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Alcohol And Sexual Risk Behavior (PNF)

Primary Purpose

Sexually Aggressive Behavior, Risky Sexual Behavior, Heavy Episodic Drinking

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Feedback
Cognitive Skills Training
Services As Usual
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Aggressive Behavior focused on measuring Personalized Feedback, Cognitive Skills Training, Sexually Aggressive Behavior, Risky Sexual Behavior, Heavy Episodic Drinking

Eligibility Criteria

18 Years - 19 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona State UniversityRecruiting
  • University of IowaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Services As Usual

Personalized Feedback and Cognitive Training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 24, 2020
Last Updated
January 5, 2023
Sponsor
Arizona State University
Collaborators
University of Iowa, University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04416711
Brief Title
Alcohol And Sexual Risk Behavior
Acronym
PNF
Official Title
Reducing Alcohol-Related Sexual Risk Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
University of Iowa, University of New Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Aggressive Behavior, Risky Sexual Behavior, Heavy Episodic Drinking
Keywords
Personalized Feedback, Cognitive Skills Training, Sexually Aggressive Behavior, Risky Sexual Behavior, Heavy Episodic Drinking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Services As Usual
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Personalized Feedback and Cognitive Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Feedback
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Skills Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Services As Usual
Intervention Description
These participants will receive services as usual
Primary Outcome Measure Information:
Title
The Illinois Rape Myth Assessment
Description
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.
Time Frame
One month
Title
Sociosexual Attitudes
Description
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.
Time Frame
One month
Title
Alcohol Use Disorder Identification Test
Description
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.
Time Frame
One month
Title
Attraction To Sexual Aggression
Description
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.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Risky Sexual Behavior
Description
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.
Time Frame
One month
Title
Sexual Experience Survey
Description
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.
Time Frame
One month

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Gender eligibility is determined by both sex (male) at birth and identification (male).
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William Corbin, PhD
Phone
480-766-1846
Email
wcorbin@asu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Treat, PhD
Phone
319-335-3104
Email
teresa-treat@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Corbin, PhD
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Teresa Treat, PhD
Organizational Affiliation
University of Iowa
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Katie Witkiewitz, PhD
Organizational Affiliation
University of New Mexico
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85287-1104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William R Corbin, PhD
Phone
480-766-1846
Email
wcorbin@asu.edu
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa A Treat, PhD
Phone
319-335-3104
Email
teresa-treat@uiowa.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
16455857
Citation
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.
Results Reference
background
Citation
Malamuth, N.M. (1989a). The attraction to sexual aggression scale: Part One. The Journal of Sex Research, 26, 26-49.
Results Reference
background
Citation
Malamuth, N.M. (1989b). The attraction to sexual aggression scale: Part Two. The Journal of Sex Research, 26, 324-354
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
18612578
Citation
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.
Results Reference
background
PubMed Identifier
10743879
Citation
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.
Results Reference
background
PubMed Identifier
17604915
Citation
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.
Results Reference
background
PubMed Identifier
11271962
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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
Results Reference
background

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Alcohol And Sexual Risk Behavior

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