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

NCT05194202 | Completed Results

• 2 other identifiers: STUDY00001967K23HD098299
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

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

  1 survey item (investigator-developed) on acceptability of healthcare providers discussing healthy/unhealthy relationships, rated using 5-point Likert scale (strongly disagree/1 to strongly agree/5)

  12 weeks

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

  1 survey item (investigator-developed) on acceptability of emergency department based healthy/unhealthy relationships intervention, rated using 5-point Likert scale (strongly disagree/1 to strongly agree/5)

  12 weeks

Secondary Outcomes (2)

• ARA Victimization

  12 weeks

• Recognition of Abusive Behaviors

  12 weeks

Study Arms (2)

ED-HEART (Intervention Arm)

EXPERIMENTAL

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.

Behavioral: ED-HEART

Enhanced Standard Care (Control Arm)

NO INTERVENTION

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.

Interventions

ED-HEART 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.

ED-HEART (Intervention Arm)

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• emergency department (ED) patient 14-19 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Adolescent Behavior; Emergencies

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Kimberly Randell
• Organization: Children's Mercy Hospital

karandell@cmh.edu

816-302-3503

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, MD

Model Details: 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).

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: January 18, 2022
• Study Start: December 9, 2021
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: November 6, 2024
• Results First Posted: November 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 12 months after study completion; indefinitely
• Access Criteria: Researchers should contact the PI (Randell) with any requests for use of the data

Locations

US (1)