Alcohol and Health: Personalized Feedback
Primary Purpose
Alcohol Drinking, Alcohol Consumption, Youth
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Feedback Intervention with Values
Personalized Feedback Intervention Traditional
Sponsored by
About this trial
This is an interventional other trial for Alcohol Drinking
Eligibility Criteria
Inclusion Criteria:
- Must be at least 18 years of age
- Must be able to speak and read English
- Must report consuming alcohol in a typical week over the past month
Exclusion Criteria:
- Must not deny drinking within the past month
- Non-English speaking
- Under the age of 18
Sites / Locations
- North Murray Hall Oklahoma State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Values-PFI
Traditional-PFI with values assessment
Traditional PFI no values assessment
Arm Description
Outcomes
Primary Outcome Measures
Alcohol consumption
measured by drinks per week
Alcohol consequences
measured by the BYAACQ to determine number of consequences experienced in the past month post-baseline
Value-behavior discrepancy for values related to alcohol use
Measured by the VLQ-A to measure change in behavioral consistency with values specifically related to alcohol use one month post-baseline
Secondary Outcome Measures
Perceptions of norms
Perceptions of descriptive norms will be more accurate one month post-baseline
Trait mindfulness
Levels of mindfulness as measured by the FFMQ will be measured at both time points
Full Information
NCT ID
NCT03337438
First Posted
October 27, 2017
Last Updated
October 29, 2019
Sponsor
Oklahoma State University
1. Study Identification
Unique Protocol Identification Number
NCT03337438
Brief Title
Alcohol and Health: Personalized Feedback
Official Title
Alcohol and Health: Personalized Feedback
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 22, 2017 (Actual)
Primary Completion Date
October 29, 2019 (Actual)
Study Completion Date
October 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oklahoma State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Heavy episodic drinking (HED) among college students remains a concern within the U.S., as rates of HED are still high in this population. Though a variety of brief motivational interventions for alcohol use in college students have demonstrated significant effects, these effects are often small and not consistently maintained over time. Personalized feedback interventions (PFIs) are a particularly promising approach, as these are often acceptable to college students, as well as low-cost, and easy to disseminate. Though presentation of interperson discrepancy via descriptive and injunctive norms has shown consistent effects within PFIs and received much attention in the literature, intraperson, or ideal-actual self discrepancies, has largely been ignored. Drawing from cognitive dissonance theory, self-regulation theory, and motivational interviewing, the current study aims to evaluate the efficacy of an alcohol PFI with a values component to incorporate ideal-self discrepancy into a typical intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Alcohol Consumption, Youth
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Values-PFI
Arm Type
Other
Arm Title
Traditional-PFI with values assessment
Arm Type
Other
Arm Title
Traditional PFI no values assessment
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Personalized Feedback Intervention with Values
Intervention Description
The PFI with values will include information commonly included in personalized feedback interventions for alcohol use, such as norms information and drinking profile, as well as feedback on three of the assessed values that are highly important to the participant.
Intervention Type
Other
Intervention Name(s)
Personalized Feedback Intervention Traditional
Intervention Description
This PFI will include information on drinking profile, norms, behavioral strategies used while drinking, and practical costs related to drinking reframed as monetary values and caloric values.
Primary Outcome Measure Information:
Title
Alcohol consumption
Description
measured by drinks per week
Time Frame
one-month post baseline
Title
Alcohol consequences
Description
measured by the BYAACQ to determine number of consequences experienced in the past month post-baseline
Time Frame
one month post-baseline
Title
Value-behavior discrepancy for values related to alcohol use
Description
Measured by the VLQ-A to measure change in behavioral consistency with values specifically related to alcohol use one month post-baseline
Time Frame
one month post-baseline
Secondary Outcome Measure Information:
Title
Perceptions of norms
Description
Perceptions of descriptive norms will be more accurate one month post-baseline
Time Frame
one month post-baseline
Title
Trait mindfulness
Description
Levels of mindfulness as measured by the FFMQ will be measured at both time points
Time Frame
one month post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be at least 18 years of age
Must be able to speak and read English
Must report consuming alcohol in a typical week over the past month
Exclusion Criteria:
Must not deny drinking within the past month
Non-English speaking
Under the age of 18
Facility Information:
Facility Name
North Murray Hall Oklahoma State University
City
Stillwater
State/Province
Oklahoma
ZIP/Postal Code
74078
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Alcohol and Health: Personalized Feedback
We'll reach out to this number within 24 hrs