- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04192448
Men, Mood, and Attention Study: Examination of Alcohol, State Anger, and Emotion Regulation Sexual Aggression (MMA)
The Roles of Acute Alcohol Intoxication, State Anger, and Emotion Regulation on Men's Sexual Aggression Intentions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Males ages 21 to 35 will be recruited from the community through fliers and advertisements in bars and local publications (print and electronic) and instructed to call the lab for telephone screening or complete an online web-screening survey. Sexual aggression is a pervasive and highly prevalent problem on college campuses, so the project will heavily advertise at the local college campus. The screening will include an assessment of typical alcohol consumption patterns, risk for current or past alcohol use disorder, and sexual risk-taking.
Participants (N=180) will be compensated $10 per hour of lab participation for a maximum payment of $80. Participants will begin by completing a series of background measures (see Measures) related to alcohol consumption and expectations, sexual aggression perpetration history, trait anger, and trait emotion regulation. Participants will complete factors of personality that have demonstrated associations with both emotion regulation and sexual aggression as covariates, including psychopathy, sensation seeking, and impulsivity.
Participants will be randomly assigned to receive beverages consisting of either an alcohol dose (target peak BAC =.08gm%) or a control (non-alcoholic) beverage. Participants will be informed into which alcohol condition they have been assigned. Using a double-blind procedure, participants will be block randomized by self-reported sexual aggression perpetration history [(none = no history of perpetration) vs. (low = history of unwanted sexual contact or sexual coercion) vs. (high = attempted or completed perpetration of incapacitated or forced rape)]. A computer algorithm will be used to assign participants to the experimental conditions such that participants with none, low, and high perpetration history are evenly distributed across beverage conditions. Individuals assigned to the alcohol condition will consume a beverage comprised of cranberry juice and 100 proof vodka, while individuals assigned to the control condition will consume a beverage comprised of cranberry juice and water. The total liquid is divided equally between three cups, and participant is given nine minutes to consume the total amount (e.g., three minutes per cup). To ensure stable absorption of alcohol and decrease the likelihood of nausea, the experimenter will instruct the participant to consume the beverages evenly and to avoid drinking quickly. Following beverage administration, participants will be Breathalyzed every five minutes until they attain two Breathalyzer readings of .08%gm to ensure their BAC will descend during the emotion induction and sexual aggression analog. A yoking procedure will be employed for control participants in which each control participant is paired with an alcohol dose participant and receive an equal number of Breathalyzer checks.
Participants will also be randomly assigned to an emotion induction condition consisting of either an anger emotion induction or a control emotion induction. This study will employ deception as individuals will not be told they have been assigned to different emotion induction conditions. The emotion induction consists of two parts: 1) an emotion recall task; and 2) provocation task. Individuals assigned to the anger induction will be instructed to recall an incident in the last 30 days when they felt angry, frustrated, or "pissed off". They will then be given five minutes to write as much as possible about that incident and their response. Participants in the control condition will be instructed to write for five minutes about a neutral topic (e.g., cooking dinner, going for a walk; Marci et al., 2007). The writing samples from all participants will be collected and coded by independent coders to identify whether participants accurately engaged in the task. Following the emotion recall portion of the induction, participants will begin a provocation task. Both groups will begin an attention task. Participants assigned to the anger condition will be given negative feedback about their performance. Participants assigned to the control condition will complete the task without feedback and then will be thanked for their participation.
Upon completion of both portions of the emotion induction, participants will read and project themselves into a written hypothetical sexual situation displayed on a computer. The stimulus story will be approximately 1,600 words and be written at a 5th grade reading level. The story will depict a sexual encounter between the participant and a hypothetical female, in which the female in the story will initially engage in consensual sexual activity however will gradually display and express resistance to engaging in intercourse. Participants will then complete assessment of outcome measures.
Immediately after completing the scenario, participants will be required to watch one of three neutral videos (e.g., comedy clips, nature documentaries) to assist with distancing and detaching from the content of the story. After completing the videos, sober participants will be debriefed and paid for their time. Intoxicated participants will be provided with food, beverages, and entertainment until their BAC descended to below .04%gm. Once their BAC has descended to below .04%gm, these participants will be debriefed and paid for their time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
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Morehead, Kentucky, United States, 40351
- Morehead State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Biologically male and identify their gender as male
- Between the ages of 21-35
- Must be Interested in sexual activity with women
- Must have engaged in at least one instance of sex without a condom in the last six months
- Must on average consume between 5 and 25 standard drinks per week
- Must have previously had an instance of heavy episodic drinking (HED; at least five alcoholic drinks in two hours) in the last six months
- No history of or current alcohol problems (as determined by the Brief Michigan Alcoholism Screening Test)
- No past or current medical condition or take medications which contraindicate alcohol consumption
Exclusion Criteria:
- being in a monogamous relationship of longer than six months or not having sexual intercourse at all within the past six months
- Any history or current alcohol problems (as determined by the Brief Michigan Alcoholism Screening Test)
- Currently taking medications which contraindicate alcohol consumption
- Currently or ever diagnosed with a medical condition that contraindicates alcohol consumption
- Currently enrolled as a student at Morehead State University
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AlcoholxAnger
Participant will receive alcohol, the dose of which will be administered to result in a BAC of .08%.
Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
|
The clinical trial does not involve any treatment.
Participant will be randomly assigned to receive alcohol (BAC = .08%)
or water (BAC = .00%).
The clinical trial does not involve any treatment.
Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
Experimental: AlcoholxControl
Participant will receive alcohol, the dose of which will be administered to result in a BAC of .08%.
Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
|
The clinical trial does not involve any treatment.
Participant will be randomly assigned to receive alcohol (BAC = .08%)
or water (BAC = .00%).
The clinical trial does not involve any treatment.
Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
Experimental: SoberxAnger
Participant will not receive alcohol, therefore their BAC will be .00%.
Participants will also receive an anger emotion induction, in which the experience of frustration and irritability is induced.
|
The clinical trial does not involve any treatment.
Participant will be randomly assigned to receive alcohol (BAC = .08%)
or water (BAC = .00%).
The clinical trial does not involve any treatment.
Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
Sham Comparator: SoberxControl
Participant will not receive alcohol, therefore their BAC will be .00%.
Participants will also receive a control emotion induction, in which they are exposed to a neutral mood induction.
|
The clinical trial does not involve any treatment.
Participant will be randomly assigned to receive alcohol (BAC = .08%)
or water (BAC = .00%).
The clinical trial does not involve any treatment.
Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Aggression Intentions
Time Frame: 20 minutes
|
Ratings (1 = Not at All to 7 = Extremely) of intentions to act sexually aggressively against a hypothetical female
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Aggression Intentions
Time Frame: 20 minutes
|
Ratings (1 = Not at All to 7 = Extremely) of intentions to act physically aggressively against a hypothetical female
|
20 minutes
|
Psychological Aggression Intentions
Time Frame: 20 minutes
|
Ratings (1 = Not at All to 7 = Extremely) of intentions to act psychologically aggressively against a hypothetical female
|
20 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth C Neilson, PhD, Assistant professor
Publications and helpful links
General Publications
- Muehlenhard CL, Peterson ZD, Humphreys TP, Jozkowski KN. Evaluating the One-in-Five Statistic: Women's Risk of Sexual Assault While in College. J Sex Res. 2017 May-Jun;54(4-5):549-576. doi: 10.1080/00224499.2017.1295014. Epub 2017 Apr 4.
- Abbey A. Alcohol-related sexual assault: a common problem among college students. J Stud Alcohol Suppl. 2002 Mar;(14):118-28. doi: 10.15288/jsas.2002.s14.118.
- Abbey A, Wegner R. Using Experimental Paradigms to Examine Alcohol's Role in Men's Sexual Aggression: Opportunities and Challenges in Proxy Development. Violence Against Women. 2015 Aug;21(8):975-96. doi: 10.1177/1077801215589378. Epub 2015 Jun 5.
- DeGue S, Valle LA, Holt MK, Massetti GM, Matjasko JL, Tharp AT. A systematic review of primary prevention strategies for sexual violence perpetration. Aggress Violent Behav. 2014 Jul-Aug;19(4):346-362. doi: 10.1016/j.avb.2014.05.004.
- Connor JP, Grier M, Feeney GF, Young RM. The validity of the Brief Michigan Alcohol Screening Test (bMAST) as a problem drinking severity measure. J Stud Alcohol Drugs. 2007 Sep;68(5):771-79. doi: 10.15288/jsad.2007.68.771.
- Martin CS, Sayette MA. Experimental design in alcohol administration research: limitations and alternatives in the manipulation of dosage-set. J Stud Alcohol. 1993 Nov;54(6):750-61. doi: 10.15288/jsa.1993.54.750.
- Giancola PR, Zeichner A. The biphasic effects of alcohol on human physical aggression. J Abnorm Psychol. 1997 Nov;106(4):598-607. doi: 10.1037//0021-843x.106.4.598.
- Davis KC, George WH, Norris J, Schacht RL, Stoner SA, Hendershot CS, Kajumulo KF. Effects of alcohol and blood alcohol concentration limb on sexual risk-taking intentions. J Stud Alcohol Drugs. 2009 Jul;70(4):499-507. doi: 10.15288/jsad.2009.70.499.
- Laber EB, Shedden K. Statistical Significance and the Dichotomization of Evidence: The Relevance of the ASA Statement on Statistical Significance and p-values for Statisticians. J Am Stat Assoc. 2017;112(519):902-904. doi: 10.1080/01621459.2017.1311265. Epub 2017 Oct 30. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-10-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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