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

Adolescent Behavior Clinical Trial

— ED-HEART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194202
• Other study ID #: STUDY00001967
• Secondary ID: K23HD098299
• Status: Completed
• Phase: N/A
• Start date: December 9, 2021
• Est. completion date: September 21, 2023

Study information

• Verified date: September 2023
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: September 21, 2023
• Est. primary completion date: September 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abuse Physical
• Adolescent Behavior
• Emergencies
• Emergency Department
• HEART
• Intimate Partner Violence

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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