Alcohol AbuseACENCT04026633
Attitudes & College Experiences
A study testing CAA in people with Alcohol Abuse, run by Brooklyn College of the City University of New York at 1 site in United States.
Trial summary
High volume drinking by young adults has proven resistant to long term change, so new approaches are needed. Given strong associations between alcohol-related attitudes and drinking behavior, the investigators adapt a theory-based attitude change strategy for use in alcohol prevention. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- CAA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18-24 years of age
- Enrolled in the university's undergraduate four-year degree program
- 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 consequence from drinking in the past month
Who cannot join
- Status as a graduating senior
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Counter Attitudinal Advocacy to Change Drinking Behavior & Related Problems
High volume drinking by young adults has proven resistant to long term change, so new approaches are needed. Given strong associations between alcohol-related attitudes and drinking behavior, the investigators adapt a theory-based attitude change strategy for use in alcohol prevention. This research tests the impact of a brief counter attitudinal advocacy activity 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. Current prevention interventions have achieved some success, but rely on a single mechanism of change: correcting exaggerated drinking norms. The investigators propose to test a novel prevention strategy targeting another mechanism of change: creating attitude-behavior dissonance. To date, changing alcohol-related attitudes and the resulting attitude-behavior discrepancy has been underutilized as a behavior change strategy for alcohol abuse prevention. Informed by an extensive literature showing strong and consistent associations between alcohol attitudes and drinking behavior, the investigators adapted a brief counter-attitudinal advocacy (CAA) manipulation to the alcohol prevention context.
- Conditions
- Alcohol Abuse
- Being tested
- CAA, Control
- Keywords
- Alcohol Intervention, College Students
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAABehavioural
Participants will write about the use of PBS and alcohol use.
ControlBehavioural
Participants will write about eating and exercise.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Enhanced Intervention | Experimental | Participants assigned to this arm will complete a personal writing task about alcohol use. Receives: Behavioral: CAA |
| Placebo Comparator | Placebo comparator | Participants assigned to this arm will complete a personal writing task about eating behaviors. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Consumption from Baseline to 1-Month
Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.
Measured: 1 month after baseline
Change in Alcohol-related consequences from Baseline to 1- and 3-Months
The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) (Kahler et al., 2005) is a 24-item self-administered checklist of problems related to drinking; responses are dichotomous (yes/no) and refer to the past month which was collected at baseline and 5-months. The BYAACQ demonstrates strong psychometric properties and is free of gender bias (Kahler et al., 2005).
Measured: 1 month and 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start10 Apr 2019
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooklyn College of the City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo DiBello, Brooklyn College of the City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026633
- Sponsor's protocol ID
- R21AA025676
- Acronym
- ACE
- Status last verified
- Aug 2022
- First submitted
- 11 Jul 2019
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Counter Attitudinal Advocacy to Change Drinking Behavior & Related Problems
- ClinicalTrials.gov ID
- NCT04026633
- Acronym / sponsor ID
- ACE / R21AA025676
- Conditions
- Alcohol Abuse
- Keywords
- Alcohol Intervention, College Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Brooklyn College of the City University of New YorkUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
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 long term change, so new approaches are needed. Given strong associations between alcohol-related attitudes and drinking behavior, the investigators adapt a theory-based attitude change strategy for use in alcohol prevention. This research tests the impact of a brief counter attitudinal advocacy activity 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. Current prevention interventions have achieved some success, but rely on a single mechanism of change: correcting exaggerated drinking norms. The investigators propose to test a novel prevention strategy targeting another mechanism of change: creating attitude-behavior dissonance. To date, changing alcohol-related attitudes and the resulting attitude-behavior discrepancy has been underutilized as a behavior change strategy for alcohol abuse prevention. Informed by an extensive literature showing strong and consistent associations between alcohol attitudes and drinking behavior, the investigators adapted a brief counter-attitudinal advocacy (CAA) manipulation to the alcohol prevention context.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Enhanced Intervention | Experimental | Behavioral: CAAParticipants assigned to this arm will complete a personal writing task about alcohol use. |
| Placebo Comparator | Placebo comparator | Behavioral: ControlParticipants assigned to this arm will complete a personal writing task about eating behaviors. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-24 years of age
- Enrolled in the university's undergraduate four-year degree program
- 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 consequence from drinking in the past month
Key exclusion criteria (1 listed)
- Status as a graduating 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 |
|---|---|---|
| CAAParticipants will write about the use of PBS and alcohol use. | Behavioural | Experimental: Enhanced Intervention |
| ControlParticipants will write about eating and exercise. | Behavioural | Placebo Comparator |
Primary outcome
Change in Alcohol Consumption from Baseline to 1-Month
Time frame: 1 month after baseline
Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.
Change in Alcohol-related consequences from Baseline to 1- and 3-Months
Time frame: 1 month and 3 months after baseline
The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) (Kahler et al., 2005) is a 24-item self-administered checklist of problems related to drinking; responses are dichotomous (yes/no) and refer to the past month which was collected at baseline and 5-months. The BYAACQ demonstrates strong psychometric properties and is free of gender bias (Kahler et al., 2005).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAA in people with Alcohol Abuse, run by Brooklyn College of the City University of New York 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 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 5 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in Alcohol Consumption from Baseline to 1-Month (time frame: 1 month after baseline). 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?
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 5 Aug 2022.