Education Program to Reduce Risky Behavior in Adolescents Ph I

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Risky Sexual Behavior, Emotional Regulation, Adolescent Behavior

Intervention / Treatment
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* Behavioral: Formative Research- Content Translation
* Behavioral: Formative Research- Content Feedback and Acceptability


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescent Advisory Board Male<br>This board consisted of 9 male adolescents recruited from the schools. | Behavioral: Formative Research- Content Translation<br>* 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<br>|
| Adolescent Advisory Board Female<br>This board consisted of 9 female adolescents recruited from the schools. | Behavioral: Formative Research- Content Translation<br>* 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<br>|
| Health Education Professionals Panel (HEPP)<br>This panel consisted of 6 health teachers and other school health professionals such as nurses and counselors. They were recruited at each participating school. | Behavioral: Formative Research- Content Feedback and Acceptability<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |