Clinical trial NCT05607784: Education Program to Reduce Risky Behavior in Adolescents Ph I
Official title: An Interactive Education Program to Reduce High Risk Behavior in Adolescents Ph I
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risky Sexual Behavior
Emotional Regulation
Adolescent Behavior
Lead sponsor: Klein Buendel, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Rhode Island Hospital
name: University of Oregon
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-11-07
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The adolescent advisory board members and the health education professionals will be recruited from participating schools.

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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: Formative Research
timeFrame: Baseline, After wireframe production (approximately 2 months after baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Golden
country: United States
facility: Klein Buendel
state: Colorado
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Christopher D Houck, PhD
role: PRINCIPAL_INVESTIGATOR
References: