Internet-based Talking About Risk and Adolescent Choices: Health and Emotion Regulation Options
Part of paid clinical trials in Golden, Colorado.
- Sponsor
- Klein Buendel, Inc.
- Study ID
- NCT06894277
- Status
- Recruiting
Conditions
- Adolescent Behavior
- Emotion Regulation
- Risky Sexual Behavior
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 14 Years
- Healthy Volunteers
- Not accepted
Interventions
- iTRAC-HERO — BEHAVIORALiTRAC-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.
Study Details
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.
Key Dates
- Start date
- Apr 1, 2025
- Status verified
- Mar 2026
- Primary completion
- Jun 8, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- No Intervention: Waitlist ControlControl participants will be assessed on the same schedule as the treatment condition and offered the intervention after 6-month follow-up.
- Experimental: iTRAC-HEROiTRAC-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).
Primary Outcome Measure
Change in Sexual Self-Efficacy (SSE) from baseline to 6 months. [ Time Frame: Baseline, 1 month post-intervention, 6 month follow up ]
Central Contacts
- Julia Berteletti3035654321
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Klein Buendel, Inc. | Golden | Colorado | 80401 |
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