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Men, Mood, and Attention Study: Examination of Alcohol, State Anger, and Emotion Regulation Sexual Aggression (MMA)

Primary Purpose

Alcohol Intoxication, Anger

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol Administration
Mood Induction
Sponsored by
Elizabeth C Neilson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Intoxication focused on measuring Sexual Violence, Alcohol consumption

Eligibility Criteria

21 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Morehead State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

AlcoholxAnger

AlcoholxControl

SoberxAnger

SoberxControl

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Sexual Aggression Intentions
Ratings (1 = Not at All to 7 = Extremely) of intentions to act sexually aggressively against a hypothetical female

Secondary Outcome Measures

Physical Aggression Intentions
Ratings (1 = Not at All to 7 = Extremely) of intentions to act physically aggressively against a hypothetical female
Psychological Aggression Intentions
Ratings (1 = Not at All to 7 = Extremely) of intentions to act psychologically aggressively against a hypothetical female

Full Information

First Posted
December 7, 2019
Last Updated
September 7, 2021
Sponsor
Elizabeth C Neilson
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1. Study Identification

Unique Protocol Identification Number
NCT04192448
Brief Title
Men, Mood, and Attention Study: Examination of Alcohol, State Anger, and Emotion Regulation Sexual Aggression
Acronym
MMA
Official Title
The Roles of Acute Alcohol Intoxication, State Anger, and Emotion Regulation on Men's Sexual Aggression Intentions
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Procedures not feasible due to COVID-19 and administrative concerns
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elizabeth C Neilson

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Given the public health and social relevance of sexual aggression and the gap in the extant literature regarding state anger, emotion regulation, alcohol, and sexual aggression, the present study will contribute to our understanding of emotion regulation's role in sexual aggression perpetration. The proposed 2-year research plan will examine the effects of alcohol intoxication, state anger, and emotion regulation on men's sexual aggression intentions. This study will recruit non-monogamous, men (individuals who identify their gender as male and whose biological sex is male) who have sex with women, ages 21-35. While more research on female perpetrators is needed, the proposed study will exclusively recruit males for the following reasons: 1) the scientific literature indicating the majority of sexually aggressive acts are perpetrated by men; and 2) the current sexual aggression analog has not been piloted with female participants and would require preliminary experiments to determine its appropriateness. The study will utilize a 2x2 design in which participants are randomized to beverage condition [alcohol (target BAC= .08gm%) or control (no alcohol control)] and an emotion induction (anger induction or control). The outcomes will be assessed using a sexual aggression analog which participants will complete on the descending limb of alcohol intoxication and indicate the likelihood that they would engage in various sexually aggressive acts. The study also includes self-report measurements of state anger and emotion regulation to explore emotion regulation as a moderator in the associations among alcohol intoxication, state anger, and sexual aggression intentions.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Intoxication, Anger
Keywords
Sexual Violence, Alcohol consumption

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study utilizes a 2x2 (Alcohol and Emotion) design in which participants will be randomly assigned to one of four groups: AlcoholxAnger, AlcoholxControl, SoberxAnger, SoberxControl
Masking
Participant
Masking Description
Participant will only be blind to emotion condition. Participants will be informed of their alcohol condition. Investigator and experimenter will be aware of participants' assigned condition.
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AlcoholxAnger
Arm Type
Experimental
Arm Description
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.
Arm Title
AlcoholxControl
Arm Type
Experimental
Arm Description
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.
Arm Title
SoberxAnger
Arm Type
Experimental
Arm Description
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.
Arm Title
SoberxControl
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Alcohol Administration
Intervention Description
The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
Intervention Type
Other
Intervention Name(s)
Mood Induction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sexual Aggression Intentions
Description
Ratings (1 = Not at All to 7 = Extremely) of intentions to act sexually aggressively against a hypothetical female
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Physical Aggression Intentions
Description
Ratings (1 = Not at All to 7 = Extremely) of intentions to act physically aggressively against a hypothetical female
Time Frame
20 minutes
Title
Psychological Aggression Intentions
Description
Ratings (1 = Not at All to 7 = Extremely) of intentions to act psychologically aggressively against a hypothetical female
Time Frame
20 minutes

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Participants must be biologically male participants whose gender identity is male.
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth C Neilson, PhD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morehead State University
City
Morehead
State/Province
Kentucky
ZIP/Postal Code
40351
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28375675
Citation
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.
Results Reference
background
PubMed Identifier
12022717
Citation
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.
Results Reference
background
PubMed Identifier
26048214
Citation
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.
Results Reference
background
PubMed Identifier
29606897
Citation
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.
Results Reference
background
PubMed Identifier
17690811
Citation
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.
Results Reference
background
PubMed Identifier
8271813
Citation
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.
Results Reference
background
PubMed Identifier
9358690
Citation
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.
Results Reference
background
PubMed Identifier
19515289
Citation
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.
Results Reference
background
PubMed Identifier
29348701
Citation
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.
Results Reference
background
Links:
URL
http://www.niaaa.nih.gov/research/guidelines-and-resources/administering-alcohol-human-studies
Description
Recommended council guidelines on ethyl alcohol administration in human experimentation

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Men, Mood, and Attention Study: Examination of Alcohol, State Anger, and Emotion Regulation Sexual Aggression

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