Alcohol And Sexual Risk Behavior

Study Overview
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Brief Summary
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The current study proposes to develop, refine, and conduct a preliminary randomized controlled trial (RCT) of an innovative prevention program that is the first to (a) simultaneously target heavy episodic drinking (HED), sexually aggressive behavior (SAB), and risky sexual behavior (RSB) among college men; (b) integrate personalized feedback and cognitive training strategies; and (c) target the five major modifiable risk factors for SAB: HED, impersonal sex, misperceptions of sexual interest, rape-supportive attitudes, and peer influence. The program will be computer-delivered as this approach is well received by college students.

Detailed Description
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The study will include three phases (pilot feasibility n=10; pilot acceptability/efficacy n=40; RCT n=140), with 190 men at risk for HED, RSB, and SAB. Participants in the RCT will be randomly assigned to either the computer-based program or services as usual at 2 large public universities in the midwest and southwest U.S. The three study phases will address the following aims: AIM ONE: Examine the feasibility of the computer administered personalized feedback and cognitive training approach (Phase I; n=10), and the acceptability and efficacy of individual intervention components based on skills assessments and interviews at 1-month follow-up (Phase II; n=40). Data from Phases I and II will be used to modify and streamline the intervention prior to the RCT (Phase III). AIM TWO: In an RCT (n=140), evaluate whether the prevention program impacts cognitive training and personalized feedback targets at 1-month follow-up, relative to services as usual (SAU). Cognitive training targets include (a) enhanced focus on women's affect; (b) reduced focus on women's non-affective cues; and (c) correction of over-perceptions of women's sexual interest. Personalized feedback targets include (a) increased readiness to change; (b) increased perceptions of risk; and (c) reduced misperceptions of peer attitudes and behaviors. AIM THREE: Evaluate whether the prevention program shows short-term effects on attitudinal (e.g., rape supportive and sociosexual attitudes) and behavioral outcomes (SAB, HED, and RSB) at 1-month follow-up.

Official Title
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Reducing Alcohol-Related Sexual Risk Behavior

Conditions
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Sexually Aggressive Behavior, Risky Sexual Behavior, Heavy Episodic Drinking

Intervention / Treatment
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* Behavioral: Personalized Feedback
* Behavioral: Cognitive Skills Training
* Other: Services As Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) be male college students aged 18-19 at ASU or Iowa; 2) report at least one binge-drinking episode in the last month; 3) be unmarried and not engaged to be married; 4) be heterosexual or bisexual; 5) be dating or sexually active with women; and 6) be above the mean in rape supportive attitudes relative to 3000 college males in prior studies conducted at the two sites. Exclusion Criteria: Do not meet the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This two-site prevention trial will be conducted at Arizona State University (ASU) and the University of Iowa (Iowa). Participants will be 190 college men aged 18-19 (50% at each site). Scientific rigor will be ensured by (a) examining the feasibility of the intervention components in Phase I (n = 10); (b) evaluating the acceptability and preliminary efficacy of the intervention components in a Phase II open trial (n = 40); and (c) conducting a small randomized controlled trial (RCT; n = 140) in which participants will be randomly assigned (stratified by rape-supportive attitudes, frequency of HED, and frequency of sexual behavior) to either the treatment or services as usual (Phase III).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Services As Usual<br>Participants assigned to the SAU condition will receive services as usual at their university, which include required programming related to heavy episodic drinking and sexually aggressive behavior either online or through new-student orientation. | Other: Services As Usual<br>* These participants will receive services as usual<br>|
| Experimental: Personalized Feedback and Cognitive Training<br>The prevention program will target heavy episodic drinking, sexually aggressive behavior, and risky sexual behavior through 2 sessions that integrate personalized feedback and cognitive training components. | Behavioral: Personalized Feedback<br>* The personalized feedback consists of four components: normative feedback, risk/protective feedback, decisional balance/goal setting, and protective strategy review. Personalized feedback targets include readiness to change, perceptions of risk, and misperceptions of peer attitudes/behaviors.<br>Behavioral: Cognitive Skills Training<br>* We will address three cognitive targets: focus on affective cues, focus on non-affective cues, and over-perception of sexual interest. The first module targets enhanced focus on women's affective cues and reduced over-perception of sexual interest. We will introduce the role of men's sexual-perception skills in satisfying social and sexual interactions with women, as well as problematic sexual behavior including RSB and SAB. Next, we will instruct participants that affective information is the best-available nonverbal information about how a woman is feeling about a specific man. This instruction will focus on distinguishing four primary dating relevant cues: sexual-interest, friendliness, sadness, and rejection. More detailed focus on each cue will emphasize the increased difficulty of reading these cues with a new partner and under the influence of alcohol and sexual arousal, as well as the importance of checking verbally on assumptions about a woman's current sexual interest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Illinois Rape Myth Assessment | The Illinois Rape Myth Assessment - Short Form (IRMA-SF) will assess rape supportive attitudes (Payne, Lonsway, & Fitzgerald, 1999). Maximum values are 1 and maximum 7. Higher scores indicate more supportive attitudes. | One month | 
| Sociosexual Attitudes | Sociosexual attitudes will be assessed using 15 items from Bailey et al. (2000). This is not a validated scale but rather several items from past research. The scale ranges from 1 to 5, with higher scores being stronger attitudes. | One month | 
| Alcohol Use Disorder Identification Test | Heavy drinking will be assessed using the AUDIT. Specifically, one item asks about frequency of alcohol use, one item asks about frequency of binge drinking, and one item asks about quantity of alcohol use. Higher scores mean more drinking. | One month | 
| Attraction To Sexual Aggression | Rape proclivity will be assessed using the Attraction to Sexual Aggression scale (Malamuth, 1989a; Malamuth, 1989b), where participants rate their likelihood of engaging in sexual aggresion from 0-100%. Higher percentage equals higher attraction to sexual aggression. | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risky Sexual Behavior | Engagement in risky sexual behavior will be assessed using 8 items from Bailey et al. (2000). Similar to sociosexual attitudes, these are items from a past study. Responses range from 1 to 7, with higher values indicating more risky sexual behavior. | One month | 
| Sexual Experience Survey | Will be assessed using a total of 21 items primarily based on the Sexual Experience Survey - Short Form Perpetrator (Koss et al., 2006a; Koss et al., 2006b; Koss et al., 2007). We will add all items together. Responses range from 1 to 4, with higher values indicating more sexual aggression. | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Personalized Feedback, Cognitive Skills Training, Sexually Aggressive Behavior, Risky Sexual Behavior, Heavy Episodic Drinking