Education Program to Reduce Risky Behavior in Adolescents Ph I

Completed

• Conditions: Emotional Regulation; Adolescent Behavior; Risky Sexual Behavior
• Interventions: Behavioral: Formative Research- Content Translation; Behavioral: Formative Research- Content Feedback and Acceptability

• Registration Number: NCT05607784
• Lead Sponsor: Klein Buendel, Inc.

Brief Summary

This phase will complete the TRAC adaptation to a web app. The pilot study (R21 HD089979) effectively translated the ER content of TRAC and the same procedures will be used to translate the remaining content.

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 bio-logical 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 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. The proposed Fast Track project will complete the technology adaptation of the program to include its sexual health content and content linking ER to sexual health. This adaptation (iTRAC for Sexual Risk Prevention; iTRAC-SRP), using well-established theoretical frameworks, will be approached with advisory boards of school professionals and early adolescents, leading to prototypes of the completed intervention in Phase 1.

Study Timeline

• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-07
• Study Start: 2022-11-28
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adolescent Advisory Board Female	Formative Research- Content Translation	This board consisted of 9 female adolescents recruited from the schools.
Adolescent Advisory Board Male	Formative Research- Content Translation	This board consisted of 9 male adolescents recruited from the schools.
Health Education Professionals Panel (HEPP)	Formative Research- Content Feedback and Acceptability	This panel consisted of 6 health teachers and other school health professionals such as nurses and counselors. They were recruited at each participating school.

Primary Outcome Measures

Name	Time	Method
Formative Research	Baseline, After wireframe production (approximately 2 months after baseline)	Advisory Focus Groups: Research summaries will also be generated to communicate with participating communities. Using these recommended D4D processes, the research will be better positioned for dissemination (and commercialization)

Trial Locations

Locations (3)

Klein Buendel; 🇺🇸 Golden, Colorado, United States

University of Oregon; 🇺🇸 Eugene, Oregon, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States