College Student DrinkingPhase 1/2NCT03440463
Alcohol Health Education With Personalized Feedback Boosters
A Phase 1/2 study testing e-checkup to go, Norms-only booster and Norms-plus-Strategies booster in people with College Student Drinking, run by Abby Braitman at 1 site in United States.
Trial summary
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). 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?
- e-checkup to go, Norms-only booster and Norms-plus-Strategies booster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 528 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2017to 4 Apr 2018
- Phase
- Phase 1/2
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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).
- Conditions
- College Student Drinking
- Being tested
- e-checkup to go, Norms-only booster, Norms-plus-Strategies booster
- 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.
e-checkup to goBehavioural
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.
Norms-only boosterBehavioural
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.
Norms-plus-Strategies boosterBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention-only Control | Placebo comparator | 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. Receives: Behavioral: e-checkup to go |
| Intervention plus Norms-only booster | Experimental | 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. Receives: Behavioral: e-checkup to go; Behavioral: Norms-only booster |
| Intervention plus Norms-plus-Strategies booster | Experimental | 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. Receives: Behavioral: e-checkup to go; Behavioral: Norms-plus-Strategies booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Consumption at 3 Months Post-intervention
Participant self-reported number of standard drinks consumed by participant in a typical week.
Measured: Past 30 days (3 months post-intervention)
Secondary outcomes (1)
Alcohol-related Consequences 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
Measured: Past 30 days (3 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start11 Apr 2017
- Primary completion4 Apr 2018
- Study completion4 Apr 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 528 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
- NCT03440463
- Sponsor's protocol ID
- 14-221
- Other IDs
- K01AA023849
- Status last verified
- May 2023
- First submitted
- 14 Feb 2018
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Braitman AL, Strowger M, Lau-Barraco C, Shipley JL, Kelley ML, Carey KB. Examining the added value of harm reduction strategies to emailed boosters to extend the effects of online interventions for college drinkers. Psychol Addict Behav. 2022 Sep;36(6):635-647. doi: 10.1037/adb0000755. Epub 2021 Jun 3.
PubMed 34081487
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Health Education With Personalized Feedback Boosters
- ClinicalTrials.gov ID
- NCT03440463
- Acronym / sponsor ID
- 14-221
- Conditions
- College Student Drinking
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- Abby BraitmanUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention-only Control | Placebo comparator | Behavioral: e-checkup to goParticipants 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. |
| Intervention plus Norms-only booster | Experimental | Behavioral: e-checkup to go, Behavioral: Norms-only boosterParticipants 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. |
| Intervention plus Norms-plus-Strategies booster | Experimental | Behavioral: e-checkup to go, Behavioral: Norms-plus-Strategies boosterParticipants 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. |
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 |
|---|---|---|
| e-checkup to goThe 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. | Behavioural | Intervention plus Norms-only booster, Intervention plus Norms-plus-Strategies booster, Intervention-only Control |
| Norms-only boosterBooster 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. | Behavioural | Intervention plus Norms-only booster |
| Norms-plus-Strategies boosterBooster 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. | Behavioural | Intervention plus Norms-plus-Strategies booster |
Primary outcome
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.
1 secondary outcome
Alcohol-related Consequences 3 Months Post-intervention
Time frame: Past 30 days (3 months post-intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34081487Braitman AL, Strowger M, Lau-Barraco C, Shipley JL, Kelley ML, Carey KB. Examining the added value of harm reduction strategies to emailed boosters to extend the effects of online interventions for college drinkers. Psychol Addict Behav. 2022 Sep;36(6):635-647. doi: 10.1037/adb0000755. Epub 2021 Jun 3.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing e-checkup to go, Norms-only booster and Norms-plus-Strategies booster in people with College Student Drinking, run by Abby Braitman at 1 site in United States.
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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 22 Jun 2023). 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 at 3 Months Post-intervention (time frame: Past 30 days (3 months post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03440463, which also lists 1 linked publication.
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 22 Jun 2023.