NCT03440476

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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
249

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

February 19, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

February 14, 2018

Last Update Submit

June 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alcohol consumption

    Participant self-reported number of standard drinks consumed by participant over the past 2 weeks.

    Past 2 weeks

Secondary Outcomes (1)

  • Alcohol-related consequences

    Past 2 weeks

Study Arms (3)

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.

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.

Behavioral: e-checkup to goBehavioral: 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.

Behavioral: e-checkup to goBehavioral: Feedback-plus-personal-contact booster

Interventions

e-checkup to goBEHAVIORAL

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.

Intervention plus feedback and personal contact boosterIntervention plus feedback boosterIntervention-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. The content is clearly automatically generated.

Intervention plus feedback 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. The email is sent from an individual on the research staff.

Intervention plus feedback and personal contact booster

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

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, 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 is not necessary.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 14, 2018

First Posted

February 22, 2018

Study Start

February 19, 2018

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations