College Student DrinkingPhase 1/2NCT03440476
Personalized Booster Feedback After Alcohol Health Education
A Phase 1/2 study testing e-checkup to go, Feedback-only booster and Feedback-plus-personal-contact 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, Feedback-only booster and Feedback-plus-personal-contact booster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2018to 30 Mar 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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.
Read more
The current project seeks to build on past progress by further developing and refining the booster. In particular, one aspect missing from online interventions is a connection with a person invested in improving the student's outcomes. The current study aims to generate a personal connection for online interventions through a follow-up booster emailed by a member of the research staff. Outcomes will be compared for participants who receive a follow-up booster with similar content, but is clearly automatically generated and not from any particular individual.
There are 3 conditions: all participants receive the initial online intervention targeting college drinking. Condition 1 (the control group) receives an email with a reminder to complete the follow-up surveys, but no feedback (i.e., no booster). Condition 2 receives an emailed booster with normative feedback plus protective strategies feedback, clearly automatically generated. Condition 3 receives an emailed booster with normative feedback plus protective strategies feedback, from a member of the research staff. The booster content alone (automatically generated) may be efficacious, or the additional personal connection may enhance the effect.
Thus, the aim of the current study is to examine if personal contact enhances the tailored feedback received via booster email.
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.
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 particular, one aspect missing from online interventions is a connection with a person invested in improving the student's outcomes. The current study aims to generate a personal connection for online interventions through a follow-up booster emailed by a member of the research staff. Outcomes will be compared for participants who receive a follow-up booster with similar content, but is clearly automatically generated and not from any particular individual.
There are 3 conditions: all participants receive the initial online intervention targeting college drinking. Condition 1 (the control group) receives an email with a reminder to complete the follow-up surveys, but no feedback (i.e., no booster). Condition 2 receives an emailed booster with normative feedback plus protective strategies feedback, clearly automatically generated. Condition 3 receives an emailed booster with normative feedback plus protective strategies feedback, from a member of the research staff. The booster content alone (automatically generated) may be efficacious, or the additional personal connection may enhance the effect.
Thus, the aim of the current study is to examine if personal contact enhances the tailored feedback received via booster email.
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 from an individual rather than automatically generated.
- Conditions
- College Student Drinking
- Being tested
- e-checkup to go, Feedback-only booster, Feedback-plus-personal-contact 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.
Feedback-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 reminders of strategies they can use to protect themselves from alcohol-related harm. The content is clearly automatically generated.
Feedback-plus-personal-contact 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 reminders of strategies they can use to protect themselves from alcohol-related harm. The email is sent from an individual on the research staff.
| 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 feedback booster | Active comparator | Participants navigate through e-checkup to go, the well-established alcohol intervention, then receives the Feedback-only booster. 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, their own use, and harm reduction strategies. The content is clearly automatically generated. Receives: Behavioral: e-checkup to go; Behavioral: Feedback-only booster |
| Intervention plus feedback and personal contact booster | Active comparator | Participants navigate through e-checkup to go, the well-established alcohol intervention, then receives the Feedback-plus-personal-contact booster. 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, their own use, and harm reduction strategies. The email is sent from a member of the research staff. Receives: Behavioral: e-checkup to go; Behavioral: Feedback-plus-personal-contact 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
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
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 start19 Feb 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 249 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
- NCT03440476
- Sponsor's protocol ID
- 17-267
- Other IDs
- K01AA023849
- Status last verified
- Jun 2022
- First submitted
- 14 Feb 2018
- Last updated
- 30 Jun 2022
- Results posted
- No
- 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 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Booster Feedback After Alcohol Health Education
- ClinicalTrials.gov ID
- NCT03440476
- Acronym / sponsor ID
- 17-267
- Conditions
- College Student Drinking
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Abby BraitmanUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
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.
The current project seeks to build on past progress by further developing and refining the booster. In particular, one aspect missing from online interventions is a connection with a person invested in improving the student's outcomes. The current study aims to generate a personal connection for online interventions through a follow-up booster emailed by a member of the research staff. Outcomes will be compared for participants who receive a follow-up booster with similar content, but is clearly automatically generated and not from any particular individual.
There are 3 conditions: all participants receive the initial online intervention targeting college drinking. Condition 1 (the control group) receives an email with a reminder to complete the follow-up surveys, but no feedback (i.e., no booster). Condition 2 receives an emailed booster with normative feedback plus protective strategies feedback, clearly automatically generated. Condition 3 receives an emailed booster with normative feedback plus protective strategies feedback, from a member of the research staff. The booster content alone (automatically generated) may be efficacious, or the additional personal connection may enhance the effect.
Thus, the aim of the current study is to examine if personal contact enhances the tailored feedback received via booster email.
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.
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 particular, one aspect missing from online interventions is a connection with a person invested in improving the student's outcomes. The current study aims to generate a personal connection for online interventions through a follow-up booster emailed by a member of the research staff. Outcomes will be compared for participants who receive a follow-up booster with similar content, but is clearly automatically generated and not from any particular individual.
There are 3 conditions: all participants receive the initial online intervention targeting college drinking. Condition 1 (the control group) receives an email with a reminder to complete the follow-up surveys, but no feedback (i.e., no booster). Condition 2 receives an emailed booster with normative feedback plus protective strategies feedback, clearly automatically generated. Condition 3 receives an emailed booster with normative feedback plus protective strategies feedback, from a member of the research staff. The booster content alone (automatically generated) may be efficacious, or the additional personal connection may enhance the effect.
Thus, the aim of the current study is to examine if personal contact enhances the tailored feedback received via booster email.
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 from an individual rather than automatically generated.
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 feedback booster | Active comparator | Behavioral: e-checkup to go, Behavioral: Feedback-only boosterParticipants navigate through e-checkup to go, the well-established alcohol intervention, then receives the Feedback-only booster. 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, their own use, and harm reduction strategies. The content is clearly automatically generated. |
| Intervention plus feedback and personal contact booster | Active comparator | Behavioral: e-checkup to go, Behavioral: Feedback-plus-personal-contact boosterParticipants navigate through e-checkup to go, the well-established alcohol intervention, then receives the Feedback-plus-personal-contact booster. 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, their own use, and harm reduction strategies. The email is sent from a member of the research staff. |
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 feedback and personal contact booster, Intervention plus feedback booster, Intervention-only Control |
| Feedback-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 reminders of strategies they can use to protect themselves from alcohol-related harm. The content is clearly automatically generated. | Behavioural | Intervention plus feedback booster |
| Feedback-plus-personal-contact 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 reminders of strategies they can use to protect themselves from alcohol-related harm. The email is sent from an individual on the research staff. | Behavioural | Intervention plus feedback and personal contact booster |
Primary outcome
Alcohol consumption
Time frame: Past 2 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- 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, Feedback-only booster and Feedback-plus-personal-contact 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 30 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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). 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 30 Jun 2022.