ClinicalTrials.gg
CompletedNCT03440463Updated Jun 22, 2023Results posted

Alcohol Health Education With Personalized Feedback Boosters

A Phase 1/2 interventional study of e-checkup to go and Norms-only booster in College Student Drinking, sponsored by Abby Braitman. Completed at 1 site in United States. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Abby Braitman · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Apr 2017, registered Feb 2018).

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Phase
Phase 1/2
Study type
Interventional
Enrollment
528
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 31 studies in Alcohol Drinking in College with a site in United States — 8 open to participants now, 9 under way, none of them phase 3. Alcohol Drinking in College · United States.

Enrollment
11th of 31
528 · median 266
Started
2017
with 1 other
Phase 1/2
4 of 31
none open now
Registered
3rd of 31
by date
Lead sponsor
4 of 31
Abby Braitman

Among the 31 studies in Alcohol Drinking in College with a site in United States, this one is the 11th largest by enrollment, is one of 2 that started in 2017, is one of 4 in phase 1/2, and was the 3rd registered.

Alcohol Drinking in College

38 studies on the registry are indexed under Alcohol Drinking in College; 8 are open to participants now.

Browse Alcohol Drinking in College studies →

Open to participants now

8 of the 31 studies in Alcohol Drinking in College with a site in United States are open now. Recruiting first, the newest first:

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All 8 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 5 Alcohol Drinking in College studies recruiting now, 1 sets no upper age limit and 4 stop at 75 or younger; none take children under 18; 5 take healthy volunteers.

This study: 18 Years to 24 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 31 studies in Alcohol Drinking in College with a site in United States, or all of them as a file.
02

Study 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). 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.

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).

03

Conditions studied

  • College Student Drinking
04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Under age of 18
  • Over age of 24
  • Not a college student
  • Did not drink alcohol in the past 2 weeks
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
528 participants (actual)

Study arms

  • 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.

    Behavioral: e-checkup to go

  • 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.

    Behavioral: e-checkup to go · Behavioral: Norms-only booster

  • 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.

    Behavioral: e-checkup to go · Behavioral: Norms-plus-Strategies booster

Interventions

  • Behaviorale-checkup to go

    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.

  • BehavioralNorms-only booster

    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.

  • BehavioralNorms-plus-Strategies booster

    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.

06

What researchers measure

Primary outcomes

  1. Alcohol Consumption at 3 Months Post-intervention

    Participant self-reported number of standard drinks consumed by participant in a typical week.

    Time frame: 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

    Time frame: Past 30 days (3 months post-intervention)

07

Results

Posted Jun 22, 2023

Participant flow

Baseline
Participant flow — Baseline
MilestoneIntervention-only ControlIntervention Plus Norms-only BoosterIntervention Plus Norms-plus-Strategies Booster
Started201163164
Completed201163164
Not completed000
1-month Follow-up
Participant flow — 1-month Follow-up
MilestoneIntervention-only ControlIntervention Plus Norms-only BoosterIntervention Plus Norms-plus-Strategies Booster
Started201163164
Completed134113107
Not completed675057
3-month Follow-up
Participant flow — 3-month Follow-up
MilestoneIntervention-only ControlIntervention Plus Norms-only BoosterIntervention Plus Norms-plus-Strategies Booster
Started201163164
Completed1178996
Not completed847468

Outcome measures

PrimaryAlcohol Consumption at 3 Months Post-intervention

Participant self-reported number of standard drinks consumed by participant in a typical week.

Time frame:
Past 30 days (3 months post-intervention)
Reported as:
Mean · drinks per week
Alcohol Consumption at 3 Months Post-intervention
drinks per weekIntervention-only ControlIntervention Plus Norms-only BoosterIntervention Plus Norms-plus-Strategies Booster
Alcohol Consumption at 3 Months Post-intervention4.08 ± 5.814.15 ± 5.714.89 ± 7.68
SecondaryAlcohol-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

Time frame:
Past 30 days (3 months post-intervention)
Reported as:
Mean · score on a scale
Alcohol-related Consequences 3 Months Post-intervention
score on a scaleIntervention-only ControlIntervention Plus Norms-only BoosterIntervention Plus Norms-plus-Strategies Booster
Alcohol-related Consequences 3 Months Post-intervention3.27 ± 5.682.37 ± 3.732.67 ± 4.11

Adverse events

Collected over 3 months post-intervention. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention-only Control0/201 (0%)0/201 (0%)0/201 (0%)
Intervention Plus Norms-only Booster0/163 (0%)0/163 (0%)0/163 (0%)
Intervention Plus Norms-plus-Strategies Booster0/164 (0%)0/164 (0%)0/164 (0%)

Baseline characteristics

Participants were students enrolled at a large, southeastern public university. To be eligible, participants must have been between the ages of 18-24, and consumed at least one alcoholic beverage in the previous 2 weeks.

Age, Continuous
Age, Continuous(years)Intervention-only ControlIntervention Plus Norms-only BoosterIntervention Plus Norms-plus-Strategies BoosterTotal
Mean19.80 ± 1.6619.75 ± 1.5320.02 ± 1.7419.85 ± 1.65
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Intervention-only ControlIntervention Plus Norms-only BoosterIntervention Plus Norms-plus-Strategies BoosterTotal
Male514751149
Female150115113378
Other0101
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Intervention-only ControlIntervention Plus Norms-only BoosterIntervention Plus Norms-plus-Strategies BoosterTotal
Hispanic or Latino176146145467
Not Hispanic or Latino25171658
Unknown or Not Reported0033
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention-only ControlIntervention Plus Norms-only BoosterIntervention Plus Norms-plus-Strategies BoosterTotal
American Indian or Alaska Native0000
Asian177933
Native Hawaiian or Other Pacific Islander0000
Black or African American807677233
White675049166
More than one race20251863
Unknown or Not Reported1751133
Drinks per typical week (quantity)
Drinks per typical week (quantity)(drinks per week)Intervention-only ControlIntervention Plus Norms-only BoosterIntervention Plus Norms-plus-Strategies BoosterTotal
Mean8.18 ± 8.416.72 ± 7.148.05 ± 10.327.69 ± 8.71
Drinking days per typical week (frequency)
Drinking days per typical week (frequency)(drinking days per week)Intervention-only ControlIntervention Plus Norms-only BoosterIntervention Plus Norms-plus-Strategies BoosterTotal
Mean2.24 ± 1.251.96 ± 1.132.23 ± 1.322.15 ± 1.24
Highest drinking occasion in a typical week (peak)
Highest drinking occasion in a typical week (peak)(drinks per day)Intervention-only ControlIntervention Plus Norms-only BoosterIntervention Plus Norms-plus-Strategies BoosterTotal
Mean4.01 ± 2.983.48 ± 2.553.71 ± 3.203.76 ± 2.93
Alcohol-related consequences (problems)
Alcohol-related consequences (problems)(score on a scale)Intervention-only ControlIntervention Plus Norms-only BoosterIntervention Plus Norms-plus-Strategies BoosterTotal
Mean6.21 ± 6.596.07 ± 7.056.28 ± 7.176.19 ± 6.91
08

Study locations

1 site
  • Old Dominion University
    Norfolk, Virginia 23529, United States
09

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2017 to primary completion in Apr 2018, 11 months.

Results were first posted in Jun 2023, 5 years 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2018
First posted
Feb 22, 2018
StartActual
Apr 11, 2017
Primary completionActual
Apr 4, 2018
CompletionActual
Apr 4, 2018
Results first posted
Jun 22, 2023
Last update
Jun 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03440463
Lead sponsor
Abby Braitman
Responsible party
Abby Braitman (Research Assistant Professor, Old Dominion University) — Sponsor-investigator
First posted
Feb 22, 2018
Start date
Apr 11, 2017
Primary completion
Apr 4, 2018
Completion
Apr 4, 2018
Results posted
Jun 22, 2023
Last update
Jun 22, 2023

Study contacts

Abby L Braitman, Ph.D.
principal investigator · Old Dominion University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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