Education Program to Reduce Risky Behavior in Adolescents Ph I (iTRAC)

Klein Buendel

Status: Completed

Conditions: Emotional Regulation; Risky Sexual Behavior; Adolescent Behavior

Treatments: Behavioral: Formative Research- Content Feedback and Acceptability; Behavioral: Formative Research- Content Translation

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT05607784

1R42HD110333-01 (U.S. NIH Grant/Contract)

0342

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Adolescent Advisory Boards:

• Attending 7th grade
• Between 12 and 14 years old
• Parent/guardian speaks English or Spanish
• Attending participating school

Exclusion Criteria for Adolescent Advisory Boards:

• Unable to read at a 4th grade level
• Have a sibling who has participated in the study
• Have a developmental disorder

Inclusion Criteria for Health Education Professionals:

• Work at participating schools
• Directly involved in the health of middle school students
• Adult (at least 18)

Exclusion Criteria for Health Education Professionals:

• Teachers not directly involved in the health of middle school students

Trial design

24 participants in 3 patient groups

Adolescent Advisory Board Male

Description:

This board consisted of 9 male adolescents recruited from the schools.

Treatment:

Behavioral: Formative Research- Content Translation

Adolescent Advisory Board Female

Description:

This board consisted of 9 female adolescents recruited from the schools.

Treatment:

Behavioral: Formative Research- Content Translation

Health Education Professionals Panel (HEPP)

Description:

This panel consisted of 6 health teachers and other school health professionals such as nurses and counselors. They were recruited at each participating school.

Treatment:

Behavioral: Formative Research- Content Feedback and Acceptability