CClinicalTrials.gg
CompletedNCT04453007TIMEUpdated May 3, 2023

Timing Personalized Feedback After Alcohol Health Education

A Phase 1/2 interventional study of e-checkup to go and Feedback 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 2023-05-03.

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

Phase
Phase 1/2
Study type
Interventional
Enrollment
195
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

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). A second randomized, controlled trial confirmed efficacy for students of legal drinking age for a longer timeline (Braitman \& Lau-Barraco, 2018). 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, to identify the most efficacious timing for sending the feedback. The content will be similar across conditions, but will be disseminated at different times to identify the most impactful timeline. There will be 6 study conditions: those who receive the emailed feedback 2, 6, 10, or 14 weeks after baseline, or at all of those times, or not at all (control). Thus, the aim of the current study is to identify optimal timing for sending the tailored booster feedback via booster email.

02

Conditions studied

  • College Student Drinking
03

Who can participate

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

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
04

Study design

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

Study arms

  • Placebo comparator
    Intervention-only Control

    Participants navigate through e-checkup to go, the well-established alcohol intervention. Any follow-up emails sent to them later contain only a reminder to participate in follow-up surveys.

    Behavioral: e-checkup to go

  • Active comparator
    Intervention plus 2-week feedback booster

    Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the feedback booster email 2 weeks later. It 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.

    Behavioral: e-checkup to go · Behavioral: Feedback booster

  • Active comparator
    Intervention plus 6-week feedback booster

    Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the feedback booster email 6 weeks later. It 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.

    Behavioral: e-checkup to go · Behavioral: Feedback booster

  • Active comparator
    Intervention plus 10-week feedback booster

    Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the feedback booster email 10 weeks later. It 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.

    Behavioral: e-checkup to go · Behavioral: Feedback booster

  • Active comparator
    Intervention plus 14-week feedback booster

    Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the feedback booster email 14 weeks later. It 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.

    Behavioral: e-checkup to go · Behavioral: Feedback booster

  • Active comparator
    Intervention plus repeated feedback boosters

    Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the multiple feedback booster emails, 2, 6, 10, and 14 weeks later. Each time, the email 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.

    Behavioral: e-checkup to go · Behavioral: Feedback booster

Interventions

  • Behaviorale-checkup to go

    The e-checkup to go alcohol program is designed to motivate individuals to reduce their alcohol 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.

  • BehavioralFeedback 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 reminders of strategies they can use to protect themselves from alcohol-related harm.

05

What researchers measure

Primary outcomes

  1. Alcohol Consumption

    Participant self-reported number of standard drinks consumed by participant over a typical week for the past 30 days.

    Time frame: past 30 days

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).

    Time frame: past 30 days

06

Study locations

1 site
  • Old Dominion University
    Norfolk, Virginia 23529, United States
07

References and documents

Publications

  • Braitman AL, Lau-Barraco C. Personalized Boosters After a Computerized Intervention Targeting College Drinking: A Randomized Controlled Trial. Alcohol Clin Exp Res. 2018 Sep;42(9):1735-1747. doi: 10.1111/acer.13815. Epub 2018 Jul 11. PubMed 29995326 ↗
  • Braitman AL, Henson JM. Personalized boosters for a computerized intervention targeting college drinking: The influence of protective behavioral strategies. J Am Coll Health. 2016 Oct;64(7):509-19. doi: 10.1080/07448481.2016.1185725. Epub 2016 May 5. PubMed 27148633 ↗

Study documents

  • Study protocol · Jun 23, 2022
  • Statistical analysis plan · Nov 13, 2020
  • Informed consent form · Mar 30, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04453007
Lead sponsor
Abby Braitman
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Abby Braitman (Assistant Professor, Old Dominion University) — Sponsor-investigator
First posted
Jul 1, 2020
Start date
Nov 30, 2020
Primary completion
Sep 12, 2022
Completion
Sep 12, 2022
Last update
May 3, 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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