Project ACE: Testing Brief Personalized Feedback Integrating Lab-based Alcohol Cue Information

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT05873556
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
100
1
2
9.8
10.2

Study Details

Study Description

Brief Summary

This study aims to develop a brief intervention that uses information from a lab-based cue reactivity protocol to create personalized feedback targeting high-risk alcohol use among young adults who drink alcohol. The intervention mainly focuses on providing feedback on individuals' drinking desire, mood, willingness to drink, and alcohol demand by comparing scores before and after viewing and smelling an alcoholic beverage in the lab session. Other psycho-educational alcohol-related content is also provided in the intervention including strategies for decreasing exposure to cues that increase drinking desires and how to cope with increased desire to drink. This brief intervention is used in a randomized controlled trial (RCT) comparing young adults who receive the brief, online intervention to those who did not receive the brief, online intervention. Participants in both groups complete baseline, lab-based cue reactivity protocol, 2-week follow-up and 3-month follow-up.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
N/A

Detailed Description

The purpose of this study is to develop and test a brief intervention that provides personalized feedback to young adults using participants' responses from a baseline survey and from a lab-based cue reactivity protocol. The aim of the intervention is to increase young adults' awareness of how alcohol cues may affect their desire to drink, mood, willingness to drink, and alcohol demand both in relation to lab-based exposure to an alcohol beverage of their choice and also more broadly in everyday life. The intervention also aims to equip young adults with strategies for reducing exposure to factors that increase their desire to drink, how to cope with an increased desire to drink, and how to reduce potential harms from drinking.

This brief personalized feedback intervention is used in a randomized controlled trial comparing young adults who receive the intervention with those who complete the assessments and lab protocol but do not receive any personalized feedback. Online assessments include an eligibility survey, baseline assessment, and follow-up assessments occurring 2-weeks and 3-months post-intervention. Everyone has one in-person session to complete the lab-based cue reactivity protocol after the baseline assessment has been completed online. The intervention will be examined for its feasibility, acceptability, and its effects in reducing alcohol-related outcomes at the follow-up assessments.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomly assigned to one of two conditions: (1) Personalized feedback based on reports from baseline and lab-session and (2) assessment-only control group.Participants will be randomly assigned to one of two conditions: (1) Personalized feedback based on reports from baseline and lab-session and (2) assessment-only control group.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Development and Preliminary Examination of Two Brief Personalized Feedback Interventions Focused on Lab-based and EMA Alcohol Cues to Reduce Hazardous Young Adult Alcohol Use
Actual Study Start Date :
May 8, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)

Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.

Behavioral: Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.

No Intervention: Assessment-only control

Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback.

Outcome Measures

Primary Outcome Measures

  1. Daily Drinking Questionnaire [2-week]

    Total number of standard drinks consumed in a typical week

  2. Daily Drinking Questionnaire [3-month]

    Total number of standard drinks consumed in a typical week

  3. Brief Young Adult Alcohol Consequences Questionnaire [2-week]

    Total number of alcohol-related consequences endorsed

  4. Brief Young Adult Alcohol Consequences Questionnaire [3-month]

    Total number of alcohol-related consequences endorsed

  5. Penn Alcohol Craving Scale [2-week]

    Subjective craving for alcohol endorsed

  6. Penn Alcohol Craving Scale [3-month]

    Subjective craving for alcohol endorsed

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Between ages 18-24

  • Lives in Washington state

  • Reports drinking at least two days per week in the last six months

  • Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month

  • Open to changing drinking behavior

  • Must be willing to come to our Seattle study office for session visit

  • Provide an email address and phone number for study communication

Exclusion Criteria:
  • Actively seeking treatment for alcohol use

  • Currently participating in another study in our research center regarding young adult drinking behavior

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington Seattle Washington United States 98195

Sponsors and Collaborators

  • University of Washington
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Jason Ramirez, PhD, University of Washington
  • Principal Investigator: Anne Fairlie, PhD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anne Fairlie, Research Associate Professor: School of Medicine, University of Washington
ClinicalTrials.gov Identifier:
NCT05873556
Other Study ID Numbers:
  • STUDY00016989
  • R34AA027302
First Posted:
May 24, 2023
Last Update Posted:
May 26, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2023