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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05194202
Other study ID # STUDY00001967
Secondary ID K23HD098299
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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