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Clinical Trials/NCT05194202
NCT05194202
Completed
N/A

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

Children's Mercy Hospital Kansas City1 site in 1 country175 target enrollmentDecember 9, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Adolescent Behavior
Sponsor
Children's Mercy Hospital Kansas City
Enrollment
175
Locations
1
Primary Endpoint
Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 9, 2021
End Date
September 21, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Children's Mercy Hospital Kansas City
Responsible Party
Principal Investigator
Principal Investigator

Kimberly Randell

Physician, MD

Children's Mercy Hospital Kansas City

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.

Outcomes

Primary Outcomes

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

Time Frame: 12 weeks

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)

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

Time Frame: 12 weeks

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)

Secondary Outcomes

  • ARA Victimization(12 weeks)
  • Recognition of Abusive Behaviors(12 weeks)

Study Sites (1)

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