Clinical trial NCT04416711: Alcohol And Sexual Risk Behavior
Official title: Reducing Alcohol-Related Sexual Risk Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: University of New Mexico
First posted: 2020-06-04
Enrollment: 108
Sex: MALE
Minimum age (years): 18
Maximum age (years): 19
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The Illinois Rape Myth Assessment
timeFrame: One month
measure: Sociosexual Attitudes
timeFrame: One month
measure: Alcohol Use Disorder Identification Test
timeFrame: One month
measure: Attraction To Sexual Aggression
timeFrame: One month
Secondary outcomes:
measure: Risky Sexual Behavior
timeFrame: One month
measure: Sexual Experience Survey
timeFrame: One month
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: Arizona State University
name: William Corbin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Teresa Treat, PhD
role: STUDY_CHAIR
affiliation: University of New Mexico
name: Katie Witkiewitz, PhD
role: STUDY_CHAIR
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