Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05607784 |
Other study ID # |
0342 |
Secondary ID |
1R42HD110333-01 |
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.