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| ID | Type | Description | Link |
|---|---|---|---|
| 5R37AA025212 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Georgia State University | OTHER |
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Although correct, consistent condom use can greatly reduce sexually transmitted infections and unplanned pregnancies, resistance of condom use is common among young adults. Young men's alcohol intoxication and sexual aggression history are predictive of greater condom use resistance and other sexual risk behaviors (e.g., unprotected sex). Moreover, emotional factors may play a role in these associations, suggesting a promising avenue for continued research. This project builds upon our prior research through investigation of the emotional mechanisms involved in young men's alcohol-related sexual risk behavior. This research addresses a critical knowledge gap and advances the field through the use of multiple methods designed to evaluate distal and proximal emotional factors implicated in alcohol-related sexual risk. Male drinkers aged 21-30 who use condoms inconsistently (N = 420) will first complete a screening procedure followed by a baseline survey that will assess relevant constructs, including emotional traits, emotion dysregulation tendencies, and alcohol expectancies. They will then complete a 30-day daily diary assessment of their daily emotional states, daily coping motives pertaining to drinking and sex, and daily drinking and sexual risk behaviors to evaluate daily relationships among these factors. The same participants will complete an in-lab experiment assessing in-the-moment effects of alcohol intoxication and provocation on emotional states and sexual risk intentions. Statistical analyses will be used to examine the daily influence of emotional states and coping motives on alcohol consumption and sexual risk behaviors and the experimental effects of alcohol intoxication and provocation on emotional states and other mediators, as well as sexual risk intentions. Moderating effects of emotion dysregulation tendencies will also be examined, and the linkages between event-level and experimental relationships will be investigated. This research is both significant and innovative in that it will address the public health concern of men's sexual risk behaviors, including condom use resistance; will evaluate the role of emotional processes in men's alcohol-related sexual risk; and will use multiple methods to gather complementary types of data that will elucidate the mechanisms underlying alcohol-related sexual risk behaviors and provide an empirical evidence base from which to develop and inform prevention and intervention programs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcoholic beverage, High Provocation Manipulation | Experimental | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. |
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| Non-alcoholic beverage, High Provocation Manipulation | Experimental | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. |
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| Alcoholic beverage, Low provocation manipulation | Experimental | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants receive an experimental manipulation designed to evoke positive emotions. |
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| Non-alcoholic beverage, Low provocation manipulation | Experimental | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High provocation manipulation | Behavioral | Participants will engage in a laboratory task and will then report their emotions following the task. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score of Sexual Risk Intentions | Scale name: Intentions to have unprotected sex Construct: Self-reported ratings of unprotected sex likelihood in a hypothetical scenario Scale range: 1 (not at all likely) to 7 (very likely) A higher value is a worse outcome. This is one total scale (no subscales). Items are averaged to compute a mean score. | within one hour of receiving the intervention |
| Sexual Risk Behavior | Number of unprotected sexual intercourse events | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
Self-defined as male
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Davis, PhD | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Phoenix | Arizona | 85004 | United States |
We will make available individual, de-identified participant data that underlie disseminated results.
Immediately following publication and ending 3 years following publication.
Researchers who provide a methodologically sound proposal for the use of the data.
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Prior to assignment to an arm, 420 participants were enrolled, then completed an in-lab baseline session. They then completed 32 days of daily surveys. Participants then returned to the lab for a second session where they were assigned to a study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcoholic Beverage, High Provocation Manipulation | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: Participants will consume an alcoholic beverage (vodka mixed with fruit juice) that is the equivalent of 3-4 standard alcoholic drinks based on their body weight. |
| FG001 | Non-alcoholic Beverage, High Provocation Manipulation | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight. |
| FG002 | Alcoholic Beverage, Low Provocation Manipulation | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants receive an experimental manipulation designed to evoke positive emotions. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: Participants will consume an alcoholic beverage (vodka mixed with fruit juice) that is the equivalent of 3-4 standard alcoholic drinks based on their body weight. |
| FG003 | Non-alcoholic Beverage, Low Provocation Manipulation | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcoholic Beverage, High Provocation Manipulation | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: Participants will consume an alcoholic beverage (vodka mixed with fruit juice) that is the equivalent of 3-4 standard alcoholic drinks based on their body weight. |
| 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, Continuous | Mean |
| 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 | Mean Score of Sexual Risk Intentions | Scale name: Intentions to have unprotected sex Construct: Self-reported ratings of unprotected sex likelihood in a hypothetical scenario Scale range: 1 (not at all likely) to 7 (very likely) A higher value is a worse outcome. This is one total scale (no subscales). Items are averaged to compute a mean score. | Of the 293 participants, 3 withdrew before completing this measure. 6 participants had missing data on this measure. Thus, the analysis population for this outcome was 284. | Posted | Mean | Standard Deviation | score on a scale | within one hour of receiving the intervention |
|
6-8 weeks
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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 | Alcoholic Beverage, High Provocation Manipulation | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: Participants will consume an alcoholic beverage (vodka mixed with fruit juice) that is the equivalent of 3-4 standard alcoholic drinks based on their body weight. |
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Data collection was paused for approximately 11 months due to COVID-19 safety protocols.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Cue Davis | Arizona State University | 602-496-3217 | Kelly.Cue.Davis@asu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2019 | Apr 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D004327 | Drinking Behavior |
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| ID | Term |
|---|---|
| D000434 | Alcoholic Beverages |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Low provocation manipulation | Behavioral | Participants will engage in a laboratory task and will then report their emotions following the task. |
|
| Alcoholic beverage | Behavioral | Participants will consume an alcoholic beverage (vodka mixed with fruit juice) that is the equivalent of 3-4 standard alcoholic drinks based on their body weight. |
|
| Non-alcoholic beverage | Behavioral | Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight. |
|
| Withdrawn by staff |
|
| BG001 | Non-alcoholic Beverage, High Provocation Manipulation | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight. |
| BG002 | Alcoholic Beverage, Low Provocation Manipulation | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants receive an experimental manipulation designed to evoke positive emotions. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: Participants will consume an alcoholic beverage (vodka mixed with fruit juice) that is the equivalent of 3-4 standard alcoholic drinks based on their body weight. |
| BG003 | Non-alcoholic Beverage, Low Provocation Manipulation | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight. |
| BG004 | Total | Total of all reporting groups |
| 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 |
|
| OG001 | Non-alcoholic Beverage, High Provocation Manipulation | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight. |
| OG002 | Alcoholic Beverage, Low Provocation Manipulation | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants receive an experimental manipulation designed to evoke positive emotions. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: Participants will consume an alcoholic beverage (vodka mixed with fruit juice) that is the equivalent of 3-4 standard alcoholic drinks based on their body weight. |
| OG003 | Non-alcoholic Beverage, Low Provocation Manipulation | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight. |
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| Primary | Sexual Risk Behavior | Number of unprotected sexual intercourse events | Posted | Mean | Standard Deviation | Unprotected sex events | 30 days |
|
|
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|
| 0 |
| 74 |
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | Non-alcoholic Beverage, High Provocation Manipulation | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke negative emotions such as frustration. High provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight. | 0 | 75 | 0 | 75 | 0 | 75 |
| EG002 | Alcoholic Beverage, Low Provocation Manipulation | Participants will receive a dose of alcohol mixed in fruit juice designed to achieve a peak breath alcohol concentration of .08%. Participants receive an experimental manipulation designed to evoke positive emotions. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Alcoholic beverage: Participants will consume an alcoholic beverage (vodka mixed with fruit juice) that is the equivalent of 3-4 standard alcoholic drinks based on their body weight. | 0 | 74 | 0 | 74 | 0 | 74 |
| EG003 | Non-alcoholic Beverage, Low Provocation Manipulation | Participants will receive a beverage that does not contain alcohol (fruit juice only). Participants then receive an experimental manipulation designed to evoke positive emotions. Low provocation manipulation: Participants will engage in a laboratory task and will then report their emotions following the task. Non-alcoholic beverage: Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight. | 0 | 70 | 0 | 70 | 0 | 70 |
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