PNF: Alcohol And Sexual Risk Behavior

Sponsor
Arizona State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04416711
Collaborator
University of Iowa (Other), University of New Mexico (Other)
190
2
2
28
95
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Personalized Feedback
  • Behavioral: Cognitive Skills Training
  • Other: Services As Usual
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
190 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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).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)
Primary Purpose:
Prevention
Official Title:
Reducing Alcohol-Related Sexual Risk Behavior
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The Illinois Rape Myth Assessment [One month]

    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.

  2. Sociosexual Attitudes [One month]

    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.

  3. Alcohol Use Disorder Identification Test [One month]

    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.

  4. Attraction To Sexual Aggression [One month]

    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.

Secondary Outcome Measures

  1. Risky Sexual Behavior [One month]

    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.

  2. Sexual Experience Survey [One month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 19 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. be male college students aged 18-19 at ASU or Iowa;
    1. report at least one binge-drinking episode in the last month;
    1. be unmarried and not engaged to be married;
    1. be heterosexual or bisexual;
    1. be dating or sexually active with women; and
    1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arizona State University Tempe Arizona United States 85287-1104
2 University of Iowa Iowa City Iowa United States 52242

Sponsors and Collaborators

  • Arizona State University
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Arizona State University
ClinicalTrials.gov Identifier:
NCT04416711
Other Study ID Numbers:
  • R34AA02771301A1
First Posted:
Jun 4, 2020
Last Update Posted:
Jan 3, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Arizona State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 3, 2022