol Consequences 3-month Follow-up | Number of consequences reported on the 24-item Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) | Number completing 3-month follow-up was slightly lower than baseline | Posted | Mean | Standard Deviation | negative consequences | 3-month follow-up (3 months after end of intervention; 4 months after baseline |
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| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Personalized Feedback Without Incentive | 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. | 0 | 52 | 0 | 52 | 0 | 52 |
| EG002 | Control | Participants in this arm will only complete baseline and follow-up surveys. | 0 | 46 | 0 | 46 | 0 | 46 |
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