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| ID | Type | Description | Link |
|---|---|---|---|
| R34AA027302 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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 provides 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Experimental | Participants randomized to the Lab-based Cue Reactivity PFI condition view the online 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. |
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| Assessment-only control | No Intervention | Participants randomized to the control group do not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Drinking Questionnaire | Number of standard drinks consumed on each day of a typical week during the [past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up]. Participants responded on a scale from 0 (0 drinks) to 25 (25 or more drinks). Totals for each day are summed to calculate the typical number of drinks consumed per week. | Baseline, 2 week follow-up, and 3 month follow-up |
| Heavy Episodic Drinking | Participants were asked, "During the past two weeks, how many times did you have [4/5 for females/males] or more drinks at one sitting?". Participants responded on a scale from 0 (0 times) to 10 (10 or more times) and possible range was 0-10. | Baseline, 2 week follow-up, and 3 month follow-up |
| Penn Alcohol Craving Scale | Self-reported subjective alcohol craving during the past week. Response options were scored from "0" to "6" with text varying across items. A sum score of the five items was calculated and the possible range was from 0-30. Higher scores reflect more craving. | Baseline, 2 week follow-up, and 3 month follow-up |
| Brief Young Adult Alcohol Consequences Questionnaire | Participants responded "no" (0) or "yes" (1) to whether they experienced each of 24 consequences during the [past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up]. A sum of the number of negative alcohol-related consequences was calculated and the possible range was 0-24. Higher values represent a worse outcome (i.e., more consequences). | Baseline, 2 week follow-up, and 3 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Ramirez, PhD | University of Washington | Principal Investigator |
| Anne Fairlie, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
The investigators plan to share limited, de-identified datasets for the purposes of data analysis and dissemination.
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Data dictionaries and limited datasets can be made available starting in May 2024.
Individual requests to access data with intended purpose should be made to Drs. Fairlie and Ramirez and will be reviewed by the investigative team.
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Participants were recruited from Washington state (e.g., via Instagram). Individuals were invited to complete an online eligibility survey for participation in a randomized clinical trial to test the effect of an online personalized feedback intervention. Recruitment (i.e., posting ads on social media) went from April 2023 to December 2023. Participant enrollment (i.e., completion of lab session) went from May 2023 to December 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Daily Drinking Questionnaire | Number of standard drinks consumed on each day of a typical week during the [past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up]. Participants responded on a scale from 0 (0 drinks) to 25 (25 or more drinks). Totals for each day are summed to calculate the typical number of drinks consumed per week. | Posted | Mean | Standard Deviation | Drinks per week | Baseline, 2 week follow-up, and 3 month follow-up |
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Adverse event data were collected between initial screening and final follow-up for each participant, a period of approximately 4 months.
We used clinicaltrials.gov definitions for adverse events and serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This is a small pilot trial designed to collect feasibility and acceptability information. The study (enrollment through 3-month) went from May 2023 to March 2024; the COVID-19 pandemic may have impacted alcohol use and contexts of alcohol use. All findings are based on self-report of alcohol use. Analyses reported here restrict the sample to 93 to account for a programming error (subsequently fixed) where control participants were initially being incorrectly emailed a link to the feedback.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Fairlie | University of Washington | 2062215896 | afairlie@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2025 | Feb 15, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2025 | Feb 15, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 19, 2023 | Feb 15, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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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.
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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. 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Student Status | Count of Participants | Participants |
|
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. 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. |
|
|
|
| Primary | Heavy Episodic Drinking | Participants were asked, "During the past two weeks, how many times did you have [4/5 for females/males] or more drinks at one sitting?". Participants responded on a scale from 0 (0 times) to 10 (10 or more times) and possible range was 0-10. | Posted | Mean | Standard Deviation | Heavy Drinking Occasions | Baseline, 2 week follow-up, and 3 month follow-up |
|
|
|
|
| Primary | Penn Alcohol Craving Scale | Self-reported subjective alcohol craving during the past week. Response options were scored from "0" to "6" with text varying across items. A sum score of the five items was calculated and the possible range was from 0-30. Higher scores reflect more craving. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 2 week follow-up, and 3 month follow-up |
|
|
|
|
| Primary | Brief Young Adult Alcohol Consequences Questionnaire | Participants responded "no" (0) or "yes" (1) to whether they experienced each of 24 consequences during the [past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up]. A sum of the number of negative alcohol-related consequences was calculated and the possible range was 0-24. Higher values represent a worse outcome (i.e., more consequences). | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 2 week follow-up, and 3 month follow-up |
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|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | 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. 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. | 0 | 51 | 0 | 51 | 0 | 51 |
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| 3-Month Follow-Up |
|
| Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section. | Generalized linear mixed model | Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution. | 0.46 | Count/Rate Ratio | 1.17 | 2-Sided | 95 | 0.77 | 1.79 | Superiority | Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up. |
| 3-Month Follow-Up |
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| Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section. | Generalized linear mixed model | Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution. | 0.34 | Count/Rate Ratio | 1.14 | 2-Sided | 95 | 0.87 | 1.48 | Superiority | Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up. |
| 3-Month Follow-Up |
|
| Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section. | Generalized linear mixed model | Models controlled for sex assigned at birth, age, and student status (4-year vs. not) and used a Poisson error distribution. | 0.92 | Count/Rate Ratio | 1.02 | 2-Sided | 95 | 0.75 | 1.38 | Superiority | Generalized linear mixed model was estimated using a sample of N=93 with a Condition × 3-Month Follow-Up interaction. AOC was the reference category for Condition, and Baseline was the reference category for 3-Month Follow-Up. |