PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury
Phase: NA
Conditions: Psychological Trauma, Depression, Coping
Sponsor: Marizen Ramirez

 
 
 
 
 
 
 
PCORI-1306-02918 Evaluation of Parent-Based Interventions to Support Children after 
Traumatic Injury 
 
ClinicalTrials.gov ID: NCT02323204 
 
5/07/2018 

 
 
 
 
IRB ID #: 
201111728 
 
To: 
 
Marizen Ramirez 
 
From:  
IRB-01  
DHHS Registration # IRB00000099, 
Univ of Iowa, 
DHHS Federalwide Assurance # FWA00003007 
 
Re: 
Evaluation of Parent Based Interventions to Support Children After Traumatic Injury 
 
Protocol Number: 
 
 
Protocol Version:  
 
 
Protocol Date:   
 
 
Amendment Number/Date(s): 
 
 
 
Approval Date: 
05/07/18 
 
 
Next IRB Approval 
Due Before: 
05/07/19 
 
Type of Application: 
Type of Application Review:  
Approved for Populations: 
 
 
 New Project  
 Full Board:  
 Children 
 Continuing Review 
Meeting Date:  
 Prisoners 
 Modification  
 Expedited 
 Pregnant Women, Fetuses, Neonates 
 
 
 
 
 
 
 
 
 
 Exempt 
      
 
 
Source of Support: 
Patient-Centered Outcomes Research Insitute 
 
Investigational New Drug/Biologic Name: 
 
Investigational New Drug/Biologic Number: 
 
Name of Sponsor who holds IND: 
 
 
Investigational Device Name: 
 
Investigational Device Number: 
 
Sponsor who holds IDE: 
  
 
 
This approval has been electronically signed by IRB Chair: 
Brian Bishop, CIP, MA 
05/07/18 1605

IRB ID#: 201111728   05/07/18   Page 2 of 3  
 
 
IRB Approval:  IRB approval indicates that this project meets the regulatory requirements for the protection 
of human subjects.  IRB approval does not absolve the principal investigator from complying with other 
institutional, collegiate, or departmental policies or procedures. 
 
Agency Notification:  If this is a New Project or Continuing Review application and the project is funded by 
an external government or non-profit agency, the original HHS 310 form, “Protection of Human Subjects 
Assurance Identification/IRB Certification/Declaration of Exemption,” has been forwarded to the UI Division of 
Sponsored Programs, 100 Gilmore Hall, for appropriate action.  You will receive a signed copy from 
Sponsored Programs. 
 
Recruitment/Consent:  Your IRB application has been approved for recruitment of subjects not to exceed 
the number indicated on your application form.  If you are using written informed consent, the IRB-approved 
and stamped Informed Consent Document(s) are attached.  Please make copies from the attached "masters" 
for subjects to sign when agreeing to participate.  The original signed Informed Consent Document should be 
placed in your research files.  A copy of the Informed Consent Document should be given to the subject.  (A 
copy of the signed Informed Consent Document should be given to the subject if your Consent contains a 
HIPAA authorization section.)  If hospital/clinic patients are being enrolled, a copy of the IRB approved 
Record of Consent form should be placed in the subject’s electronic medical record. 
 
Continuing Review:  Federal regulations require that the IRB re-approve research projects at intervals 
appropriate to the degree of risk, but no less than once per year.  This process is called “continuing review.”  
Continuing review for non-exempt research is required to occur as long as the research remains active for 
long-term follow-up of research subjects, even when the research is permanently closed to enrollment of new 
subjects and all subjects have completed all research-related interventions and to occur when the remaining 
research activities are limited to collection of private identifiable information. Your project “expires” at 12:01 
AM on the date indicated on the preceding page (“Next IRB Approval Due on or Before”).  You must obtain 
your next IRB approval of this project on or before that expiration date.  You are responsible for submitting a 
Continuing Review application in sufficient time for approval before the expiration date, however the HSO will 
send a reminder notice approximately 60 and 30 days prior to the expiration date. 
 
Modifications:  Any change in this research project or materials must be submitted on a Modification 
application to the IRB for prior review and approval, except when a change is necessary to eliminate apparent 
immediate hazards to subjects.  The investigator is required to promptly notify the IRB of any changes made 
without IRB approval to eliminate apparent immediate hazards to subjects using the Modification/Update 
Form. Modifications requiring the prior review and approval of the IRB include but are not limited to:  changing 
the protocol or study procedures, changing investigators or funding sources, changing the Informed Consent 
Document, increasing the anticipated total number of subjects from what was originally approved, or adding 
any new materials (e.g., letters to subjects, ads, questionnaires). 
 
Unanticipated Problems Involving Risks:  You must promptly report to the IRB any serious and/or 
unexpected adverse experience, as defined in the UI Investigator’s Guide, and any other unanticipated 
problems involving risks to subjects or others.  The Reportable Events Form (REF) should be used for 
reporting to the IRB. 
 
Audits/Record-Keeping:  Your research records may be audited at any time during or after the 
implementation of your project.  Federal and University policies require that all research records be 
maintained for a period of three (3) years following the close of the research project.  For research that 
involves drugs or devices seeking FDA approval, the research records must be kept for a period of three 
years after the FDA has taken final action on the marketing application. 
 
Additional Information:  Complete information regarding research involving human subjects at The 
University of Iowa is available in the “Investigator’s Guide to Human Subjects Research.”  Research 
investigators are expected to comply with these policies and procedures, and to be familiar with the 
University’s Federalwide Assurance, the Belmont Report, 45CFR46, and other applicable regulations prior to 
conducting the research.  These documents and IRB application and related forms are available on the 
Human Subjects Office website or are available by calling 335-6564. 

IRB ID#: 201111728   05/07/18   Page 3 of 3  
 
 
 
 

PI:
Marizen Ramirez
IRB ID #: 201111728
Project Details
I. Project Introduction
I.1
Project to be reviewed by:
IRB-01
I.2
Project Title:
Evaluation of Parent Based Interventions to Support Children After Traumatic Injury
I.3
Short Title (optional):
Psychological First Aid for Injured Kids
I.4
Provide a short summary of the purpose and procedures of the study proposed in this IRB application.
DO NOT include information on studies not proposed in this application.
Use LAY terminology only. This must be easily understandable by IRB community members and nonscientists.
DO NOT cut and paste technical abstracts from funding applications that may not be understood by a general audience.
Phase 1
We propose to conduct eight focus groups: two composed of approximately 6-10 parents each at University of Iowa Children's Hospital
and two composed of approximately 6-10 parents at Blank Children's Hospital. We will also conduct two of approximately 6-10
pediatric health care providers each from the University of Iowa Children's Hospital and two of approximately 6-10 pediatric health care
providers each from Blank Children's Hospital. The purpose of the parent focus groups is to establish the parent's willingness to
participate in a study to reduce the psychological effects of injury on their children, and a parent's acceptability of the LPC for Injured
Kids materials. The purpose of the pediatric health care provider focus groups is to understand the types of trauma experienced by
children, the psychosocial consequences encountered by traumatized children and the types of services perceived as available,
accessible, and acceptable to families particularly from rural Iowa. In addition, providers will be asked to provide feedback on the LPC
for Injured Kids materials. If a health care provider is unable to participate in the focus group but wishes to be interviewed individually,
the purpose and the questions asked during the interview will be identical to those of the focus group. Each focus group/interview is
expected to last between 60 and 90 minutes.
Phase 2
Children between 10-17 years of age presenting to the UIHC and Blank Children's Hospital with an unintentional injury requiring
admission will be the sample population. Blank Children's Hospital has submitted a separate IRB for their participation in the study. A
child will be included if they are 10-17 years old with an unintentional injury. Consenting children and their parents will be asked to
complete a series of four questionnaires: before hospital discharge, at 6 weeks post discharge, 3-months and 6-months post discharge.
The parent-child dyads will be randomized (1:1) to receive training in Link for Injured Kids or to receive Trauma Education (parent
booklet, "So, you've been in an Accident"). The survey completed in the hospital will be a paper survey or online via iPads, and
follow-up surveys can be completed on paper or online.
I.5
Specify your research question(s), study aims or hypotheses (do not indicate "see protocol")
Phase 1
Assess the feasibility of LPC for Injured Kids through qualitative research with parents of previously injured children and social workers
and pediatric trauma providers from the UI Children's Hospital and Blank Children's Hospital. The focus group findings will also help
inform and refine intervention materials and delivery.
Phase 2
Through a randomized trial, determine the range of potential psychosocial and behavioral health indicators possibly impacted by Link
for Injured Kids. This will identify the types of outcomes which could include PTSD, depression, nonspecific distress, quality of life,
absenteeism, school performance, coping skills, communication skills, and access to mental health.
I.6
Background and significance and/or Preliminary studies related to this project.
(do not indicate "see protocol")
According to the Centers for Disease Control and Prevention, the number one cause of death and morbidity among children ages 1-19 is
unintentional injury. Each year, approximately 12,000 children die from unintentional injury causes (1). Of all injury causes, motor
vehicle crash leads to the most number of deaths to children in U.S. as passengers, teen drivers and pedestrians. Almost 400,000 injured
teen drivers and occupants were seen in emergency departments in the US in 2005 (2). In the U.S., falls lead to the highest number of
childhood injury emergency department visits followed by injuries due to being struck by or against an object (1). Fire or burns are also
an important cause of injury as the second leading cause of injury death to children between 1 and 19 (1).
Unintentional injuries, particularly severe injuries that impact daily functioning, can have longlasting psychological effects. Prevalence
of posttraumatic stress symptoms is estimated at 29% during the first month post-trauma and 13% between 3-6 months post-trauma. (3)
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Within 12 months of being hospitalized because of injury, 19-32% of adolescents developed PTSD. (4) A variety of injury experiences
can lead to PTSD symptoms including traffic crashes, burns, falls and animal attacks. (5) Adolescents involved in a mass burn incident
had significantly more mental problems than community controls one year after the incident (6), and, 12% of schoolchildren exposed to
an industrial fire met the criteria for PTSD. (7) Approximately 30% of pediatric pedestrian injury cases have acute stress disorder or
PTSD. (8-10) Many cases of psychological trauma are missed in hospital settings and sent home. This proposed project will empower
families with skills to identify trauma-induced mental health distress and resources for referral to advanced mental health care.
Our innovative project addresses the need for evidence-based practices to improve the acute care of children post-injury. Psychological
First Aid (PFA), analogous to physical first aid (11), “uses interpersonal skills provided by individuals to respond to psychological
consequences of [trauma] in their own lives, as well as in the lives of their family, friends, and neighbors (p. 4–5)” (11). Informed by
previous research on posttraumatic risk and resilience, PFA provides information, education, comfort and support through human
contact in order to accelerate recovery and promotion of mental health (12, 13).
In 2006, psychologists developed a child-focused version of PFA in school and community settings called “Listen, Protect, Connect
(LPC)-Model and Teach.” LPC outlines steps for administering PFA to children after any type of crises, either a large-scale disaster or
local emergency. The effectiveness of PFA has not been scientifically evaluated. We propose to create an adapted version of LPC for
families. LPC has the potential to be a national tool that possibly improves coping, access to mental health care, and acute PTSD
symptoms for children impacted by both individual and community emergencies (see Approach for description of LPC).
Preliminary Studies
Dr. Ramirez (PI) has over ten years of experience conducting pediatric injury, violence and disaster preparedness research, including
studies of school-related injuries to children with disabilities (14-16); high school sports injuries (17); and emergency preparedness
among staff, students and parents (18-20). Recently, Dr. Ramirez began studies focused on the psychological trauma in school settings.
Studies of Psychological First Aids. In July 2008, Dr. Ramirez conducted studies of Listen Connect Protect (LPC) in the school setting, a
precursor to the work proposed here. In the first study, 200 randomly selected flood-affected children were invited to participate, but
only 8 enrolled into the study. In the second study, students seen at or referred to school nurses’ offices potentially impacted by various
types of trauma (e.g., unintentional injury, violence, the floods) were enrolled. In total, 20 students were treated with LPC and
followed-up.
The LPC intervention had high fidelity and acceptance among clients and nurse providers. Specifically, 90% of sessions followed the
Listen Steps, 85% the Protect Steps, and 75% the Connect Steps. Feedback from subjects and nurse providers was also extremely
positive, with 80% of children reporting feeling comfortable speaking with the school nurse, and 60% of students indicating that the
LPC sessions were helpful in dealing with recent life events. One student with elevated scores of distress on the K6 screening tool
(PTSD screener included in the LPC repertoire) was immediately referred to advanced mental health care. Human subject protection
approval for LPC has already been obtained, and protocols were developed and tested. The new project will adapt materials from this
school-based study and apply the intervention to families of injured children seen at the UIHC.
Flood-induced stress among college students. In August 2008, Dr. Ramirez conducted a university-wide survey to measure disaster
health impacts of the Great Flood of Iowa among University of Iowa students. Of the 10,500 summer enrolled students, 1,404
responded. Eight percent of students had symptoms consistent with PTSD. The most commonly reported symptom was feeling
emotionally upset (12%). Another 7% reported frequent trouble sleeping and 6% reported frequent trouble concentrating. About 7% of
students reported increased drug and/or alcohol use following the floods.
“So you’ve been in an accident,” the second early intervention strategy to be tested in the proposed study, takes into account the
challenges of hectic hospital settings and busy families. Given time and other constraints, educational materials may be a simple,
cost-effective early intervention option when nothing else is available. Dr. Kenardy (Co-I of this research project) tested his materials at
two children’s hospitals in Queensland. In the intervention hospital, pediatric trauma patients (11-17 years old) and their parents received
booklets within 72 hours of admission, while control patients and parents at the other hospital received no materials. Over the follow-up
period, children in the intervention hospital had significantly lower levels of stress. Their parents also showed promising outcomes such
as fewer intrusive post-traumatic stress symptoms than control group parents. In their implementation evaluation of the materials, 97%
of parents and 83% of children in the intervention arm reported reading them, and of those, 72% of parents perceived the booklets as
having a positive effect on them and 57% thought the materials benefitted their children (18,19).
I.7
Literature cited / references (if attaching a grant or protocol enter N/A).
1. Borse N, Gilchrist J, Dellinger A, Rudd R, Ballesteros M, Sleet D. CDC Childhood Injury Report: Patterns of Unintentional Injuries
among 0 -19 Year Olds in the United States, 2000-2006. Atlanta: Centers for Disease Control and Prevention, National Center for Injury
Prevention and Control; 2008.
2. CoI, Violence and Poison Prevention: American Academy of Pediatrics. Policy statement-Pedestrian safety. Pediatrics
2009;124(2):802-12.
3. Olofsson E, Bunketorp O, Andersson AL. Children and adolescents injured in traffic--associated psychological consequences: a
literature review. Acta Paediatr 2009;98(1):17-22.
4. Zatzick DF, Jurkovich GJ, Fan MY, Grossman D, Russo J, Katon W, et al. Association between posttraumatic stress and depressive
symptoms and functional outcomes in adolescents followed up longitudinally after injury hospitalization. Arch Pediatr Adolesc Med
2008;162(7):642-8.
5. Daviss W, Racusin R, Fleischer A, Mooney D, Ford J, McHugo G. Acute stress disorder symptomatology during hospitalization for
pediatric injury. J Am Acad Child Adolesc Psychiatry 2000;39(5):569-75.
6. Dorn T, Yzermans JC, Spreeuwenberg PM, Schilder A, van der Zee J. A cohort study of the long-term impact of a fire disaster on the
physical and mental health of adolescents. J Trauma Stress 2008;21(2):239-42.
7. March JS, Amaya-Jackson L, Terry R, Costanzo P. Posttraumatic symptomatology in children and adolescents after an industrial fire.
J Am Acad Child Adolesc Psychiatry 1997;36(8):1080-8.
8. de Vries AP, Kassam-Adams N, Cnaan A, Sherman-Slate E, Gallagher PR, Winston FK. Looking beyond the physical injury:
posttraumatic stress disorder in children and parents after pediatric traffic injury. Pediatrics 1999;104(6):1293-9.
9. Stallard P, Salter E, Velleman R. Posttraumatic stress disorder following road traffic accidents - a second prospective study. Eur Child
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Adolesc Psychiatry 2004;13(3):172-8.
10. Winston FK, Kassam-Adams N, Vivarelli-O'Neill C, Ford J, Newman E, Baxt C, et al. Acute stress disorder symptoms in children
and their parents after pediatric traffic injury. Pediatrics 2002;109(6):e90.
11. Institute of Medicine. Preparing for the Psychological Consequences of Terrorism: A Public Health Strategy. Washington, DC:
National Academies Press; 2003.
12. Everly GS, Jr., Flynn BW. Principles and practical procedures for acute psychological first aid training for personnel without mental
health experience. Int J Emerg Ment Health 2006;8(2):93-100.
13. Berger R, Pat-Horenczyk R, Gelkopf M. School-based intervention for prevention and treatment of elementary-students' terror-
related distress in Israel: a quasi-randomized controlled trial. J Trauma Stress 2007;20(4):541-51.
14. Ramirez M, Yang J, Bourque L, Javien J, Kashani S, Limbos MA, et al. Sports injuries to high school athletes with disabilities.
Pediatrics 2009;123(2):690-6.
15. Ramirez M, Peek-Asa C, Kraus JF. Disability and risk of school related injury. Inj Prev 2004;10(1):21-6.
16. Limbos MA, Ramirez M, Park LS, Peek-Asa C, Kraus JF. Injuries to the head among children enrolled in special education. Arch
Pediatr Adolesc Med 2004;158(11):1057-61.
17. Ramirez M, Schaffer KB, Shen H, Kashani S, Kraus JF. Injuries to high school football athletes in California. Am J Sports Med
2006;34(7):1147-58.
18. Kenardy J, Cobham V, Nixon RD, McDermott B, March S. Protocol for a randomised controlled trial of risk screening and early
intervention comparing child- and family-focused cognitive-behavioural therapy for PTSD in children following accidental injury. BMC
Psychiatry 2010;10:92.
19. Kenardy J, Thompson K, Le Brocque R, Olsson K. Information-provision intervention for children and their parents following
pediatric accidental injury. Eur Child Adolesc Psychiatry 2008;17(5):316-25.
II. Research Team
II.1
Principal Investigator
Name
E-mail
College
Marizen Ramirez marizen-ramirez@uiowa.edu College of Public Health
II.2
Team Members
UI Team Members
Name
E-mail
College
Contact Key
Prsn
UI
COI
VAMC
COI
Consent Process
Involvement
Deactivated
Marizen Ramirez, PHD
marizen-
ramirez@uiowa.edu
College of
Public Health
Yes
Yes
No
Yes
No
Mallory Bolenbaugh, BS
mallory-ermler@uiowa.edu Graduate
College
No
No
No
Yes
No
Cassidy Branch, BS, MA
cassidy-branch@uiowa.edu VP Research
Yes
No
No
Yes
No
Collin Calvert, MPH
collin-calvert@uiowa.edu
College of
Public Health
No
No
No
No
No
Gretchen Cress, BSN, RN
gretchen-cress@uiowa.edu Carver College
of Medicine
No
No
No
Yes
No
Jonathan Davis, MS
jonathan-
a-davis@uiowa.edu
College of
Public Health
No
Yes
No
No
No
Patricia Espe Pfeifer, PHD patricia-
espepfeifer@uiowa.edu
Carver College
of Medicine
No
Yes
No
Yes
No
Javier Flores, BS
javier-flores@uiowa.edu
Graduate
College
No
No
No
No
No
Kelly Guinn, BA
kelly-guinn@uiowa.edu
Graduate
College
No
No
No
Yes
No
Charles Jennissen, MD
charles-
jennissen@uiowa.edu
Carver College
of Medicine
No
Yes
No
No
No
Corinne Peek-Asa, PHD
corinne-
peek-asa@uiowa.edu
College of
Public Health
No
Yes
No
No
No
Graeme Pitcher, MD
graeme-pitcher@uiowa.edu Carver College
of Medicine
No
Yes
No
No
No
Lisa Roth, BS
lisa-m-roth@uiowa.edu
College of
Public Health
Yes
Yes
No
Yes
No
Ruthann Schrock, BSN
ruthann-
schrock@uiowa.edu
University
Hospitals
No
No
No
Yes
No
Karen Smith, RD, MS
karen-l-smith@uiowa.edu
College of
Public Health
No
No
No
No
No
Kristel Wetjen, RN
kristel-wetjen@uiowa.edu
University
Hospitals
No
Yes
No
Yes
No
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Name
E-mail
College
Contact Key
Prsn
UI
COI
VAMC
COI
Consent Process
Involvement
Deactivated
Tammy Wilgenbusch, PHD tammy-
wilgenbusch@uiowa.edu
Carver College
of Medicine
No
Yes
No
Yes
No
Non-UI Team Members
Name
Institution Location
FWA
Role
DHHS Contact Key
Prsn
UI
COI
VAMC
COI
Consent
Process
Involvement
Email
Bridget Cho
University
of Kansas-
Lawrence
Lawrence,
KS
00003310
Bridget is a
clinical
psychology
practicum
student
working
with study
Co-I Dr.
Briana
Woods-
Jaeger. In
her role
Bridget is
involved
with both
clinical
work and
research
with Dr.
Woods-
Jaeger and
will be
working
under her
supervision
on this
study.
Yes
No
No
No
Yes
bridget.cho@ku.edu
Sun Young Hwang
Children's
Mercy
Hospital
Kansas
City, MO 00002496
Sun Young
Hwang will
be an intern
that will be
responsible
for
consenting
participants
and
delivering
the
intervention
and
collecting
data per
protocol.
Yes
No
No
No
Yes
shwang@cmh.edu
Teresa Maag
Children's
Mercy
Hospital
Kansas
City, MO 00002496
Teresa will
serve as a
clinical
research
coordinator
and serve
as the site
coordinator
for CMH.
Yes
No
No
No
Yes
tamaag@cmh.edu
Kimberly Randell
Children's
Mercy
Hospital
Kansas
City, MO 00002496
Dr. Randell
is an
emergency
room
physician
who will
provide
clinical
oversight
Yes
No
No
No
Yes
krandell@cmh.edu
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Name
Institution Location
FWA
Role
DHHS Contact Key
Prsn
UI
COI
VAMC
COI
Consent
Process
Involvement
Email
for the
project
team at
Children's
Mercy
Hospital
Chris Sexton
Children's
Mercy
Hospital
Kansas
City, MO 00002496
Dr. Chris
Sexton is a
research
associate
and will
assist in
executing
the study
protocols.
Yes
No
No
No
Yes
csexton@cmh.edu
Emily Siedlik
Children's
Mercy
Hospital
Kansas
City, MO 00002496
Emily will
be a
research
assistant
and adhere
to study
protocols.
She will be
delivering
intervention
and
conducting
data
collection
Yes
No
No
No
Yes
easiedlik@cmh.edu
Lauren Slagel
Children's
Mercy
Hospital
Kansas
City, MO 0002496
Lauren is a
research
assistant
who will
assist in
engagement
activities
and
collecting
stakeholder
feedback.
Yes
No
No
No
Yes
leslagel@cmh.edu
Shallyn Ward
Children's
Mercy
Hospital
Kansas
City, MO 00002496
Shallyn is a
research
assistant at
Children’s
Mercy
Hospital.
She will be
assisting
with
participant
follow-up,
booster
calls, and
survey data
entry. She
will also
assist with
PCORI
stakeholder
engagement
activities
and may
provide
back-up for
screening,
recruitment,
and
Yes
No
No
No
Yes
slward@cmh.edu
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Name
Institution Location
FWA
Role
DHHS Contact Key
Prsn
UI
COI
VAMC
COI
Consent
Process
Involvement
Email
intervention
for eligible
participants
at CMH.
Chalott Williams
Children's
Mercy
Hospital
Kansas
City, MO 00002496
Charlott
will be a
research
assistant
and adhere
to all
protocols.
She will be
delivering
the
intervention
and
conducting
data
collection.
Yes
No
No
No
Yes
cwilliams@cmh.edu
Briana Woods-Jaeger
Children's
Mercy
Hospital
Kansas
City, MO 00002496
Briana
Woods-
Jaeger will
work
remotely as
a research
team
member to
assist in
fidelity
testing of
audio
recordings.
Yes
No
No
No
Yes
bwoodsjaeger@cmh.edu
II.3
The Principal Investigator of this study is:
Faculty
II.6
Identify the key personnel. The system will automatically designate the PI and all faculty members on the project as “key personnel.” For
information about other team members who should be designated as “key personnel” please click on the help information.
Name
Is Key Personnel
Marizen Ramirez, PHD
Yes
Mallory Bolenbaugh, BS
No
Cassidy Branch, BS, MA
No
Collin Calvert, MPH
No
Gretchen Cress, BSN, RN
No
Jonathan Davis, MS
Yes
Patricia Espe Pfeifer, PHD
Yes
Javier Flores, BS
No
Kelly Guinn, BA
No
Charles Jennissen, MD
Yes
Corinne Peek-Asa, PHD
Yes
Graeme Pitcher, MD
Yes
Lisa Roth, BS
Yes
Ruthann Schrock, BSN
No
Karen Smith, RD, MS
No
Kristel Wetjen, RN
Yes
Tammy Wilgenbusch, PHD
Yes
Bridget Cho
No
Sun Young Hwang
No
Teresa Maag
No
Kimberly Randell
No
Chris Sexton
No
Emily Siedlik
No
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Name
Is Key Personnel
Lauren Slagel
No
Shallyn Ward
No
Chalott Williams
No
Briana Woods-Jaeger
No
II.5
Select research team member who is the primary contact for study participants.
Cassidy Branch
III. Funding/Other Support
III.1
Funding Sources
Type
Source
Grant Title
Name of PI
on Grant
Status
Status
Description
* Private Foundation/Association
Patient-Centered
Outcomes Research
Insitute
Evaluation of Parent_Based Intervention
to Support Children after Traumatic Injury
Marizen
Ramirez
Awarded
* new source name
III.2
Which office will process the agreement for this project
Sponsored Programs - Federal/State/Local Agency Funded
III.3
Does any member of the research team have a financial conflict of interest related to this project according to the Conflict of Interest in
Research policy? If yes, please indicate which members below.
Name
Has Conflict of Interest
Marizen Ramirez, PHD
No
Mallory Bolenbaugh, BS
No
Cassidy Branch, BS, MA
No
Collin Calvert, MPH
No
Gretchen Cress, BSN, RN
No
Jonathan Davis, MS
No
Patricia Espe Pfeifer, PHD
No
Javier Flores, BS
No
Kelly Guinn, BA
No
Charles Jennissen, MD
No
Corinne Peek-Asa, PHD
No
Graeme Pitcher, MD
No
Lisa Roth, BS
No
Ruthann Schrock, BSN
No
Karen Smith, RD, MS
No
Kristel Wetjen, RN
No
Tammy Wilgenbusch, PHD
No
Bridget Cho
No
Sun Young Hwang
No
Teresa Maag
No
Kimberly Randell
No
Chris Sexton
No
Emily Siedlik
No
Lauren Slagel
No
Shallyn Ward
No
Chalott Williams
No
Briana Woods-Jaeger
No
III.5
What is the current status of this funding source?
Source
Status Other Status Description
Patient-Centered Outcomes Research Insitute Awarded
IV. Project Type
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IV.1
Do you want the IRB to give this project
Regular (expedited or full board) review
IV.2
Enter the date you will be ready to begin screening subjects/collecting data for this project.
10/17/2011
IV.3
Are you requesting a waiver of informed consent/authorization (subjects will not be given any oral or written information about the
study)?
No
V. Other Committee Review
V.1
Does this project involve any substance ingested, injected, or applied to the body?
Do not answer yes, if the involvement includes a device, wire, or instrument
No
V.2
Are any contrast agents used for any purpose in this study?
No
V.9
Will any subject be asked to undergo a diagnostic radiation procedure (including radiographic, nuclear medicine, DEXA)?
No
V.14
Will any subject be asked to undergo a radiation therapy procedure (including external beam therapy, brachytherapy, or nuclear medicine
therapy)?
No
V.20
Does this project involve the deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from
recombinant or synthetic nucleic acid molecules, into one or more human research participant?
No
V.21
Will any portion of this project be conducted in the CRU, or does it use any CRU resources?
Yes
V.22
Will this project use any resource/patients of the HCCC?
No
V.25.a
Will the study involve any of the following activity at UI Health Care, even if subjects or their insurance will not be billed for the item or
service, and regardless of the study funding source (including studies with departmental or no funding)?
Procedures, tests, examinations, hospitalizations, use of Pathology services, use of clinic facilities or clinical equipment, or any
patient care services, including services conducted in the Clinical Research Unit; or
Physician services or services provided by non-physicians who are credentialed to bill (ARNPs, Physician Assistants, etc.)
No
V.26
The study involves nursing, nursing resources or evaluates nursing practices.
Yes
VI. Subjects
VI.1
How many adult subjects do you expect to consent or enroll for this project?
300
VI.2
What is the age of the youngest adult subject?
18.0
VI.3
What is the age of the oldest adult subject?
75.0
VI.4
What is the percentage of adult male subjects?
50
VI.5
What is the percentage of adult female subjects?
50
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VI.6
How many minor subjects do you expect to consent or enroll for this project?
300
VI.7
What is the age of the youngest minor subject?
10.0
VI.8
What is the age of the oldest minor subject?
17.2
VI.9
What is the percentage of minor male subjects?
50
VI.10
What is the percentage of minor female subjects?
50
VI.11
Will any of the minors enrolled be in foster care or Wards of the court?
No
VI.13
Describe EACH of your subject populations
Include description of any control group(s)
Specify the Inclusion/Exclusion criteria for EACH group
Studies under IRB-03 enrolling non veterans as part of the subject population must present a compelling argument to the IRB for
the inclusion of non-Veterans (e.g., insufficient number of Veterans; survey of VA employees; study of active duty military; study
involving Veterans’ family members), and the research is relevant to the care of Veterans or active duty military personnel.
Phase 1
University of Iowa Children's Hospital- UI Children's (Complete)
Parent population: Parent's of children ages 10-17 years of age who are treated for a unintentional traumatic injury in the last 12 months at UI
Children's Hospital. Parents of children with intentional injuries will be excluded from the focus groups. Only one parent of a potential parent
dyad (mother or father) will be included in the focus group.
Provider population: Emergency Medicine and Trauma physicians, nurses, pediatric psychiatrists and psychologists, social workers, and parent
advocates serving the pediatric unintentional traumatic injury population.
Blank Children's Hospital- Complete
Qualitative formative research will be conducted at Blank Children's Hospital to solidify themes and confirm that the research protocol can be
effectively itengrated into both settings. Two provider focus groups will be held at Blank Children's Hospital
Parent population: Parents of children 10-17 years of age who are treated for a unintentional traumatic injury in the last 12 months at Blank
Children's Hospital. Parents of children with intentional injuries will be excluded from the focus groups. Only one parent of a potential parent
dyad (mother or father) will be included in the focus group. Two parent focus groups will be held in the Des Moines area.
Provider population: Emergency Medicine and Trauma physicians, nurses, pediatric psychiatrists and psychologists, social workers,child life
specialist and parent advocates serving the pediatric unintentional traumatic injury population.
Phase 2
Children with new unintentional injuries (not a complication from previous injury) will be recruited to participate in the randomized trial. All
children will be between the ages of 10-17.2 (17 years, 3 months) years of age. All children admitted for injury will be identified, and direct
questioning later will screen out those who had intentional injuries. Children with unintentional injuries will be administered the COAT which
is a measure of orientation to self, place and memory, and those that pass the COAT will be recruited into the study. One parent of the child
will be recruited for participation. Inclusion and exclusion criteria are the same for both randomization groups. Exclusions include non-English
speaking, diagnosis of intellectual deficit or psychosis, suicide attempt in the last year, and residential treatment placement in the last year.
VI.14
Provide an estimate of the total number of subjects that would be eligible for inclusion in each of your study populations (include your
control population if applicable)
Phase 1
University of Iowa Children's Hospital-UI Children's(complete)
Parent population- UI Children's: Approximately 140 pediatric patients between the age of 10 and 18 are treated by UI Children's Hospital
each year, therefore, approximately 140 parents will be eligible for participation in the focus group.
Provider population- UI Children's: Approximately 10-15 UI Children's Hospital providers serve the injured pediatric population. All
providers will be eligible for the focus group or a personal interview.
Blank Children's Hospital- Complete
Parent Population-Approximately 100 pediatric patients between the age of 10 and 18 are treated by Blank Children's Hospital each year,
therefore, approximately 100 parents will be eligible for participation in the focus group.
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Provider population- Approximately 10-15 Blank Children's Hospital providers serve the injured pediatric population. All providers will be
eligible for the focus group or a personal interview.
Phase 2
Approximately 480 pediatric patients between the age of 10 and 17 are admitted by UI Children's and Blank Children's Hospital each year,
therefore, for a 2.5 year study period, approximately 1200 parent-child dyads will be eligible to participate in the study.
Children's Mercy Hospital in Kansas City admits 540 children who were age 10-17 on an annual basis. As they join year 3 of the study this
will be the number of parent-child dyads eligible to participate in the study from that site.
VI.15
Describe how you will have access to each of your study populations in sufficient number to meet your recruitment goals.
Phase 1
University of Iowa Children's Hospital(completed)
Parent population: Using the Iowa Trauma Database, Ms. Wetjen, UIHC Pediatric Nurse Trauma Coordinator, will identify parents whose
children previously received an unintentional injury and were treated at the UIHC in the past 12 months.
Provider population: Given Ms Wetjen's leadership role in the UIHC Trauma team, she will facilitate the invitation and recruitment of pediatric
unintentional injury health care providers.
Blank Children's Hospital- Completed
Parent population: Using the Iowa Trauma Database, Ms. Wetjen, UIHC Pediatric Nurse Trauma Coordinator will work with Blank Children's
Hospital Pediatric Trauma Coordinator to identify parents whose children previously received an unintentional injury and were treated at the
Blank Children's Hospital in the past 12 months.
Provider population: Given Ms Wetjen's leadership role in the UIHC Trauma team, she will work with Blank Children's Hospital Pediatric
Trauma Nurse to identify pediatric unintentional injury health care providers.
Phase 2
The UIHC and Children's Mercy Hospital team will review patient admission records morning and afternoon/evening to identify eligible
patients (injury admissions between 10-17 years of age). The UIHC team will determine if the child meets inclusion criteria by reviewing
information collected from EPIC. The Children's Mercy Hospitial team will determine if the child meets inclusion criteria by reviewing
information collected from Cerner medical record system.
VI.16
Do you plan to recruit/enroll non-English speaking people?
No
VI.18
Do you propose to enroll any of the following in this study as subjects?
Employee of the PI or employee of a research team member
Individual supervised by PI or supervised by member of research team
Individual subordinate to the PI or subordinate to any member of the research team
Student or trainee under the direction of the PI or under the direction of a member of the research team
Yes
VI.19
Provide justification for why these subjects must be included in the study.
Phase 1
There is very limited pediatric psychiatric and psychological staff within the UIHC staff, therefore a staff member of Dr. Wilgenbusch's
clinic will be asked to participate in the health care provider focus group.
Phase 2
These groups will not be enrolled.
VI.20
Will subjects provide any information about their relatives?
Yes
VI.21
Describe in detail how this information will be obtained. NOTE: The collection of identified data about family members makes the
family member a subject in the study. This would require a consent process with the family member or a request for waiver of
consent to collect these data. See the Research Guide for more information.
Phase 1
Parents will be asked to describe the circumstances and resulting injuries their children received.
Phase 2
Parents will be asked to complete a questionnaire that gathers information about their child/adolescent's (the subjects in this study with
the injury) symptoms of traumatic stress and quality of life. Parents will also complete a participant information form asking for
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information about the child/adolescent's age, injury, and general family information.
VI.22
List the data to be collected about subject relatives including the names of any surveys, questionnaires etc. to be used. Attach data
collection tools under the Relative/Proxy Data Collection Instruments category.
Phase 1
None of the child's identifying information will be recorded or the circumstances around their injury.
Phase 2
Foa PTSD - Parent Version
Strengths and Difficulties - Parent Version
Quality of life - Parent Version
VI.23
Will anyone (other than the subject) provide you with information about the subject (e.g. proxy interviews)?
Yes
VI.24
Describe in detail how this information will be obtained.
Phase 1 : No
Phase 2
Parents will be asked to complete a questionnaire that gathers information about their child/adolescent's (the subjects in this study with
the injury) symptoms of traumatic stress and quality of life. Parents will also complete a participant information form asking for
information about the child/adolescent's age, injury, and general family information.
VI.25
List the data to be collected from proxy individuals including the names of any surveys, questionnaires etc. to be used. Attach data
collection tools under the Relative/Proxy Data Collection Instruments category.
Phase 2
Foa PTSD - Parent Version
Strengths and Difficulties - Parent Version
Quality of life - Parent Version
Participant Information Form
VI.26
Is this project about pregnant women?
No
VI.27
Will this project involve fetuses?
No
VI.28
Does this project involve adult subjects who may be incompetent or have limited decision-making capacity on initial enrollment into the
study?
No
VI.32
Does this project involve subjects whose capacity to consent may change over the course of the study?
No
VI.37
Does this project involve prisoners as subjects?
No
VII.A. Project Description (A)
VII.A.1
Where will project procedures take place (check all that apply)?
UIHC - UI Children's Hospital
Other UI campus site - Westlawn
U.S. off-campus - Blank Children's Hospital, Children's Mercy Hospital and Clinics
VII.A.2
Is this project also being conducted by other researchers at their own sites (e.g. a multi-site collaborative project)?
Yes
VII.A.3
What is the UI site’s role(s) for this project (check all that apply)?
Clinical/participating site
Coordinating Center
Statistical/Data Management Center
VII.A.4
Provide specific and detailed information describing how the UI investigator will coordinate all aspects of the study, such as:
Name, location, and IRB of record for each site,
Verification of IRB approval and continuing review for all sites
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Managing variation in requirements from the IRBs or institutional policies of the different sites.
Outline all activities that will occur at each participating site
The University of Iowa researchers will participate in all aspects of data collection, management, and analysis. Because of it's
larger size and higher number of pediatric trauma admissions, the University of Iowa is anticipated to collect roughly two thirds of
the data proposed. The UI researchers will act as the coordinating center for the multi-site collaboration, and will provide
information and interim reports to Blank Children's Hospital and Children's Mercy Hospital as outlined below. The UI researchers
will also ensure adherence to IRB protocol, and communicate progress with the funding agency.
VII.A.5
Describe in detail the procedures that will be used to identify and report unanticipated problems from participating sites to the
lead institution.
The University of Iowa researchers convene with Blank Children's Hospital researchers in monthly meetings where progress and
problems can be discussed. The team members at Children's Mercy Hospital will be given meeting updates via phone or email. If
an unanticipated problem requires urgent attention, Blank Children's Hospital and Children's Mercy Hospital will contact the
University of Iowa PI, project manager, and(or) site coordinator via phone or email to report the problem.
VII.A.6
Describe in detail the procedures that will be used to identify and report unanticipated problems from the lead institution to
participating sites.
The University of Iowa researchers convene with Blank Children's Hospital and Children's Mercy Hospital researchers in monthly
meetings where progress and problems can be discussed. If the unanticipated problem requires urgent attention, the University of
Iowa team will contact the Blank Children's Hospital study coordinator, and the Children's Mercy Hospital study coordinator, via
phone or email to report the problem.
VII.A.7
Describe in detail the procedures that will be used to communicate protocol modifications from the lead institution to the
participating sites.
The University of Iowa researchers convene with Blank Children's Hospital and Children's Mercy Hospital researchers in monthly
meetings, where any protocol modifications can be discussed. If immediate change is required, the University of Iowa team will
contact the study coordinator at Blank Children's Hospital and the study coordinator at Children's Mercy Hospital to communicate
the modifications. These modifications will then need to be reflected in an IRB modification at each institution.
VII.A.8
Describe in detail the procedures that will be used to communicate interim results from the lead institution to the participating
sites.
Interim results will be reported at monthly meetings, and any updates sent to the funding agency will be forwarded to Blank
Children's Hospital and Children's Mercy Hospital.
VII.A.9
Describe in detail the procedures that will be used to communicate other new information which may impact a subject's
willingness to participate, or continue participating from the lead institution to the participating sites.
The University of Iowa researchers convene with Blank Children's Hospital and Children's Mercy Hospital researchers in monthly
meetings, where such information could be discussed. If immediate attention is required, the University of Iowa team will contact
the study coordinator at Blank Children's Hospital and the study coordinator at Children's Mercy Hospital to communicate the new
information.
VII.A.10
What are collaborating site roles for this project?
Clinical/participating site - Blank Children's Hospital, Children's Hospital and Clinics of Minnesota, and Children's Mercy
Hospital-Kansas City, 3 sites
VII.B. Project Description (B)
VII.B.1
Does this project involve any of the following (Check all that apply):
Registry – The collection and maintenance of data (not including biologic samples) in which: (1) the individuals in the registry have
a common or related condition(s), and/or (2) the individuals in the registry are interested in being contacted for future studies by
investigators other than those listed in Section II of this project.(UI Guide)
Repository – The collection, storage, and distribution of human biologic samples and/or data materials for research purposes.
Repository activities involve three components: (i) the collection of data and/or specimens such as blood, tissue, saliva, etc.; (ii) the
storage of data or specimens, and data management function; and (iii) the sharing of data/specimens with recipient investigators other
than the original investigators. (paraphrased from OHRP)
Expanded Access – A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide
investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial. Examples of
expanded access include non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment
IND, compassionate use, emergency use, continued access to investigational drug, and parallel track (ClinicalTrials.gov & FDA).
Clinical (or Treatment) trial – A prospective biomedical or behavioral research study of new treatments, new drug or combinations
of drugs, new devices, or new approaches to surgery or radiation therapy. (NIH and ClinicalTrials.gov & FDA)
Physiology intervention/study – A pharmacologic or measurement study aimed at understanding basic mechanisms of disease
and/or of normal human physiology, often without any therapeutic intent (though a clinical trial could include such components, often
labeled as “translational” or “basic science” aims.) Measurements in such studies could include, but are not limited to, a blood draw,
EKG, EEG, MRI, auditory or sensory testing, checking vital signs, DEXA scans, eye tracking, specimen collection, exercise, fasting,
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VII.B.1.b
Provide the NCT (National ClinicalTrials.gov Identifier) number
VII.B.2
Does this project involve a drug washout (asking subject to stop taking any drugs s/he is currently taking)?
No
VII.B.11
Is there a separate, written protocol that will be submitted in addition to this IRB New Project form? (Note: a grant application is not
considered to be a protocol)
No
VII.B.18
Does this project involve testing the safety and/or efficacy of a medical device?
No
VII.C. Project Description (C)
VII.C.1
Does this project involve any research on genes or genetic testing/research?
No
VII.D. Project Description (D)
VII.D.1
Check all materials/methods that will be used in recruiting subjects (you will need to attach copies of all materials at the end of the
application):
E-mail -
Letter -
Use of any information available to the researchers or their colleagues because this person is a patient OR use of any information
considered to be Protected Health Information (PHI) OR review of patient/clinic records - Phase 1 Name, address and telephone contact
information for parent's of children identified in the UIHCTrauma system as having an unintentional injury. Phase 2 Name, address and
telephone contact information for parents of children identified in the UIHCTrauma system as having an unintentional injury.
Other - Phase 1 - Blank Children's Hospital will use Name, address and telephone contact information for parents of children identified
in the Blank Children's Trauma system as having an unintentional injury. Blank Children's Hospital staff will do mailing of introductory
letter so no PHI will be shared with UI research staff.
VII.D.2
List the individual data elements you will need to access/use from the patient or clinic records to identify potential subjects for
recruitment
Phase 1
-Injured child's age to ensure the child is between 10 and 17 years of age
-Type of injury to determine intention
-Parent names
-Parent address to send informational sheet and consent letter
-Parent phone numbers to follow-up after study information sheet
Phase 2
-Injured child's age to ensure the child is between 10 and 17.2 years of age
-Admission to UIHC and Children's Mercy Hospital Pediatric Unit for injury. Later, direct questioning will be used to determine whether
the injury was intentional, and thus if the child is eligible.
-Parent and child names
VII.D.3
Describe why you could not practicably recruit subjects without access to and use of the information described above
Phase 1
Unintentional injuries among children ages 10-17 are not rare but severe injury requiring a visit to an Emergency Department and
Trauma activation are difficult to identify. Use of the Iowa Trauma database allows the researchers to identify this high risk population.
Phase 2
Unintentional injuries among children ages 10-17 are not rare but severe requiring a visit to an Emergency Department, Trauma
activation and hospital admission. These are difficult to identify. Use of medical record data allows the researchers to identify this high
risk population.
special diets, etc.
Behavioral intervention/study – May be used to refer to studies of individual or group behavior. This option does not include drugs,
biologics, or devices but could include psychotherapy, lifestyle counseling, behavior modification, etc.
Diagnostic trial – Protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition
(ClinicalTrials.gov & FDA)
Non-clinical – any college/department that would regularly submit to IRB-02
Other
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VII.D.4
Describe why you could not practicably obtain authorization from potential subjects to review their patient or clinic records for
recruitment purposes.
It would not be practicable to contact subjects to ask if you can review the medical record to see if they are eligible because you won't
know who to contact until you do review the medical record.
VII.D.5
Describe plans to protect the identifiers from improper use or disclosure
All identifying information will be kept in password-protected computer files that are only available to the research team.
VII.D.6
Describe plans to destroy identifiers at the earliest opportunity consistent with conduct of the research
Phase 1
Following the completion of the focus groups or interview identifying information will be destroyed.
Phase 2
Following completion of the randomized trial and data analysis the identifying information will be destroyed.
VII.D.7
Does the research team agree that the requested information will not be reused or disclosed to any other person or entity, except as
required by law, for authorized oversight of the study, or for other research for which the use or disclosure of the requested
information would be permitted by the HIPAA Privacy Rule
Yes
VII.D.8
Will a member of the research team discuss the study with the subject in person prior to the subject agreeing to participate?
Yes
VII.D.9
Describe the physical location where the consent process will take place:
Phase 1
Among the parent focus group, verbal consent will take place on the phone. The parental focus group will take place at the Coral Ridge
Community Center. Parental focus groups for the Blank Children's Hospital site will take place at the Blank Park Zoo.
If a parent is unable to attend a focus group a telephone interview option will be provided. The parent will again give consent over the
phone.
The consent process with providers will take place via a letter with elements of consent included. The research team will discuss the
elements of the study with each provider upon arrival to the focus group. The provider focus group will take place at Blank Children's
Hospital.
Phase 2
This discussion will likely take place in the child's hospital room. If it is a shared room, we will work with Kristel Wetjen- Trauma
Coordinator at UI Children's to use another private room on the same floor. Children's Mercy Hospital staff will identify private space
for the discussion.
VII.D.10
Will a member of the research team discuss the study with the subject by phone prior to the subject agreeing to participate?
Yes
VII.D.11
Describe:
Phase 1
UI Children's Hospital-A research team member will contact potential parent focus group participant by phone to explain the purpose of
the focus group/telephone interview after the parent has received the introductory letter and the letter with consent elements. Each
potential provider participant will receive an email with elements of consent.
Blank Children's Hospital- After the parent has received the introductory letter and has emailed or called the UI research staff to express
interest in participating in the study, a research team member will then send out the letter with consent elements. Research staff will then
contact potential parent focus group participant by phone to explain the purpose of the focus group/telephone interview and answer any
questions. Each potential provider participant will receive a letter with elements of consent.
Phase 2
No, the discussion will be done in person.
VII.D.12
Who will be involved in the consent process (including review of consent document, answering subjects' questions)?
Name
Consent Process Involvement
Marizen Ramirez, PHD
Yes
Mallory Bolenbaugh, BS
Yes
Cassidy Branch, BS, MA
Yes
Collin Calvert, MPH
No
Gretchen Cress, BSN, RN
Yes
Jonathan Davis, MS
No
Patricia Espe Pfeifer, PHD
Yes
Javier Flores, BS
No
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Name
Consent Process Involvement
Kelly Guinn, BA
Yes
Charles Jennissen, MD
No
Corinne Peek-Asa, PHD
No
Graeme Pitcher, MD
No
Lisa Roth, BS
Yes
Ruthann Schrock, BSN
Yes
Karen Smith, RD, MS
No
Kristel Wetjen, RN
Yes
Tammy Wilgenbusch, PHD
Yes
Bridget Cho
Yes
Sun Young Hwang
Yes
Teresa Maag
Yes
Kimberly Randell
Yes
Chris Sexton
Yes
Emily Siedlik
Yes
Lauren Slagel
Yes
Shallyn Ward
Yes
Chalott Williams
Yes
Briana Woods-Jaeger
Yes
VII.D.15
Check all materials that will be used to obtain/document informed consent:
Letter or Information sheet containing elements of consent
Consent Document
Assent Document
VII.D.16
Are you requesting a waiver of documentation of consent (either no subject signature or no written document)?
Yes
VII.D.17
Choose one of the following to indicate why you are requesting that the IRB waive the requirement to obtain a subject signature as
documentation of consent:
A.  The research presents no more than minimal risk (minimal risk means the probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance
of routine physical or psychological examinations or tests)
     AND
The study involves no procedures for which consent is normally required ouside of a research context. (This type of waiver is often
permitted for a minimal risk mail-out survey that includes a cover letter with all elements of consent, and returning the survey indicates
consent. You cannot request this waiver if the study also involves the use of any protected health information (PHI).)
VII.D.18
Explain why this meets the chosen criteria in A. or B. above:
Phase 1
As defined in the risk section, this study will involve minimal risk to the parents including psychological/emotional response to
discussing the injury to their child. The child will not be involved in the study in any way. The study involves minimal risks for the
providers as they will be discussing content of the program and how the program will fit into the clinic setting. Providers will not be
asked to report any personal information.
Phase 2
The waiver will not be applied to Phase 2
VII.D.19
Before the subject gives consent to participate are there any screening questions that you need to directly ask the potential subject to
determine eligibility for the study?
Yes
VII.D.20
List any screening questions you will directly ask the potential subject to determine eligibility.
To verify that a child's injury is unintentional, we will speak with the child's nurse or Kristel Wetjen, the nurse on our research team, as
she is usually in contact with all pediatric patients. Children's Mercy Hospital research staff will work with nursing staff for verification
of unintentional injury. The modified version of the COAT, a measure of orientation and awareness, will be given to all eligible children
to ensure the child has the capacity to assent.
1. What is your name?
2. How old are you? What is your birthday?
3. Where do you live?
4. What is your father’s name?
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What is your mother’s name
5. What school do you go to?
What grade are you in?
6. Where are you now?
7. Is it daytime or night-time?
7. What is the month?
8. What is the year?
A child will be required to score 55 (of a potential score of 65) to be eligible for the study.
We would speak with the nurse or review medical records to determine if the parent of the patient is not English speaking; if patient is
diagnosed with intellectual deficit or psychosis; if patient has previously attempted suicide; or if patient had been in residential
treatment.
VII.D.21
Will you keep a screening log or other record that would include information on people who do not enroll in the study?
Yes
VII.D.22
Describe the information being collected and the purpose for keeping this information.
For children who screen ineligible, we will record their score, age and mechanism of injury so that we can describe the differences
in children who did and did not participate in the study.
VII.D.23
Will this information be shared with anyone outside the UI research team members?
No
VII.D.25
After the subject agrees to participate (signs consent), are there any screening procedures, tests, or studies that need to be done to
determine if the subject is eligible to continue participating?
No
VII.D.27
Discuss how much time a potential subject will have to agree to consider participation and whether or not they will be able to discuss the
study with family/friends before deciding on participation.
Phase 1
Potential focus group members will have approximately a week between receipt of the letter/email with elements of consent to consider
participation. In addition, they will be allowed time during the phone conversation with research staff to consider participation.
Phase 2
The parent-child dyad will be given approximately 15 minutes to consider participation and be allowed to discuss their participation with each
other.
VII.D.28
How long after the subject agrees to participate do study procedures begin?
Phase 1
Focus groups and telephone interviews will occur approximately 1-2 weeks after the letter with elements of consent for parents and 1-2 weeks
after email with elements of consents for providers. Provider key informant interviews will also follow this same timeline.
Phase 2
The study procedures will begin as soon as consent is received.
VII.D.29
Provide a description of the enrollment and consent process for adult subjects
Describe each study population separately including control population
Include when recruitment and consent materials are used
Use 3rd person active voice “The Principal Investigator will identify subjects. For example, the principal investigator will identify
potential subjects, the study coordinator will discuss the study with subjects over the telephone and schedule the first study visit,
etc...”
Describe the steps that will be taken by the research team to minimize the possibility of coercion or undue influence during the
consent process
Phase 1
UI Children's Hopsital-Ms. Wetjen will identify potential parent focus group members through the Iowa State Trauma Registry (as previously
described). Ms. Frederick will prepare and mail the introductory letter to potential focus group members. Within a week of mailing the
introductory letter, Ms. Frederick will mail the letter with elements of consent to potential parent participants. One week after mailing the
consent letter, Drs. Harland, Ramirez or Ms. Fredrick will attempt to contact the potential subjects to discuss the study over the phone. The
researchers will strictly adhere to phone scripts when contacting potential subjects over the phone to reduce the possibility of coercion. If the
initial phone contact is not successful, the research team will try to contact the potential subject two additional times within a week of the
initial phone call. If phone contacts are unsuccessful than the team will contact potential subjects by e-mail with a maximum of two e-mails.
All letters contain information allowing potential subjects to opt out of the study by calling or e-mailing Dr. Harland or Ms. Frederick. Dr.
Harland, Dr. Ramirez, or Ms. Fredrick will complete the consent process over the phone with the parents. If a parent agrees to participate in a
focus group a letter confirming the date, time and location of the focus group will be mailed to the parent. The letter will include materials to
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be discussed during the focus group and a map. The materials may also be delivered by email. If a parent agrees to participate in an interview,
the materials will be mailed or sent by e-mail per the participants request.
For the provider focus groups, Ms. Wetjen will e-mail the providers about their potential participation in the study focus group. The e-mail
content will be the introductory letter with the elements of consent. Providers interested in participating will be asked to RSVP through a
doodle calendar link or they may contact Dr. Harland either by phone or email to enroll in the focus group or discuss any questions they may
have about the group. If a healthcare provider is unable to participate in a schedule focus group but wishes to provide a key informant
interview the interview will be completed by Dr. Harland or Dr. Ramirez.
Blank Children's Hospital-
For parent focus groups- Pediatric Trauma Coordinator at Blank Children's Hospital will identify potential parent focus group members
through the Iowa State Trauma Registry (as previously described). Pediatric Trauma Coordinator will provide a cover letter from Blank
Children's Hospital expressing their willingness to forward information about the study and noting the attached recruitment materials from UI
Researchers. Staff from Blank Children's Hospital will mail the introductory letters out so no PHI information will be provided to UI .
Interested participants will be able to contact UI research staff via the study email provided or by calling Ms. Roth at the number listed in the
letter. Once they have positively responded via email or phone about their interest in the study, UI research staff will mail the letter with
elements of consent to potential parent participants. Potential participants will be contacted one week after mailing the consent letter, UI
reserach staff will attempt to contact the potential subjects to discuss the study over the phone. The researchers will strictly adhere to phone
scripts when contacting potential subjects over the phone to reduce the possibility of coercion. If the initial phone contact is not successful, the
research team will try to contact the potential subject two additional times within a week of the initial phone call. All letters contain
information allowing potential subjects to opt out of the study by calling Ms. Roth or emailing the study email address. UI research staff will
complete the consent process over the phone with the parents. If a parent agrees to participate in a focus group a letter confirming the date,
time and location of the focus group will be mailed to the parent. The letter will include materials to be discussed during the focus group and a
map. The materials may also be delivered by email. If a parent agrees to participate in an interview, the materials will be mailed or sent by
e-mail per the participants request.
For the provider focus groups, Pediatric Trauma Coordinator will provide a cover letter from Blank Children's Hospital expressing their
willingness to forward information about the study and noting the attached recruitment materials from UI Researchers. Materials will be
distributed to all providers at Blank Children's Hospital who interact with traumatically injured children. The materials will include the
introductory letter with the elements of consent. Providers interested in participating will be asked to RSVP through email to the study email or
to Lisa Roth, Project Manager to enroll in the focus group or discuss any questions they may have about the group. If providers do not respond
after first correspondence they will not be recontacted. Providers may also indicate by email or phone if they do not wish to participate in this
study. If a healthcare provider is unable to participate in a schedule focus group but wishes to provide a key informant interview the interview
will be completed by Dr. Ramirez.
Phase 2
A study team member will be texted or notified if a child is admitted to the UIHC/Children's Mercy Hospital with trauma. The text/notification
will not contain identifying information, just information like "A patient is added to the database." The research team will review the child's
medical record to determine if he/she meets eligibility criteria, and consult the child's care team to determine if the injury was truly
unintentional. On a daily basis, the research team will review each child's medical record to determine when the child is likely to be
discharged. On the day of discharge or any convenient time recommended by the provider, a member of the research team will present to the
child's room to determine if the child has an appropriate level of consciousness to complete the consent process (a COAT orientation score of
at least 55), and if appropriate recruit the dyad. The team member will discuss the study and complete the consent process with the dyad
in-person. If timing is inconvenient due to a conflicting event, such as a medical procedure, the team member will give the PCORI infographic
to the parent. This half-sheet contains brief information about the study and contact information for the study team. The team member will
only give this half-sheet to families they have approached in person, and they will return at a more convenient time to continue the recruitment
process. To minimize the possibility of coercion during the consent process, the research team will follow the consent document closely and
stress to the dyad that the child's health care will not be affected by participation in the study.
For research subjects that were assented as children but turned 18 prior to the end of their involvement in the study, the research team will mail
a re-consent instruction letter along with a new consent document to the subject. The consent document will be different than the consent
document signed by the parent at initial recruitment. The documents will be mailed to research subjects via U.S. mail and provided a postage
paid envelope in which to return the signed consent document to the research team.
VII.D.30
Describe how you will obtain the consent of the parents or legal guardians for child/minor subjects in this study
Describe each study population separately including control population
Include when recruitment and consent materials are used
Use FIRST person, and provide detail as to order of events
Describe the steps that will be taken by the research team to minimize the possibility of coercion or undue influence during the
consent process
The ICTS flexible nursing staff will alert the research team if a child presents to the UIHC as an admission for trauma. Children's Mercy
Hospital research staff will be alerted by Emergency Room staff if a child present for admission of a trauma. The research team will review the
child's medical record to determine if he/she meet eligibility criteria, and consult the child's care team to verify that the injury was indeed
unintentional. On a daily basis, the research team will review each child's medical record to determine when the child is likely to be
discharged. On the day of discharge, a member of the research team will present to the child's room to determine if the child has an appropriate
level of consciousness to complete the consent process, and if appropriate recruit the dyad. If timing is inconvenient due to a conflicting event,
such as a medical procedure, the team member will give the PCORI infographic to the parent. This half-sheet contains brief information about
the study and contact information for the study team. The team member will only give this half-sheet to families they have approached in
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person, and they will return at a more convenient time to continue the recruitment process. The child-parent dyad will be recruited
simultaneously therefore the parent or legal guardian will be available at the time of the child's assent. The team member will discuss the study
and complete the consent process with the dyad in-person. To minimize the possibility of coercion during the consent process, the research
team will follow the consent document closely and stress to the dyad that the child's health care will not be affected by participation in the
study.
For research subjects that were assented as children but turned 18 prior to the end of their involvement in the study, the research team will mail
a re-consent instruction letter along with a new consent document to the subject. The consent document will be different than the consent
document signed by the parent at initial recruitment. The documents will be mailed to research subjects via U.S. mail and provided a postage
paid envelope in which to return the signed consent document to the research team.
VII.D.31
What are the plans for the assent process for children/minors in this study? (You may choose more than one procedure if you have
different child populations in your study)
Children/minors will sign an assent or consent document -
VII.D.36
Provide a detailed description and rationale for each of the procedures chosen above and describe the child/minor populations to which
they apply in your study.
Phase 2
All children 10-17.2 years of age will be asked to sign an assent document. We chose to use the assent document for all participants aged
10-17.2 years because the language is simple and easy to understand, especially since the children are undergoing medical procedures in the
hospital.
It was discovered on 7/15/2016 that some children who signed the assent document turned 18 at some point during the 9-month follow-up
period of the study. For research subjects that were assented as children but turned 18 prior to the end of their involvement in the study, the
research team will mail a re-consent instruction letter along with a new consent document to the subject. The consent document will be
different than the consent document signed by the parent at initial recruitment. The documents will be mailed to research subjects via U.S. mail
and provided a postage paid envelope in which to return the signed consent document to the research team.
VII.D.37
Does the study include any form of deception (e.g., providing participants with false information, misleading information, or withholding
information about certain study procedures)?
Examples:
Procedure includes a cover story that provides a plausible but inaccurate account of the purposes of the research.
Participants will be provided with false information regarding the particular behaviors of interest in the research.
Procedures include a confederate pretending to be another participant in the study.
Participants will be told that the research includes completion of a particular task, when in fact, that task will not be administered.
Study is designed to introduce a new procedure (or task) that participants are not initially told about.
If yes, a waiver of informed consent must be requested under question IV.3.
No
VII.E. Project Description (E)
VII.E.1
Will subjects be randomized?
Yes
VII.E.1.a
Will any subjects be blinded to which study arm they have been assigned?
No
VII.E.2
Describe randomization scheme/assignment including ratio such as 1:1, 2:1 etc.
Phase 1: No randomization
Phase 2
The parent-child dyad will be randomized at a 1:1 ratio by a program developed in Microsoft Access or Excel.
VII.E.3
Will any questionnaires, surveys, or written assessments be used to obtain data directly from subjects in this study?
Yes
VII.E.4
List all questionnaires, surveys, written assessments and ATTACH each one to the application. (NOTE: You are NOT prohibited
from attaching copyrighted materials to this application)
Phase 1
Two focus group questionnaires have been developed: a questionnaire for parents of injured children and a questionnaire for staff who
serve these injured children. The questions for the parent interview will be equivalent to the parent focus group questions. The questions
for provider key informant interviews will equivalent to those of the provider focus group. At each focus group, one study staff member
will ask the questions and a second person will take notes on the answers from the participants. In the telephone interview, notes will be
taken by the research staff member completing the telephone interview
Phase 2
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The parent and child will be asked to answer 4 questionnaires each over the course of the study: one during hospitalization, one at
6-weeks, one at 3-months and one at 6-months post hospitalization. The 6-week, 3-month and 6-month questionnaires will be the same
questionnaire.
Both parent and child will complete the baseline questionnaire and follow-up questionnaire three times.
The parent and the child questionnaires will contain the following validated questionnaires: Strengths and Difficulties Questionnaire; the
Pediatric Quality of Life Inventory; CESD; Foa PTSD; Multidimensional scale of perceived social support; open family communication;
and how I cope under pressure.
The questionnaires listed are contained within the attached documents. Please see the following for where they can be found in both
parent and child surveys. Parent Baseline Survey #11 is Foa PTSD (#8 in follow-up surveys) #13 is Multidimensional scale of perceived
social support (#2 in follow-up) #14 is CES-D (#3 in follow-up) #16 is How I cope under pressure (#5 in follow-up) #17 is Open family
communication (#7 in follow-up) #21 is Quality of Life (#9 in follow-up) #22 is Strengths and Difficulties (#10 in follow-up) Child
Baseline Survey #6 is the Pediatric Quality of Life Inventory (#9 in follow-up surveys) #7 is Strengths and Difficulties (#10 in
follow-up) #9 is Foa PTSD (#3 in follow-up) #10 is CES-D (#4 in follow-up) #11 is How I cope under pressure (#5 in follow-up) #12 is
Multidimensional scale of perceived social support (#7 in follow-up) #13 is Open family communication (#8 in follow-up)
VII.E.5
Does this project involve creating any audiotapes, videotapes, or photographs?
Yes
VII.E.6
Provide a detailed description in sequential order of the study procedures following the consent process - DO NOT cut and paste from the
Consent Document.
Describe study populations separately if they will be participating in different procedures - include CONTROL population if applicable.
DESCRIBE:
What subjects will be asked to do/what happens in the study (in sequential order)
The time period over which procedures will occur
The time commitment for the subject for individual visits/procedures
Long-term followup and how it occurs
Phase 1
Participants will be asked to come to a 60-90 minute focus group session at the University of Iowa and Blank Children's Hospital. During each
focus group, participants will be asked questions about their opinions, recommendations and additions to the LPC for Injured Kids materials,
and the applicability of the program in a rural Iowa population. Each focus group will be audio recorded to ensure all recommendations,
additions or corrections are documented. This audio recording will be done with a hand held audio recorder. Audio transcripts of each focus
group will be downloaded into a password protected computer. The expected time to complete the telephone interview is 20-30 minutes and
will answer the questions asked of the focus group.
If a health care provider is unable to attend the focus group but interested in participating in a key informant interview, Dr. Ramirez will
complete the interview. The key informat interview questions will be equivalent to those of the provider focus group. These interviews will
also be audio recorded, transcribed and downloaded into a password protected computer.
The time commitment will be 60-90 minutes. There will be no follow-up visits.
Participants are free to not respond to any questions they prefer not to answer.
Phase 2
All subjects: Following consent, the research team will collect contact information (address, phone number, e-mail addresses) from the
parent-child dyad. The parent-child dyad will then complete their baseline questionnaires. Each questionnaire will take approximately 10
minutes to complete. The questionnaire will measure depressive symptoms, symptoms of post traumatic stress disorder, social support,
strengths and weakness, quality of life and family communication. The contact information and baseline questionnaires will be collected with
an iPad or by paper form, and entered into electronic databases upon return to the research team space in Westlawn at the UIHC site and the
Clinical Trials Coordinators office in the Division of Developmental and Behavioral Sciences at Children's Mercy Hospital and filed in locked
filling cabinets. Identifying data will be kept separate from questionnaire data.
Link is our new program of psychological first aid adapted from LPC. After our early formative phase 1 work, we had made some
modifications to LPC that were not in agreement with the original developers. In order to translate LPC to a program that was acceptable and
appropriate for our population, and also after consultation with UI Legal Counsel, we decided to create Link. Therefore, we would not run into
copyright issues. Link has elements similar to that described in the LPC program that we created - including screening for stress and
motivational interviewing skills. The large difference in Link is that the three original LPC steps - Listen Protect and Connect are not
referenced. However, both programs are based on psychological first aid.
Link Intervention: Intervention parents will get a 20-45 minute training on the Link for Injured Kids Program during their child's
hospitalization. The training will involve viewing a Link training program on an iPad and a brief training in motivational interviewing. All
Link training sessions will be audio recorded to ensure fidelity among the research team. Two weeks after hospital discharge, a packet will be
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mailed to the family's home address containing the Link pocket card, trifold, and instructional DVD. At 6-weeks post-discharge, the instructor
will conduct a telephone booster session with the parent trained in Link.
Trauma Education Intervention: Parents will be given the booklet "So Your Child Has Been in an Accident... An Information Booklet for
Parents." This booklet will be sent again to the family's address 2-weeks after their hospital release. At 6-weeks post-discharge, the
interventionist will conduct a brief telephone survey to assess the parent's perceptions regarding the Trauma Education program.
All subjects: The dyads will be asked to complete follow-up questionnaires at 6 weeks, 3-months, 6-months post hospitalization. The
questionnaire will measure depressive symptoms, symptoms of post traumatic stress disorder, social support, family communication, strengths
and difficulties and quality of life and asks about any mental health or community resources they may have used since the last questionnaire.
The research team will e-mail a link for the parent and the child to complete their surveys as well as mail a hard copy version of the
questionnaire with a cover letter explaining that the survey can be completed on paper or online and a postage paid envelope. If completed
online, the questionnaires will be done electronically using REDCap, a U of I supported online survey system. A telephone call will be placed
to the dyad the day the hard copy questionnaire is mailed informing the dyad of the mailing; the dyad will also have the option of completing
the survey over the phone at the time of the call.
For subjects that were consented as children, but turned 18 prior to the end of their involvement in the study: after obtaining re-consent when
the subject turns 18, these subjects will complete follow up questionnaires at the same intervals described for all subjects.
If an online or mailed questionnaire is not returned within 7 days the research team will attempt to contact the dyad by phone 12 times (for
each follow-up period) to remind them to complete the questionnaire or to make arrangements for the questionnaire to be completed at an
already scheduled follow-up appointment at the hospital. For 6-week questionnaire, they will be contacted 12 times up to 6 weeks following
their eligibility to complete that questionnaire. For 3-month questionnaire, they will be contacted 12 times up to 3 months following their
eligibility to complete that questionnaire. For 6-month questionnaire they will be contacted 12 times up to 6 months following their eligibility
to complete that questionnaire. After a month of no response for any survey timepoint, we will resend the package or online link. If a dyad
does not complete the 6-week questionnaire, they will still be asked to complete the 3-month and 6-month questionnaires.
The research team will complete the medical record abstraction within 12 months of receiving the medical record consent. The data collected
from the medical record includes measures of injury severity, the type of injury the child sustained, external cause of injury, length of stay,
diagnostic procedures, Glasgow Coma Scale measures, comorbidities, and initial vital signs and all discharge codes.
VII.E.7
Will you attempt to recontact subjects who are lost to follow-up?
No - those lost to followup will not be recontacted
VII.E.9
Will subjects be provided any compensation for participating in this study?
Yes
VII.E.10
Cash
No
VII.E.11
Gift Card
No
VII.E.12
Check
Yes
VII.E.13
Who will be providing the research compensation check to the subject?
Accounting Services directly via the e-Voucher system
VII.E.16
Other
Yes
VII.E.17
Describe:
Phase 1: A light meal will be provided to all focus groups. For the parent focus groups, on-site child care will also be provided.
Phase 2: None
VII.E.18
If you plan to compensate subjects using cash, checks or cash equivalent does your unit have a Cash Handling
Procedure in place that has been approved by Accounting Services?
Yes
VII.E.19
Describe the compensation plan including
Compensation amount and type per visit
Total compensation
Pro-rating for early withdrawal from study
Phase 1
Since the focus groups will take place at common meal times (lunch for providers and dinner for parents), a light meal will be provided
before the focus group. Parent focus group participants will receive a $20 gift card to compensate them for their time upon completion of
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the focus group. In addition, for the parent focus groups, on-site child care will be provided. Parents will also be compensated for
mileage to travel to and from the focus group in the form of a gift card. The rate of $0.55/mile will be paid and the gift card will be
rounded up to the nearest $5 increment. Parent interviews will receive the $20 compensation for completion of the interview.
Providers participating in a key informant interview will not be compensated.
Phase 2
Trauma Education group: Both the parent and the child will receive $25 for completion of each questionnaire for a total of $100/subject
or $200/family.
Link Intervention group: Both the parent and the child will receive $25 for completion of each questionnaire for a total of $100/subject
or $200/family.
For both the Trauma Education and Link Intervention group, both the parent and child will receive a $25 check for each completed
questionnaire delivered via the e-voucher system.
VIII. Risks
VIII.1
What are the risks to subjects including
- emotional or psychological
- financial
- legal or social
- physical?
Phase 1
This study involves minimal risk. Responding to focus groups questions may incur some emotional or psychological risks to parents whose
children suffered a traumatic injury. Providers may also have this response when talking about a particularly severe traumatic injury of a child
they treated.
Phase 2
This study involves minimal risk. Responding to questionnaire items may incur some emotional or psychological risks to a parents or child.
Data abstracted from the medical record will be data related to the unintentional injury admission.
VIII.2
What have you done to minimize the risks?
If applicable to this study ALSO include:
How you (members of your research team at Iowa) will monitor the safety of individual subjects.
Include a description of the availability of medical or psychological resources that subjects might require as a consequence of
participating in this research and how referral will occur if necessary (e.g. availability of emergency medical care,
psychological counseling, etc.)
Phase 1
Staff who are experienced in conducting focus groups will be used in this project. If a focus group participant become visibly upset during the
session, they will be referred to Dr. Tammy Wilgenbusch, Pediatric Psychology, UI Children's Hospital.
In the parent focus group, participation in the focus group may risk a loss of confidentiality although parents will only be asked to use their
first name or a pseudo name during group introductions.
In the provider focus group, providers will be asked to remove their UIHC/ Blank Children's Hospital badges to reduce the risk of loss of
confidentiality. Only the research team will receive the RSVP's through the doodle link or email to ensure confidentiality.
Phase 2
All parent-child dyads recruited at UIHC will be provided contact information for Dr. Patti Espe-Pfeiffer and the UIHC pediatric psychiatry
clinic should either experience an emotional/psychological issue requiring further attention. All parent-child dyads recruited at Children's
Mercy Hospital will be provided with contact information for a general social work hersupport should with either experience an
emotional/psychological issues requiring further attention.
Medical record abstraction data will be recorded by study subject identification number to reduce the likelihood of breach of confidentiality.
As mandatory reporters, the discovery of child abuse by a research team member will result in an immediate report to the University of Iowa
Police and local police, consistent with Iowa Code 262.9(37).
VIII.3
Does this study have a plan to have an individual or committee review combined data from all subjects on a periodic basis (such as
summary or aggregate safety and/or efficacy data)?
No
IX. Benefits
IX.1
What are the direct benefits to the subject (do not include compensation or hypothesized results)?
Participants may not benefit from being in this study.
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IX.2
What are the potential benefits to society in terms of knowledge to be gained as a result of this project?
Phase 1
Parents of children with a traumatic unintentional injury, the children themselves, and health care providers of these injured children may
potentially benefit from the development of this new program to reduce psychological trauma following an unintentional injury.
Phase 2
Parents of children with a traumatic unintentional injury and the children themselves may potentially benefit from these programs to reduce
psychological trauma following an unintentional injury.
X. Privacy & Confidentiality
X.1
What are you doing to protect the privacy interests of the subjects?
Phase 1
Information from the focus groups will be recorded in an anonymous fashion. Telephone interviews will not be recorded. The research team
will only ask questions that will help them to answer the study questions. During the provider focus groups, providers will be asked to remove
their UI/ Blank Children's Hospital identification badge before entering the session.
Phase 2
All dyads will be assigned a random identification number. The questionnaire, and medical record data and the personal identifiers will be kept
in seperate databases and be made available only to research staff. Data abstracted from the medical record will only be related to the
unintentional injury hospital admission and recorded on forms that document only the study identification number.
X.2
Are you collecting the Social Security Number of any subjects for any purpose?
No
X.4
How will information/data be collected and stored for this study (check all that apply):
Paper/hard copy records (hard copy surveys, questionnaires, case report forms, pictures, etc.) - Phase 1 Hand written notes from the
sessions will be placed in a locked filling cabinet. The notes will not contain identifying information. Focus group participants will be
recorded as Participant A, B, etc. Transcriptions of key Informant interviews will be not contain identifying information. Phase 2 The
baseline questionnaire and medical record abstraction form may be hard copies. The participants will be asked to place their completed
questionnaire in a manilla envelope only identified by their study ID number. These envelopes will be collected by the research team and
transported from the UIHC/Children's Mercy Hospital to the study offices in Westlawn or the Clinical Trail Coordinators office in the
Division of Development and Behavioral Sciences at Children's Mercy Hospital The hard copies will be stored in a locked filling cabinet
in Westlawn (UIHC) or Clinical Trials Coordinator Office in the Division of Development and Behavioral Sciences (CMH).If follow-up
questionnaires are completed in hard copy, the hard copy will only contain the study identification number and be returned in first class
postage paid envelopes.
Electronic records (computer files, electronic databases, etc.) - Phase 1 All audio files, and electronic documents containing the
transcription of the audio files, will be saved on the College of Public Health servers and will be password protected. Following the
focus groups, the audio recorders will be placed in locked filing cabinets. Once transcription has been completed and verified, the audio
files will be deleted from the audio recorders. Phase 2 The questionnaires will be completed using REDCap, an electronic online survey
system supported by the U of I. A subject's study ID will be linked to the data and no identifying information will be in the follow-up
surveys. Two electronic ACCESS databases will be created for tracking research subjects and for entering the baseline questionnaire.
Audio recordings from external sites will be sent to the University of Iowa research team via uploading the audio files to a group
SharePoint site. On the SharePoint site, each external site will have a site-specific audio file folder that is only accessible to their staff
and the UI research team for the purpose of downloading files to the CPH secure servers. All audio recordings and electronic files will
be stored on secure servers and only be accessible by password protected computers by the research team. Non-UI team members will
be issued a HawkID in order to access the data files stored in REDCap.
Name - Tim Shie
Title - Director of Information Technology, College of Public Health
University Job Classification - IT Director
X.5
Do the confidentiality protections indicated above allow only members of the research team to access the data/specimens?
No
X.6
Describe
Because the funding agency requires engagement activities of projects, we will identify partners to be consultants to the research team.
Consultants may include previous study participants. These consultants may provide services by providing: feedback/suggestions about
their experience with study processes, ideas about dissemination, testimonials, or collaborating on presentations. They will not be
engaged in any research activities, and will not have access to any coded or identifiable data.
X.7
Does your study meet the NIH criteria for a Certificate of Confidentiality or will you be applying for Certificate of Confidentiality?
No
XI. Data Analysis
XI.1
Describe the analysis methods you will use, including, if applicable, the variables you will analyze
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Phase 1
The focus group data and key informant interviews will be analyzed using content analysis and identification of themes. Focus group and
interview data will also be used to incorporate changes into the LPC for Injured Kids program.
Phase 2
If we achieve randomization, we will compare the differences in distributions between intervention and control groups using simple chi-square
tests for categorical outcomes (low, medium, high levels of coing; being symptomatic for PTSD, Depression, etc.) and t-tests or Wilcoxon
rank-sum tests for continuous variables depending on their normality (e.g. scores for PTSD, depression, social support).
If we do not achieve randomization (i.e. distribution of demographics are not balanced across intervention and control arms), we will also
adjust for confounding using Generalized Linear Models and appropriate link functions (logit for binary outcomes, linear for continuous
outcomes).
XI.2
Provide the rationale or power analysis to support the number of subjects proposed to complete this study.
Phase 1
The research team needs each final focus group to contain at least 6 parents or providers to get an adequate response to the focus group
questions. The focus group will have potentially unpredictable schedule, either due to children in the home (parents) or heavy work load
(providers) therefore we are recruiting 10 members per focus group to ensure we have at least 6 attending each focus group.
Phase 2
We conducted sample size based on testing a moderate effect size of 0.5 standard deviation comparing Trauma Education vs Link. With an
alpha of 0.05, a sample size of 134 parent-child dyads in each of the arms (n=268) has 100% power to examine comparisons. We will
oversample by 12% for a total n = 300.
XII. Future Research
XII.1
Do you wish to keep any information about subjects involved with this research project so that members of the current research team may
contact them in the future for your own research projects?
No
XII.2
Do you wish to keep any information about subjects involved with this research project so that other researchers may contact them for
future research?
No
XII.4
Does this project involve storing any data, tissues or specimens for future research?
No
HawkIRB
https://hawkirb.research.uiowa.edu/hawkirb/summary/projects.page?mo...
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