College Student DrinkingPhase 1NCT03433794
Alcohol Health Education Among College Drinkers
A Phase 1 study testing Alcohol 101 Plus (TM), Booster and Lilly for Better Health in people with College Student Drinking, run by Abby Braitman.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- College Student Drinking
- What is being tested?
- Alcohol 101 Plus (TM), Booster and Lilly for Better Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 537 participants
- Where
- No sites listed yet
- Study dates
- 29 Jan 2013to 10 Sep 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Under age of 18
- Over age of 24
- Not a college student
- Did not drink alcohol in the past 2 weeks
About this study
Official title: Alcohol Health Education
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:
Read more
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.
Read the 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.
- Conditions
- College Student Drinking
- Being tested
- Alcohol 101 Plus (TM), Booster, Lilly for Better Health
- Medical subject headings
- Alcohol Drinking in College
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol 101 Plus (TM)Behavioural
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.
BoosterBehavioural
Also called Personalized Normative Feedback
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).
Lilly for Better HealthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 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. Receives: Behavioral: Lilly for Better Health |
| Intervention Only | Active comparator | Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. This is an online intervention, free to institutions and individuals. 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 basic information such as sex, weight, and state of residence so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. Receives: Behavioral: Alcohol 101 Plus (TM) |
| Intervention-plus-Booster | Experimental | Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. This is an online intervention, free to institutions and individuals. 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 basic information such as sex, weight, and state of residence so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. 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. Receives: Behavioral: Alcohol 101 Plus (TM); Behavioral: Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Consumption
Participant self-reported number of standard drinks consumed by participant over the past 2 weeks
Measured: Past 2 weeks, reported at Baseline assessment (pre-intervention)
Secondary outcomes (1)
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).
Measured: Past 2 weeks, reported at Baseline assessment (pre-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start29 Jan 2013
- Primary completion10 Sep 2014
- Study completion10 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for College Student DrinkingStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abby Braitman
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Abby Braitman, Old Dominion University
- Investigators
- Abby L Braitman, Ph.D., Principal investigator, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433794
- Sponsor's protocol ID
- 12-194
- Other IDs
- F32AA021310
- Status last verified
- Nov 2020
- First submitted
- 8 Feb 2018
- Last updated
- 1 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Health Education
- ClinicalTrials.gov ID
- NCT03433794
- Acronym / sponsor ID
- 12-194
- Conditions
- College Student Drinking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- Abby BraitmanUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 29 Jan 2013 (actual)
- Primary completion
- 10 Sep 2014 (actual)
- Study completion
- 10 Sep 2014 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Posted 10 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Lilly for Better HealthThe 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. |
| Intervention Only | Active comparator | Behavioral: Alcohol 101 Plus (TM)Participants navigated through Alcohol 101 Plus (TM) for 60 minutes. This is an online intervention, free to institutions and individuals. 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 basic information such as sex, weight, and state of residence so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. Their email 2 weeks later contained only a reminder to participate in follow-up surveys. |
| Intervention-plus-Booster | Experimental | Behavioral: Alcohol 101 Plus (TM), Behavioral: BoosterParticipants navigated through Alcohol 101 Plus (TM) for 60 minutes. This is an online intervention, free to institutions and individuals. 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 basic information such as sex, weight, and state of residence so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Under age of 18
- Over age of 24
- Not a college student
- Did not drink alcohol in the past 2 weeks
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 |
|---|---|---|
| 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. | Behavioural | Intervention Only, Intervention-plus-Booster |
| BoosterAlso: Personalized Normative FeedbackPersonalized 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). | Behavioural | Intervention-plus-Booster |
| Lilly for Better HealthThis 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. | Behavioural | Control |
Primary outcome
Alcohol Consumption
Time frame: Past 2 weeks, reported at Baseline assessment (pre-intervention)
Participant self-reported number of standard drinks consumed by participant over the past 2 weeks
1 secondary outcome
Alcohol-related Consequences
Time frame: Past 2 weeks, reported at Baseline assessment (pre-intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Abby L Braitman, Ph.D. principal investigator
Old Dominion University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alcohol 101 Plus (TM), Booster and Lilly for Better Health in people with College Student Drinking, run by Abby Braitman.
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 3 inclusion and 4 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 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Alcohol Consumption (time frame: Past 2 weeks, reported at Baseline assessment (pre-intervention)). 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 1 Dec 2020.