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

Primary Purpose

Adolescent Behavior, Emergency Department, Abuse Physical

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ED-HEART
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adolescent Behavior

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Children's Mercy Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ED-HEART (Intervention Arm)

Enhanced Standard Care (Control Arm)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
October 18, 2021
Last Updated
September 21, 2023
Sponsor
Children's Mercy Hospital Kansas City
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05194202
Brief Title
Emergency Department Healthcare Education Assessment and Response for Teen Relationships: A Pilot Feasibility Study
Acronym
ED-HEART
Official Title
Promoting Healthy Relationships Among At-Risk Adolescents: A Feasibility Trial in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
September 21, 2023 (Actual)
Study Completion Date
September 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Behavior, Emergency Department, Abuse Physical, Abuse Mental, Abuse Verbal, Abuse Domestic, HEART, Intimate Partner Violence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ED-HEART (Intervention Arm)
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Standard Care (Control Arm)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ED-HEART
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number/proportion of participants reporting Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) as acceptable.
Description
2 survey items on acceptability, rated using 5-point Likert scale. Answers dichotomized to strongly/agree-agree vs. neutral/disagree/strongly disagree.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number/proportion of participants reporting of adolescent relationship abuse (ARA) victimization
Description
Report of ARA will be considered positive for any positive answer to one or more of six survey items assessing ARA
Time Frame
12 weeks
Title
Participant recognition of abusive behaviors as assessed by survey
Description
19 survey items using 5-point Likert scale to categorize each behavior from not abusive to extremely abusive.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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