Prevention Program for Risky Sexual Behavior

(PNF Trial)

No longer recruiting at 1 trial location

Overseen By Teresa Treat, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Arizona State University

Disqualifiers: Not male, Not college student, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to develop and test a new program to reduce risky behaviors among college men, focusing on heavy drinking, sexually aggressive actions, and unsafe sexual practices. The program includes personalized feedback and cognitive skills training, delivered through a computer for easy student access. It targets male college students who have experienced at least one binge-drinking episode in the past month and hold certain attitudes towards sexual behavior. Participants will either receive the new program or continue with their university's usual services. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to more effective interventions for college students.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this prevention program is safe for college students?

Research has shown that personalized feedback methods, like the one used in this study, are generally safe and well-tolerated. These methods help reduce risky behaviors, such as heavy drinking and unsafe sexual activities, without causing harm. For example, one study found that even a single session of personalized feedback effectively reduced problem drinking.

Similarly, cognitive skills training, another part of the trial, has been widely studied. Evidence suggests that these sessions significantly help reduce substance use and risky behaviors. In one study, students who attended at least 60% of the cognitive training sessions showed lower rates of risky behavior.

Both personalized feedback and cognitive skills training have been researched for their safety and effectiveness in managing risky behaviors, especially among college students. Overall, these approaches have been well-received and are considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines Cognitive Skills Training and Personalized Feedback to tackle risky sexual behaviors and heavy episodic drinking. Unlike standard interventions that might rely solely on educational programs or counseling, this approach integrates personalized, data-driven feedback with cognitive training exercises to directly influence behavior change. This dual-component strategy aims to enhance self-awareness and decision-making skills, potentially offering more effective and lasting results compared to traditional methods. By addressing both cognitive and behavioral aspects, this program could significantly reduce risky behaviors and improve overall well-being.

What evidence suggests that this trial's treatments could be effective for risky sexual behavior?

This trial will compare different approaches to reducing risky sexual behavior and heavy drinking among college students. Research has shown that personalized feedback, one of the strategies tested in this trial, can reduce dangerous drinking by correcting misunderstandings about peer drinking habits, leading to less risky behavior such as heavy drinking and sexual aggression. Another strategy in this trial, training in thinking skills, improves how students manage their emotions and make decisions, which can reduce risky sexual behavior and aggression. These approaches target key risk factors like binge drinking and misconceptions about sexual interest, which are linked to sexually aggressive behavior. Early studies combining these strategies have shown promise in addressing these related issues among college men. ^{6 7 8 9 10}

Who Is on the Research Team?

William Corbin, PhD

Principal Investigator

Arizona State University

Katie Witkiewitz, PhD

Principal Investigator

University of New Mexico

Teresa Treat, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for male college students aged 18-19 at ASU or Iowa who binge drink, are unmarried, dating or sexually active with women, and have above-average rape-supportive attitudes. Heterosexual or bisexual men can join. The study aims to help reduce heavy drinking and prevent sexual aggression.

Inclusion Criteria

You have shown support for rape in previous studies conducted at the same location.

You cannot be married or planning to get married.

You are in a romantic or sexual relationship with a woman.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Feasibility

Examine the feasibility of the computer-administered personalized feedback and cognitive training approach

1 month

1 visit (in-person)

Pilot Acceptability/Efficacy

Assess the acceptability and efficacy of individual intervention components based on skills assessments and interviews

1 month

1 visit (in-person)

Randomized Controlled Trial (RCT)

Evaluate the impact of the prevention program on cognitive training and personalized feedback targets

1 month

2 sessions (computer-based)

Follow-up

Participants are monitored for short-term effects on attitudinal and behavioral outcomes

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol And Sexual Risk Behavior
• Cognitive Skills Training
• Personalized Feedback
• Services As Usual

Trial Overview

The study tests a new prevention program that combines personalized feedback with cognitive skills training to address heavy drinking, sexual aggression, and risky behavior in college men. It's computer-delivered and tackles factors like misperceptions of sexual interest.

How Is the Trial Designed?

Group I: Personalized Feedback and Cognitive Training Experimental Treatment 2 Interventions

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.

Group II: Services As Usual Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Published Research Related to This Trial

The 'Reducing the Risk' sexuality education curriculum significantly improved knowledge and communication about abstinence and contraception among 758 high school students over an 18-month period, particularly benefiting those who had not yet initiated sexual intercourse.

For students who had not engaged in sexual activity before the program, the curriculum effectively delayed the onset of intercourse and increased contraceptive use, especially among lower risk youths and females, while not significantly impacting sexually experienced students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing the risk: impact of a new curriculum on sexual risk-taking. Kirby, D., Barth, RP., Leland, N., et al.[2015]

The Interactive Program (IP) significantly improved parental communication and established stronger rules regarding sexual health behaviors among adolescents compared to the Attention Control Program (ACP).

Participants in the IP also showed enhanced self-control, gaining better knowledge about prevention and improved resistance skills against peer pressure related to sexual activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-adolescent relationship education (PARE): program delivery to reduce risks for adolescent pregnancy and STDs. Lederman, RP., Chan, W., Roberts-Gray, C.[2021]

A 3-hour training program on sexual assertiveness for high school girls significantly improved their sexual assertiveness scores compared to a control group, demonstrating its effectiveness.

The 6-hour program also improved sexual assertiveness scores but did not show any additional benefits over the 3-hour program, suggesting that shorter training may be sufficient and more convenient for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of a sexual assertiveness training program in high school girls]. Chang, SB., Lee, SK., Kim, YR.[2019]

The sexual risk reduction intervention significantly improved adolescents' knowledge, self-efficacy, attitudes, and intentions regarding safer sex practices, based on a randomized control trial with 763 participants.

Despite these positive outcomes, the program did not change attitudes toward abstinence, peer norms, or perceived vulnerability, suggesting that while knowledge and intentions improved, the overall behavioral impact may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Sexual Risk Reduction Program for African-American Adolescents on Social Cognitive Antecedents of Behavior Change. Walsh, S., Jenner, E., Leger, R., et al.[2022]

Social skills training has been shown to effectively reduce substance use and related behaviors in adolescents, such as aggression and truancy, suggesting it is a valuable prevention strategy.

The effectiveness of social skills training is enhanced when it includes modeling techniques and focuses on normal adolescents, with long-term benefits that generalize to various aspects of adolescent life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of adolescent substance abuse through social skill development. Pentz, MA.[2004]

The newly developed computer-assisted instructional package for life skills (CAIFLS) significantly improved life skills awareness among 87 Thai early adolescents, with the experimental group showing a meaningful increase in scores compared to the control group (p < .05).

Students expressed high satisfaction with the CAIFLS program, indicating it is an effective tool for educating adolescents about risky sexual behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a computer-assisted instructional package for life skills to prevent risky sexual behaviors in early adolescents, Bangkok, Thailand. Neranon, W., Thongsong, L.[2022]

A study involving 56 sexually active female adolescents identified 59 high-risk contexts for unwanted sexual activity, emphasizing the importance of relevant scenarios in refusal skills training.

Contexts such as unsupervised activities with alcohol and feelings of obligation were rated as both common and difficult, highlighting key areas to focus on in developing effective refusal skills training to reduce unwanted sexual activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing refusal skills: identifying contexts that place adolescents at risk for unwanted sexual activity. Warzak, WJ., Grow, CR., Poler, MM., et al.[2006]

The Safer Choices program, evaluated over 31 months with 3869 ninth-grade students, significantly improved condom use and reduced unprotected intercourse, demonstrating its effectiveness in lowering sexual risk behaviors.

While the program enhanced several psychosocial factors related to safe sex, it did not significantly affect the rates of sexual initiation among students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safer choices: reducing teen pregnancy, HIV, and STDs. Coyle, K., Basen-Engquist, K., Kirby, D., et al.[2022]

A school-based substance use prevention program called Saluda, which included social skills training and problem-solving training, significantly reduced alcohol use and intentions to use other substances among 341 Spanish students aged 12 to 15.

The most effective results were observed in the full program that included all components, indicating that a comprehensive approach may be more beneficial than tailored interventions focusing on individual components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Component analysis of a school-based substance use prevention program in Spain: contributions of problem solving and social skills training content. Espada, JP., Griffin, KW., Pereira, JR., et al.[2021]

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