NCT04453007

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2022

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

June 26, 2020

Last Update Submit

April 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alcohol Consumption

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

    past 30 days

Secondary Outcomes (1)

  • Alcohol-Related Consequences

    past 30 days

Study Arms (6)

Intervention-only Control

PLACEBO COMPARATOR

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

Intervention plus 2-week feedback booster

ACTIVE COMPARATOR

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 goBehavioral: Feedback booster

Intervention plus 6-week feedback booster

ACTIVE COMPARATOR

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 goBehavioral: Feedback booster

Intervention plus 10-week feedback booster

ACTIVE COMPARATOR

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 goBehavioral: Feedback booster

Intervention plus 14-week feedback booster

ACTIVE COMPARATOR

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 goBehavioral: Feedback booster

Intervention plus repeated feedback boosters

ACTIVE COMPARATOR

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 goBehavioral: Feedback booster

Interventions

e-checkup to goBEHAVIORAL

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.

Intervention plus 10-week feedback boosterIntervention plus 14-week feedback boosterIntervention plus 2-week feedback boosterIntervention plus 6-week feedback boosterIntervention plus repeated feedback boostersIntervention-only Control

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.

Intervention plus 10-week feedback boosterIntervention plus 14-week feedback boosterIntervention plus 2-week feedback boosterIntervention plus 6-week feedback boosterIntervention plus repeated feedback boosters

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Old Dominion University

Norfolk, Virginia, 23529, United States

Location

Related Publications (2)

  • 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.

    PMID: 29995326BACKGROUND
  • 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.

    PMID: 27148633BACKGROUND

MeSH Terms

Conditions

Alcohol Drinking in College

Condition Hierarchy (Ancestors)

Alcohol DrinkingDrinking BehaviorBehavior

Study Officials

  • Abby L Braitman, Ph.D.

    Old Dominion University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The intervention is an online program, not an individual administering it, so masking is not necessary. Similarly, the same online survey is deployed in all follow-up assessments regardless of condition, and data are not collected by individuals, so masking of investigators is not necessary.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 1, 2020

Study Start

November 30, 2020

Primary Completion

September 12, 2022

Study Completion

September 12, 2022

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations