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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34AA027302-01A1 | 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 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.
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 is used in a randomized controlled trial comparing young adults 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 (4x/day), and follow-up assessments occurring 2-weeks and 3-months post-intervention. The 2-week and 3-month follow-ups occurred 2-weeks and 3-months, respectively, from Day 17 of the EMA period, because the intervention was delivered on Day 17. 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 |
|---|---|---|---|
| Cue Reactivity Personalized Feedback Intervention (PFI) | Experimental | 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. |
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| Assessment-only control | No Intervention | Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol Cue Reactivity Personalized Feedback Intervention | Behavioral | This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults. |
| 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 |
| Number of Heavy Episodic Drinking Occasions | 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. | 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 | 98155 | United States |
We plan to share limited, de-identified datasets for the purposes of data analysis and dissemination.
Data dictionaries and limited datasets can be made available starting in February 2023.
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 using a variety of recruitment methods (e.g., predominantly Instagram, random selection of students from university registrar's lists). 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/enrollment period went from April 2022 to January 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Assessment-only Control | Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group. |
| FG001 | Cue Reactivity Personalized Feedback Intervention (PFI) | 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. Alcohol Cue Reactivity Personalized Feedback Intervention: This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults. |
| 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 will be an assessment-only control group. |
| BG001 | 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. | Young adults | Posted | Mean | Standard Deviation | Drinks per week | Baseline, 2 week follow-up, and 3 month follow-up |
|
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 will be an assessment-only control group. |
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This is a small pilot trial designed to collect feasibility and acceptability information. Study data were collected during the COVID-19 pandemic from April 2022 through May 2023, which may have impacted alcohol use and contexts of alcohol use among young adult participants. All findings are based on self-report of alcohol use.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne Fairlie | University of Washington | (206) 221-5896 | 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 | Apr 30, 2024 | Apr 30, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2024 | Apr 30, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2022 | May 31, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Participants will be randomly assigned to one of two conditions (Personalized feedback and assessment-only control group).
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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.
Alcohol Cue Reactivity Personalized Feedback Intervention: This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Current educational status | Currently a 4-year college/university student versus not | Count of Participants | Participants |
|
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. Alcohol Cue Reactivity Personalized Feedback Intervention: This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults. |
|
|
|
| Primary | Number of Heavy Episodic Drinking Occasions | 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. | Young adults | Posted | Mean | Standard Deviation | Number heavy episodic 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. | Young adults | 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. | Young adults | Posted | Mean | Standard Deviation | Number of consequences (range 0-24) | Baseline, 2 week follow-up, and 3 month follow-up |
|
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Cue Reactivity Personalized Feedback Intervention (PFI) | 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. Alcohol Cue Reactivity Personalized Feedback Intervention: This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults. | 0 | 51 | 0 | 51 | 0 | 51 |
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| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| 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. | 0.30 | Count/Rate Ratio | 1.24 | 2-Sided | 95 | 0.82 | 1.88 | Superiority | Generalized linear mixed model was estimated using a sample of N=99 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. | 0.73 | Count/Rate Ratio | 1.05 | 2-Sided | 95 | 0.80 | 1.38 | Superiority | Generalized linear mixed model was estimated using a sample of N=99 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. | 0.38 | Count/Rate Ratio | 0.88 | 2-Sided | 95 | 0.66 | 1.17 | Superiority | Generalized linear mixed model was estimated using a sample of N=99 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. |