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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA025043 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| University of Houston | OTHER |
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High volume drinking by young adults has proven resistant to change, so new approaches are needed. We adapt a theory-based attitude change strategy for use in alcohol prevention. This research tests the impact of brief writing and advocacy activities on subsequent drinking and negative consequences.
The persistence of risky drinking among young adults in college calls for continued efforts to prevent harms related to alcohol. Many prevention interventions rely on a primary mechanism of change: correcting exaggerated drinking norms. We propose to test a novel prevention strategy targeting another mechanism of change: creating attitude-behavior dissonance. To date, attitude change activities have not been harnessed as a behavior change strategy for alcohol abuse prevention, so this study adapts counter-attitudinal advocacy (CAA) to the alcohol prevention context. The goals of the proposed research are to demonstrate (a) the utility of CAA to change high volume drinking and related consequences, (b) that attitude change and attitude-behavior dissonance mediates the CAA manipulation effect, and (c) that CAA-induced risk reduction is not inferior to an established intervention based on Personalized Normative Feedback (PNF). A pair of studies will be implemented across two sites. First surveys to document peer behaviors and normative perceptions (N = 500 at each site) will be conducted, in order to deliver accurate, campus-specific PNF. The next study consists of a randomized controlled trial (RCT) with 2 experimental conditions (CAA and PNF) and a 3rd assessment only control condition to determine the impact of CAA on alcohol outcomes. For the RCT, a total of 600 heavy drinking students who have endorsed alcohol-related negative consequences will be recruited. Alcohol outcomes will be assessed at 1-, 3-, and 6-month follow-ups to test hypotheses that, relative to assessment only control, the CAA manipulation will decrease alcohol consumption and consequences. We will also test the hypothesis that CAA condition will be no less efficacious than (i.e., not inferior to) the PNF condition. The RCT also allows tests of hypotheses about effect moderators and mediators. This study will demonstrate the generalizability of CAA activities to the alcohol prevention context, as well as their generalizability across demographically different settings. Implications for the public health include establishing the efficacy of a new approach for reducing high volume drinking and related consequences among young adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counter Attitudinal Advocacy | Experimental | Participants in this arm will articulate ways to avoid alcohol-related consequences using self-generated protective strategies and publicly state those strategies. |
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| Personalized Normative Feedback | Active Comparator | Participants in this arm will view personalized normative feedback regarding their 1) own drinking quantity and frequency of drinking, 2) perceptions of typical drinking by same-sex students' on campus (i.e., perceived descriptive norms), and 3) actual drinking rates by same-sex students' on campus (i.e., actual descriptive norms). |
|
| Assessment-only Control | No Intervention | Participants in this arm will not receive any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counter Attitudinal Advocacy | Behavioral | same as Counter Attitudinal Advocacy arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drinks Per Week as Assessed by the Daily Drinking Questionnaire | Number of standard drinks consumed in a typical week over the past 30 days; scores can range from zero but have no upper limit as they are counts of drinks | 6-month follow up |
| Alcohol-related Consequences as Assessed by the Young Adult Alcohol Consequences Questionnaire | The Young Adult Alcohol Consequences Questionnaire is a checklist of 48 different consequences that could be experienced over the past 30 days; the total score ranges from 0-48; higher scores indicate more problems experienced in the past 30 days | 6-month follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kate B Carey, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | United States | ||
| University of Houston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40080603 | Derived | Carey KB, DiBello AM, Hatch MR, Weinstein AP, Neighbors C. Efficacy of counter-attitudinal advocacy and personalized feedback for heavy-drinking college students. J Consult Clin Psychol. 2025 May;93(5):357-368. doi: 10.1037/ccp0000949. Epub 2025 Mar 13. |
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After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.
Within one year of study completion
to be determined
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| ID | Title | Description |
|---|---|---|
| FG000 | Counter Attitudinal Advocacy | Participants in this arm will articulate ways to avoid alcohol-related consequences using self-generated protective strategies and publicly state those strategies. Counter Attitudinal Advocacy: same as Counter Attitudinal Advocacy arm |
| FG001 | Personalized Normative Feedback | Participants in this arm will view personalized normative feedback regarding their 1) own drinking quantity and frequency of drinking, 2) perceptions of typical drinking by same-sex students' on campus (i.e., perceived descriptive norms), and 3) actual drinking rates by same-sex students' on campus (i.e., actual descriptive norms). Personalized Normative Feedback: same as Personalized Normative Feedback arm |
| FG002 | Assessment-only Control | Participants in this arm will not receive any intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Counter Attitudinal Advocacy | Participants in this arm will articulate ways to avoid alcohol-related consequences using self-generated protective strategies and publicly state those strategies. Counter Attitudinal Advocacy: same as Counter Attitudinal Advocacy arm |
| BG001 | Personalized Normative Feedback |
| Units | Counts |
|---|---|
| Participants |
|
| 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 as Assessed by the Daily Drinking Questionnaire | Number of standard drinks consumed in a typical week over the past 30 days; scores can range from zero but have no upper limit as they are counts of drinks | Participants were included in this analysis if they provided drinks per week data at the 6-month follow-up | Posted | Mean | Standard Deviation | drinks per week | 6-month follow up |
|
through study completion, an average of 12 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 | Counter Attitudinal Advocacy | Participants in this arm will articulate ways to avoid alcohol-related consequences using self-generated protective strategies and publicly state those strategies. Counter Attitudinal Advocacy: same as Counter Attitudinal Advocacy arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate B. Carey | Brown University | 4018636558 | kate_carey@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 30, 2023 | Oct 21, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
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| Personalized Normative Feedback | Behavioral | same as Personalized Normative Feedback arm |
|
|
| Houston |
| Texas |
| 77204-5022 |
| United States |
| technical problem |
|
Participants in this arm will view personalized normative feedback regarding their 1) own drinking quantity and frequency of drinking, 2) perceptions of typical drinking by same-sex students' on campus (i.e., perceived descriptive norms), and 3) actual drinking rates by same-sex students' on campus (i.e., actual descriptive norms). Personalized Normative Feedback: same as Personalized Normative Feedback arm |
| BG002 | Assessment-only Control | Participants in this arm will not receive any intervention. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Drinks per week | A sum of the number of standard drinks reported across the 7 days of a typical week in the last month. | Mean | Standard Deviation | drinks per week |
|
| Alcohol problems | Count of alcohol problems endorsed in the last month, using the 48-item Young Adult Alcohol Consequences Questionnaire; the total score ranges from 0-48 and higher scores indicate more problems experienced in the past 30 days. | Mean | Standard Deviation | problems |
|
Participants in this arm will view personalized normative feedback regarding their 1) own drinking quantity and frequency of drinking, 2) perceptions of typical drinking by same-sex students' on campus (i.e., perceived descriptive norms), and 3) actual drinking rates by same-sex students' on campus (i.e., actual descriptive norms). Personalized Normative Feedback: same as Personalized Normative Feedback arm |
| OG002 | Assessment-only Control | Participants in this arm will not receive any intervention. |
|
|
|
| Primary | Alcohol-related Consequences as Assessed by the Young Adult Alcohol Consequences Questionnaire | The Young Adult Alcohol Consequences Questionnaire is a checklist of 48 different consequences that could be experienced over the past 30 days; the total score ranges from 0-48; higher scores indicate more problems experienced in the past 30 days | Participants were included if they provided data at the 6 month follow-up | Posted | Mean | Standard Deviation | problems | 6-month follow up |
|
|
|
|
| 0 |
| 191 |
| 0 |
| 191 |
| 0 |
| 191 |
| EG001 | Personalized Normative Feedback | Participants in this arm will view personalized normative feedback regarding their 1) own drinking quantity and frequency of drinking, 2) perceptions of typical drinking by same-sex students' on campus (i.e., perceived descriptive norms), and 3) actual drinking rates by same-sex students' on campus (i.e., actual descriptive norms). Personalized Normative Feedback: same as Personalized Normative Feedback arm | 0 | 196 | 0 | 196 | 0 | 196 |
| EG002 | Assessment-only Control | Participants in this arm will not receive any intervention. | 0 | 200 | 0 | 200 | 0 | 200 |
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| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |