Alcohol And Sexual Risk Behavior (PNF)

Arizona State University (ASU)

Status: Enrolling

Conditions: Heavy Episodic Drinking; Risky Sexual Behavior; Sexually Aggressive Behavior

Treatments: Behavioral: Personalized Feedback; Other: Services As Usual; Behavioral: Cognitive Skills Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04416711

R34AA02771301A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 estimated patients

Sex: Male

Ages: 18 to 19 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Services As Usual

Active Comparator group

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.

Treatment:

Other: Services As Usual

Personalized Feedback and Cognitive Training

Experimental group

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.

Treatment:

Behavioral: Cognitive Skills Training

Behavioral: Personalized Feedback