Emergency Department Healthcare Education Assessment and Response for Teen Relationships: A Pilot Feasibility Study (ED-HEART)

Promoting Healthy Relationships Among At-Risk Adolescents: A Feasibility Trial in the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Adolescent Behavior; Intimate Partner Violence; Emergency Department; Abuse Physical; Abuse Mental; Abuse Verbal; Abuse Domestic; HEART
• Intervention / Treatment: Behavioral: ED-HEART

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimberly Randell, MD, MSc; Phone Number: 816-302-3503; Email: karandell@cmh.edu
• Study Contact Backup: Name: Anne Kleinwolterink; Phone Number: 816-802-1487; Email: aekleinwolterink@cmh.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number/proportion of participants reporting Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) as acceptable.	2 survey items on acceptability, rated using 5-point Likert scale. Answers dichotomized to strongly/agree-agree vs. neutral/disagree/strongly disagree.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number/proportion of participants reporting of adolescent relationship abuse (ARA) victimization	Report of ARA will be considered positive for any positive answer to one or more of six survey items assessing ARA	12 weeks
Participant recognition of abusive behaviors as assessed by survey	19 survey items using 5-point Likert scale to categorize each behavior from not abusive to extremely abusive.	12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): September 21, 2023
• Study Completion (Actual): September 21, 2023

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: STUDY00001967; K23HD098299 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study information will be shared with other members on the research team. Study data will be collected and stored via the Research Electronic Data Capture (REDCap) system. De-identifiable information may also be shared with other researchers.
• IPD Sharing Time Frame: 12 months after study completion; indefinitely
• IPD Sharing Access Criteria: Researchers should contact the PI (Randell) with any requests for use of the data
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No