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

Primary Purpose

Alcohol Consumption

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Consumption

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)

Assessment-only control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Daily Drinking Questionnaire
Total number of standard drinks consumed in a typical week
Daily Drinking Questionnaire
Total number of standard drinks consumed in a typical week
Brief Young Adult Alcohol Consequences Questionnaire
Total number of alcohol-related consequences endorsed
Brief Young Adult Alcohol Consequences Questionnaire
Total number of alcohol-related consequences endorsed
Penn Alcohol Craving Scale
Subjective craving for alcohol endorsed
Penn Alcohol Craving Scale
Subjective craving for alcohol endorsed

Secondary Outcome Measures

Full Information

First Posted
May 15, 2023
Last Updated
May 24, 2023
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05873556
Brief Title
Testing Brief Personalized Feedback Integrating Lab-based Alcohol Cue Information
Acronym
Project ACE
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Assessment-only control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Daily Drinking Questionnaire
Description
Total number of standard drinks consumed in a typical week
Time Frame
2-week
Title
Daily Drinking Questionnaire
Description
Total number of standard drinks consumed in a typical week
Time Frame
3-month
Title
Brief Young Adult Alcohol Consequences Questionnaire
Description
Total number of alcohol-related consequences endorsed
Time Frame
2-week
Title
Brief Young Adult Alcohol Consequences Questionnaire
Description
Total number of alcohol-related consequences endorsed
Time Frame
3-month
Title
Penn Alcohol Craving Scale
Description
Subjective craving for alcohol endorsed
Time Frame
2-week
Title
Penn Alcohol Craving Scale
Description
Subjective craving for alcohol endorsed
Time Frame
3-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Fairlie, PhD
Phone
206-221-5896
Email
afairlie@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Ramirez, PhD
Phone
206-221-5201
Email
jjramirz@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Ramirez, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Fairlie, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Fairlie, PhD
Phone
206-221-5896
Email
afairlie@uw.edu
First Name & Middle Initial & Last Name & Degree
Jason Ramirez, PhD
Phone
206-221-5201
Email
jjramirz@uw.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Testing Brief Personalized Feedback Integrating Lab-based Alcohol Cue Information

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