Adolescent BehaviorED-HEARTNCT05194202
Emergency Department Healthcare Education Assessment and Response for Teen Relationships: A Pilot Feasibility Study
A study testing ED-HEART in people with Adolescent Behavior and Emergency Department, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Emergency Department, Abuse Physical
- What is being tested?
- ED-HEART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2021to 21 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- emergency department (ED) patient 14-19 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
About this study
Official title: Promoting Healthy Relationships Among At-Risk Adolescents: A Feasibility Trial in the Emergency Department
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.
Read the 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.
- Conditions
- Adolescent Behavior, Emergency Department, Abuse Physical, Abuse Mental, Abuse Verbal, Abuse Domestic
- Being tested
- ED-HEART
- Medical subject headings
- Adolescent Behavior, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED-HEARTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ED-HEART (Intervention Arm) | Experimental | All adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey. Receives: Behavioral: ED-HEART |
| Enhanced Standard Care (Control Arm) | No intervention | All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm
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)
Measured: 12 weeks
Participant Acceptability Ratings for ED-based Relationship Intervention in ED-Heart Intervention Arm
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)
Measured: 12 weeks
Secondary outcomes (2)
ARA Victimization
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.
Measured: 12 weeks
Recognition of Abusive Behaviors
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start9 Dec 2021
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Kimberly Randell, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194202
- Sponsor's protocol ID
- STUDY00001967
- Other IDs
- K23HD098299
- Acronym
- ED-HEART
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2021
- Last updated
- 6 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study information will be shared with other members on the research team. Study data will be collected and stored via the Research Electronic Data Capture (REDCap) system. De-identifiable information may also be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Healthy Relationships Among At-Risk Adolescents: A Feasibility Trial in the Emergency Department
- ClinicalTrials.gov ID
- NCT05194202
- Acronym / sponsor ID
- ED-HEART / STUDY00001967
- Conditions
- Adolescent Behavior, Emergency Department, Abuse Physical, Abuse Mental, Abuse Verbal, Abuse Domestic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Posted 6 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| ED-HEART (Intervention Arm) | Experimental | Behavioral: ED-HEARTAll adolescents take a baseline survey in the Emergency Department (ED), receive Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED HEART) by a trained health educator, complete an exit survey while in the ED, complete a 6-week check-in to confirm contact information and aid retention, and complete a 12-week follow up survey. |
| Enhanced Standard Care (Control Arm) | No intervention | –All adolescents take a baseline survey in the Emergency Department (ED), receive enhanced standard care (i.e., standard care + teen resource list), complete a 6-week check in to confirm contact information and aid retention, and complete a 12-week follow up survey. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- emergency department (ED) patient 14-19 years of age.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ED-HEARTBehavioral 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. | Behavioural | ED-HEART (Intervention Arm) |
Primary outcome
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)
2 secondary outcomes
ARA Victimization
Time frame: 12 weeks
Recognition of Abusive Behaviors
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Study information will be shared with other members on the research team. Study data will be collected and stored via the Research Electronic Data Capture (REDCap) system. De-identifiable information may also be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ED-HEART in people with Adolescent Behavior and Emergency Department, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Acceptability Ratings for Healthcare Provider Discussions on Relationships in ED-Heart Intervention Arm (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.