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Completed

NCT Number: NCT05194202

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

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.

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Key information

Conditions

Adolescent Behavior Abuse Domestic Abuse Mental Abuse Physical Abuse Verbal Behavior Disease Attributes Emergencies Emergency Department Heart Intimate Partner Violence Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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

  1. ARA Victimization

    Time frame: 12 weeks

    Report of ARA victimization will be considered positive for any positive answer to one or more of six survey items assessing physical ARA, sexual ARA, sexual exploitation within a dating relationship, and (among females) reproductive coercion.

  2. Recognition of Abusive Behaviors

    Time frame: 12 weeks

    19 survey items, adapted from the Recognition of ARA Scale. Each item answered with 5-point Likert scale that categorizes each behavior from not abusive (1) to extremely abusive (5). Scored as mean; higher score indicates increased recognition of behaviors as abusive.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: ED-HEART

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2022
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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