CompletedNot Applicable

Education Program to Reduce Risky Behavior in Adolescents Ph I

United States24 participantsStarted 2022-11-28

Plain-language 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.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Formative Research

Timeframe: Baseline, After wireframe production (approximately 2 months after baseline)

Trial details

NCT IDNCT05607784

SponsorKlein Buendel, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Risky Sexual Behavior trials

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.