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| ID | Type | Description | Link |
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| F32AA021310 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol 101 Plus (TM) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Consumption | Participant self-reported number of standard drinks consumed by participant over the past 2 weeks | Past 2 weeks, reported at Baseline assessment (pre-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Past 2 weeks, reported at Baseline assessment (pre-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abby L Braitman, Ph.D. | Old Dominion University | Principal Investigator |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
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| Baseline |
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| 2-Week Assessment |
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| 9-Month Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol Consumption | Participant self-reported number of standard drinks consumed by participant over the past 2 weeks | Posted | Mean | Standard Deviation | drinks | Past 2 weeks, reported at Baseline assessment (pre-intervention) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
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| Dr. Abby Braitman | Old Dominion University | 757-683-3708 | abraitma@odu.edu |
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| ID | Term |
|---|---|
| D000067292 | Alcohol Drinking in College |
| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D007117 | Immunization, Secondary |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D007114 | Immunization |
| D007167 | Immunotherapy |
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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.
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| Booster | Behavioral | 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). |
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| Lilly for Better Health | Behavioral | 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. |
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| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
| OG002 | 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. |
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| 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). | Posted | Mean | Standard Deviation | problems | Past 2 weeks, reported at Baseline assessment (pre-intervention) |
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| 0 |
| 183 |
| 0 |
| 183 |
| 0 |
| 183 |
| EG001 | 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. | 0 | 173 | 0 | 173 | 0 | 173 |
| EG002 | 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. | 0 | 181 | 0 | 181 | 0 | 181 |
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| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |