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Timing Personalized Feedback After Alcohol Health Education (TIME)

Primary Purpose

College Student Drinking

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
e-checkup to go
Feedback booster
Sponsored by
Abby Braitman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for College Student Drinking

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

  • Old Dominion University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Intervention-only Control

Intervention plus 2-week feedback booster

Intervention plus 6-week feedback booster

Intervention plus 10-week feedback booster

Intervention plus 14-week feedback booster

Intervention plus repeated feedback boosters

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
June 26, 2020
Last Updated
April 28, 2023
Sponsor
Abby Braitman
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04453007
Brief Title
Timing Personalized Feedback After Alcohol Health Education
Acronym
TIME
Official Title
Timing Personalized Feedback After Alcohol Health Education
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
September 12, 2022 (Actual)
Study Completion Date
September 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abby Braitman
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
College Student Drinking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention-only Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Intervention plus 2-week feedback booster
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention plus 6-week feedback booster
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention plus 10-week feedback booster
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention plus 14-week feedback booster
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention plus repeated feedback boosters
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
e-checkup to go
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Feedback booster
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alcohol Consumption
Description
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 Outcome Measure Information:
Title
Alcohol-Related Consequences
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Under age of 18 Over age of 24 Not a college student Did not drink alcohol in the past 2 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abby L Braitman, Ph.D.
Organizational Affiliation
Old Dominion University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Old Dominion University
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23529
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29995326
Citation
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.
Results Reference
background
PubMed Identifier
27148633
Citation
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.
Results Reference
background

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Timing Personalized Feedback After Alcohol Health Education

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