Alcohol DrinkingNCT04042909
Using Counter Attitudinal Advocacy to Change Drinking Behavior
A study testing Counter Attitudinal Advocacy and Personalized Normative Feedback in people with Alcohol Drinking and Alcohol Abuse, run by Brown University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Abuse
- What is being tested?
- Counter Attitudinal Advocacy and Personalized Normative Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 591 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Nov 2019to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-26
- Male or female student at Brown University or University of Houston
- Past month heavy episodic drinking (for men, >5 drinks in one day, for women >4 drinks in one day)
- At least two self-reported negative consequences from drinking in the past month
Who cannot join
- status as a second semester Senior
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Houston
Houston, Texas, 77204-5022
Brown University
Providence, Rhode Island, 02912
About this study
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.
Read the detailed description
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.
- Conditions
- Alcohol Drinking, Alcohol Abuse
- Being tested
- Counter Attitudinal Advocacy, Personalized Normative Feedback
- Keywords
- brief intervention, college students
- Medical subject headings
- Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counter Attitudinal AdvocacyBehavioural
Also called CAA
same as Counter Attitudinal Advocacy arm
Personalized Normative FeedbackBehavioural
Also called PNF
same as Personalized Normative Feedback arm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Counter Attitudinal Advocacy |
| 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). Receives: Behavioral: Personalized Normative Feedback |
| Assessment-only Control | No intervention | Participants in this arm will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start12 Nov 2019
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 591 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Houston
- Responsible party
- Principal investigator, Kate Carey, Brown University
- Investigators
- Kate B Carey, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042909
- Sponsor's protocol ID
- 1809002214
- Other IDs
- R01AA025043
- Status last verified
- May 2025
- First submitted
- 31 Jul 2019
- Last updated
- 16 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40080603
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Counter Attitudinal Advocacy to Change Drinking Behavior
- ClinicalTrials.gov ID
- NCT04042909
- Acronym / sponsor ID
- 1809002214
- Conditions
- Alcohol Drinking, Alcohol Abuse
- Keywords
- brief intervention, college students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Houston
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Posted 16 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Counter Attitudinal Advocacy | Experimental | Behavioral: Counter Attitudinal AdvocacyParticipants in this arm will articulate ways to avoid alcohol-related consequences using self-generated protective strategies and publicly state those strategies. |
| Personalized Normative Feedback | Active comparator | Behavioral: Personalized Normative FeedbackParticipants 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-26
- Male or female student at Brown University or University of Houston
- Past month heavy episodic drinking (for men, >5 drinks in one day, for women >4 drinks in one day)
- At least two self-reported negative consequences from drinking in the past month
Key exclusion criteria (1 listed)
- status as a second semester Senior
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counter Attitudinal AdvocacyAlso: CAAsame as Counter Attitudinal Advocacy arm | Behavioural | Counter Attitudinal Advocacy |
| Personalized Normative FeedbackAlso: PNFsame as Personalized Normative Feedback arm | Behavioural | Personalized Normative Feedback |
Primary outcome
Drinks Per Week as Assessed by the Daily Drinking Questionnaire
Time frame: 6-month follow up
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
Alcohol-related Consequences as Assessed by the Young Adult Alcohol Consequences Questionnaire
Time frame: 6-month follow up
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40080603Carey 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Alcohol Drinking
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
Alcohol Use Disorder
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Not yet recruiting
Hybrid Type 1 Trial of a Parent-Based Intervention Addressing Social Media and Adolescent Alcohol Use
Adolescent Alcohol Use
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Recruiting
Multisensory Processing of Alcohol Cues in Young Adult Binge Drinkers
Drinking, Binge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate B Carey, PhD principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counter Attitudinal Advocacy and Personalized Normative Feedback in people with Alcohol Drinking and Alcohol Abuse, run by Brown University at 2 sites 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 16 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Drinks Per Week as Assessed by the Daily Drinking Questionnaire (time frame: 6-month follow up). The study lists 2 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 NCT04042909, which also lists 1 linked publication.
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 16 May 2025.