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

NCT ID: NCT05194202

Last Updated: 2024-11-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2023-09-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a mixed methods feasibility evaluation that will use a randomized controlled trial to assess feasibility of Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) (intervention arm: ED-HEART + teen resource list; control arm: enhanced standard care \[standard care + teen resource list\]). Adolescents age 14-19 years will be recruited and enrolled during an emergency department visit. Investigators will evaluate feasibility using the eight Bowen model feasibility constructs: acceptability, demand, implementation, practicality, adaptation, integration, expansion, and limited-efficacy testing. Investigators will also examine theory of planned behavior constructs (attitudes, beliefs, perceived behavioral control, intention) to facilitate exploratory analysis of factors that may contribute to differential outcomes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adolescent Behavior Emergency Department Abuse Physical Abuse Mental Abuse Verbal Abuse Domestic HEART Intimate Partner Violence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Adolescents will be enrolled in one of two arms: Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) (intervention arm) or Enhanced Usual Care (control arm). Adolescents will complete study surveys at baseline (Baseline Survey; intervention and control arms), immediately post-intervention (Exit Survey, intervention arm), and 12 weeks after intervention delivery (Follow-up Survey, intervention and control arms).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ED-HEART (Intervention Arm)

All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey.

Group Type EXPERIMENTAL

ED-HEART

Intervention Type BEHAVIORAL

Behavioral intervention that assesses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.

Enhanced Standard Care (Control Arm)

All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ED-HEART

Behavioral intervention that assesses 1) healthy and unhealthy relationship behaviors, 2) conversation with partners around boundaries within relationships, 3) harm reduction strategies, and 4) resources for Adolescent Relationship Abuse (ARA) and related concerns, including Point of Care (POC) Reproductive and Sexual Health (RSH) harm reduction resources.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kimberly Randell

Physician, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K23HD098299

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001967

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Text Messaging Follow-up From ED
NCT03370978 WITHDRAWN NA
Emergency Care at Home
NCT06299774 RECRUITING NA