Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05607784
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2022-10-13
Brief Title:
Education Program to Reduce Risky Behavior in Adolescents Ph I
Sponsor:
Klein Buendel Inc
Organization:
Klein Buendel Inc
Study Overview
Official Title:
An Interactive Education Program to Reduce High Risk Behavior in Adolescents Ph I
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iTRAC
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 eg 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 25 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 TRACs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R42HD110333-01 | NIH | None | httpsreporternihgovquickSearch1R42HD110333-01 |