Alcohol UseNCT06776796
Testing the Efficacy of a Brief Alcohol Intervention Among College Students
A study testing Online Personalized Normative Feedback Intervention Targeting Alcohol Misuse and Mental Health and Substance Use Resources in people with Alcohol Use and Personalized Normative Feedback, run by Georgia State University at 1 site in United States.
Trial summary
Individuals will be recruited to participate in a randomized controlled trial to test the efficacy of a prevention program aimed at reducing alcohol use among college students. If randomized to the intervention, participants will view personalized content based on their alcohol use and chosen identity and learn about… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Alcohol Use, Personalized Normative Feedback
- What is being tested?
- Online Personalized Normative Feedback Intervention Targeting Alcohol Misuse and Mental Health and Substance Use Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 461 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2023to 21 Jan 2024
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-25 years old
- Current student at university of study
- Valid email address at university of study
- Identifies as Black, White and LGBTQA+, Latine/a/o or Hispanic,
- Endorse engaging in heavy episodic drinking at least once in the past month on the screening survey
Who cannot join
- Individuals who identify their sex at birth as intersex or who identify as both heterosexual and gender diverse (Transgender, Genderqueer, Gender non-conforming, Non-binary, Androgynous, and Two-spirit) will be excluded due to the lack of normative data about these groups.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Trial to Test the Efficacy of a Brief Alcohol Intervention Among College Students
Individuals will be recruited to participate in a randomized controlled trial to test the efficacy of a prevention program aimed at reducing alcohol use among college students. If randomized to the intervention, participants will view personalized content based on their alcohol use and chosen identity and learn about various topics related to alcohol use, including ways to reduce their use. Control participants will be directed to a website where information regarding mental health and substance use may be found. Baseline mental health, alcohol use, and related constructs will be assessed. Participants will complete a 3-month follow-up survey to assess the efficacy of the tool in symptom reduction.
Read the detailed description
Students will be recruited by campus flyers, social media, and a registrar list to participate in a randomized controlled trial (RCT) to test the efficacy of a prevention program aimed at reducing alcohol use among college students. Participants will also be recruited from a list of students who completed the Panthers4Life community needs assessment. Interested students will first complete a screener to determine eligibility (i.e., enrolled GSU student, 18-25 years of age, identifies as Black, White and LGBTQA+, Latine/a/o or Hispanic, and engaged in heavy episodic drinking at least once in the past month). Individuals who identify their sex at birth to be intersex or who identify themselves to be both heterosexual and gender diverse (Transgender, Genderqueer, Gender non-conforming, Non-binary, Androgynous, and Two-spirit) will be excluded due to the lack of normative data about these groups. Eligible participants will immediately be given the informed consent and asked to complete a baseline survey (15 minutes). In the baseline survey, participants will select identity group(s) they most identify with and select identity group(s) they would like to receive personalized normative feedback about. Participants will then be randomized to either complete a brief online intervention (treatment group) or view website information about substance use and mental health (control group).
If randomized to the intervention, participants will complete an intervention in Qualtrics Survey Platform that takes approximately 15 minutes to complete. They will view personalized content based on their alcohol use and chosen identity (e.g., if a participant chooses woman and LGBQA+ they will receive personalized normative feedback for women LGBQA+ students at GSU) and learn about various topics related to alcohol use, including ways to reduce their use. The intervention is a modified version of an existing evidence-based program, the Brief Alcohol Screening and Intervention for College Students (BASICS).
Participants assigned the control condition will be directed to a website where information regarding mental health and substance use may be found.
In both groups, the investigators will assess baseline mental health, alcohol use, and related constructs. Both groups will also be asked to complete a 3-month follow-up survey to assess the efficacy of the tool in symptom reduction. Cultural acceptability will also be assessed to determine if cultural adaptations are needed to enhance efficacy among groups represented in our sample. Participants will be compensated up to $30 in Amazon gift cards for their time ($15 for the baseline survey and $15 for the 3-month follow up).
- Conditions
- Alcohol Use, Personalized Normative Feedback
- Being tested
- Online Personalized Normative Feedback Intervention Targeting Alcohol Misuse, Mental Health and Substance Use Resources
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Personalized Normative Feedback Intervention Targeting Alcohol MisuseBehavioural
This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse. It is tailored by the identities chosen by participants including gender, race/ethnicity, and sexual orientation. The intervention is a modified version of an existing evidence-based program, the Brief Alcohol Screening and Intervention for College Students (BASICS) (Dimeff, et. al, 1999).
Mental Health and Substance Use ResourcesBehavioural
Participants were directed to a website where information regarding mental health and substance use may be found.
| Study group | Role | What they receive |
|---|---|---|
| Online Personalized Normative Feedback Intervention Targeting Alcohol Misuse | Experimental | This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse. It is tailored by the identities chosen by participants including gender, race/ethnicity, and sexual orientation. The intervention is a modified version of an existing evidence-based program, the Brief Alcohol Screening and Intervention for College Students (BASICS) (Dimeff, et. al, 1999). Receives: Behavioral: Online Personalized Normative Feedback Intervention Targeting Alcohol Misuse |
| Mental Health and Substance Use Resources | Placebo comparator | Participants were directed to a website where information regarding mental health and substance use may be found. Receives: Behavioral: Mental Health and Substance Use Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Alcohol use
Number of drinks will be assessed using the daily drinking questionnaire. Higher scores indicate higher alcohol use.
Measured: Baseline and 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start23 Aug 2023
- Primary completion21 Jan 2024
- Study completion21 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Gilmore, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776796
- Sponsor's protocol ID
- H24001
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gilmore AK, Leone RM, Reuben K, Garner JB, Flowers N, Chipman T, Patton EE, Capobianco J, Zong ZY, Stappenbeck CA, Ellis JR, Fortson K, Mullican KN, Larimer M. Pilot randomized controlled trial of a tailored personalized normative feedback intervention for college student alcohol use. Drug Alcohol Depend. 2025 Oct 1;275:112824. doi: 10.1016/j.drugalcdep.2025.112824. Epub 2025 Aug 8.
PubMed 40834655
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial to Test the Efficacy of a Brief Alcohol Intervention Among College Students
- ClinicalTrials.gov ID
- NCT06776796
- Acronym / sponsor ID
- H24001
- Conditions
- Alcohol Use, Personalized Normative Feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 21 Jan 2024 (actual)
- Study completion
- 21 Jan 2024 (actual)
- First posted
- 15 Jan 2025 (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.
Individuals will be recruited to participate in a randomized controlled trial to test the efficacy of a prevention program aimed at reducing alcohol use among college students. If randomized to the intervention, participants will view personalized content based on their alcohol use and chosen identity and learn about various topics related to alcohol use, including ways to reduce their use. Control participants will be directed to a website where information regarding mental health and substance use may be found. Baseline mental health, alcohol use, and related constructs will be assessed. Participants will complete a 3-month follow-up survey to assess the efficacy of the tool in symptom reduction.
Detailed description
Students will be recruited by campus flyers, social media, and a registrar list to participate in a randomized controlled trial (RCT) to test the efficacy of a prevention program aimed at reducing alcohol use among college students. Participants will also be recruited from a list of students who completed the Panthers4Life community needs assessment. Interested students will first complete a screener to determine eligibility (i.e., enrolled GSU student, 18-25 years of age, identifies as Black, White and LGBTQA+, Latine/a/o or Hispanic, and engaged in heavy episodic drinking at least once in the past month). Individuals who identify their sex at birth to be intersex or who identify themselves to be both heterosexual and gender diverse (Transgender, Genderqueer, Gender non-conforming, Non-binary, Androgynous, and Two-spirit) will be excluded due to the lack of normative data about these groups. Eligible participants will immediately be given the informed consent and asked to complete a baseline survey (15 minutes). In the baseline survey, participants will select identity group(s) they most identify with and select identity group(s) they would like to receive personalized normative feedback about. Participants will then be randomized to either complete a brief online intervention (treatment group) or view website information about substance use and mental health (control group).
If randomized to the intervention, participants will complete an intervention in Qualtrics Survey Platform that takes approximately 15 minutes to complete. They will view personalized content based on their alcohol use and chosen identity (e.g., if a participant chooses woman and LGBQA+ they will receive personalized normative feedback for women LGBQA+ students at GSU) and learn about various topics related to alcohol use, including ways to reduce their use. The intervention is a modified version of an existing evidence-based program, the Brief Alcohol Screening and Intervention for College Students (BASICS).
Participants assigned the control condition will be directed to a website where information regarding mental health and substance use may be found.
In both groups, the investigators will assess baseline mental health, alcohol use, and related constructs. Both groups will also be asked to complete a 3-month follow-up survey to assess the efficacy of the tool in symptom reduction. Cultural acceptability will also be assessed to determine if cultural adaptations are needed to enhance efficacy among groups represented in our sample. Participants will be compensated up to $30 in Amazon gift cards for their time ($15 for the baseline survey and $15 for the 3-month follow up).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Personalized Normative Feedback Intervention Targeting Alcohol Misuse | Experimental | Behavioral: Online Personalized Normative Feedback Intervention Targeting Alcohol MisuseThis is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse. It is tailored by the identities chosen by participants including gender, race/ethnicity, and sexual orientation. The intervention is a modified version of an existing evidence-based program, the Brief Alcohol Screening and Intervention for College Students (BASICS) (Dimeff, et. al, 1999). |
| Mental Health and Substance Use Resources | Placebo comparator | Behavioral: Mental Health and Substance Use ResourcesParticipants were directed to a website where information regarding mental health and substance use may be found. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-25 years old
- Current student at university of study
- Valid email address at university of study
- Identifies as Black, White and LGBTQA+, Latine/a/o or Hispanic,
- Endorse engaging in heavy episodic drinking at least once in the past month on the screening survey
Key exclusion criteria (1 listed)
- Individuals who identify their sex at birth as intersex or who identify as both heterosexual and gender diverse (Transgender, Genderqueer, Gender non-conforming, Non-binary, Androgynous, and Two-spirit) will be excluded due to the lack of normative data about these groups.
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 |
|---|---|---|
| Online Personalized Normative Feedback Intervention Targeting Alcohol MisuseThis is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse. It is tailored by the identities chosen by participants including gender, race/ethnicity, and sexual orientation. The intervention is a modified version of an existing evidence-based program, the Brief Alcohol Screening and Intervention for College Students (BASICS) (Dimeff, et. al, 1999). | Behavioural | Online Personalized Normative Feedback Intervention Targeting Alcohol Misuse |
| Mental Health and Substance Use ResourcesParticipants were directed to a website where information regarding mental health and substance use may be found. | Behavioural | Mental Health and Substance Use Resources |
Primary outcome
Changes in Alcohol use
Time frame: Baseline and 3-months
Number of drinks will be assessed using the daily drinking questionnaire. Higher scores indicate higher alcohol use.
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 15 Jan 2025.
- Derived from this study: PubMed 40834655Gilmore AK, Leone RM, Reuben K, Garner JB, Flowers N, Chipman T, Patton EE, Capobianco J, Zong ZY, Stappenbeck CA, Ellis JR, Fortson K, Mullican KN, Larimer M. Pilot randomized controlled trial of a tailored personalized normative feedback intervention for college student alcohol use. Drug Alcohol Depend. 2025 Oct 1;275:112824. doi: 10.1016/j.drugalcdep.2025.112824. Epub 2025 Aug 8.
- Individual participant dataSharing planned: Undecided
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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 Online Personalized Normative Feedback Intervention Targeting Alcohol Misuse and Mental Health and Substance Use Resources in people with Alcohol Use and Personalized Normative Feedback, run by Georgia State University 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 5 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 15 Jan 2025. 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?
Changes in Alcohol use (time frame: Baseline and 3-months). 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 NCT06776796, 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 15 Jan 2025.