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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: BASICCS
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Daily Drinking Questionnaire
Time Frame: 1-month
Number of standard drinks consumed each day of typical week past month
1-month
Daily Drinking Questionnaire
Time Frame: 3-month
Number of standard drinks consumed each day of typical week past month
3-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)
1-month
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)
3-month
Estimated Blood Alcohol Concentration (eBAC)
Time Frame: 1-month
estimated peak blood alcohol concentration
1-month
Estimated Blood Alcohol Concentration (eBAC)
Time Frame: 3-month
estimated peak blood alcohol concentration
3-month
Brief Young Adult Alcohol Consequences Questionnaire
Time Frame: 1-month
Number of alcohol-related consequences endorsed
1-month
Brief Young Adult Alcohol Consequences Questionnaire
Time Frame: 3-month
Number of alcohol-related consequences endorsed
3-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 26, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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