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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Consumption
• Intervention / Treatment: Behavioral: Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Fairlie, PhD; Phone Number: 206-221-5896; Email: afairlie@uw.edu
• Study Contact Backup: Name: Jason Ramirez, PhD; Phone Number: 206-221-5201; Email: jjramirz@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: Anne Fairlie, PhD; Phone Number: 206-221-5896; Email: afairlie@uw.edu
      • Contact: Jason Ramirez, PhD; Phone Number: 206-221-5201; Email: jjramirz@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Drinking Questionnaire	Total number of standard drinks consumed in a typical week	2-week
Daily Drinking Questionnaire	Total number of standard drinks consumed in a typical week	3-month
Brief Young Adult Alcohol Consequences Questionnaire	Total number of alcohol-related consequences endorsed	2-week
Brief Young Adult Alcohol Consequences Questionnaire	Total number of alcohol-related consequences endorsed	3-month
Penn Alcohol Craving Scale	Subjective craving for alcohol endorsed	2-week
Penn Alcohol Craving Scale	Subjective craving for alcohol endorsed	3-month

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: STUDY00016989; R34AA027302 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators plan to share limited, de-identified datasets for the purposes of data analysis and dissemination.
• IPD Sharing Time Frame: Data dictionaries and limited datasets can be made available starting in May 2024.
• IPD Sharing Access Criteria: Individual requests to access data with intended purpose should be made to Drs. Fairlie and Ramirez and will be reviewed by the investigative team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No