Alcohol And Sexual Risk Behavior

NCT04416711 | Completed

• 1 other identifier: R34AA02771301A1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sexually Aggressive Behavior; Risky Sexual Behavior; Heavy Episodic Drinking

Keywords

Personalized Feedback; Cognitive Skills Training; Sexually Aggressive Behavior; Risky Sexual Behavior; Heavy Episodic Drinking

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Risky Sexual Behavior

  One month

• Sexual Experience Survey

  One month

Study Arms (2)

Services As Usual

ACTIVE COMPARATOR

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

Personalized Feedback and Cognitive Training

EXPERIMENTAL

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; Behavioral: Cognitive Skills Training

Interventions

Personalized Feedback BEHAVIORAL

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.

Personalized Feedback and Cognitive Training

Cognitive Skills Training BEHAVIORAL

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.

Personalized Feedback and Cognitive Training

Services As Usual OTHER

These participants will receive services as usual

Services As Usual

Eligibility Criteria

• Age: 18 Years - 19 Years
• Gender Eligibility Details: Gender eligibility is determined by both sex (male) at birth and identification (male).
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) be male college students aged 18-19 at ASU or Iowa;
• \) report at least one binge-drinking episode in the last month;
• \) be unmarried and not engaged to be married;
• \) be heterosexual or bisexual;
• \) be dating or sexually active with women; and
• \) be above the mean in rape supportive attitudes relative to 3000 college males in prior studies conducted at the two sites.

Sponsors & Collaborators

• Arizona State University: lead
• University of Iowa: collaborator
• University of New Mexico: collaborator

Study Sites (2)

Arizona State University

Tempe, Arizona, 85287-1104, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (13)

• 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.

  PMID: 16455857 BACKGROUND

• Malamuth, N.M. (1989a). The attraction to sexual aggression scale: Part One. The Journal of Sex Research, 26, 26-49.

  BACKGROUND

• Malamuth, N.M. (1989b). The attraction to sexual aggression scale: Part Two. The Journal of Sex Research, 26, 324-354

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18612578 BACKGROUND

• 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.

  PMID: 10743879 BACKGROUND

• 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.

  PMID: 17604915 BACKGROUND

• 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.

  PMID: 11271962 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

Study Officials

• William Corbin, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

• Teresa Treat, PhD

  University of Iowa

  STUDY CHAIR

• Katie Witkiewitz, PhD

  University of New Mexico

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 24, 2020
• First Posted: June 4, 2020
• Study Start: October 1, 2021
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be uploaded into the NIMH NDA every April and October. The data collection is proposed to last 2.5 years.
• Access Criteria: Access to the data will be granted through the NIMH NDA.

Locations

US (2)