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 — 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.

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 Control
    Control participants will be assessed on the same schedule as the treatment condition and offered the intervention after 6-month follow-up.
  • Experimental: iTRAC-HERO
    iTRAC-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

Locations (1)

FacilityCityStateZIPSite coordinators
Klein Buendel, Inc.GoldenColorado80401
Julia Berteletti
3035654321

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