CompletedNot Applicable

Emergency Department Healthcare Education Assessment and Response for Teen Relationships: A Pilot Feasibility Study

United States175 participantsStarted 2021-12-09

Plain-language summary

This is a single-site, randomized, controlled trial. Investigators will evaluate feasibility of the Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) intervention among adolescents age 14-19 years receiving care in the Children's Mercy emergency department.

Who can participate

Age range

14 Years – 19 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: * emergency department (ED) patient 14-19 years of age. Exclusion Criteria: * Developmental delay, severe illness, or cognitive impairment precluding informed consent/assent or completion of study activities, as determined by ED team or study team. * Current ED evaluation for acute sexual assault/abuse. * Current mental or behavioral health symptoms precluding completion of study activities, as determined by ED team or study team. * Caregiver declines to step out to allow assent/consent in private or adolescent declines for caregiver to step out to allow assent/consent or participation in private. * Adolescent is non-English speaking. * Parent is non-English or non-Spanish speaking.

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

Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm

Timeframe: 12 weeks

Participant Acceptability Ratings for ED-based Relationship Intervention in ED-Heart Intervention Arm

Timeframe: 12 weeks

Trial details

NCT IDNCT05194202

SponsorChildren's Mercy Hospital Kansas City

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-21

Results submitted2024-08-22

View on ClinicalTrials.gov More Adolescent Behavior trials