跳至主要内容
临床试验/NCT06894277
NCT06894277招募中不适用

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

Klein Buendel, Inc.2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Change in Sexual Self-Efficacy (SSE) from baseline to 6 months.

研究概览

简要总结

Using the efficacious iTRAC intervention to enhance emotion regulation competencies as a foundation, this study will create and test iTRAC-HERO to teach emotion regulation skills in the context of sexual health education.

详细描述

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 biological 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 unaddressed in most sexual health education. Our 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 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 biological 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 trial 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. This study will complete the technology adaptation of the program to include its sexual health content and content linking ER to sexual health. This phase will create iTRAC-HERO as a web app. Once completed, acceptability testing will be completed with early adolescents to allow for modifications based on participant feedback. Once finalized, a small RCT will assess impact on adolescents' self-efficacy for preventing sexual risk as well as engagement in sexual behaviors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Waitlist Control

No Intervention

Control participants will be assessed on the same schedule as the treatment condition and offered the intervention after 6-month follow-up.

iTRAC-HERO

Experimental

iTRAC-HERO is an 8-module, web-based intervention for middle school boys and girls to complete. Its goal is primary prevention of adolescent sexual risk behaviors by targeting emotion regulation and sexual self-efficacy. (e.g., to refuse sexual advances).

干预措施: iTRAC-HERO (Behavioral)

结局指标

主要结局

Change in Sexual Self-Efficacy (SSE) from baseline to 6 months.

时间窗: Baseline, 1 month post-intervention, 6 month follow up

The Sexual Self-Efficacy Scale (12 items) will measure self-efficacy for safer sexual activity as a main outcome which will indicate iTRAC-HERO's efficacy and ability to promote healthier sexual behaviors with the full sample (not just those who are sexually active).

Change in Self Efficacy for HIV Prevention from baseline to 6 month.

时间窗: Baseline, 1 month post-intervention, 6 month follow up

The Self-Efficacy for HIV Prevention Scale (12 items) assesses a range of behaviors related to prevention of HIV, other STIs, or unintended pregnancy, including refusing sexual behaviors, discussing sexual histories with partners, buying condoms, taking free condoms, carrying condoms, and asking a partner to use a condom.

次要结局

  • Change in Sexual Risk Cognition from baseline to 6 months(Baseline, 1 month post-intervention, 6 month follow up)
  • Change in attitudes towards abstinence from baseline to 6 months(Baseline, 1 month post-intervention, 6 month follow up)
  • Change in frequency of sexual and substance use behaviors from baseline to 6 months(Baseline, 1 month post-intervention, 6 month follow up)
  • Change in adolescent substance use behaviors from baseline to 6 months(Baseline, 1 month post-intervention, 6 month follow up)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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