Alcohol; Use, ProblemNCT04052386
Brief Alcohol Screening for Community College Students (BASICCS)
A study testing BASICCS in people with Alcohol; Use, Problem, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol; Use, Problem
- What is being tested?
- BASICCS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2017to 26 Jun 2017
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- not meeting inclusion criteria, not consenting to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alcohol; Use, Problem
- Being tested
- BASICCS
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASICCSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BASICCS | Experimental | 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. Receives: Behavioral: BASICCS |
| Control | No intervention | Participants randomized to the control group did not receive any intervention. They were an assessment-only control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Drinking Questionnaire
Number of standard drinks consumed each day of typical week past month
Measured: 1-month
Daily Drinking Questionnaire
Number of standard drinks consumed each day of typical week past month
Measured: 3-month
Frequency of Binge Drinking
Number of times in past month engaged in heavy episodic drinking (4+ drinks for women, 5+ drinks for men)
Measured: 1-month
Frequency of Binge Drinking
Number of times in past month engaged in heavy episodic drinking (4+ drinks for women, 5+ drinks for men)
Measured: 3-month
Estimated Blood Alcohol Concentration (eBAC)
estimated peak blood alcohol concentration
Measured: 1-month
Estimated Blood Alcohol Concentration (eBAC)
estimated peak blood alcohol concentration
Measured: 3-month
Brief Young Adult Alcohol Consequences Questionnaire
Number of alcohol-related consequences endorsed
Measured: 1-month
Brief Young Adult Alcohol Consequences Questionnaire
Number of alcohol-related consequences endorsed
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start20 Jan 2017
- Primary completion26 Jun 2017
- Study completion26 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol; Use, ProblemStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomly assigned to one of two conditions (BASICCS and assessment-only control group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Christine Lee, University of Washington
- Investigators
- Christine M Lee, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052386
- Sponsor's protocol ID
- 50262
- Other IDs
- R34AA023047
- Status last verified
- Aug 2019
- First submitted
- 7 Aug 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share limited datasets for the purposes of data analysis and dissemination.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Alcohol Screening for Community College Students (BASICCS)
- ClinicalTrials.gov ID
- NCT04052386
- Acronym / sponsor ID
- 50262
- Conditions
- Alcohol; Use, Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 9 Aug 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two conditions (BASICCS and assessment-only control group).
| Arm | Type | Receives |
|---|---|---|
| BASICCS | Experimental | Behavioral: BASICCSParticipants 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. |
| Control | No intervention | –Participants randomized to the control group did not receive any intervention. They were an assessment-only control group. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- not meeting inclusion criteria, not consenting to participate
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 |
|---|---|---|
| BASICCSParticipants 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. | Behavioural | BASICCS |
Primary outcome
Daily Drinking Questionnaire
Time frame: 1-month
Number of standard drinks consumed each day of typical week past month
Daily Drinking Questionnaire
Time frame: 3-month
Number of standard drinks consumed each day of typical week past month
Frequency of Binge Drinking
Time frame: 1-month
Number of times in past month engaged in heavy episodic drinking (4+ drinks for women, 5+ drinks for men)
Frequency of Binge Drinking
Time frame: 3-month
Number of times in past month engaged in heavy episodic drinking (4+ drinks for women, 5+ drinks for men)
Estimated Blood Alcohol Concentration (eBAC)
Time frame: 1-month
estimated peak blood alcohol concentration
Estimated Blood Alcohol Concentration (eBAC)
Time frame: 3-month
estimated peak blood alcohol concentration
Brief Young Adult Alcohol Consequences Questionnaire
Time frame: 1-month
Number of alcohol-related consequences endorsed
Brief Young Adult Alcohol Consequences Questionnaire
Time frame: 3-month
Number of alcohol-related consequences endorsed
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 9 Aug 2019.
- Individual participant dataSharing planned: Yes. We plan to share limited datasets for the purposes of data analysis and dissemination.
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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.
Christine M Lee, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BASICCS in people with Alcohol; Use, Problem, run by University of Washington 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 1 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 9 Aug 2019. 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. 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?
Daily Drinking Questionnaire (time frame: 1-month). The study lists 8 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 9 Aug 2019.