- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06776796
Testing the Efficacy of a Brief Alcohol Intervention Among College Students
A Pilot Randomized Controlled Trial to Test the Efficacy of a Brief Alcohol Intervention Among College Students
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30303
- Georiga State University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
• 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Online Personalized Normative Feedback Intervention Targeting Alcohol Misuse
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).
|
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).
|
|
Placebo Comparator: Mental Health and Substance Use Resources
Participants were directed to a website where information regarding mental health and substance use may be found.
|
Participants were directed to a website where information regarding mental health and substance use may be found.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 3-months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H24001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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