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Testing Brief Personalized Feedback Integrating EMA Alcohol Cue Information (Project ACE)

Primary Purpose

Alcohol Drinking, Problem Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol Cue Reactivity Personalized Feedback Intervention
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking focused on measuring Alcohol, Intervention, Young Adults, Personalized Feedback

Eligibility Criteria

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

Inclusion Criteria:

  • 1) Between ages 18-24, 2) Lives in Washington state, 3) Reports drinking at least two days per week in the last six months, 4) Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month, 5) Open to changing drinking behavior, 6) Schedule allows for participation in study with daily surveys, 7) Able to attend Zoom training session, 8) Must have cellphone for daily surveys.

Exclusion Criteria:

  • 1) Actively seeking treatment for alcohol use, 2) Currently participating in another study in our research center regarding young adult drinking behavior.

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cue Reactivity Personalized Feedback Intervention (PFI)

Assessment-only control

Arm Description

Participants randomized to the Cue Reactivity PFI condition will receive personalized feedback at the end of completing 17 days of ecological momentary assessments (EMAs) four times a day. The personalized feedback will be delivered online and contains information summarizing participants' desire to drink as it varied as a function of several real-world factors across the 17-day EMA period.

Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.

Outcomes

Primary Outcome Measures

Daily Drinking Questionnaire
Self-reported number of standard drinks consumed in a typical week
Daily Drinking Questionnaire
Self-reported number of standard drinks consumed in a typical week
Number of heavy episodic drinking episodes
Self-reported number of occasions of heavy episodic drinking (4+ drinks for females/5+ drinks for males)
Number of heavy episodic drinking episodes
Self-reported number of occasions of heavy episodic drinking (4+ drinks for females/5+ drinks for males)
Brief Young Adult Alcohol Consequences Questionnaire
Total number of alcohol-related consequences based on self-report
Brief Young Adult Alcohol Consequences Questionnaire
Total number of alcohol-related consequences based on self-report
Penn Alcohol Craving Scale
Self-reported subjective alcohol craving, sum of five items with possible range from 0-30, higher scores reflect more craving
Penn Alcohol Craving Scale
Self-reported subjective alcohol craving, sum of five items with possible range from 0-30, higher scores reflect more craving

Secondary Outcome Measures

Full Information

First Posted
May 9, 2022
Last Updated
May 11, 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
NCT05373706
Brief Title
Testing Brief Personalized Feedback Integrating EMA 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
Completed
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)

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 incorporates ecological momentary assessments (EMAs; i.e., four brief surveys per day for 17 days) to create personalized feedback targeting high-risk alcohol use among young adult drinkers. The intervention mainly focuses on providing feedback on individuals' drinking desire and how it varies as a function of a number of real-world factors. 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 will be used in a randomized controlled trial (RCT) comparing young adults who receive the intervention with those who only complete identical assessments.
Detailed Description
The purpose of this study is to develop and test a brief intervention that provides personalized feedback to young adults using participants' own event-level, real-world experiences. The aim of the intervention is to increase young adults' awareness of their desire to drink as it varies as a function of a number of real-world factors including alcohol cues, social context, physical context, anticipation of later drinking, mood, and time of day. 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 will be used in a randomized controlled trial comparing young adult drinkers who receive the intervention with those who complete the EMAs but do not receive any personalized feedback. Assessments include an eligibility survey, baseline assessment, 17 days of EMAs and follow-up assessments occurring 2-weeks and 3-months post-intervention. 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 Drinking, Problem Drinking
Keywords
Alcohol, Intervention, Young Adults, Personalized Feedback

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 (Personalized feedback and assessment-only control group).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cue Reactivity Personalized Feedback Intervention (PFI)
Arm Type
Experimental
Arm Description
Participants randomized to the Cue Reactivity PFI condition will receive personalized feedback at the end of completing 17 days of ecological momentary assessments (EMAs) four times a day. The personalized feedback will be delivered online and contains information summarizing participants' desire to drink as it varied as a function of several real-world factors across the 17-day EMA period.
Arm Title
Assessment-only control
Arm Type
No Intervention
Arm Description
Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group.
Intervention Type
Behavioral
Intervention Name(s)
Alcohol Cue Reactivity Personalized Feedback Intervention
Intervention Description
This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.
Primary Outcome Measure Information:
Title
Daily Drinking Questionnaire
Description
Self-reported number of standard drinks consumed in a typical week
Time Frame
2-week
Title
Daily Drinking Questionnaire
Description
Self-reported number of standard drinks consumed in a typical week
Time Frame
3-month
Title
Number of heavy episodic drinking episodes
Description
Self-reported number of occasions of heavy episodic drinking (4+ drinks for females/5+ drinks for males)
Time Frame
2-week
Title
Number of heavy episodic drinking episodes
Description
Self-reported number of occasions of heavy episodic drinking (4+ drinks for females/5+ drinks for males)
Time Frame
3-month
Title
Brief Young Adult Alcohol Consequences Questionnaire
Description
Total number of alcohol-related consequences based on self-report
Time Frame
2-week
Title
Brief Young Adult Alcohol Consequences Questionnaire
Description
Total number of alcohol-related consequences based on self-report
Time Frame
3-month
Title
Penn Alcohol Craving Scale
Description
Self-reported subjective alcohol craving, sum of five items with possible range from 0-30, higher scores reflect more craving
Time Frame
2-week
Title
Penn Alcohol Craving Scale
Description
Self-reported subjective alcohol craving, sum of five items with possible range from 0-30, higher scores reflect more craving
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: 1) Between ages 18-24, 2) Lives in Washington state, 3) Reports drinking at least two days per week in the last six months, 4) Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month, 5) Open to changing drinking behavior, 6) Schedule allows for participation in study with daily surveys, 7) Able to attend Zoom training session, 8) Must have cellphone for daily surveys. Exclusion Criteria: 1) Actively seeking treatment for alcohol use, 2) Currently participating in another study in our research center regarding young adult drinking behavior.
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
98155
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We 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 February 2023.
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 EMA Alcohol Cue Information

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