- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03440463
Alcohol Health Education With Personalized Feedback Boosters
Heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. Negative consequences from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g., assault, even death). Although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment.
In a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention (Braitman & Henson, 2016). Although promising, the booster incorporated in the study needs further empirical refinement. In addition, the intervention originally tested (Alcohol 101 Plus) is no longer widely available.
The current project seeks to build on past progress by further developing and refining the booster. In addition, it examines the utility of the booster after a different, widely-used, empirically-supported online intervention (e-checkup to go). e-checkup to go directly provides personalized normative feedback, but not protective strategies, the two components of the examined booster. Hence, the current study compares the reinforcing content (normative feedback) to the combination of reinforcing and novel content (norms PLUS protective strategies). There are 3 conditions: all participants receive the initial online intervention targeting college drinking. Condition 1 does not receive a booster email. Condition 2 receives an emailed booster with normative feedback only. Condition 3 receives an emailed booster with normative feedback plus protective strategies. The aims of the current study are as follows:
Aim 1: Examine if novel feedback in the form of protective strategies enhances the reinforcing normative feedback received via booster email (i.e., a comparison of reinforcing normative feedback only versus reinforcing normative feedback plus novel protective strategy feedback).
Aim 2: Examine previously identified potential moderators and mediators of reductions in alcohol use and related problems.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. Negative consequences from frequent or heavy alcohol use can be mild (e.g., hangovers, missed classes), moderate (e.g., poor grades, damaged relationships), or severe (e.g., assault, even death). Given the potentially dangerous consequences, reducing alcohol use and associated problems is a major health priority. Although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. The benefits of online interventions include cost-effectiveness and ease of administration, plus they offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment.
Although post-intervention boosters have been shown to be effective for individuals seeking treatment for alcohol-related injuries in emergency medical settings, limited studies have investigated the efficacy of boosters for college students who have received alcohol interventions. In a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention, while at the same time maintaining low cost and easy dissemination (Braitman & Henson, 2016). Although promising, the booster incorporated in the study needs further empirical refinement. In addition, the intervention originally tested (Alcohol 101 Plus) is no longer widely available.
The current project seeks to build on past progress reducing the gap between online and more efficacious in-person interventions. The current study further develops and refines the booster to identify optimal administration for maximum efficacy. In addition, it examines the utility of the booster after a different, widely-used, empirically-supported online intervention (e-checkup to go). The new intervention (e-checkup to go) directly provides personalized normative feedback, but not protective strategies, the two components of the examined booster. Hence, the current study compares the reinforcing content (personalized normative feedback) to the combination of reinforcing and enhancing/novel content (norms PLUS protective strategies). This addresses a major question of the relatively new booster literature for college drinking regarding if reinforcing content is sufficient to boost efficacy versus if novel information is an important supplementary component. There are 3 conditions: all participants receive the initial online intervention targeting college drinking. Condition 1 does not receive a booster email. Condition 2 receives an emailed booster with normative feedback only. Condition 3 receives an emailed booster with normative feedback plus protective strategies feedback. The booster content of tailored norms alone (reinforcing content) may alone be efficacious, or receiving tailored norms and strategies students can use to reduce consumption and related harm (protective behavioral strategies; novel content) may enhance the effect.
Thus, the aims of the current study are as follows:
Aim 1: Examine if novel feedback in the form of protective strategies enhances the reinforcing tailored normative feedback received via booster email (i.e., a comparison of reinforcing normative feedback only versus reinforcing normative feedback plus novel protective strategy feedback).
Hypothesis 1a: Both groups receiving emailed feedback will reduce drinking and alcohol-related problems as compared to the intervention-only control condition.
Hypothesis 1b: Reductions in drinking and problems will be stronger for those who receive emails with novel protective strategy feedback rather than reinforcing norms alone.
Aim 2: Examine previously identified potential moderators and mediators of reductions in alcohol use and related problems (i.e., gender, norms, strategies).
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Virginia
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Norfolk, Virginia, United States, 23529
- Old Dominion University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Intervention-only Control
Participants navigate through e-checkup to go, the well-established alcohol intervention.
Their email 2 weeks later contains only a reminder to participate in follow-up surveys.
|
The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors.
The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training.
It is self-guided and requires no face-to-face time with an administrator.
It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
|
Experimental: Intervention plus Norms-only booster
Participants navigate through e-checkup to go, the well-established alcohol intervention.
Their email 2 weeks later contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and their own use.
|
The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors.
The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training.
It is self-guided and requires no face-to-face time with an administrator.
It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and how they compare.
|
Experimental: Intervention plus Norms-plus-Strategies booster
Participants navigate through e-checkup to go, the well-established alcohol intervention.
Their email 2 weeks later contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant reported perceived alcohol norms, actual alcohol norms, and their own use.
It also includes reported harm reduction strategies, and other strategies they might consider.
|
The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors.
The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training.
It is self-guided and requires no face-to-face time with an administrator.
It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and how they compare.
These booster emails will also contain reminders of strategies they can use to protect themselves from alcohol-related harm, both ones they've reported using in the past and others they might consider using in the future.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Consumption at 3 Months Post-intervention
Time Frame: Past 30 days (3 months post-intervention)
|
Participant self-reported number of standard drinks consumed by participant in a typical week.
|
Past 30 days (3 months post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol-related Consequences 3 Months Post-intervention
Time Frame: Past 30 days (3 months post-intervention)
|
Assessed via the "Young Adult Alcohol Consequences Questionnaire" (Read et al., 2006). Participants indicate if they experienced an alcohol-related problem with a yes (=1) or no (=0). Scores are created by summing across all 48 items (range 0 to 48), where higher scores indicate experiencing more alcohol-related consequences/problems. Read, J. P., Kahler, C. W., Strong, D. R., & Colder, C. R. (2006). Development and preliminary validation of the young adult alcohol consequences questionnaire. Journal of Studies on Alcohol, 67, 169-177. doi:10.15288/jsa.2006.67.169 |
Past 30 days (3 months post-intervention)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abby L Braitman, Ph.D., Old Dominion University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-221 (Ethics committee of the University of Cologne)
- K01AA023849 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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