AzTrials
AzTrials

Sexually Aggressive BehaviorPNFNCT04416711

Alcohol And Sexual Risk Behavior

A study testing Personalized Feedback, Cognitive Skills Training and Services As Usual in people with Sexually Aggressive Behavior and Risky Sexual Behavior, run by Arizona State University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 to 19 years, men only
What is being tested?
Personalized Feedback, Cognitive Skills Training and Services As Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
2 sitesUnited States
Study dates
1 Oct 2021to 31 Jan 2025
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 18 to 19 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • Do not meet the inclusion criteria

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Iowa

    Iowa City, Iowa, 52242

  • Arizona State University

    Tempe, Arizona, 85287-1104

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Personalized Feedback, Cognitive Skills Training, Services As Usual
Keywords
Personalized Feedback, Cognitive Skills Training, Sexually Aggressive Behavior, Risky Sexual Behavior, Heavy Episodic Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized FeedbackBehavioural

    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.

  • Cognitive Skills TrainingBehavioural

    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.

  • Services As UsualOther

    These participants will receive services as usual

Study groups in NCT04416711
Study groupRoleWhat they receive
Services As UsualActive comparatorParticipants 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.
Receives: Other: Services As Usual
Personalized Feedback and Cognitive TrainingExperimentalThe 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.
Receives: Behavioral: Personalized Feedback; Behavioral: Cognitive Skills Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One month

  2. 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.

    Measured: One month

  3. 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.

    Measured: One month

  4. 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.

    Measured: One month

Secondary outcomes (2)

  1. 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.

    Measured: One month

  2. 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.

    Measured: One month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start1 Oct 2021
  3. Primary completion31 Jan 2025
  4. Study completion31 Jan 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04416711
Sponsor's protocol ID
R34AA02771301A1
Acronym
PNF
Status last verified
Jun 2025
First submitted
24 May 2020
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • 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.

    PubMed 16455857

  • 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.

  • 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.

    PubMed 18612578

  • 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.

    PubMed 10743879

  • 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.

    PubMed 17604915

  • 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.

    PubMed 11271962

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Personalized Feedback, Cognitive Skills Training and Services As Usual in people with Sexually Aggressive Behavior and Risky Sexual Behavior, run by Arizona State University at 2 sites 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 6 inclusion and 1 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 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

The Illinois Rape Myth Assessment (time frame: One month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04416711, which also lists 13 linked publications.

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 4 Jun 2025.

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