Recruiting

Health & Emotion

Sponsor:

Klein Buendel, Inc.

Code:

NCT06894277

Conditions

Risky Sexual Behavior

Emotion Regulation

Adolescent Behavior

Eligibility Criteria

Sex: All

Age: 12 - 14

Healthy Volunteers: Not accepted

Interventions

iTRAC-HERO

Study Details

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.

Conditions

Risky Sexual Behavior

Emotion Regulation

Adolescent Behavior

Study ID

NCT06894277

Start date

Apr 1, 2025

Status verified date

Jun, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 8, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 14

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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).

Interventions

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 education provided can be applied to experiences that are emotionally arousing and lead to risk.

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 ]
  • Change in Self Efficacy for HIV Prevention from baseline to 6 month. [ Time Frame: Baseline, 1 month post-intervention, 6 month follow up ]

Central Contacts and Locations

Central contacts

Julia Berteletti

3035654321jberteletti@kleinbuendel.com

Locations

Klein Buendel, Inc.

Recruiting

Golden, Colorado, United States, 80401

Contacts

Julia Berteletti

303-565-4321jberteletti@kleinbuendel.com

More Information

Sponsor

Klein Buendel, Inc.

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • Risky Sexual Behavior
  • Emotion Regulation
  • Adolescent Behavior

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Klein Buendel, Inc. on 2026-06-16.