Menu
Recruiting NCT06894277

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

No phase Interventional Risky Sexual Behavior Emotion Regulation Adolescent Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iTRAC-HERO.
Who it may be relevant to
Registry conditions: Risky Sexual Behavior, Emotion Regulation, Adolescent Behavior. Basic parameters: 12 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral iTRAC-HERO
    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

Primary outcome measures

  • Change in Sexual Self-Efficacy (SSE) from baseline to 6 months. [Time frame: Baseline, 1 month post-intervention, 6 month follow up]
  • Change in Self Efficacy for HIV Prevention from baseline to 6 month. [Time frame: Baseline, 1 month post-intervention, 6 month follow up]
Secondary outcome measures (4)
  • Change in Sexual Risk Cognition from baseline to 6 months [Time frame: Baseline, 1 month post-intervention, 6 month follow up]
  • Change in attitudes towards abstinence from baseline to 6 months [Time frame: Baseline, 1 month post-intervention, 6 month follow up]
  • 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]
  • Change in adolescent substance use behaviors from baseline to 6 months [Time frame: Baseline, 1 month post-intervention, 6 month follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Klein Buendel, Inc. — Golden

Identifiers

NCT: NCT06894277 · 0346 · 5R42HD110333-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗