Alcohol And Sexual Risk Behavior (PNF)

Reducing Alcohol-Related Sexual Risk Behavior

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.

Study Overview

• Status: Completed
• Conditions: Risky Sexual Behavior; Heavy Episodic Drinking; Sexually Aggressive Behavior
• Intervention / Treatment: Other: Services As Usual; Behavioral: Personalized Feedback; Behavioral: Cognitive Skills Training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85287-1104
      • Arizona State University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 19 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Services As Usual; 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; These participants will receive services as usual
Experimental: Personalized Feedback and Cognitive Training; 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; 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.; Behavioral: Cognitive Skills Training; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: University of Iowa; University of New Mexico
• Investigators: Principal Investigator: William Corbin, PhD, Arizona State University; Study Chair: Teresa Treat, PhD, University of Iowa; Study Chair: Katie Witkiewitz, PhD, University of New Mexico

Publications and helpful links

General Publications

• Kahler CW, Hustad J, Barnett NP, Strong DR, Borsari B. Validation of the 30-day version of the Brief Young Adult Alcohol Consequences Questionnaire for use in longitudinal studies. J Stud Alcohol Drugs. 2008 Jul;69(4):611-5. doi: 10.15288/jsad.2008.69.611.
• Bohner G, Siebler F, Schmelcher J. Social norms and the likelihood of raping: Perceived rape myth acceptance of others affects men's rape proclivity. Pers Soc Psychol Bull. 2006 Mar;32(3):286-97. doi: 10.1177/0146167205280912.
• Malamuth, N.M. (1989a). The attraction to sexual aggression scale: Part One. The Journal of Sex Research, 26, 26-49.
• Malamuth, N.M. (1989b). The attraction to sexual aggression scale: Part Two. The Journal of Sex Research, 26, 324-354
• Bohner, G., Reinhard, M.A., Rutz, S., Sturm, S., Kerschbaum, B., & Effler, D. (1998). Rape myths as neutralizing cognitions: Evidence for a causal impact of anti-victim attitudes on men's self-reported likelihood of raping. European Journal of Social Psychology, 28, 257-268.
• Babor, T. F., de la Fuente, J. R., Saunders, J., & Grant, M. (1992). AUDIT. The Alcohol Use Disorders Identification Test. Guidelines for Use in Primary Health Care. Geneva, Switzerland: World Health Organization.
• Sobell, L. C., & Sobell, M. B. (1992). Timeline Follow-back: A technique for assessing self-reported ethanol consumption. In J. Allen & R. Z. Litten (Eds.), Measuring Alcohol Consumption: Psychosocial and Biological Methods (pp. 41-72). Totowa, NJ: Humana Press.
• Bailey JM, Kirk KM, Zhu G, Dunne MP, Martin NG. Do individual differences in sociosexuality represent genetic or environmentally contingent strategies? Evidence from the Australian twin registry. J Pers Soc Psychol. 2000 Mar;78(3):537-45. doi: 10.1037//0022-3514.78.3.537.
• Larimer ME, Cronce JM. Identification, prevention, and treatment revisited: individual-focused college drinking prevention strategies 1999-2006. Addict Behav. 2007 Nov;32(11):2439-68. doi: 10.1016/j.addbeh.2007.05.006. Epub 2007 May 17.
• Wood MD, Read JP, Palfai TP, Stevenson JF. Social influence processes and college student drinking: the mediational role of alcohol outcome expectancies. J Stud Alcohol. 2001 Jan;62(1):32-43. doi: 10.15288/jsa.2001.62.32.
• Koss, M. P., Abbey, A., Campbell, R., Cook, S., Norris, J., Testa, M., Ullman, S., West, C., & White, J. (2006a). The Sexual Experiences Short Form Perpetration (SES-SFP). Tucson, AZ: University of Arizona.
• Koss, M. P. Abbey, A., Campbell, R., Cook, S., Norris, J., Testa, M., Ullman, S., West, C., & White, J. (2006b). The Sexual Experiences Long Form Perpetration (SES-LFP). Tucson, AZ: University of Arizona.
• Koss, M. P., Abbey, A., Campbell, R., Cook, S; Norris, J., Testa, C., Ullman, S., West, C., & White, J. (2007). Revising the SES: A collaborative process to improve assessment of sexual aggression and victimization. Psychology of Women Quarterly, 31, 357-370

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: May 24, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Risky Sexual Behavior; Personalized Feedback; Cognitive Skills Training; Sexually Aggressive Behavior; Heavy Episodic Drinking
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Aggression
• Other Study ID Numbers: R34AA02771301A1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Per NOT-AA-19-020, this study will submit and share data with NIAAA Data Archive (NIAAADA), a data repository housed within the NIMH Data Archive (NDA).
• IPD Sharing Time Frame: Data will be uploaded into the NIMH NDA every April and October. The data collection is proposed to last 2.5 years.
• IPD Sharing Access Criteria: Access to the data will be granted through the NIMH NDA.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No