Internet-based Talking About Risk and Adolescent Choices: Health and Emotion Regulation Options

Not Applicable

Recruiting

• Conditions: Risky Sexual Behavior; Emotion Regulation; Adolescent Behavior

• Registration Number: NCT06894277
• Lead Sponsor: Klein Buendel, Inc.

Brief Summary

Using the efficacious iTRAC intervention to enhance emotion regulation competencies as a foundation, this study will create and test iTRAC-HERO to teach emotion regulation skills in the context of sexual health education.

Detailed Description

Adolescence is a critical developmental period during which behavioral patterns are formed that have powerful influences on current and future health. This is particularly true for sexual behavior, which is affected by the biological changes of puberty as well as normative developmental tasks around sexual exploration. Engaging in sexual behavior in early adolescence (before age 15) is associated with more partners, less condom use, and more frequent sex as teens get older, and these factors increase risk for negative health outcomes (e.g., sexually transmitted infections and unplanned pregnancy) throughout their lives. Many sexual health interventions teach prevention skills, such as assertiveness or condom use; the premise of the current application is that these skills are often unused by adolescents because of deficits in emotion regulation (ER), which is unaddressed in most sexual health education. Our research team has developed and tested a novel, engaging, efficacious, and developmentally tailored group intervention (Project TRAC) to teach ER skills to early adolescents within the context of sexual health. A study of Project TRAC showed that participants taught ER skills were less likely to start having sex over the 2.5 year follow up. While efficacious, the small group format of the Adolescence is a critical developmental period during which behavioral patterns are formed that have powerful influences on current and future health. This is particularly true for sexual behavior, which is affected by the biological changes of puberty as well as normative developmental tasks around sexual exploration. Engaging in sexual behavior in early adolescence (before age 15) is associated with more partners, less condom use, and more frequent sex as teens get older, and these factors increase risk for negative health outcomes (e.g., sexually transmitted infections and unplanned pregnancy) throughout their lives. Many sexual health interventions teach prevention skills, such as assertiveness or condom use; the premise of the current trial is that these skills are often unused by adolescents because of deficits in emotion regulation (ER), which is un-addressed in most sexual health education. The research team has developed and tested a novel, engaging, efficacious, and developmentally tailored group intervention (Project TRAC) to teach ER skills to early adolescents within the context of sexual health. A study of Project TRAC showed that participants taught ER skills were less likely to start having sex over the 2.5 year follow up. While efficacious, the small group format of the program presents barriers to sustainability and dissemination; significant advantages of web-based delivery exist. To explore whether the ER concepts of TRAC could be taught in a web-based format, the investigators completed a pilot study to translate TRAC's ER content to a web-based intervention (iTRAC), using Designing for Dissemination principles that enhance the likelihood of successful dissemination upon completion. iTRAC demonstrated feasibility and acceptability, and a randomized trial showed that iTRAC participants reported significantly better emotional competence compared to waitlist control participants. This study will complete the technology adaptation of the program to include its sexual health content and content linking ER to sexual health. This phase will create iTRAC-HERO as a web app. Once completed, acceptability testing will be completed with early adolescents to allow for modifications based on participant feedback. Once finalized, a small RCT will assess impact on adolescents' self-efficacy for preventing sexual risk as well as engagement in sexual behaviors.

Study Timeline

• Study First Submitted: 2025-02-26
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-25
• Status Verified: 2025-04
• Study Start: 2025-04-01
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-12-08
• Study Completion: 2025-12-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Attending 7th grade
• Between 12 and 14 years old
• Parent/guardian speaks English or Spanish
• Attending participating school

Exclusion Criteria

• Unable to read at a 4th grade level
• Have a sibling who has participated in the study
• Have a development disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Sexual Self-Efficacy (SSE) from baseline to 6 months.	Baseline, 1 month post-intervention, 6 month follow up	The Sexual Self-Efficacy Scale (12 items) will measure self-efficacy for safer sexual activity as a main outcome which will indicate iTRAC-HERO's efficacy and ability to promote healthier sexual behaviors with the full sample (not just those who are sexually active).
Change in Self Efficacy for HIV Prevention from baseline to 6 month.	Baseline, 1 month post-intervention, 6 month follow up	The Self-Efficacy for HIV Prevention Scale (12 items) assesses a range of behaviors related to prevention of HIV, other STIs, or unintended pregnancy, including refusing sexual behaviors, discussing sexual histories with partners, buying condoms, taking free condoms, carrying condoms, and asking a partner to use a condom.

Secondary Outcome Measures

Name	Time	Method
Change in Sexual Risk Cognition from baseline to 6 months	Baseline, 1 month post-intervention, 6 month follow up	The Sexuality Questionnaire for Adolescents (34 items) is a multiple choice test to assess sexual health knowledge and has been shown to be sensitive to intervention impact.
Change in attitudes towards abstinence from baseline to 6 months	Baseline, 1 month post-intervention, 6 month follow up	The Abstinence Attitudes questionnaire assesses agreement with values related to abstinence (α= .86).
Change in frequency of sexual and substance use behaviors from baseline to 6 months	Baseline, 1 month post-intervention, 6 month follow up	The Adolescent Risk Behavior Assessment (ARBA) will assess sexual behavior, including behaviors relevant to this developmental period.
Change in adolescent substance use behaviors from baseline to 6 months	Baseline, 1 month post-intervention, 6 month follow up	Youth Risk Behavior Surveillance System items will be used to assess tobacco/vape use, violence (e.g., fighting), and substance use behaviors.

Trial Locations

Locations (1)

Klein Buendel, Inc.; 🇺🇸 Golden, Colorado, United States