iTRAC: Education Program to Reduce Risky Behavior in Adolescents

Sponsor
Klein Buendel, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05607784
Collaborator
Rhode Island Hospital (Other), University of Oregon (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
24
3
9.1
8
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Formative Research- Content Translation
  • Behavioral: Formative Research- Content Feedback and Acceptability

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 Design

Study Type:
Observational
Anticipated Enrollment :
24 participants
Observational Model:
Ecologic or Community
Time Perspective:
Other
Official Title:
An Interactive Education Program to Reduce High Risk Behavior in Adolescents
Actual Study Start Date :
Nov 28, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Adolescent Advisory Board Male

This board will consist of 8 male adolescents recruited from the schools.

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

Adolescent Advisory Board Female

This board will consist of 8 female adolescents recruited from the schools.

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

Health Education Professionals Panel (HEPP)

This panel will consist of 8 health teachers and other school health professionals such as nurses and counselors. They will be recruited at each participating school.

Behavioral: 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

Outcome Measures

Primary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Exclusion Criteria for Health Education Professionals:
  • Teachers not directly involved in the health of middle school students

Contacts and Locations

Locations

Site City State Country Postal Code
1 Klein Buendel Golden Colorado United States 80401
2 University of Oregon Eugene Oregon United States 97403
3 Rhode Island Hospital Providence Rhode Island United States 02903

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Christopher D Houck, PhD, Rhode Island Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Klein Buendel, Inc.
ClinicalTrials.gov Identifier:
NCT05607784
Other Study ID Numbers:
  • 0342
First Posted:
Nov 7, 2022
Last Update Posted:
Feb 2, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 2, 2023