NCT03337438

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

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

Study Start

First participant enrolled

October 22, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

October 27, 2017

Last Update Submit

October 29, 2019

Conditions

Alcohol DrinkingAlcohol Consumption, Youth

Outcome Measures

Primary Outcomes (3)

  • Alcohol consumption

    measured by drinks per week

    one-month post baseline

  • Alcohol consequences

    measured by the BYAACQ to determine number of consequences experienced in the past month post-baseline

    one 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

    one month post-baseline

Secondary Outcomes (2)

  • Perceptions of norms

    one month post-baseline

  • Trait mindfulness

    one month post-baseline

Study Arms (3)

Values-PFI

OTHER
Other: Personalized Feedback Intervention with Values

Traditional-PFI with values assessment

OTHER
Other: Personalized Feedback Intervention Traditional

Traditional PFI no values assessment

OTHER
Other: Personalized Feedback Intervention Traditional

Interventions

Personalized Feedback Intervention with ValuesOTHER

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.

Values-PFI
Personalized Feedback Intervention TraditionalOTHER

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.

Traditional PFI no values assessmentTraditional-PFI with values assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Must not deny drinking within the past month
  • Non-English speaking
  • Under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Murray Hall Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Location

MeSH Terms

Conditions

Alcohol DrinkingUnderage Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAdolescent Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

October 27, 2017

First Posted

November 9, 2017

Study Start

October 22, 2017

Primary Completion

October 29, 2019

Study Completion

October 29, 2019

Last Updated

October 30, 2019

Record last verified: 2019-10

Locations

US(1)