Clinical trial NCT06894277: Internet-based Talking About Risk and Adolescent Choices: Health and Emotion Regulation Options
Official title: Interactive Emotion Regulation Skills Training to Improve Adolescent Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Risky Sexual Behavior
Emotion Regulation
Adolescent Behavior
Keywords: Risky Sexual Behavior
Emotion Regulation
Adolescent Behavior
Lead sponsor: Klein Buendel, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Rhode Island Hospital
name: University of Oregon
First posted: 2025-03-25
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist Control Trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Sexual Self-Efficacy (SSE) from baseline to 6 months.
timeFrame: Baseline, 1 month post-intervention, 6 month follow up
measure: Change in Self Efficacy for HIV Prevention from baseline to 6 month.
timeFrame: Baseline, 1 month post-intervention, 6 month follow up
Secondary outcomes:
measure: Change in Sexual Risk Cognition from baseline to 6 months
timeFrame: Baseline, 1 month post-intervention, 6 month follow up
measure: Change in attitudes towards abstinence from baseline to 6 months
timeFrame: Baseline, 1 month post-intervention, 6 month follow up
measure: Change in frequency of sexual and substance use behaviors from baseline to 6 months
timeFrame: Baseline, 1 month post-intervention, 6 month follow up
measure: Change in adolescent substance use behaviors from baseline to 6 months
timeFrame: Baseline, 1 month post-intervention, 6 month follow up
Other outcomes:
measure: Change in Emotion Regulation Skills from baseline to 6 months
timeFrame: Baseline, 1 month post-intervention, 6 month follow up
measure: Change in frequency of dificulties with emotion regulation from baseline to 6 months
timeFrame: Baseline, 1 month post-intervention, 6 month follow up
measure: Change in usage of emotion regulation behaviors taught in iTRAC-HERO from baseline to 6 months
timeFrame: Baseline, 1 month post-intervention, 6 month follow up
measure: Change in perceptions of one's ability to manage negative emotions from baseline to 6 months
timeFrame: Baseline, 1 month post-intervention, 6 month follow up
measure: Change in beliefs about controllability of emotions from baseline to 6 months
timeFrame: Baseline, 1 month post-intervention, 6 month follow up
Locations:
city: Golden
country: United States
facility: Klein Buendel, Inc.
state: Colorado
Study officials:
affiliation: Rhode Island Hospital
name: Christopher Houck, PhD
role: PRINCIPAL_INVESTIGATOR
References: