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Alcohol Health Education Among College Drinkers

Alcohol Health Education

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03433794
Enrollment
537
Registered
2018-02-15
Start date
2013-01-29
Completion date
2014-09-10
Last updated
2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

College Student Drinking

Brief summary

Alcohol use among college students is both widespread and problematic. There are many negative consequences associated with frequent alcohol use, ranging from mild (e.g., hangovers, missed classes) to severe (e.g., assault, even death). Online interventions targeting alcohol use among college students reduce alcohol consumption and associated problems. These interventions are popular among colleges because they are relatively inexpensive and easily disseminated. However, online interventions are not as efficacious as face-to-face interventions, such as brief motivational interviews. The proposed project employs emailed boosters in a randomized, controlled trial in an effort to improve the efficacy an existing, popular, free online intervention, while at the same time maintaining low cost and easy dissemination. Adding boosters after interventions is a common technique to improve the efficacy of the original intervention. Boosters have been used successfully for alcohol use interventions among those seeking injury treatment in emergency medical settings. However, prior research has not supported booster efficacy for college student alcohol interventions. The current project develops and evaluates the effectiveness of boosters for a widely-used college student alcohol intervention. Specifically, the present project improves boosters by providing easy access via email; providing succinct, personalized feedback; and providing reminders of protective behavioral strategies. To test the effectiveness of adding boosters, participants randomized to alcohol-intervention-plus-boosters receive emails 2 weeks after the intervention with tailored feedback based upon their reported alcohol consumption. Participants are assessed up to nine months. The current research addresses the following specific aims: Aim 1: Improve the efficacy of an easily-disseminated computerized intervention by adding personalized follow-up boosters, where efficacy is evidenced by reduced drinking and negative alcohol-related consequences (i.e., stronger effect sizes in the booster group immediately after receiving the booster). Aim 2: Extend the duration of the reduction in drinking and associated problems through the use of these personalized follow-up boosters (i.e., significant differences between the booster and control groups at later timepoints). Aim 3: Examine protective behavioral strategies highlighted by the booster as mediating behavioral mechanisms of change.

Detailed description

Alcohol use within the college student population is both widespread and problematic. There are many negative consequences associated with frequent alcohol use, ranging from mild (e.g., hangovers, missed classes) to severe (e.g., assault, even death). College student alcohol use is a significant problem, and reducing consumption and associated problems is a priority among researchers, educators, and mental health professionals who work with this population. Online interventions targeting alcohol use among college students reduce alcohol consumption and associated problems. These interventions are popular among colleges because they are relatively inexpensive and easily disseminated. However, online interventions are not as efficacious as face-to-face interventions, such as brief motivational interviews. The current project employs emailed boosters in a randomized, controlled trial in an effort to improve the efficacy an existing, popular, free online intervention, Alcohol 101 Plus (TM), while at the same time maintaining low cost and easy dissemination. Adding boosters after interventions is a common technique to improve the efficacy of the original intervention. Boosters have improved the efficacy or effect duration for interventions targeting smoking cessation, mammograms, dating violence, caregiver skills, binge eating, and many other behaviors. Boosters have been used successfully for alcohol use interventions among those seeking injury treatment in emergency medical settings. Despite these successes, prior research has not supported booster efficacy for college student alcohol interventions. The current project develops and evaluates the effectiveness of boosters for a widely-used college student alcohol intervention by improving on the design of boosters. Specifically, the present project improves boosters by providing easy access via email to minimize burden; providing succinct, personalized feedback; and providing reminders of protective behavioral strategies. To test the effectiveness of adding boosters, participants randomized to the alcohol-intervention-plus-boosters condition receive emails 2 weeks after the intervention with tailored feedback based upon their reported alcohol consumption. Participants are initially assessed biweekly, then every three months up to nine months. The current research addresses the following specific aims: Aim 1: Improve the efficacy of an easily-disseminated computerized intervention by adding personalized follow-up boosters, where efficacy is evidenced by reduced drinking and negative alcohol-related consequences (i.e., stronger effect sizes in the booster group immediately after receiving the booster). Aim 2: Extend the duration of the reduction in drinking and associated problems through the use of these personalized follow-up boosters (i.e., significant differences between the booster and control groups at later timepoints after the significant differences between the intervention-only and control groups erode). Aim 3: Examine protective behavioral strategies highlighted by the booster as mediating behavioral mechanisms of change. 3A: Determine if increased exposure to protective strategies through an emailed booster results in increased use of these strategies. 3B: Determine if those who increase their use of protective behavioral strategies decrease their alcohol consumption and related problems they experience. 3C: Assess the combination of these two effects (i.e., the indirect effect). The proposed study will be a critical first step to adapt existing online interventions. The findings from this study will be used to identify implications for modifying the protocol or booster.

Interventions

BEHAVIORALAlcohol 101 Plus (TM)

It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.

BEHAVIORALBooster

Personalized feedback was emailed to participants. Content included sex-specific descriptive normative information (i.e., drinks per week typically consumed by males and females at the same institution), as well as reminders of harm reduction strategies (i.e., techniques the participant reported using in their last survey, versus techniques not used).

BEHAVIORALLilly for Better Health

This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Abby Braitman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The intervention is an online program, not an individual, so masking is not necessary. Similarly, the same online survey is deployed in all follow-up assessments regardless of condition, and data are not collected by individuals, so making is not necessary.

Eligibility

Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
No

Inclusion criteria

* Current college students at the sponsor institution at the time of enrollment * Between the ages of 18 and 24 * Consumed at least standard drink of alcohol in the past 2 weeks

Exclusion criteria

* Under age of 18 * Over age of 24 * Not a college student * Did not drink alcohol in the past 2 weeks

Design outcomes

Primary

MeasureTime frameDescription
Alcohol ConsumptionPast 2 weeks, reported at Baseline assessment (pre-intervention)Participant self-reported number of standard drinks consumed by participant over the past 2 weeks

Secondary

MeasureTime frameDescription
Alcohol-related ConsequencesPast 2 weeks, reported at Baseline assessment (pre-intervention)Participant self-report on the Young Adult Alcohol Consequences Questionnaire (YAACQ; Read, Kahler, Strong, & Colder, 2006), which assesses alcohol-related problems experienced by the participant. Total scores are created by summing all individual items, and range from 0 to 48, with higher values representing more problems experienced (i.e., worse outcomes).

Participant flow

Pre-assignment details

Participants read study description and eligibility criteria, and signed up to attend a baseline session. Upon joining the study and completing an informed consent document, they were randomly assigned to arm/group of the study. After completing the online survey, 26 individuals were identified as ineligible and not enrolled.

Participants by arm

ArmCount
Control
The control group spent 60 minutes on an online education session (Lilly for Better Health) directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. Lilly for Better Health: This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.
183
Intervention Only
Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. Alcohol 101 Plus (TM): It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.
173
Intervention-plus-Booster
Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. Importantly, their email 2 weeks later contained a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and reported harm reduction strategies. Alcohol 101 Plus (TM): It is a combination of several components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. Booster: Content included sex-specific descriptive normative information, as well as reminders of harm reduction strategies.
181
Total537

Baseline characteristics

CharacteristicControlIntervention OnlyIntervention-plus-BoosterTotal
Age, Continuous19.792 years
STANDARD_DEVIATION 1.779
19.792 years
STANDARD_DEVIATION 1.726
19.370 years
STANDARD_DEVIATION 1.476
19.650 years
STANDARD_DEVIATION 1.674
Race/Ethnicity, Customized
African-American or Black
74 Participants59 Participants68 Participants201 Participants
Race/Ethnicity, Customized
Asian or Pacific Islander
11 Participants8 Participants6 Participants25 Participants
Race/Ethnicity, Customized
Caucasian or White
82 Participants92 Participants88 Participants262 Participants
Race/Ethnicity, Customized
Hispanic
24 Participants18 Participants13 Participants55 Participants
Race/Ethnicity, Customized
Native American
1 Participants0 Participants3 Participants4 Participants
Race/Ethnicity, Customized
non-Hispanic
158 Participants154 Participants167 Participants479 Participants
Race/Ethnicity, Customized
Other
10 Participants10 Participants14 Participants34 Participants
Region of Enrollment
United States
183 participants173 participants181 participants537 participants
Sex: Female, Male
Female
122 Participants116 Participants124 Participants362 Participants
Sex: Female, Male
Male
61 Participants57 Participants57 Participants175 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1830 / 1730 / 181
other
Total, other adverse events
0 / 1830 / 1730 / 181
serious
Total, serious adverse events
0 / 1830 / 1730 / 181

Outcome results

Primary

Alcohol Consumption

Participant self-reported number of standard drinks consumed by participant over the past 2 weeks

Time frame: Past 2 weeks, reported at Baseline assessment (pre-intervention)

ArmMeasureValue (MEAN)Dispersion
ControlAlcohol Consumption16.929 drinksStandard Deviation 14.826
Intervention OnlyAlcohol Consumption17.988 drinksStandard Deviation 16.87
Intervention-plus-BoosterAlcohol Consumption18.039 drinksStandard Deviation 16.382
Secondary

Alcohol-related Consequences

Participant self-report on the Young Adult Alcohol Consequences Questionnaire (YAACQ; Read, Kahler, Strong, & Colder, 2006), which assesses alcohol-related problems experienced by the participant. Total scores are created by summing all individual items, and range from 0 to 48, with higher values representing more problems experienced (i.e., worse outcomes).

Time frame: Past 2 weeks, reported at Baseline assessment (pre-intervention)

ArmMeasureValue (MEAN)Dispersion
ControlAlcohol-related Consequences6.656 problemsStandard Deviation 5.566
Intervention OnlyAlcohol-related Consequences7.156 problemsStandard Deviation 6.066
Intervention-plus-BoosterAlcohol-related Consequences7.011 problemsStandard Deviation 6.367

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026