Promoting Healthy Relationships Among At-Risk Adolescents: A Feasibility Trial in the Emergency Department
Phase: NA
Conditions: Adolescent Behavior, Emergency Department, Abuse Physical, Abuse Mental, Abuse Verbal, Abuse Domestic, HEART, Intimate Partner Violence
Sponsor: Children's Mercy Hospital Kansas City

Page 1 of 36 
 
Study Title: Emergency Department Healthcare Education Assessment and 
Response for Teen Relationships (ED-HEART): A Pilot Feasibility Study 
 
NCT Number: NCT05194202 
IRB number: STUDY00001967 
Document Date: 6/21/2024 
 

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PROTOCOL TITLE:  
Emergency Department Healthcare Education Assessment and Response for Teen 
Relationships (ED-HEART): A Pilot Feasibility Study 
PRINCIPAL INVESTIGATOR: 
Kimberly A. Randell, MD, MSc 
Division of Emergency Medicine 
2401 Gillham Rd  
Kansas City MO 64110 
816-302-3503 
karandell@cmh.edu 
IND/IDE NUMBER:  
 
N/A 
 
VERSION NUMBER/DATE: 
Version 4, 6/19/2024 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
3/9/2022 
Additional text/email if needed to send survey 
link after phone call at 6-week check-in  
No 
2 
04/27/2022 
Update 6-week check in and 12-week follow 
up to allow for coordinator to check in at 
inpatient and outpatient visits during follow 
up window to complete surveys 
Yes 
3 
05/16/2022 
Increase the 12-week survey gift card from 
$20 to $25 
Yes 
4 
07/20/2022 
Add a reminder to contact participant at week 
11 for the 12 week survey completion 
Add option to notify participants of 6-week 
check in and12-week f/u survey availability via 
social media. 
 
 
Yes 
5 
6/19/2024 
Increase sample size to 175 
No 
 
 
 

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Table of Contents 
STUDY INFORMATION 
1.0 Study Summary 
2.0 Objectives 
3.0 Background 
4.0 Study Design 
5.0 Research Interventions 
PARTICIPANT MANAGEMENT 
6.0 Inclusion and Exclusion Criteria 
7.0 Local Number of Participants 
8.0 Screening and Recruitment Methods 
9.0 Surveys and Psychometric Testing 
10.0 Additional Study Activities 
11.0 Follow-Up 
12.0 Genetic Analysis Information 
13.0 Sharing of Results with Participants 
14.0 Risks to Participants 
15.0 Potential Benefits 
16.0 Investigator Assessment of Risk/Benefits Ratio 
17.0 Payment, Reimbursement and Tangible Property Provided to Participants 
18.0 Compensation for Research-Related Injury 
19.0 Economic Burden to Participants 
20.0 Parental Permission and Adult Consent Process 
21.0 Assent of Pediatric Participants 
22.0 HIPAA and Confidentiality 
23.0 Provisions to Protect the Privacy Interests of Participants 
24.0 Withdrawal of Participants 
DATA MANAGEMENT 
25.0 Data Collection 
26.0 Adverse Events and Unanticipated Problems 
27.0 Data Analysis 
28.0 Data and Specimen Management 
29.0 Storage/Banking of Data and Specimens for Future Research 

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30.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
DATA MANAGEMENT 
31.0 Settings and Locations 
32.0 Multi-Site Research 
33.0 International Research 
ADDENDUMS 
Addendum A: Waiver of Documentation of Permission/Consent 
Addendum B: Waiver/Alteration of Permission/Assent/Consent 
Addendum C: Non-English Speaking Participants 
Addendum D: Surrogate Decision Maker Consent 
Addendum E: Waiver/Alteration of HIPAA Authorization 
 
 
 

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STUDY INFORMATION 
1.0 
Study Summary* 
1.1  Synopsis 
 
Study Title 
Emergency Department Healthcare Education Assessment 
and Response for Teen Relationships (ED-HEART): A Pilot 
Feasibility Study 
Study Design 
We will evaluate feasibility of ED-HEART using the Bowen 
feasibility model and a randomized controlled trial 
comparing ED-HEART to enhanced usual care among 
adolescents seen in the ED. 
Primary Objective 
To determine feasibility of ED-HEART, through assessment 
of eight constructs: acceptability, demand, implementation, 
practicality, adaptation, integration, expansion, and limited-
efficacy testing. 
Secondary Objective(s) To examine Theory of Planned Behavior constructs that may 
impact ED-HEART efficacy. 
To conduct exploratory analysis of factors that may impact 
efficacy and implementation of ED-HEART. 
Study Population 
Adolescents (age 14-19 years) seeking ED care 
Sample Size 
174 adolescents 
Study Duration for 
Individual Participants 
12 weeks 
Study Specific 
Abbreviations/ 
Definitions  
adolescent relationship abuse (ARA) 
emergency contraception (EC) 
emergency department (ED) 
Emergency Department Healthcare Education Assessment 
and Response for Teen Relationships (ED-HEART) 
motivational interviewing (MI) 
point of care (POC) 
reproductive and sexual health (RSH) 
sexually transmitted infection (STI) 
theory of planned behavior (TPB) 
 
2.0 
Objectives* 
2.1 
Purpose, specific aims or objectives:   
Our primary aim is to determine feasibility of Emergency Department Healthcare 
Education Assessment and Response for Teen Relationships (ED-HEART). We will 
conduct a randomized, controlled trial using mixed methodology to assess eight 

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feasibility constructs: acceptability, demand, implementation, practicality, 
adaptation, integration, expansion, and limited-efficacy testing.  
Secondary aims are to: 
• Examine Theory of Planned Behavior constructs that may impact ED-HEART 
efficacy. 
• Conduct exploratory analysis of factors that may impact efficacy and 
implementation of ED-HEART. 
2.2 
Hypothesis to be tested/Exploratory study design:  
Hypothesis 1.1: ED-HEART will be feasible as measured by data from adolescents and ED 
stakeholders. 
Hypothesis 1.2: Adolescents receiving ED-HEART will report less ARA at three-month 
follow-up, compared to controls. 
☐ Children/Minors (under 7 years of age) 
☒ Children/Minors (7-17 years of age) 
☐ Neonates (infants less than 30 days old) 
☐ Neonates of Uncertain Viability (infants 
less than 30 days old) 
☐ Non-Viable Neonates (infants less than 
30 days old) 
☒ Wards of the State 
☐ Fetuses 
☐ Pregnant Women  
☐ Adults with impaired decision-making 
capacity   
☐ CM Employees 
☐ CM Students/Residents/ Fellows 
☐ Economically or Educationally 
Disadvantaged Persons 
☐ Prisoners 
Adolescents aged 14-17 years: 
• Adolescent assent procedures will follow practices accepted by the 
Society for Adolescent Health and Medicine and current regulatory 
guidelines and align with those previously used for CM studies involving 
adolescents 
• All adolescents will be encouraged to ask questions, provided necessary 
time to consider participation, and able to stop participation at any time, 
should they choose to do so. 
• All adolescents will be assured that their decision to participate or not will 
have no impact on their relationship with and care received at CM. 
 
Wards of the State: 

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• Assent procedures for Wards of the State will mirror those for non-Wards.  
• Procedures will follow practices accepted by the Society for Adolescent 
Health and Medicine and current regulatory guidelines and align with 
those previously used for CM studies involving adolescents.  
• Adolescents who are Wards of the State will be encouraged to ask 
questions, provided necessary time to consider participation, and able to 
stop participation at any time, should they choose to do so. 
• All adolescents who are Wards of the State will be assured that their 
decision to participate or not will have no impact on their relationship with 
and care received at CM. 
 
7.0 
Local Number of Participants 
 
 
Group 1: 
Intervention Arm 
Group 2: Control 
Arm 
Total 
Enrollment Goal 
87 
87 
174 
 
8.0 
Identification and Recruitment of Potential Participants* 
Identification of Potential Participants:   
How will participants be identified? (Check all that apply) 
 
☐ Chart reviews  
 
☐ By their treating physician who will then provide the study team’s contact 
information to the potential participant/family 
☐ By their treating physician who will obtain patient/family permission to share 
contact information with the study team 
☐ By a partnering community-based organization who will then provide the 
study team’s contact information to the potential participant/family 
☐ By a partnering community-based organization who will obtain patient/family 
permission to share contact information with the study team 
☐ Self-refer in response to IRB approved advertisements or websites  
☒ Through Cerner or other CM sources (e.g., databases, billing records, 
pathology reports, admission logs, etc.) May involve access of records by 
individuals not involved in the patient’s care. 
• We will use the Cerner ED tracking board to identify potential 
participants.  

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☐ List of candidates provided through the Data Report Request Form  
☐ Registry of individuals interested in research opportunities   
☐ Past participant list 
☐ Participants will roll-over from another research study: Study 
#___________________ 
☐ Other: 
______________________________________________________________ 
 
Pre-Screening prior to HIPAA Authorization 
Will any of the identification methods checked above involve 
access to Protected Health Information (PHI) prior to obtaining 
HIPAA Authorization? 
☒ Yes 
 
☐ No 
• We request a Partial Waiver of HIPAA Authorization for Screening 
Purposes. See Addendum E: Waiver/Alteration of HIPAA Authorization 
Recruitment of Potential Participants:   
• We will use our electronic ED tracking board to identify potential 
adolescent participants. For those who are eligible per age as 
listed on the tracking board, the study team will check the 
electronic health record to determine if a research note for this 
study is present. Those adolescents who have already participated 
in this study are not eligible. The study team will approach 
potential participants sequentially during their ED visit based on 
arrival and availability. We will carefully time our approach of 
potentially eligible patients to minimize impact on patient care 
and ED flow. We will ensure balanced enrollment in regard to sex 
(male/female) using data that is easily accessible on the electronic 
tracking board. 
 
9.0 
Surveys and Psychometric Testing: 
Study surveys were developed by the study team and based on extant 
literature. Surveys will be delivered via REDCap and completed on a 

ED-HEART Pilot 
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smart phone, desktop, or tablet computer. Surveys and their domains are 
listed below.  
• Adolescents:  
o Baseline Survey (intervention, control arms): unique code 
questions,39 demographics, ARA victimization and 
perpetration,35,40,41 recognition of abusive behaviors,35,41 
self-efficacy,42 consequences of ARA, ARA resource 
knowledge/use,35 readiness to engage in healthy 
relationship behaviors 
o Exit Survey (intervention arm only): fidelity, acceptability, 
self-efficacy,35 use of POC resources, ARA disclosure 
o Follow-up Survey (intervention, control arms): unique 
code questions,39 ARA victimization and 
perpetration,35,40,41 recognition of abusive behaviors,35,41 
self-efficacy,35 consequences of ARA, ARA resource 
knowledge/use  
10.0 Additional Research Activities 
Data collection from the medical record: A study team member will use a 
REDCap instrument to collect insurance type from the medical record for 
each participant. Additionally, upon completion of enrollment, we will 
collect aggregate medical record data (i.e., the number of participants for 
whom each order is used) using the Cerner study order set (this is an 
order set designated for use for any POC resource for which a medical 
record order is required).  
Screening Log: The study team will maintain an adolescent screening log 
that includes patient age, sex, and reason for study exclusion. Age and 
sex will be obtained from the Cerner ED tracking board. No PHI will be 
included in the Screening Log. The Screening Log will enable the study 
team to determine the number of adolescents who are excluded and for 
what reason(s), the number who are potentially eligible for participation 
but the enrollment opportunity is missed, etc.  
Refusal Log: The study team will maintain a refusal log to better 
understand potential differences between adolescents that participate 
and those that do not. Adolescents who decline to participate will be 
asked if they will provide information anonymously. If they agree to do 
this, they will complete an anonymous survey that assesses age, sex, 
gender, race, ethnicity, primary language, and reason for not 
participating. This survey will be administered via REDCap/tablet 
computer. If the adolescent declines to complete the refusal survey, the 
study team member will complete items on age and sex (available on the 

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ED tracking board used for screening purposes) and reason for study 
declination, if provided.  
 
11.0 Follow-up 
• Participants will complete a 6-week check-in to confirm and update 
contact information. This will be done via email, text, that has the 
weblink to a REDCap survey that asks if current contact information is 
current and offers opportunity to update contact information if 
needed. We will send up to 2 emails and/or 2 text reminders for the 
6-week check in. If by week 7 the participant has not completed the 
follow-up survey, a study team member will call them using the 
phone number(s) provided to remind them about the survey 
(maximum number of phone calls = 3). If needed at the time of the 
call, the follow-up survey weblink will be sent via email and/or text.  
• Option to notify participants of 6-week check in and 12-week follow 
up survey availability via social media using a Children’s Mercy 
Hospital channel (e.g. Facebook, Twitter, Instagram, etc.). 
• Participants will receive a reminder contact about the upcoming 
survey, sent one week ahead of the 12-week survey (at week 11) via 
the participant’s preferred method of contact and/or social media 
handle using a Children’s Mercy Hospital channel. 
• Participants will complete the Follow-up Survey at 12 weeks 
(completion window 10-14 weeks). 
• Participants will receive an email and/or text inviting them to 
complete the follow-up survey using a weblink provided. We will send 
up to 2 emails and/or 2 text reminders, as needed. If by week 13 the 
participant has not completed the follow-up survey, a study team 
member will call them using the phone number(s) provided to remind 
them about the survey (maximum number of phone calls = 3). If 
needed at the time of the call, the follow-up survey weblink will be 
sent via email and/or text.  
• To aid in completion of the Follow-Up Surveys, the study team will 
check the medical record to see if participants have scheduled 
appointments at Children’s Mercy during the 6 week and 12 week 
follow-up window. If they have an appointment, or are admitted to 
Children’s Mercy, the study team will approach them at this time to 
offer opportunity to complete the Follow-up Survey via tablet 
computer at this appointment. 
12.0 Genetic Analysis Information 

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N/A  
 
13.0 Sharing of Results with Participants 
We will not share results of research procedures with participants. 
Results derived from clinical care procedures (i.e., lab testing) will be 
shared with participant by the ED team as per usual standard of care.  
 
14.0 Risks to Participants* 
Breach of confidentiality: As with any study, there is potential for breach 
of confidentiality. Strict measures will be taken to ensure participant 
privacy and confidentiality. All data will be managed in accordance with 
hospital institutional review board and HIPPA requirements to ensure 
confidentiality and protection of research participants. Participants will 
provide assent/consent and complete data collection privately to 
maintain confidentiality. Study personnel will not use study data and 
records for any purpose other than conducting the study. Only 
researchers involved in this study will have access to the collected data. 
All data will be de-identified then stored in the secure REDCap database, 
and all participants will be assigned a unique identification number. The 
contact information needed to facilitate the 6-week check-in and 3-
month Follow-up will not be linked to survey data. All personally 
identifiable information will be kept strictly confidential and stored in 
REDCap and only accessible by Dr. Randell and the necessary, designated 
study staff. At the completion of data collection and gift card provision, 
personally identifiable information will be destroyed. 
Mandatory reporting: During the consent process, we will inform 
participants that we are unable to maintain confidentiality if they verbally 
disclose abuse that requires a mandated report by state law or 
relationship behaviors that raise significant concern for safety of a minor 
(i.e., < 18 years of age) adolescent participant. 
Emotional distress: Participants may experience distress triggered by the 
study topic. However, our prior experience with similar studies and 
available published evidence suggests this risk is minimal.43-45 We include 
information in the consent process that reminds participants that they 
are not required to answer questions that make them feel uncomfortable 
and may choose to terminate study participation at any time. CMH social 
workers and a community-based intimate partner violence advocate are 
available 24 hours daily for patients and families; participants will be 
informed of this availability during the informed consent process, as well 
as upon interview completion. Additionally, each participant will receive 
a list of teen community resources (e.g., local intimate partner violence 

ED-HEART Pilot 
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agency, teen resource center, mental health resources, and agency 
advocating for sexual minority youth; national suicide hotline, ARA, and 
sexual exploitation resources), such that they may contact needed 
resources at any time without disclosure of need to the study team. 
Study risks are not greater than minimal for all participants. 
 
15.0 Potential Benefits* 
 
Participants may benefit directly from the teen resource list that will be 
provided to each participant. Participants in the intervention arm may 
benefit from receipt of the ED-HEART intervention. Information provided 
in the teen resource list and ED-HEART intervention may enable 
participants to better delineate healthy vs. unhealthy relationship 
behaviors, to provide support for peers experiencing ARA, and to access 
CM and community resources for common issues, including ARA.  
Benefits to society/science may include 1) improved care of adolescents 
treated receiving care in ED settings in the future, through ED-HEART 
implementation, and 2) better understanding of effective interventions 
to promote healthy adolescent relationships and mitigate harms of ARA.  
 
16.0 Investigator Assessment of Risk/Benefits Ratio*  
16.1 
 
 
Select as applicable: 
Pediatric Risk Category: 
☒ 
Category 1  
Research not involving greater than minimal risk  
(45 CFR §46.404 and 21 CFR §50.51)   
☐ 
Category 2 
Research involving greater than minimal risk but 
presenting the prospect of direct benefit to the 
individual participants. (45 CFR §46.405 and 21 CFR 
§50.52) 
☐ 
Category 3 
Research involving greater than minimal risk and no 
prospect of direct benefit to individual participants, 
but 
likely to yield generalizable knowledge about the 
participant's disorder or condition.  
(45 CFR §46.406 and 21 CFR §50.53) 
☐ 
Category 4 
Research not otherwise approvable which presents 
an opportunity to understand, prevent, or alleviate a 
serious problem affecting the health or welfare of 
children. (45 CFR §46.407 and 21 CFR §50.54) 
Select if applicable: 
Adult Risk Category: 

ED-HEART Pilot 
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☒ 
Not Greater than Minimal Risk 
☐ 
Greater than Minimal Risk 
 
 
17.0 Payment, Reimbursement and Tangible Property provided to 
participants*  
Is payment, reimbursement, or tangible property part of the study?  
☒  Yes                 ☐  No (If No, delete the following subsections) 
 
Payment to Participants: 
 
☐  Greenphire/ClinCard 
☐  Gift Card: (Merchant:_____________) 
☒  Other: __CC pay________ 
 
Payment Schedule: Adolescent participants may receive a total of $50 over 
3 months for study participation, as indicated in the table below.   
Initial visit 
6-week check-in 
3 months 
$20 
$5 (to be added to final payment) $25 
 
 
Reimbursement:  N/A          
Tangible Property:  N/A 
 
18.0 Compensation for Research-Related Injury 
Being in this study involves no more than minimal risk, therefore we do not 
require compensation for research-related injury. 
19.0 Economic Burden to Participants 
Participants may incur costs related to text messaging and data charges for 
surveys completed on their cellular phone. Participants may incur costs related 
to follow up after the ED visit at which they enroll in the study (e.g., positive STI 
testing).  
20.0  Parental Permission and Adult Consent Process* 
 
20.1 
 All participants will provide informed consent/assent before 
participating in study procedures, as described below. 
 

ED-HEART Pilot 
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Written Informed Permission/Consent 
☐ Written informed permission of parent/LAR for pediatric participants 
 
Study group(s) to which this method applies: N/A 
☒ Written informed consent of adult participants 
Study group(s) to which this method applies: Adolescent participants age 18-19 
years of age will provide written consent. 
☐ Written informed consent of participants turning 18 
 
Study group(s) to which this method applies: N/A 
 
Waiver of Documentation of Permission/Consent 
Permission/Consent form provided but signature will NOT be obtained (e.g., verbal consent) 
Must complete Addendum A: Waiver of Documentation of Permission/Consent 
 
☒ Waiver of written documentation of permission of parent/LAR for pediatric 
participants  
Study group(s) to which this method applies: We request waiver of written 
parent/LAR permission for adolescent participants 14-17 years of age. Verbal 
permission will be obtained for the minor adolescent to independently provide 
assent.  
See  Addendum A: Waiver of Documentation of Permission/Consent 
☐ Waiver of written documentation of consent of adult participants  
Study group(s) to which this method applies:  
☐ Waiver of written documentation of consent of participants turning 18  
 
Study group(s) to which this method applies:  N/A 
 
Waiver or Alteration of Permission/Consent 
 
☒ Waiver/Alteration of permission of parent/LAR for pediatric participants 
Study group(s) to which this method applies: We request a waiver of parent/LAR 
permission for adolescent participants 14-17 years of age presenting to the ED 
without a parent/LAR.  

ED-HEART Pilot 
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See Addendum B: Waiver of Permission/Assent/Consent 
☐ Waiver/Alteration of consent of adult participants 
Study group(s) to which this method applies:  
☒ Waiver of documentation of consent of participants turning 18 
Study group(s) to which this method applies:  
Additional Methods 
☒ Obtaining permission/assent/consent of non-English speaking parents or 
participants 
Study group(s) to which this method applies: We will obtain parent/LAR 
permission from Spanish-speaking parents presenting with adolescent 
participants 14-17 years of age. See Addendum C: Non-English Speaking 
Participants 
☐ Surrogate decision maker consent form adults not capable of consenting for 
themselves 
 
Study group(s) to which this method applies: N/A 
20.2  Permission/Consent/Consent at 18 Discussion: N/A 
 
20.3  Documentation of Permission/Consent/Consent at 18: The 6-week check 
in and 3-month follow-up surveys will include a question asking the patient if 
they have turned 18 since they enrolled in the study. For those that answer 
“yes,” we will use branching logic to ensure that they consent to participate at 
this point.   
 
20.4  Identification of participants turning 18: N/A  
 
 
21.0 Assent of Pediatric Participants 
 
21.1 
Select the option(s) that apply to the study: 
 
☐ Obtaining assent of pediatric participants is NOT POSSIBLE due to: 
☐  The capability of the participants (considering the ages, maturity, physical 
and/or psychological state) is so limited that they cannot reasonably be 
consulted. 

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☐  The intervention or procedure involved in the research holds out a prospect 
of direct benefit that is important to the health or well-being of the 
participants and is available only in the context of the research. 
 
☐ Obtaining assent of pediatric participants is NOT PRACTICLE given the 
context of this study (e.g., minimal risk, no direct contact with participants). 
Must complete Addendum B: Waiver/Alteration of 
Permission/Assent/Consent 
 
☒ Assent of pediatric participants WILL BE SOUGHT following assessment of 
ability to assent. 
 
 
21.2  Assessment of Ability to Assent: Study team members will verify with the 
clinical care team that the patient has the capacity to assent.   
 
21.3  Assent Discussion: Informed assent will occur during the ED visit in a 
private setting (i.e., parent/LAR will not be present during the assent process). 
The study team will:  
1) Provide ample opportunity for potential participants to ask questions and to 
consider participation, including coming back later during the visit to allow the 
adolescent time for consideration.  
2) Use teach-back to confirm comprehension of study procedures.  
3) Communicate that current and future care at CM will not be impacted by the 
decision to participate in the study or not.  
 
21.4  Documentation of Assent or Inability to Assent: We will use eConsent to 
document participant assent 
 
22.0 HIPAA and Confidentiality 
22.1 
HIPAA Authorization  
 
☒  Full Written HIPAA Authorization will be obtained (within the p/a/c form or 
standalone form) from adolescent participants 18-19 years of age.  
 
☒ Partial Waiver of HIPAA Authorization: 
We request a partial waiver of HIPAA Authorization for: 
• Use of the ED tracking board to facilitate recruitment and pre-
screening and data collection from the electronic health record.   
 
See Addendum E: Waiver/Alteration of HIPAA Authorization 
 

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☐ Alteration of HIPAA Authorization (some but not all required elements of an 
Authorization are present, e.g., signature will not be obtained) 
See Addendum E: Waiver/Alteration of HIPAA Authorization 
 
 
☐ Waiver of HIPAA Authorization (authorization will NOT be obtained): 
 
See Addendum E: Waiver/Alteration of HIPAA Authorization 
 
☐ If Other, explain: 
 
22.2 
Data confidentiality:  
• PHI will be stored in a secure CM REDCap file, accessible only to 
members of the study team.  
• We will destroy PHI at the earliest opportunity. We will maintain PHI 
through completion of enrollment and data analysis. PHI will then be 
deleted.  
• PHI will only be accessed by members of the study team as necessary 
for study procedures. Good Clinical Practice guidelines will be 
followed in order to ensure that study data is not disclosed to 
unauthorized persons.  
• Study team training will include the importance of data confidentiality 
and mechanisms to protect confidentiality.  
22.3 
As this is an NIH-funded study, a Certificate of Confidentiality has 
been issued for this study.  
 
23.0 Provisions to Protect the Privacy Interests of Participants* 
23.1 
The study team will take great care to protect participant privacy.  
Recruitment and enrollment will occur privately.  
Participants will be assigned a study number. Surveys will be completed 
confidentially and will not contain identifying information. We will use a unique, 
participant-created code to link study surveys over time, such that participant 
identity is not linked to the study survey data.39 Contact information used to 
facilitate follow-up survey completion will be stored in a separate REDCap tool 
and thus not linked to study data. Identifying information necessary for gift card 
provision will be obtained upon survey completion via a separate REDCap tool 
and thus this information will not be linked to an individual participant’s survey 
data.  

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All data will be managed in accordance with the CM Institutional Review Board 
and HIPAA requirements to ensure confidentiality and protection of research 
participants. Study team members will not use study data and records for any 
purpose other than for conducting the study.  PHI will be kept in a password 
protected database that is separate from the study survey database. PHI will be 
deleted at the earliest opportunity. There are no patient identifiers recorded in 
the permanent research record. Clinical information will not be released without 
written permission of the participant, except as necessary for monitoring by IRB, 
the FDA, the OHRP, the Sponsor, or the Sponsor’s designee. 
23.2 
To ensure participants feel at ease with study procedures, we will 
thoroughly explain study procedures, ensure ample opportunity for questions at 
any point during the study, provide assurance that participation is voluntary and 
can be terminated at any point, and provide assurance that the decision to 
participate or not will not impact the participant’s relationship with Children’s 
Mercy 
23.3 
Study team members will only have access to data required to complete 
their designated study duties. Study team member training will include necessity 
of and mechanisms to protect privacy and confidentiality. 
 
24.0 Withdrawal of Participants* 
All participants may withdraw from the study at any time by notifying the 
research team. If a participant withdraws from the study, any data collected up 
to that point will be kept and deidentified for analysis purposes. 
DATA MANAGEMENT 
25.0 Data Collection* 
Sources of data include adolescent participants (surveys, audio recordings of ED-
HEART delivery), the medical records of adolescent participants (chart review by 
study team), the Cerner ED tracking board, and Health Educator field notes. See 
Section 9 (Surveys and Psychometric Testing) for a detailed description of survey 
data.Sensitive Data: Study data includes report of ARA and receipt of POC RSH 
resources accessed during the ED visit. 
Identifiable Data:  PHI sufficient to enable delivery of the study follow-up 
survey and to enable monitoring of intervention fidelity (i.e., audio 
recording of ED-HEART delivery) will be recorded. This information will 
not be retained as a part of permanent study data.    
 
1. Name/Initials 
☐ Accessed only 
☒ Recorded 

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2. All elements of date (except year) directly 
related to an individual (e.g., date of birth, 
admission date, discharge date, date of 
death) 
☐ Accessed only 
☒ Recorded 
3. Medical record number 
☐ Accessed only 
☒ Recorded 
4. Account number 
☐ Accessed only 
☒ Recorded 
5. Health plan identification number 
☐ Accessed only 
☐ Recorded 
6. Social Security Number 
☐ Accessed only 
☐ Recorded 
7. Device identifiers and serial number 
☐ Accessed only 
☐ Recorded 
8. Certificate/License number 
☐ Accessed only 
☐ Recorded 
9. Telephone number 
☐ Accessed only 
☒ Recorded 
10. Fax number 
☐ Accessed only 
☐ Recorded 
11. Email addresses 
☐ Accessed only 
☒ Recorded 
12. Web addresses (URLs); Internet IP addresses 
☐ Accessed only 
☐ Recorded 
13. Street address, city, county, precinct, zip 
code or equivalent geographical codes 
☐ Accessed only 
☒ Recorded 
14. Full face photographic images and any 
comparable images 
☐ Accessed only 
☐ Recorded 
15. Biometric identifiers, including finger and 
voice print 
☐ Accessed only 
☒ Recorded 
16. Vehicle identifiers and serial numbers, 
including license plate number 
☐ Accessed only 
☐ Recorded 
17. Any other unique identifying number, 
characteristic or code that may help identify 
individual participants including their initials 
(e.g., student or employee ID number) 
☐ Accessed only 
☐ Recorded 
18. Elements of date, including year, for persons 
90 years or older 
☐ Accessed only 
☐ Recorded 
19. Other: 
☐ Accessed only 
☐ Recorded 
 
 
26.0 Adverse Events and Unanticipated Problems* 
Monitoring:  The PI and study team will meet weekly during enrollment and the 
3-month follow-up period to identify and discuss adverse events and 
unanticipated problems. Study team members will promptly notify the PI if an 
adverse event or unanticipated problem is identified.  
Reporting:  We will follow Policy 5.11 Reportable Events of the CM Research 
Program Policies and Procedures in regards to reporting adverse events and 
other unanticipated problems to the CM IRB. 
 

ED-HEART Pilot 
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27.0 Data Analysis 
We will generate a descriptive summary of feasibility using the Bowen model’s 
eight constructs (Table 2). 
Table 2: Assessment of Bowen Feasibility Constructs 
Construct 
Definition 
Assessment measures 
Acceptability  
To what extent is ED-
HEART suitable?  
Adolescent surveys, Health Educator 
field notes 
Demand  
To what extent is ED-
HEART likely to be used?  
Proportion of screened adolescents 
eligible; proportion of eligible 
adolescents enrolled; Health Educator 
field notes 
Implementation  To what extent can ED-
HEART be delivered as 
planned?  
Fidelity assessment per 
adolescent survey, Health Educator field 
notes, audio recordings of intervention 
delivery  
Practicality  
What factors make delivery 
challenging or facilitate 
delivery?  
Health Educator field notes 
Adaptation  
To what extent does ED-
HEART perform in a new 
system?  
Comparison with published outcomes in 
original setting33  
Integration  
To what extent can ED-
HEART be integrated within 
existing system?  
Health Educator field notes 
Expansion  
To what extent can the 
existing system be expanded 
to provide ED-HEART?  
Health Educator field notes 
Limited efficacy   Are ED-HEART outcomes 
promising?  
Primary outcome: any ARA at 3-month 
follow up33 , per adolescent survey 
 
Acceptability ratings will be collapsed to dichotomous variables. ED-
HEART will be deemed acceptable if the test of the proportion of 
very/fairly satisfactory ratings for adolescents, the health educator, and 
ED staff being <85% is not statistically significant. We will compare ED 
length of stay between the two arms, and calculate the mean/median 
number of interruptions per participant, with a list of reasons for 
interruption. For limited efficacy assessment, our primary outcome is any 
ARV as individual types of abuse rarely occur in isolation and HEART is 
designed to address ARV broadly. We will compare odds of reporting ARA 
at follow-up for the two arms by fitting a logistic regression model with 
any ARV at follow-up (yes or no) as the dependent variable, baseline ARA 

ED-HEART Pilot 
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(yes or no) as a covariate, and study arm as focal predictor. This approach 
should have higher statistical power than the Fisher’s Exact Test used in 
the power analysis, making our sample size somewhat conservative. We 
will analyze secondary outcomes (ARA perpetration, ARA victimization, 
recognition of abusive behaviors, knowledge of ARA resources, self-
efficacy to use harm reduction strategies, use of harm reduction 
strategies and resources) similarly. Factors potentially affecting 
intervention efficacy (e.g., sex, gender, race/ethnicity, recognition of 
behaviors as abusive, intention to engage in healthy relationship 
behaviors, adolescent change talk, MI fidelity [MI-consistent/-
inconsistent behaviors], intervention intensity [number of intervention 
topics discussed]) will be considered as additional model predictors. We 
will summarize demographics and report baseline prevalence of any ARA 
and individual types of ARA. We will check for differences in 
demographics and baseline variables between the two arms, as well as 
for demographic differences between participants and refusals. 
2.3 
A sample size of 69 per arm provides 80.4% power to detect a 
between-arm difference, assuming control and intervention arm TVD 
rates of 0.55 and 0.30, respectively, at 3 months at follow-up (two-sided 
Fisher’s Exact Test at alpha=0.05). We set a final sample as n=174 
participants (n=87 each arm) to account for an estimated 20% loss to 
follow up, based on our previous work.  
28.0 Data and Specimen Management* 
Data Management:  Data will include that obtained from the study surveys and 
medical record, as described above. 
Data will be collected via REDCap or paper survey or EHR review. Data 
from the surveys and EHR will be stored in REDCap. Paper surveys, if used 
in the event of a REDCap or other IT issue, will be stored in a locked office 
of the investigators. 
Deidentified data will be exported from REDCap to statistical programs 
for analysis (e.g., SAS, SPSS, Excel). All data will be securely stored on 
password-protected CM servers.  
Strict measures will be taken to ensure participant privacy and 
confidentiality. Participants will be assigned a unique study identification 
number. Additionally, survey data will be collected using a unique, 
participant-created code such that a link between participant survey 
number and participant identity do not need to be linked.39 The study 
REDCap project will be set up such that the study team will not be able to 
link survey data to individual participant identity. All personally 
identifiable information needed to facilitate data collection and 
intervention fidelity review will be kept strictly confidential, stored on 

ED-HEART Pilot 
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REDCap, and accessible only to designated study team members.  Only 
study team members needing access to data to fulfill their study 
responsibilities will have access to the data. Non-study team members 
will not have access to the data.  
Data will be stored per CM records retention policy.  
Specimen Management: N/A  
Biosafety Information 
Will this study involve handling, transporting, or shipping any 
potentially hazardous biological material at/from a Children’s Mercy 
location (e.g., blood, stool, saliva, tissue)? 
☐ Yes 
☒ No 
Will this study involve processing any potentially hazardous biological 
material at a Children’s Mercy location (e.g., blood, stool, saliva, 
tissue)? 
☐ Yes 
☒ No 
29.0 Storage/Banking of Data and Specimens for Future Research 
N/A   
 
30.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
N/A as this study does not involve more than Minimal Risk to 
participants. 
 
STUDY MANAGEMENT 
31.0 Setting & Locations 
Study processes will occur at Children’s Mercy, with participant recruitment and 
procedures occurring in the EDs. The treating ED team, an ED social worker, and 

ED-HEART Pilot 
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an intimate partner violence advocate are available to participants 24 hours daily 
in the ED setting.   
 
32.0 Multi-Site Research 
 
All study procedures will occur at CM. However, some co-investigators 
are from non-CM institutions: Elizabeth Miller, MD, PhD (University of 
Pittsburgh), Ann Davis, PhD (University of Kansas Medical Center), Megha 
Ramaswamy, PhD (University of Kansas Medical Center). These study 
members are categorized as not participating in human participants 
research as they will at no time interact with study participants or have 
access to identifiable data.    
 
33.0 International Research 
 
N/A 
 
 
 
 

ED-HEART Pilot 
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Addendum A: Waiver of Documentation of Permission/Consent 
 
Regulatory Criteria: To qualify for a waiver of documentation of parental permission or 
adult consent, the study must fit into at least one of the three scenarios below. Indicate 
which scenario(s) applies. 
 
☐ The only record linking the participant and the research would be the 
permission/consent form and the principal risk is potential harm resulting from a 
breach of confidentiality. Each parent/LAR or adult participant will be asked whether 
they want documentation linking the participant with the research, and the 
parent/LAR’s or adult participant’s wishes will govern. 
 
OR 
 
☒ The research presents no more than minimal risk of harm to participants and 
involves no procedures for which written parental permission or adult consent is 
normally required outside of the research context. 
 
OR 
 
☐ The parent(s)/LAR or adult participants are members of a distinct cultural group or 
community in which signing forms is not the norm, the research presents no more 
than minimal risk of harm to participants and an appropriate alternative mechanism 
for documenting that informed parental/LAR permission or adult consent was 
obtained will be provided. Describe the alternative mechanism provided: 

ED-HEART Pilot 
Page 25 of 36 
 
 
Addendum B: Waiver/Alteration of Permission/Assent/Consent 
 
What’s the difference between a “waiver” and an “alteration” of parental permission, 
child assent, or adult consent?   
 
• A “waiver” of parental permission, child assent, or adult consent is when all 9 
required elements of permission/consent are waived. If the IRB approves a 
waiver, then the study team does not need to obtain the parental permission or 
adult consent in order to include a participant in the study. 
 
• An “alteration” of parental permission, child assent, or adult consent is when 
one or more of the 9 required elements are waived because they are not 
relevant to the research activity. If the IRB approves an alteration, then the study 
team must still obtain parental permission or adult consent in order to include a 
participant in the study, but certain elements may not be required in the 
form/discussion. 
 
 
Criteria 
Explain how the study meets the criteria 
The research involves no more 
than minimal risk to the 
participants 
Study participation entails no more than minimal risk for 
participants. 
The research could not 
practicably be carried out 
without the requested 
waiver/alteration (i.e., explain 
why the study could not be 
done if 
permission/assent/consent 
were required) 
Exclusion of adolescent presenting to the ED 
unaccompanied by a parent would result in sampling bias. 
Adolescents commonly present to the ED unaccompanied 
by a parent. Further, a common reason for adolescents to 
seek medical are without a parent is to address 
reproductive and sexual health concerns; these adolescents 
are at increased risk for ARA and should not be excluded 
from this study. 
If the research involves using 
identifiable private 
information or identifiable 
biospecimens, the research 
could not practicably be 
carried out without using such 
information or biospecimens 
in an identifiable format 
PHI is needed to enable data collection at the 12-week 
follow up. PHI collected is limited to that needed for 12-
week follow up. 
The waiver/alteration will not 
adversely affect the rights and 
welfare of the participants 
Waiver of parental permission for adolescents presenting to 
the ED unaccompanied by a parent will not adversely affect 
the rights and welfare of participants as this study is 
minimal risk and all participants will provide assent.  

ED-HEART Pilot 
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Whenever appropriate, the 
participants or legally 
authorized representatives 
will be provided with 
additional pertinent 
information after participation 
Whenever appropriate, the participants or legally 
authorized representatives will be provided with additional 
pertinent information after participation. 
 
Proposed Alteration (if applicable):  
Select which required elements of permission are to be omitted. 
☐ A statement that the study involves research, an explanation of the purposes of 
the research and the expected duration of the participant's participation, a 
description of the procedures to be followed, and identification of any 
procedures that are experimental; 
 
☐ A description of any reasonably foreseeable risks or discomforts to the 
participant; 
 
☐ A description of any benefits to the participant or to others that may reasonably 
be expected from the research; 
 
☐ A disclosure of appropriate alternative procedures or courses of treatment, if any, 
that might be advantageous to the participant; 
 
☐ A statement describing the extent, if any, to which confidentiality of records 
identifying the participant will be maintained; 
 
☐  For research involving more than minimal risk, an explanation as to whether any 
compensation and an explanation as to whether any medical treatments are 
available if injury occurs and, if so, what they consist of, or where further 
information may be obtained; 
 
☐  An explanation of whom to contact for answers to pertinent questions about the 
research and research participants' rights, and whom to contact in the event of a 
research-related injury to the participant; 
 
☐  A statement that participation is voluntary, refusal to participate will involve no 
penalty or loss of benefits to which the participant is otherwise entitled, and the 
participant may discontinue participation at any time without penalty or loss of 
benefits to which the participant is otherwise entitled; and 
 
☐  One of the following statements about any research that involves the collection 
of identifiable private information or identifiable biospecimens: 
 

ED-HEART Pilot 
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☐  A statement that identifiers might be removed from the identifiable private 
information or identifiable biospecimens and that, after such removal, the 
information or biospecimens could be used for future research studies or 
distributed to another investigator for future research studies without 
additional informed consent from the participant or the legally authorized 
representative, if this might be a possibility; or 
 
☐  A statement that the participant's information or biospecimens collected as 
part of the research, even if identifiers are removed, will not be used or 
distributed for future research studies. 
 
Provide the rationale for omitting the item(s) selected: N/A 
 
 
 

ED-HEART Pilot 
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Addendum C: Non-English Speaking Participants 
 
There are special considerations that must be made when obtaining 
permission/assent/consent from participants who prefer to communicate in a language 
other than English. To ensure that adequate processes are in place to obtain effective 
permission/assent/consent from these participants address each of the items below. 
 
Indicate which language(s) other than English are understood by prospective 
participants or representatives. 
 
☒  Spanish 
☐  Arabic 
☐  Burmese 
☐  Somali 
☐  Vietnamese 
☐  Other:_______________________________________________ 
 
 
Describe the plan for enrolling non-English speaking participants (e.g., fully translated 
consent forms, use of Qualified Bilingual Study Staff or interpreters): 
 
For enrollment of minor participants with Spanish-speaking parents who are present at 
the time of the ED visit, we will use: 
• Qualified bilingual study staff or an interpreter. 
• A Spanish version of the Study Information Sheet for Parents. 
 
If providing fully translated consent forms, explain if the ORI Translation Program for 
internally and/or federally funded studies will be used, or if translation services will be 
obtained through the study sponsor or some other service. 
 
As this is a federally funded study, we will use the ORI Translation Program for 
documents requiring translation (i.e., Study Information Sheet for Parents). 
 

ED-HEART Pilot 
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Addendum D: Surrogate Decision Maker Consent 
 
N/A Not applicable 
 
 
 
 

ED-HEART Pilot 
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Addendum D: Surrogate Decision Maker Consent 
 
Not applicable 
 
 
 

ED-HEART Pilot 
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Addendum E: Waiver/Alteration of HIPAA Authorization 
 
 
What’s the difference between a “waiver” and an “alteration” of HIPAA 
Authorization? 
 
• A “waiver” of HIPAA Authorization is when the requirement to obtain 
authorization is completely waived. If the IRB approves a waiver, then the study 
team does not need to obtain HIPAA Authorization in order to include a 
participant in the study. 
 
• An “alteration” of HIPAA Authorization is when one or more of the required 
elements of authorization are waived.  If the IRB approves an alteration, then 
the study team must still obtain HIPAA Authorization in order to include a 
participant in the study, but certain elements may not be required in the 
form/discussion. 
 
 
 
Criteria 
Explain how the study meets the 
criteria 
The use or disclosure of PHI involves no 
more than minimal risk to the privacy of 
individuals based upon the following:  
a. Plan to protect PHI from 
improper use and disclosure: 
b. Plan to destroy PHI at the 
earliest opportunity, unless 
there is a health or research 
justification for retaining the 
PHI: 
c. Assurance that PHI will not be 
reused or disclosed to any 
other person or entity: 
 
Partial Waiver of HIPAA 
Authorization and Alteration of 
HIPPA Authorization: 
a. Only researchers involved in 
this study will have access to PHI 
and will use it only for study 
purposes as described in this 
protocol. Recorded data will be 
stored in the secure REDCap 
database and all participants will 
be assigned a unique study 
identification number.  
b. All recorded PHI will be deleted 
upon study completion, such that 
only de-identified data is 
permanently stored as part of this 
study.  
c. PHI will not be reused or 
disclosed to anyone not involved 
in this research. Good Clinical 
Practice guidelines will be 

ED-HEART Pilot 
Page 32 of 36 
 
 
 
 
followed in order to ensure that 
information will not be disclosed 
to unauthorized persons. 
The research cannot practicably 
be conducted without the 
waiver/alteration, i.e., explain 
why a signature for HIPAA 
Authorization cannot be obtained. 
Partial Waiver of HIPAA 
Authorization for pre-
screening/recruitment:  Data will 
be accessed prior to recruitment 
of participants by reviewing the 
clinic electronic tracking boards.  
PHI will not be recorded prior to 
obtaining informed 
permission/assent/consent. 
The research cannot practicably 
be conducted without access to 
and use of the PHI, i.e., explain 
why access to PHI is needed for 
this study. 
Partial Waiver of HIPPA 
Authorization:  Without access to 
PHI via the Cerner electronic 
tracking boards  for 
screening/recruitment, we will be 
unable to practicably identify 
which patients are potentially 
eligible for study participation.  

ED-HEART Pilot 
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References  
 
1. 
Vagi K, Olsen E, Basile K, AM V-K. Teen dating violence (physical and sexual) 
among US high school students: Findings from the 2013 National Youth Risk 
Behavior Survey. JAMA Pediatrics. 2015;169:474-482. 
2. 
Dick RN, McCauley HL, Jones KA, et al. Cyber dating abuse among teens using 
school-based health centers. Pediatrics. 2014;134:e1560-e1567. 
3. 
Zweig J, Dank M, Yahner J, Lachman P. The rates of cyber dating abuse among 
teens and how it relates to other forms of teen dating violence. J Youth Adolesc. 
2013;42(7):1063-1077. 
4. 
Anderson PM, Coyle KK, Johnson A, Denner J. An exploratory study of adolescent 
pimping relationships. J Primary Prev. 2014;35(2):113-117. 
5. 
Kennedy MA, Klein C, Bristowe JTK, Cooper B, Yuille J. Routes of recruitment into 
prostitution: pimps' techniques and other circumstances that lead to street 
prositution. J Aggress Maltreat Trauma. 2007;15(2):1-19. 
6. 
Rothman EF, Bazzi AR, Bair-Merritt MH. "I'll do whatever as long as you keep 
telling me that I'm important": a case study illustrating the link between 
adolescetn dating violence and sex trafficking victimization. J Applied Res 
Children. 2015;6(1-21). 
7. 
Miller E, Decker MR, McCauley HL, et al. Pregnancy coercion, intimate partner 
violence and unintended pregnancy. Contraception. 2010;81(4):316-322. 
8. 
Miller E, McCauley HL, Tancredi DJ, Decker MR, Anderson H, Silverman JG. 
Recent reproductive coercion and unintended pregnancy among female family 
planning clients. Contraception. 2014;89(122-128). 
9. 
Exner-Cortens D, Eckenrode J, Rothman E. Longitudinal associations between 
teen dating violence victimization and adverse health outcomes. Pediatrics. 
2013;131(1):71-78. 
10. 
Decker MR, Silverman JG, Raj A. Dating violence and sexually transmitted 
disease/HIV testing and diagnosis among adolescent females. Pediatrics. 
2005;116(2):e272-276. 
11. 
Decker MR, Miller E, McCauley HL, et al. Intimate partner violence and partner 
notification of sexually transmitted infections among adolescent and young adult 
family planning clinics. In J STI AIDS. 2011;22(6):345-347. 
12. 
Silverman JG, Raj A, Mucci LA, Hathaway JE. Dating violence against adolescent 
girls and associated substance use, unhealthy weight control, sexual risk 
behavior, pregnancy, and suicidality. JAMA. 2001;286(5):572-579. 
13. 
Foshee V, Reyes H, Gottfredson N, Change L, Ennett S. A longitudinal 
examination of psychological, behavioral, adademic and relationship 
consequences of dating abuse victimization among a primarily rural sample of 
adolescents. J Adolesc Health. 2013;53(6):732-729. 
14. 
Coyne-Beasley T, Moracco KE, Casteel M. Adolescent femicide: A population-
based study. Arch Pediatr Adolesc Med. 2003;157(4):355-360. 

ED-HEART Pilot 
Page 34 of 36 
 
15. 
Cui M, Ueno K, Gordon M, Fincham F. The continuation of intimate partner 
violence from adolescence to young adulthood. J Marriage Fam. 2013;75(2):300-
313. 
16. 
Exner-Cortens D, Eckenrode J, Bunge J, Rothman E. Revictimization after 
adolescent dating violence in a matched, national sample of youth. J Adolesc 
Health. 2017;60(2):176-183. 
17. 
Carroll BC, Raj A, Noel SE, Bauchner H. Dating violence among adolescents 
presenting to a pediatric emergency department. Arch Pediatr Adolesc Med. 
2011;165(12):1101-1106. 
18. 
Erickson M-JE, Gittelman MA, Dowd D. Risk factors for dating violence among 
adolescent females presenting to the pediatric emergency department. J 
Trauma. 2010;69(4 Suppl):S227-232. 
19. 
Patton RA, Cunningham RM, Blow FC, Zimmerman MA, Booth BM, Walton MA. 
Transactional sex involvement: exploring risk and promotive factors among 
substance-using youth in an urban emergency department. J Stud Alcohol Drugs. 
2014;75:573-579. 
20. 
Whiteside L, Walton MA, Stanley R, et al. Dating aggression and risk behaviors 
among teenage girls seeking gynecologic care. Acad Emerg Med. 2009;16:632-
638. 
21. 
Adams SH, Newacheck PW, Park MJ, Brindis CD, Irwin CE, Jr. Medical home for 
adolescents: low attainment rates for those with mental health problems and 
other vulnerable groups. Acad Pediatr. 2013;13(2):113-121. 
22. 
Miller MK, Champassak S, Goggin K, et al. Brief behavioral intervention to 
improve adolescent sexual health: a feasibility study in the emergency 
department. Pediatr Emerg Care. 2016;32(1):17019. 
23. 
Wilson KM, Klein JD. Adolescents who use the emergency department as their 
usual source of care. Arch Pediatr Adolesc Med. 2000;154(4):361-365. 
24. 
Ball B, Holland KM, Marshall KJ, et al. Implementing a targeted teen dating abuse 
prevention program: challenges and success experienced by Expect Respect 
facilitators. J Adolesc Health. 2015;56:S40-S46. 
25. 
Randell KA, Bair-Merritt MH, Miller MK, et al. Cyber Adolescent Relationship 
Abuse and Reproductive Coercion: Victimization and Perpetration among 
Adolescents Utilizing a Pediatric Emergency Department. J Adolesc Health. 
2016;58(2):S75-S76. 
26. 
Cunningham RM, Chermack ST, Ehrlich PF, et al. Alcohol interventions among 
underage drinkers in the ED: a randomized controlled trial. Pediatrics. 
2015;136(4):e783. 
27. 
Mollen CJ, Miller MK, Hayes K, Wittink M, Barg F. Developing emergency 
department-based education about emergency contraception: adolescent 
preferences. Acad Emerg Med. 2013;20(11):1164-1170. 
28. 
Rothman E, Wang N. A feasibility test of a brief motivational interviewing 
intervention to reduce dating abuse perpetration in a hospital setting. Psychol 
Violence. 2016;6(3):433-441. 

ED-HEART Pilot 
Page 35 of 36 
 
29. 
Cunningham RM, Whiteside L, Chermack ST, et al. Dating violence: outcomes 
following a brief motivational interviewing intervention among at-risk 
adolescents in an urban emergency department. Acad Emerg Med. 
2013;20(6):562-569. 
30. 
Ngo QM, Eisman AB, Walton MA, et al. Emergency department alcohol 
intervention: effects on dating violence and depression. Pediatrics. 
2018;142(1):e20173525. 
31. 
Ranney ML, Pittman S, Dunsiger S, et al. Emergency department text messaging 
for adolescent violence and depression prevention: A pilot randomized 
controlled trial. Psychol Serv. 2018;15(4):419-428. 
32. 
Randell KA, Wieblehaus J, Pickett M, Sherman AK, Miller MK. Physician and 
Parent Conversations with Adolescents about Dating. Pediatric Academic 
Societies Meeting; 2018; Toronto, Canada. 
33. 
Miller MK, Mollen CJ, O'Malley D, et al. Providing adolescent sexual health care 
in the pediatric emergency department: Views of health care providers. Pediatr 
Emerg Care. 2014;30(2):84-90. 
34. 
Miller MK, Hornberger L, Sherman AK, Dowd MD. Acceptability of sexual health 
discussion and testing in the pediatric acute care setting. Pediatr Emerg Care. 
2013;29(5):592-597. 
35. 
Miller E, Goldstein S, McCauley HL, et al. A school health center intervention for 
abusive adolescent relationships: a cluster RCT. Pediatrics. 2015;135(1):76-85. 
36. 
Miller E, Levenson RR. Hanging Out or Hooking Up: Clinical Guidelines on 
Responding to Adolescent Relationship Aubse. Futures Without Violence; 2013. 
37. 
Bowen DJ, Kreuter M, Spring B, et al. How we design feasibility studies. Am J Prev 
Med. 2009;36(5):452-457. 
38. 
Azjen I. From intentions to action: a theory of planned behavior. In: Kuhl J, 
Beckman J, eds. Action Control: From Cognition to Behavior. Springer; 1985:11-
39. 
39. 
Ripper L, Ciaravino S, Jones KA, Jaime M, Miller E. Use of  respondent generated 
personal code for matching anonymous adolescent surveys in longitudinal 
studies. J Adolesc Health. 
40. 
Harris K, Florey F, Tabor J, Bearman P, Jones J, Udry J. The national longitudinal 
study of adolescent health: Research design. Chapel Hill, NC: Carolina Population 
Center, University of North Carolina at Chapel Hill; 2003. 
41. 
McCauley HL, Silverman JG, Jones KA, et al. Psychometric properties and 
refinement of the Reproductive Coercion Scale. Contraception. 2017;95:292-298. 
42. 
Schwarzer R, Jeruselem M. Generalized Self-Efficacy Scale. In: Wienman J, Wright 
S, Johnston M, eds. Measures in Psychology: A user's portfolio. Causal and 
Control Beliefs. Windsor, United Kingdon: NFER-NELSON; 1995:35-37. 
43. 
Shorey RC, Cornelius TL, Bell KM. Reactions to participating in dating violence 
research: are our questions distressing participants? J Interpers Violence. 
2011;26(14):2890-2907. 

ED-HEART Pilot 
Page 36 of 36 
 
44. 
Shorey RC, Febres J, Brasfield H, Zucosky H, Cornelius TL, Stuart GL. Reactions to 
dating violence research: Do difficulties with distress tolerance increase negative 
reactions? J Family Violence. 2013;28(5):479-487. 
45. 
Ybarra ML, Langhinrichsen-Rohling J, Friend J, Diener-West M. Impact of asking 
sensitive questions about violence to children and adolescents. J Adolesc Health. 
2009;45(5):499-507.