- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04052386
Brief Alcohol Screening for Community College Students (BASICCS)
August 8, 2019 updated by: Christine Lee, University of Washington
The present study focuses on examining the feasibility, acceptability, and preliminary effects of an adapted alcohol intervention for high-risk college students attending community colleges.
Investigators adapted BASICS (an efficacious in-person intervention developed for high-risk drinkers attending 4-year colleges and universities) to a web-conferencing format that allows the facilitator and participant to see and discuss live web-based personalized feedback.
SMS text messages with protective behavioral strategies were also provided.
The objective of the R34 was to establish feasibility and acceptability as well as to determine preliminary or likely effect sizes.
Study Overview
Detailed Description
Young adulthood (ages 18-29) is associated with increased risk for alcohol-related negative consequences; however, little is known about effective interventions for young adults attending community colleges (CCs).
Thus, it is critical to develop an intervention that meets the various needs and demanding lifestyles of CC students.
The investigators proposed to develop a user-friendly and convenient intervention that addresses relevant social norms, the impact of high-risk alcohol use on health and well-being in relevant life domains beyond student life and academic achievement, and provides ongoing exposure to behavior change strategies.
To address the notable differences between CC students and traditional 4-year students, the investigators adapted BASICS to a web-conferencing format that allows the facilitator and participant to see and discuss live web-based personalized feedback (FB).
This intervention for CC students, BASICCS, will focus on relevant normative feedback and alcohol's impact on multiple roles and personal goals of the CC student.
Providing tips and protective behavioral strategies (PBS) after BASICS interventions via handouts or mailed postcards is standard practice and with preliminary evidence supporting the use of mobile phone text messaging (TM) or short message service (SMS) to reduce heavy-episodic drinking; thus, in this study SMS text messages were used to deliver ongoing protective behavioral strategies (PBS) the month after participating in the BASICCS session.
The objective of this research was to establish feasibility and acceptability as well as to determine preliminary or likely effect sizes.
CC student drinkers were recruited to participate and if eligible, they were randomized to one of two conditions (BASICCS or assessment-only control) and completed 1- and 3-month follow-ups.
Study Type
Interventional
Enrollment (Actual)
142
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98105
- University of Washington
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- being 18-29 years old; enrolled full- or part-time at one of the three community colleges where data collection took place; consuming 4+/5+ drinks for women/men on one occasion in the past month or exceeding weekly NIAAA drinking recommendations (8+/15+ for women/men); and possessing a cell phone with text-messaging capability
Exclusion Criteria:
- not meeting inclusion criteria, not consenting to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: BASICCS
Participants randomized to the BASICCS condition received a personalized feedback intervention conducted through a web-conferencing platform.
They also received up to 24 text messages with protective behavioral strategies for drinking during the following month.
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Participants randomized to the BASICCS condition received a personalized feedback intervention conducted through a web-conferencing platform.
The personalized feedback intervention included tailored feedback on drinking quantity and frequency of alcohol, BAC, alcohol-related consequences, normative perceptions of peer drinking, alcohol outcome expectancies, family history of risk, and financial costs of alcohol.
They also received up to 24 text messages with protective behavioral strategies for drinking during the following month.
|
No Intervention: Control
Participants randomized to the control group did not receive any intervention.
They were an assessment-only control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily Drinking Questionnaire
Time Frame: 1-month
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Number of standard drinks consumed each day of typical week past month
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1-month
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Daily Drinking Questionnaire
Time Frame: 3-month
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Number of standard drinks consumed each day of typical week past month
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3-month
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Frequency of Binge Drinking
Time Frame: 1-month
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Number of times in past month engaged in heavy episodic drinking (4+ drinks for women, 5+ drinks for men)
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1-month
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Frequency of Binge Drinking
Time Frame: 3-month
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Number of times in past month engaged in heavy episodic drinking (4+ drinks for women, 5+ drinks for men)
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3-month
|
Estimated Blood Alcohol Concentration (eBAC)
Time Frame: 1-month
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estimated peak blood alcohol concentration
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1-month
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Estimated Blood Alcohol Concentration (eBAC)
Time Frame: 3-month
|
estimated peak blood alcohol concentration
|
3-month
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Brief Young Adult Alcohol Consequences Questionnaire
Time Frame: 1-month
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Number of alcohol-related consequences endorsed
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1-month
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Brief Young Adult Alcohol Consequences Questionnaire
Time Frame: 3-month
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Number of alcohol-related consequences endorsed
|
3-month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christine M Lee, PhD, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2017
Primary Completion (Actual)
June 26, 2017
Study Completion (Actual)
June 26, 2017
Study Registration Dates
First Submitted
August 7, 2019
First Submitted That Met QC Criteria
August 8, 2019
First Posted (Actual)
August 9, 2019
Study Record Updates
Last Update Posted (Actual)
August 9, 2019
Last Update Submitted That Met QC Criteria
August 8, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 50262
- R34AA023047 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
We plan to share limited datasets for the purposes of data analysis and dissemination.
IPD Sharing Time Frame
Data dictionaries and limited datasets can be made available starting in September 2020.
IPD Sharing Access Criteria
Individual requests to access data with intended purpose should be made to Dr. Lee and will be reviewed by the investigative team.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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