Prevention Program for Risky Sexual Behavior

(PNF Trial)

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: Unknown

190 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

What safety data exists for the Prevention Program for Risky Sexual Behavior?

The provided research abstracts do not directly address safety data for the Prevention Program for Risky Sexual Behavior or its related interventions. They focus on the effectiveness of various educational and training programs in reducing risky sexual behaviors and substance use among adolescents. None of the studies specifically mention safety data or adverse effects related to the interventions. ^{1 2 3 4}

Is Cognitive Skills Training a promising treatment for risky sexual behavior?

Yes, Cognitive Skills Training is a promising treatment for risky sexual behavior. It helps improve refusal skills, enhances communication with parents, and increases knowledge about prevention, which can reduce risky sexual activities among adolescents. ^{5 6 7 8 9}

Research Team

William Corbin, PhD

Principal Investigator

Arizona State University

Teresa Treat, PhD

Principal Investigator

University of Iowa

Katie Witkiewitz, PhD

Principal Investigator

University of New Mexico

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

[Effects of a sexual assertiveness training program in high school girls]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Safer choices: reducing teen pregnancy, HIV, and STDs. [2022]

3. United States 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. [2021]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Reducing the risk: impact of a new curriculum on sexual risk-taking. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Enhancing refusal skills: identifying contexts that place adolescents at risk for unwanted sexual activity. [2006]

7. England pubmed.ncbi.nlm.nih.gov

Effects of a Sexual Risk Reduction Program for African-American Adolescents on Social Cognitive Antecedents of Behavior Change. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Parent-adolescent relationship education (PARE): program delivery to reduce risks for adolescent pregnancy and STDs. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

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