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NCT Number: NCT06894277

An Interactive Education Program to Reduce High Risk Behavior in Adolescents Ph II (iTRAC HERO)

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.

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Key information

Age range

12 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location status: Recruiting

Location contact

Julia Berteletti

CONTACT

[email protected]

303-565-4321

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iTRAC-HERO

Behavioral

iTRAC-HERO will consist of eight, approximately 45-minute, "gamified" digital modules of 4-6 activities (games, videos, etc.). No instruction is needed to use the program. Content will use gender- and sexuality-inclusive language and avoid heteronormative descriptions of risk. This content will include strategies for (and practice with) recognizing and managing emotions, particularly in relation to sexual health situations, to enhance the likelihood that the emotion regulation and sexual health education provided can be applied to experiences that are emotionally arousing and lead to risk.

Primary outcomes

  1. Change in Sexual Self-Efficacy (SSE) from baseline to 6 months.

    Time frame: 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).

  2. Change in Self Efficacy for HIV Prevention from baseline to 6 month.

    Time frame: 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 outcomes

  1. Change in Sexual Risk Cognition from baseline to 6 months

    Time frame: 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.

  2. Change in attitudes towards abstinence from baseline to 6 months

    Time frame: Baseline, 1 month post-intervention, 6 month follow up

    The Abstinence Attitudes questionnaire assesses agreement with values related to abstinence (α= .86).

  3. Change in frequency of sexual and substance use behaviors from baseline to 6 months

    Time frame: 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.

  4. Change in adolescent substance use behaviors from baseline to 6 months

    Time frame: 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.

Other outcomes

  1. Change in Emotion Regulation Skills from baseline to 6 months

    Time frame: Baseline, 1 month post-intervention, 6 month follow up

    The Difficulties in Emotion Regulation Scale (36 items) uses six subscales (e.g., lack of emotional awareness, limited access to ER strategies; all α > .80) to assess perceptions of skill in ER based on Linehan's theoretical work.

  2. Change in frequency of dificulties with emotion regulation from baseline to 6 months

    Time frame: Baseline, 1 month post-intervention, 6 month follow up

    The Affect Dysregulation Scale (6 items) assesses the frequency of difficulties with ER (α= .72), and is shown to be related to adolescent risk behaviors.

  3. Change in usage of emotion regulation behaviors taught in iTRAC-HERO from baseline to 6 months

    Time frame: Baseline, 1 month post-intervention, 6 month follow up

    The Emotion Regulation Behaviors Scale- Revised measures use of the specific emotion regulation strategies taught in iTRAC (α= .73).

  4. Change in perceptions of one's ability to manage negative emotions from baseline to 6 months

    Time frame: Baseline, 1 month post-intervention, 6 month follow up

    The Emotional Self-Efficacy Subscale of the Self-Efficacy Questionnaire for Children assesses perception of one's ability to cope with negative emotions (α= .83).

  5. Change in beliefs about controllability of emotions from baseline to 6 months

    Time frame: Baseline, 1 month post-intervention, 6 month follow up

    The Implicit Theories of Emotions for Children Self subscale (6 items) is based on Dweck and colleagues' work on implicit theories of intelligence and Tamir's adult measure of emotion malleability. It assesses adolescents' beliefs about the controllability of their emotions (α=.86).

Study contacts

Contact information is provided by the study sponsor or research team.

Julia Berteletti

CONTACT

[email protected]

3035654321

Sponsors and collaborators

Lead sponsor

Klein Buendel, Inc.

Industry

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Rhode Island Hospital
  • University of Oregon

Registry information

Official study title

An Interactive Education Program to Reduce High Risk Behavior in Adolescents Ph II

Acronym: iTRAC-HERO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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