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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04052386
Other study ID # 50262
Secondary ID R34AA023047
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2017
Est. completion date June 26, 2017

Study information

Verified date August 2019
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 142
Est. completion date June 26, 2017
Est. primary completion date June 26, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 29 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Daily Drinking Questionnaire Number of standard drinks consumed each day of typical week past month 1-month
Primary Daily Drinking Questionnaire Number of standard drinks consumed each day of typical week past month 3-month
Primary Frequency of Binge Drinking Number of times in past month engaged in heavy episodic drinking (4+ drinks for women, 5+ drinks for men) 1-month
Primary Frequency of Binge Drinking Number of times in past month engaged in heavy episodic drinking (4+ drinks for women, 5+ drinks for men) 3-month
Primary Estimated Blood Alcohol Concentration (eBAC) estimated peak blood alcohol concentration 1-month
Primary Estimated Blood Alcohol Concentration (eBAC) estimated peak blood alcohol concentration 3-month
Primary Brief Young Adult Alcohol Consequences Questionnaire Number of alcohol-related consequences endorsed 1-month
Primary Brief Young Adult Alcohol Consequences Questionnaire Number of alcohol-related consequences endorsed 3-month
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