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CompletedNCT03440476Updated Jun 30, 2022

Personalized Booster Feedback After Alcohol Health Education

A Phase 1/2 interventional study of e-checkup to go and Feedback-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 2022-06-30.

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

Phase
Phase 1/2
Study type
Interventional
Enrollment
249
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). 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.

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.

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
249 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

  • Active comparator
    Intervention plus feedback booster

    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 go · Behavioral: Feedback-only booster

  • Active comparator
    Intervention plus feedback and personal contact booster

    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 go · Behavioral: Feedback-plus-personal-contact 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.

  • BehavioralFeedback-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 reminders of strategies they can use to protect themselves from alcohol-related harm. The content is clearly automatically generated.

  • BehavioralFeedback-plus-personal-contact 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.

05

What researchers measure

Primary outcomes

  1. Alcohol consumption

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

    Time frame: 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).

    Time frame: Past 2 weeks

06

Study locations

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

References and documents

Study documents

  • Study protocol · Jun 23, 2022
  • Statistical analysis plan · Nov 13, 2020
  • Informed consent form · Nov 27, 2017

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
NCT03440476
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
Feb 22, 2018
Start date
Feb 19, 2018
Primary completion
Mar 30, 2019
Completion
Mar 30, 2019
Last update
Jun 30, 2022

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
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