Clinical trial NCT05194202: Emergency Department Healthcare Education Assessment and Response for Teen Relationships: A Pilot Feasibility Study
Official title: Promoting Healthy Relationships Among At-Risk Adolescents: A Feasibility Trial in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Emergency Department
Abuse Physical
Abuse Mental
Abuse Verbal
Abuse Domestic
HEART
Intimate Partner Violence
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-01-18
Enrollment: 175
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm
timeFrame: 12 weeks
measure: Participant Acceptability Ratings for ED-based Relationship Intervention in ED-Heart Intervention Arm
timeFrame: 12 weeks
Secondary outcomes:
measure: ARA Victimization
timeFrame: 12 weeks
measure: Recognition of Abusive Behaviors
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
Study officials:
References: