Education Program to Reduce Risky Behavior in Adolescents Ph I

Adolescent Behavior Clinical Trial

— iTRAC  

Official title:

An Interactive Education Program to Reduce High Risk Behavior in Adolescents Ph I

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05607784
• Other study ID #: 0342
• Secondary ID: 1R42HD110333-01
• Status: Completed
• Start date: November 28, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2023
• Source: Klein Buendel, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Emotional Regulation
• Risky Sexual Behavior

Intervention

Behavioral:
• Formative Research- Content Translation
This formative research includes brainstorming translation of content and reviewing wireframe prototypes generated from this process. It also includes attending to cultural, developmental, and gender considerations. The design development cycles will begin with advisory focus group feedback about how the existing activities convey the content (i.e., what and how they are learning). They will advise on activity design for the remaining content (sexual health and content connecting this with ER) to ensure these are engaging, appropriate, and informative. They will also provide perspectives about design, structure, navigability, and approach
• Formative Research- Content Feedback and Acceptability
This formative research includes providing feedback on the proposed content and ensure contextual acceptability in schools. The design development cycles will begin with advisory focus group feedback about how the existing activities convey the content (i.e., what and how they are learning). They will advise on activity design for the remaining content (sexual health and content connecting this with ER) to ensure these are engaging, appropriate, and informative. They will also provide perspectives about design, structure, navigability, and approach

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon
United States	Klein Buendel	Golden	Colorado
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
Klein Buendel, Inc.	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Rhode Island Hospital, University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Formative Research	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)	Baseline, After wireframe production (approximately 2 months after baseline)