Alcoholic IntoxicationNCT03956238
Alcohol Myopia, Objectification, and Sexual Assault
A study testing Alcohol intoxication and Objectification in people with Alcoholic Intoxication, run by University of Nebraska Lincoln at 1 site in United States.
Trial summary
The present project integrates previous research on factors associated with alcohol-involved sexual assault, with research on how intoxication alters attention and social perceptions in ways that increase the risk of sexual aggression and victimization. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholic Intoxication
- What is being tested?
- Alcohol intoxication and Objectification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 359 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-30 years of age
- at least social drinkers
- single
- men attracted to women, women attracted to men
Who cannot join
- current/past alcohol dependence (as assessed by a score of 8 or higher on the Alcohol Dependence Scale), alcohol-related treatment, or hospitalization due to alcohol use
- any past serious head injuries (as indicated by HELPS Brain Injury Screening Tool)
- serious psychological symptoms (defined as past psychotic, paranoid, or bipolar disorders, or current major depression)
- abstinence from alcohol use
- a condition or medication use in which alcohol consumption is medically contraindicated
- any legal restriction against drinking (e.g., as condition of probation or parole)
Show all 9Show fewer
- presence of a positive breath alcohol concentration (BAC) upon arrival to the laboratory
- if the participant is less than six feet tall and weighs over 250 pounds or is over six feet tall and weighs over 300 pounds
- if a female participant is pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska-Lincoln
Lincoln, Nebraska, 68588
About this study
Official title: Integrating Alcohol Myopia and Objectification to Understand Sexual Assault
The present project integrates previous research on factors associated with alcohol-involved sexual assault, with research on how intoxication alters attention and social perceptions in ways that increase the risk of sexual aggression and victimization. Specifically, this project examines whether alcohol intoxication on the part of a male perpetrator impairs attentional capacity and leads to a narrowing of the perceptual field causing a dehumanizing perspective of women as sexual objects for men's pleasure rather than individuals with thoughts and feelings, thereby increasing the propensity for sexual aggression. The present research also examines whether women's responses to this sexual objectification from men interfere with risk perception in sexual situations, particularly when women are drinking, increasing the likelihood of sexual victimization.
Read the detailed description
These studies will provide a comprehensive test of our proposed model of alcohol-involved sexual assault that includes situation-specific mechanisms and key moderators of sexual violence. Specifically, hypotheses will be tested in the context of two carefully controlled laboratory studies. In Study 1, laboratory alcohol administration procedures will be used to manipulate intoxication (vs. placebo control) in men. Impaired attention and objectification will then be measured multi-modally including behavioral, self-report, and implicit measures. Finally, sexual aggression will be measured with a laboratory-based analogue of sexual assault. Study 2 will include women and follow the same alcohol administration procedures as Study 1. Additionally, mirroring men's objectification, objectifying gazes (vs. eye gazes) will also be manipulated. Impaired attention, self-objectification, and decreased sexual risk perceptions will then be assessed. Prior the laboratory visit, all participants will complete a battery of questionnaires to assess key moderators including a history of sexual assault perpetration and victimization, prior sexual objectification and self-objectification, as well as alcohol-related sex expectances and rape myth acceptance. The overall model will be analyzed within a conditional process model framework.
- Conditions
- Alcoholic Intoxication
- Being tested
- Alcohol intoxication, Objectification
- Keywords
- Alcohol intoxication, Alcohol use, Drinking, Sexual assault, Sexual violence, Aggression, Attention, Victimization, Public health
- Medical subject headings
- Alcoholic Intoxication, Alcohol Drinking, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol intoxicationBehavioural
Men and women assigned to moderate alcohol dose condition (target BAC .08%) or placebo control condition with NIAAA approved alcohol administration procedures
ObjectificationBehavioural
Women assigned to objectifying gazes condition or eye contact control condition
| Study group | Role | What they receive |
|---|---|---|
| Males and Alcohol Intoxication | Experimental | Men assigned to alcohol intoxication arm (target BAC .08%) Receives: Behavioral: Alcohol intoxication |
| Males and Placebo Control | Placebo comparator | Men assigned to placebo control arm Receives: Behavioral: Alcohol intoxication |
| Females and Alcohol Intoxication and Objectifying Gazes | Experimental | Women assigned to alcohol intoxication arm (target BAC .08%) and objectifying gazes arm Receives: Behavioral: Alcohol intoxication; Behavioral: Objectification |
| Females and Alcohol Intoxication and Eye Gazes | Experimental | Women assigned to alcohol intoxication arm (target BAC .08%) and eye gazes arm Receives: Behavioral: Alcohol intoxication; Behavioral: Objectification |
| Females and Placebo Control and Objectifying Gazes | Experimental | Women assigned to placebo control arm and objectifying gazes arm Receives: Behavioral: Alcohol intoxication; Behavioral: Objectification |
| Females and Placebo Control and Eye Gazes | Placebo comparator | Women assigned to placebo control arm and eye gazes arm Receives: Behavioral: Alcohol intoxication; Behavioral: Objectification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory analogue of sexual aggression
After learning that a woman does not like sexual media, male participants choose to show her a sexually explicit video or control video (selection of the sexually explicit video indicates more sexual aggression)
Measured: 20 minutes post alcohol or placebo dosing
Sexual assault vignette measure of risk perception
Female participants read 18 vignettes describing a sexual interaction between a man and a woman that gets progressively riskier for sexual assault and indicate when they would leave the interaction (scores range from 1-18 and higher scores indicate worse risk perception)
Measured: 20 minutes post alcohol or placebo dosing
Secondary outcomes (8)
Eye-tracking measure of sexual objectification
Male participants wear a portable eye tracker and discuss media preferences with a female confederate while dwell time on the female confederate's face and body is monitored (longer dwell times on the woman's body and shorter dwell times on the woman's face indicate more sexual objectification)
Measured: 2 minutes post alcohol or placebo dosing
Eye-tracking measure of self-objectification
Female participants wear a portable eye tracker and interact with a male confederate in front of a mirror while dwell time on the participant's body is monitored (longer dwell times on the participant's body indicates more self-objectification)
Measured: 2 minutes post alcohol or placebo dosing
Object brief-implicit association task
On a computer, male participants sort stimuli words representing the categories object (e.g., tool), human (e.g., person), women (e.g., female), and men (male). Participants must respond as quickly and accurately as possible to categorize the words on a computer screen to object, human, women, and men categories via a computer key press. Responding faster to object and woman words and slower to woman and human words indicates implicit objectification of women
Measured: 25 minutes post alcohol or placebo dosing
Self-object brief-implicit association task
On a computer, female participants sort stimuli words representing the categories object (e.g., tool), human (e.g., person), me (e.g., self), and others (them). Participants must respond as quickly and accurately as possible to categorize the words on a computer screen to object, human, me, and others categories via a computer key press. Responding faster to object and me words and slower to human and me words indicates implicit self-objectification.
Measured: 25 minutes post alcohol or placebo dosing
Self-report state mindful attention awareness scale
Male and female participants self-report how attentive they feel on a 0 to 6 point scale (averaged lower scores indicate more mindful attention awareness)
Measured: 30 minutes post alcohol or placebo dosing
Self-report other-objectification questionnaire
Male participants self-report how frequently they objectified the female confederate on a 1 to 6 point scale (averaged higher scores indicate more other-objectification)
Measured: 35 minutes post alcohol or placebo dosing
Self-report self-objectification questionnaire
Female participants self-report how important appearance related attributes (e.g., sex appeal) are important to their self-concept relative to non-appearance attributes (e.g., hobbies) on a 0 to 9 point scale. Appearance attributes and non-appearance attributes are separately summed and non-appearance attribute scores are subtracted from appearance attribute scores (higher scores indicate more self-objectification)
Measured: 35 minutes post alcohol or placebo dosing
Saliva collection
Female participants provide saliva samples to assess cortisol associated with stress responses
Measured: 5 minutes pre alcohol or placebo dosing, 5 minutes post alcohol dosing, and 20 minutes post alcohol or placebo dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start22 Apr 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic IntoxicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Sarah Gervais, PhD, Principal investigator, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956238
- Sponsor's protocol ID
- 18599
- Other IDs
- R01AA025090
- Status last verified
- Jul 2023
- First submitted
- 2 May 2019
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data may be shared with other researchers (e.g., posted to the Open Science Framework) to aid with reproducibility and replicability of science.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Alcohol Myopia and Objectification to Understand Sexual Assault
- ClinicalTrials.gov ID
- NCT03956238
- Acronym / sponsor ID
- 18599
- Conditions
- Alcoholic Intoxication
- Keywords
- Alcohol intoxication, Alcohol use, Drinking, Sexual assault, Sexual violence, Aggression, Attention, Victimization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present project integrates previous research on factors associated with alcohol-involved sexual assault, with research on how intoxication alters attention and social perceptions in ways that increase the risk of sexual aggression and victimization. Specifically, this project examines whether alcohol intoxication on the part of a male perpetrator impairs attentional capacity and leads to a narrowing of the perceptual field causing a dehumanizing perspective of women as sexual objects for men's pleasure rather than individuals with thoughts and feelings, thereby increasing the propensity for sexual aggression. The present research also examines whether women's responses to this sexual objectification from men interfere with risk perception in sexual situations, particularly when women are drinking, increasing the likelihood of sexual victimization.
Detailed description
These studies will provide a comprehensive test of our proposed model of alcohol-involved sexual assault that includes situation-specific mechanisms and key moderators of sexual violence. Specifically, hypotheses will be tested in the context of two carefully controlled laboratory studies. In Study 1, laboratory alcohol administration procedures will be used to manipulate intoxication (vs. placebo control) in men. Impaired attention and objectification will then be measured multi-modally including behavioral, self-report, and implicit measures. Finally, sexual aggression will be measured with a laboratory-based analogue of sexual assault. Study 2 will include women and follow the same alcohol administration procedures as Study 1. Additionally, mirroring men's objectification, objectifying gazes (vs. eye gazes) will also be manipulated. Impaired attention, self-objectification, and decreased sexual risk perceptions will then be assessed. Prior the laboratory visit, all participants will complete a battery of questionnaires to assess key moderators including a history of sexual assault perpetration and victimization, prior sexual objectification and self-objectification, as well as alcohol-related sex expectances and rape myth acceptance. The overall model will be analyzed within a conditional process model framework.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Males and Alcohol Intoxication | Experimental | Behavioral: Alcohol intoxicationMen assigned to alcohol intoxication arm (target BAC .08%) |
| Males and Placebo Control | Placebo comparator | Behavioral: Alcohol intoxicationMen assigned to placebo control arm |
| Females and Alcohol Intoxication and Objectifying Gazes | Experimental | Behavioral: Alcohol intoxication, Behavioral: ObjectificationWomen assigned to alcohol intoxication arm (target BAC .08%) and objectifying gazes arm |
| Females and Alcohol Intoxication and Eye Gazes | Experimental | Behavioral: Alcohol intoxication, Behavioral: ObjectificationWomen assigned to alcohol intoxication arm (target BAC .08%) and eye gazes arm |
| Females and Placebo Control and Objectifying Gazes | Experimental | Behavioral: Alcohol intoxication, Behavioral: ObjectificationWomen assigned to placebo control arm and objectifying gazes arm |
| Females and Placebo Control and Eye Gazes | Placebo comparator | Behavioral: Alcohol intoxication, Behavioral: ObjectificationWomen assigned to placebo control arm and eye gazes arm |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 21-30 years of age
- at least social drinkers
- single
- men attracted to women, women attracted to men
Key exclusion criteria (9 listed)
- current/past alcohol dependence (as assessed by a score of 8 or higher on the Alcohol Dependence Scale), alcohol-related treatment, or hospitalization due to alcohol use
- any past serious head injuries (as indicated by HELPS Brain Injury Screening Tool)
- serious psychological symptoms (defined as past psychotic, paranoid, or bipolar disorders, or current major depression)
- abstinence from alcohol use
- a condition or medication use in which alcohol consumption is medically contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol intoxicationMen and women assigned to moderate alcohol dose condition (target BAC .08%) or placebo control condition with NIAAA approved alcohol administration procedures | Behavioural | Females and Alcohol Intoxication and Eye Gazes, Females and Alcohol Intoxication and Objectifying Gazes, Females and Placebo Control and Eye Gazes, Females and Placebo Control and Objectifying Gazes, Males and Alcohol Intoxication, Males and Placebo Control |
| ObjectificationWomen assigned to objectifying gazes condition or eye contact control condition | Behavioural | Females and Alcohol Intoxication and Eye Gazes, Females and Alcohol Intoxication and Objectifying Gazes, Females and Placebo Control and Eye Gazes, Females and Placebo Control and Objectifying Gazes |
Primary outcome
Laboratory analogue of sexual aggression
Time frame: 20 minutes post alcohol or placebo dosing
After learning that a woman does not like sexual media, male participants choose to show her a sexually explicit video or control video (selection of the sexually explicit video indicates more sexual aggression)
Sexual assault vignette measure of risk perception
Time frame: 20 minutes post alcohol or placebo dosing
Female participants read 18 vignettes describing a sexual interaction between a man and a woman that gets progressively riskier for sexual assault and indicate when they would leave the interaction (scores range from 1-18 and higher scores indicate worse risk perception)
8 secondary outcomes
Eye-tracking measure of sexual objectification
Time frame: 2 minutes post alcohol or placebo dosing
Eye-tracking measure of self-objectification
Time frame: 2 minutes post alcohol or placebo dosing
Object brief-implicit association task
Time frame: 25 minutes post alcohol or placebo dosing
Self-object brief-implicit association task
Time frame: 25 minutes post alcohol or placebo dosing
Self-report state mindful attention awareness scale
Time frame: 30 minutes post alcohol or placebo dosing
Self-report other-objectification questionnaire
Time frame: 35 minutes post alcohol or placebo dosing
Self-report self-objectification questionnaire
Time frame: 35 minutes post alcohol or placebo dosing
Saliva collection
Time frame: 5 minutes pre alcohol or placebo dosing, 5 minutes post alcohol dosing, and 20 minutes post alcohol or placebo dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data may be shared with other researchers (e.g., posted to the Open Science Framework) to aid with reproducibility and replicability of science.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Gervais, PhD principal investigator
University of Nebraska Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol intoxication and Objectification in people with Alcoholic Intoxication, run by University of Nebraska Lincoln at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory analogue of sexual aggression (time frame: 20 minutes post alcohol or placebo dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.