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| ID | Type | Description | Link |
|---|---|---|---|
| F31AA027471-01 | U.S. NIH Grant/Contract | View source |
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Insufficient recruitment due to COVID pandemic; termination of funding
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The present study will evaluate college students (N=100) from 2- and 4-year colleges/universities between 21-24 years old to assess anxiety, affect, broad social motives (BSM) and peer group influences on drinking and other risk-taking behaviors. This study will employ two sound scientific methods for testing behavior during drinking events (i.e., lab alcohol administration and daily diary) and use novel strategies to compare results of these two methods in the same sample. Using an ad-lib drinking paradigm, students' risk-taking, as measured by the Balloon Analogue Risk Task (BART), will be assessed when alone and during one of two randomly assigned peer group conditions (close friends or new peers). Participants will be allowed to freely drink (within safety limits) with their peer group prior to completing the BART again. These same students will complete daily electronic diaries on four weekends (Thursday - Sunday; total 24 assessments) regarding BSM, motives to drink, peers in their social group, alcohol use and consequences, and if/how their social group changed (e.g., few close friends to large party with many new peers) during the drinking event. Competing hypotheses will be tested such that: 1) anxiety is expected to be a stronger predictor of drinking behavior and greater differences in risk-taking in the new peer condition than close friend condition or 2) BSM is expected to be a stronger predictor of drinking behavior and greater differences in risk-taking in the close friend condition than new peers condition. Results are expected to be replicated in the daily diary reports. Further, this multimethod approach will allow us to evaluate how behavior assessed in the lab predicts naturally occurring behaviors in an uncontrolled setting. For example, the investigators will assess whether greater increases in self-reported risk-taking from baseline to after entering peer groups in the bar lab setting will predict heavier drinking on nights when most drinking companions are close friends reported during daily diary.
Participants (N=100) will be recruited through direct outreach to University of Washington (UW) students via the UW Registrar's directory list, as well as community flyers distributed at colleges in the local area, online advertisements, and word of mouth. Participants will complete screening measures online. Eligible participants will be stratified on sex, age, and past 30-day peak alcohol use and randomly assigned to one of two conditions: close friends (N=50), where participants will recruit two of their existing friends, or new peers (N=50), where participants will drink with two strangers. To ensure at least two eligible friends, those in the close friend group will be asked to provide email and phone numbers of five to seven close friends. Close friends will have to meet the same inclusion and exclusion criteria as target participants and will go through the same procedures as target participants during alcohol administration. For each pair of participants matched on the three strata (age, sex, alcohol use), strangers in the new peer group will be matched to the sex of the close friends of the other matched participant's group.
Participants will be asked not to travel to the bar together to ensure they are not exposed to their peer group before entry to the bar, and must get to the lab without operating any vehicle with wheels (e.g. car, bike). Upon arriving to the lab, all participants and peers will review and sign the consent form, and provide a baseline breath alcohol content (BrAC) reading. Female participants and friends will also be asked to take a urine pregnancy test. Participants and friends will complete baseline measures and the Balloon Analogue Risk Task (BART) individually prior to entry to the bar. Then they will be taught the procedures for the daily diary portion of the study (see below). Participants will join their close friends or new peers in the bar and be given 20 minutes to relax while the researcher prepares the materials. After entering groups but prior to receiving alcohol, participants and peers will complete pre-alcohol measures and the BART. They will then be allowed to order anything from the bar menu for the following hour. Participants and close friends will be allowed to drink freely within limits (BrAC = .12%), for safety. During ad-lib, estimated BAC levels based on age, sex, and weight will be calculated prior to each drink served to ensure the safety of consuming each drink without interrupting social interaction and making the participant's BAC more salient by taking BrAC readings regularly. Participants or close friends whose BAC may exceed .12% will only be served placebo beverages for the remainder of the hour. BrAC readings will be taken at the end of ad-lib, every 10 minutes until peak BrAC is reached and readings are descending, and every 30 minutes thereafter. After ad-lib, participants will complete post-alcohol measures and the BART, then provided entertainment until they reach a BAC below .03%. The full protocol will take approximately 2.5 hours. On average, alcohol metabolizes at a rate of .015% per hour, so a participant who reaches .12% will be in the lab on average 8.5 hours. Once sober, participants and friends will be taken home in a taxi or ride share service (e.g. Uber, Lyft). Close friends will not complete the following daily diary protocols.
Daily diary measures will start on the Thursday following each participant's alcohol administration appointment and be collected for potential drinking events on Thursday, Friday, and Saturday over the following four consecutive weeks. Each day, participants will be notified of surveys by text message at 4 pm and the following morning at 11am (Friday, Saturday, and Sunday) for a total of 24 assessments. Surveys will be available for 2 hours and reminders sent via text 30 minutes before closing. Afternoon assessments take approximately 5 minutes and measure BSM, motives to drink, motives to refrain from drinking, evening plans, and what type of peers they plan to spend the evening with (e.g. close friends, new peers, family, alone). For the daily diary, BSM items have been modified to select experiences which may vary daily (e.g. "making social plans got me excited and energized today) and drinking motives have been modified into a brief prospective measure consistent with modifications used in other studies15. At morning assessments, participants will retrospectively report amount of drinks and other substances consumed, time spent drinking, and consequences experienced while drinking or currently (morning after drinking). Participants will be asked how many times their social group changed during the event defined as the majority of their drinking companions being of a different peer type than before. For instance, a participant may be at a house party with primarily close friends, but someone invites several people the participant does not know well and they are now drinking with mostly new peers. For each peer group reported (up to five groups), participants will report the following characteristics of the group: size (i.e. number of people they had direct contact with), number of drinking companions of each peer type (e.g. close friends, new peers, family), gender composition of the group (same-sex vs. mixed-sex), time spent with and drinks consumed with each group. On non-drinking evenings, participants will report similar information regarding their social groups and other activities. This survey will take approximately 5-7 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Peers | Experimental | Participants will drink with two new peers (i.e. strangers), who they did not know prior to the study and their Peer Type. |
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| Close Friends | Experimental | Participants will recruit and drink with two of their close friends and their Peer Type |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Type - New Peer | Behavioral | Participants drink with 2 unfamiliar confederate peers |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use | Number of drinks consumed | During 1 hour ad-lib period, starting an average of 1 hour after Baseline. |
| Alcohol Use - Daily Diary | Number of drinks consumed, self-reported the morning after drinking events | 4 weeks following ad-lib. |
| Alcohol Consequences | Self-report of the Young Adult Alcohol Problems Screening Test (YAAPST). Count of number of consequences experienced. Range: 0-27. Higher scores represent more consequences experienced. | 4 weeks following ad-lib. |
| Risk-taking | Scores on the Balloon Analogue Risk Task (BART). Scores are calculated by adding the number of pumps for unexploded balloons, with higher scores reflecting greater risk-taking. Range varies - explosions are at a random point between 1 and 128 pumps. | Change from baseline (alone) to 20 minutes following Peer Type intervention. |
| Risk-taking | Scores on the Balloon Analogue Risk Task (BART). Scores are calculated by adding the number of pumps for unexploded balloons, with higher scores reflecting greater risk-taking. Range varies - explosions are at a random point between 1 and 128 pumps. | Change from baseline (alone) to immediately following ad-lib, an average of 2 hours after baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary E Larimer, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for the Study of Health and Risk Behaviors | Seattle | Washington | 98105 | United States |
Participants were completed informed consent and enrolled at the time of the alcohol administration session.
Participants were recruited through University registrar's list emails, flyers posted around campus, and social media advertisements. Participants were recruited and enrolled between December 2019 and July 2022. Recruitment was paused from March 2020 to August 2021 due to the COVID-19 pandemic and again from August 2022 until early termination in June 2023 due to key personnel and funding changes. Study effective termination was July 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | New Peers | Participants will drink with two new peers (i.e. strangers), who they did not know prior to the study and their Peer Type. Peer Type - New Peer: Participants drink with 2 unfamiliar confederate peers |
| FG001 | Close Friends | Participants will recruit and drink with two of their close friends and their Peer Type Peer Type - Close Friends: Participants drink with 2 close friends |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants enrolled completed Baseline
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| ID | Title | Description |
|---|---|---|
| BG000 | New Peers | Participants will drink with two new peers (i.e. strangers), who they did not know prior to the study and their Peer Type. Peer Type - New Peer: Participants drink with 2 unfamiliar confederate peers |
| BG001 | Close Friends |
| 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 | Alcohol Use | Number of drinks consumed | Posted | Mean | Standard Deviation | Number of drinks | During 1 hour ad-lib period, starting an average of 1 hour after Baseline. |
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One month
All-Cause Mortality was not monitored during the 4-week follow-up period because all assessments were self-reported. Mortality would have only been reported to study staff if the participant's next of kin choose to share that information.
Serious adverse events monitored was consuming alcohol at potentially lethal doses of BAC > .30.
Other non-serious adverse events monitored was becoming nauseous by self-report or exceeding a BrAC > .15 during alcohol administration procedures.
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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 | New Peers | Participants will drink with two new peers (i.e. strangers), who they did not know prior to the study and their Peer Type. Peer Type - New Peer: Participants drink with 2 unfamiliar confederate peers |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Canning | University of Washington | 206.221.4430 | jrcannin@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 | Jul 18, 2021 | Dec 11, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2023 | Dec 11, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D012309 | Risk-Taking |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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Participants will be randomly assigned to one of two conditions, which will run in parallel.
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| Peer Type - Close Friends |
| Behavioral |
Participants drink with 2 close friends |
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Participants will recruit and drink with two of their close friends and their Peer Type Peer Type - Close Friends: Participants drink with 2 close friends |
| 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 | Count of Participants | Participants |
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| Broad Social Motives for Friends | Measures reward responsiveness towards social interactions with friends. Measured by 21 items on a 5-point Likert scale ranging from 1 = Strongly disagree to 5 = strong agree. Mean scores were created from all items. Higher values are better. | Mean | Standard Deviation | units on a scale |
|
| Broad Social Motives for New Peers | Measures reward responsiveness toward social interactions with strangers and people just meeting for the first time. Measures by 20 items on a 5 point Likert scale ranging from 1 = strong disagree to 5 = strongly agree. Mean scores were created from all items. Higher values are better. | Mean | Standard Deviation | units on a scale |
|
| Negative Affect | The state version of the Positive and Negative Affect Scale (PANAS; Watson, Clark, & Tellegen, 1988) is a 20-item measure. All adjectives reflect positive (e.g., excited) or negative (e.g., hostile) feeling words. Response options are rated on a 5-point Likert scale from 0 = "Very slightly or not at all" to 4 = "Extremely". Mean scores were created from all items. Lower values are better. | Mean | Standard Deviation | units on a scale |
|
| Positive Affect | The state version of the Positive and Negative Affect Scale (PANAS; Watson, Clark, & Tellegen, 1988) is a 20-item measure. All adjectives reflect positive (e.g., excited) or negative (e.g., hostile) feeling words. Response options are rated on a 5-point Likert scale from 0 = "Very slightly or not at all" to 4 = "Extremely". Mean scores were created from all items. Higher values are better. | Mean | Standard Deviation | units on a scale |
|
| Prior 30 day Alcohol Consequences | The Young Adult Alcohol Problem Screening Test (YAAPST; Hurlbut & Sher, 1992) includes 27 items measuring frequency of experiencing negative alcohol consequences. Frequency options vary by item, please see Hurlbut & Sher, 1992 for full scoring instructions. A sum score was created as a consequence severity score. The scale can range from 0 to 134. Lower scores are better. | Mean | Standard Deviation | units on a scale |
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| Prior 30 day Alcohol Use | The Time-Line Follow Back (TLFB; Sobell & Sobell, 1992) is a semi-structured interview to collect details of drinking events over the past month. Average number of standard drinks was calculated for results. | Mean | Standard Deviation | Number of standard drinks |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Alcohol Use - Daily Diary | Number of drinks consumed, self-reported the morning after drinking events | Posted | Mean | Standard Deviation | Number of drinks | 4 weeks following ad-lib. |
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| Primary | Alcohol Consequences | Self-report of the Young Adult Alcohol Problems Screening Test (YAAPST). Count of number of consequences experienced. Range: 0-27. Higher scores represent more consequences experienced. | Posted | Mean | Standard Deviation | Number of consequences | 4 weeks following ad-lib. |
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| Primary | Risk-taking | Scores on the Balloon Analogue Risk Task (BART). Scores are calculated by adding the number of pumps for unexploded balloons, with higher scores reflecting greater risk-taking. Range varies - explosions are at a random point between 1 and 128 pumps. | Posted | Mean | Standard Deviation | Number of pumps | Change from baseline (alone) to 20 minutes following Peer Type intervention. |
|
|
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| Primary | Risk-taking | Scores on the Balloon Analogue Risk Task (BART). Scores are calculated by adding the number of pumps for unexploded balloons, with higher scores reflecting greater risk-taking. Range varies - explosions are at a random point between 1 and 128 pumps. | Posted | Mean | Standard Deviation | Number of pumps | Change from baseline (alone) to immediately following ad-lib, an average of 2 hours after baseline. |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Close Friends | Participants will recruit and drink with two of their close friends and their Peer Type Peer Type - Close Friends: Participants drink with 2 close friends | 0 | 8 | 0 | 8 | 0 | 8 |
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