iTRAC-HERO for Risky Sexual Behavior

(iTRAC-HERO Trial)

Overseen By Julia Berteletti

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Klein Buendel, Inc.

Disqualifiers: Reading level, Sibling, Development disorder

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called iTRAC-HERO, which helps middle school students manage emotions and make safer sexual health choices. The program includes eight online modules designed to boost confidence in refusing risky situations. It targets seventh graders at participating schools whose parents speak English or Spanish. This trial is for students comfortable reading at a fourth-grade level and without developmental disorders. Participants in the control group will gain access to the program after six months. As an unphased trial, this study offers students the chance to be among the first to benefit from innovative educational tools.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the iTRAC-HERO intervention is safe for middle school students?

Research shows that the iTRAC-HERO program, which teaches skills to manage emotions, is likely safe for participants. Studies of similar programs have shown good results, such as delaying sexual activity and reducing risky sexual behaviors. This suggests that teenagers generally receive the tools and methods used in iTRAC-HERO well. As an online educational program, iTRAC-HERO does not involve taking medicine or undergoing physical procedures, typically resulting in fewer side effects compared to drug treatments. Research has identified no specific safety issues, further supporting its safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about iTRAC-HERO because it offers a fresh approach to preventing risky sexual behavior in adolescents by focusing on emotion regulation and sexual self-efficacy. Unlike traditional programs that may rely on in-person education or generalized health classes, iTRAC-HERO is a web-based intervention specifically designed for middle school students, making it easily accessible and potentially more engaging for tech-savvy teens. By targeting the ability to manage emotions and confidently refuse unwanted sexual advances, this program aims to empower young people in a way that current options might not fully address.

What evidence suggests that iTRAC-HERO is effective for reducing risky sexual behavior?

Research has shown that iTRAC-HERO builds on the success of a similar program called iTRAC. Studies found that teenagers who learned to manage their emotions through iTRAC delayed having vaginal sex by about 30 months compared to others. Additionally, those already sexually active showed a decrease in risky behaviors, such as having unprotected sex. These findings suggest that teaching emotion management can help young people make safer choices about sexual health. In this trial, participants in the iTRAC-HERO arm will engage in an 8-module, web-based intervention designed to encourage both emotional and sexual self-control in middle school students. ^{1 2 4 5 6}

Who Is on the Research Team?

Christopher Houck, PhD

Principal Investigator

Rhode Island Hospital

Are You a Good Fit for This Trial?

This trial is for adolescents who may engage in risky sexual behavior and need to improve their emotion regulation skills. Specific eligibility criteria are not provided, so it's best to contact the study team for details.

Inclusion Criteria

Attending 7th grade

I am between 12 and 14 years old.

Attending participating school

Exclusion Criteria

Unable to read at a 4th grade level

Have a sibling who has participated in the study

Have a developmental disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development and testing of the iTRAC-HERO web app, including acceptability testing and modifications based on participant feedback

Not specified

Treatment

Participants complete the 8-module iTRAC-HERO web-based intervention targeting emotion regulation and sexual self-efficacy

8 weeks

Follow-up

Participants are monitored for changes in emotion regulation behaviors, self-efficacy, and sexual risk behaviors

6 months

What Are the Treatments Tested in This Trial?

Interventions

• iTRAC-HERO

Trial Overview The iTRAC-HERO program is being tested. It's an internet-based intervention that builds on the existing iTRAC system, aiming to teach adolescents how to manage their emotions better in situations related to sexual health.

How Is the Trial Designed?

Group I: iTRAC-HERO Experimental Treatment 1 Intervention

iTRAC-HERO is an 8-module, web-based intervention for middle school boys and girls to complete. Its goal is primary prevention of adolescent sexual risk behaviors by targeting emotion regulation and sexual self-efficacy. (e.g., to refuse sexual advances).

Group II: Waitlist Control Active Control 1 Intervention

Control participants will be assessed on the same schedule as the treatment condition and offered the intervention after 6-month follow-up.

Who Is Running the Clinical Trial?

Klein Buendel, Inc.

Lead Sponsor

Trials

41

Recruited

20,000+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

Rhode Island Hospital

Collaborator

Trials

275

Recruited

71,400+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

In a study involving 26 healthy male volunteers, applying 5.0 g of a 2.5% testosterone gel daily for 10 days successfully restored physiological testosterone levels, while 2.5 g was insufficient for this purpose.

Washing the gel off 10 minutes after application did not affect testosterone absorption, which helps minimize the risk of contamination for female partners or infants, enhancing the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of a new transdermal testosterone gel in gonadotrophin-suppressed normal men. Rolf, C., Kemper, S., Lemmnitz, G., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9560987/

A Pilot Study of a Tablet-Based Emotion Regulation ... This study examined the feasibility, acceptability, and preliminary outcomes of iTRAC (internet-based Talking About Risk and Adolescent Choices), a tablet ...

2. researchgate.net researchgate.net/publication/325068247_Sexual_Risk_Outcomes_of_an_Emotion_Regulation_Intervention_for_At-Risk_Early_Adolescents

Sexual Risk Outcomes of an Emotion Regulation ... Results: Adolescents who received ER skills training exhibited a delay in the transition to vaginal sex over 30 months compared with those in the comparison ...

3. reporter.nih.gov reporter.nih.gov/project-details/10928821

Project Details Internet-based TRAC (i-TRAC): Interactive Emotion Regulation Skills Training to Improve Adolescent Sexual Health Adolescence is a critical developmental ...

4. kbcollaboratory.com kbcollaboratory.com/tag/sexual-behavior/

Sexual Behavior Archives iTRAC will be a web-based program for “Talking about Risk and Adolescent Choices” to prevent risky sexual behavior and negative sexual health ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6317536/

Sexual Risk Outcomes of an Emotion Regulation ... The ER intervention appears to have reduced risk in the following 2 ways: delaying sexual activity and reducing sexual risk behaviors among sexually active ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29748192/

Sexual Risk Outcomes of an Emotion Regulation Intervention ... Objective: With this study, we examined the efficacy of a health intervention program that was focused on emotion regulation (ER) skills in reducing sexual risk ...