Feelings and Body Investigators (FBI): Interoceptive Exposure for Child Abdominal Pain
Phase: NA
Conditions: Functional Abdominal Pain
Sponsor: Duke University

Feeling and Body Investigators for Pediatric Abdominal Pain (FBI)
 NCT02075437 
01/28/2019 

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The Duke Tummy Pain Study for Children
 
 
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Feelings/Body Investigators
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A) Additional Investigators, Primary Study Coordinator (CRC), and the Primary Regulatory 
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Small, Brian 
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B) All Other Key Personnel
Curtis, Mikayla 
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Datta, Nandini 
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Davenport, Clemontina 

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Erwin, Savannah 
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Farber, Madeline 
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Ives, Lindsay 
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Marsan, Samuel 
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Mauro, Christian 
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Pendergast, Jane 
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Rivera-Cancel, Alannah 
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Romer, Adrienne 
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Savereide, Erik 
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Wagner, Henry 
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drugs, devices or technologies used in this research?
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policy Use of Research Data by Former Duke Students or Former Duke Faculty and 
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In the panel below, “PHI” is Protected Health Information.

       Entry 1       
Name
Stephen W. Porges
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stephen_porges@med.unc.edu
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UNC Chapel-Hill
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volunteer at Duke on the 
study?
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Greg Lewis
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greg_lewis@med.unc.edu
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UNC Chapel-Hill
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volunteer at Duke on the 
study?
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       Entry 3       
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Maria Isabel Davila Hernandez
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maria_davila@med.unc.edu
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UNC Chapel-Hill
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Duke P.H.I.?
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volunteer at Duke on the 
study?
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Name
Helen L. Egger, M.D.
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helen.egger@duke.edu
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NYU & Duke

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volunteer at Duke on the 
study?
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Name
Nancy Spencer
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 Yes   
 No
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volunteer at Duke on the 
study?
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Kyra Citron
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kec61@duke.edu
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Duke University
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volunteer at Duke on the 
study?
 Yes   
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Bruny Kenou
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bvk5@duke.edu
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Duke University
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volunteer at Duke on the 
study?
 Yes   
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       Entry 8       
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Ashley Kelly

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ashley.kelley@duke.edu
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Duke University
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volunteer at Duke on the 
study?
 Yes   
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       Entry 9       
Name
Tejaswi Siripurapu
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siripurapu20t@ncssm.edu
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North Carolina School of Science and Mathematics
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Duke P.H.I.?
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  No
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volunteer at Duke on the 
study?
 Yes   
 No
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Research Abstract
Please type your Research Abstract here:
The Research Abstract should summarize the main points of your study in one paragraph. The following 
guidelines may help you:
 
1. Purpose and objective (1-2 sentences)
2. Study activities and population group (2-4 sentences)
3. Data analysis and risk/safety issues (1-2 sentences)
This proposal, 
is in 
Feelings and Body Investigators (FBI): Interoceptive Exposure for Child Abdominal Pain 
response to PA-11-177, Translational Research for the Development of Novel Interventions for Mental 
Disorders (R21/R33). We describe the development and pilot-testing of an acceptance-based 
behavioral treatment for young children (5-8 years old) with functional abdominal pain (FAP; R21, 
 is one of the most frequent somatic syndromes in young children, causes 
n=26, R33, n=100). FAP
significant impairment, and is predictive of psychiatric and pain disorders. No treatments exist for very 
young children with FAP. Early intervention may not only improve pain and decrease impairment, but also 
may have broad implications for the prevention of future psychiatric and pain disorders and for 
improvement in the emergence of adaptive self-regulatory capacities (e.g. emotion regulation). We 
propose that FAP results from the influence of pain on neurodevelopment of the gut-brain axis combined 
with maladaptive interactions with the social environment that inadvertently increase somatic fear. We 
address these vulnerabilities by 1) linking intervention strategies to unique patterns of neural circuit 
maturation associated with early visceral pain on the gut-brain axis, 2) adapting acceptance-based 
behavioral strategies used to address psychopathology in older children to younger children, and 3) 
incorporating caregivers as role models and facilitators. 
the R21, we iteratively develop the 
For 
intervention, training children to be “FBI agents- Feeling and Body Investigators,” an acceptance-based 
interoceptive exposure intervention. Interoceptive exposure involves the deliberate manipulation of 
somatic signals to reduce somatic fear and enhance functioning (e.g. getting the gut to have more 
1) gather body clues (
), 2) investigate (
: perform 
butterflies). Child/caregiver dyads: 
Learn
Experience
interoceptive mystery missions to explore a body sensation), 3) organize body clues (
: recall 
Contextualize
other contexts that evoke similar sensations, e.g. emotions), and 4) go on increasingly daring missions (Ch
: decrease avoidance and safety behaviors, provoke stronger sensations while performing 
allenge
activities). Ten sessions are done in clinic (n=8) and home via web-camera (n=2) to facilitate 
generalization. The intervention is theoretically grounded in attachment research and developmental 
neuroscience, with a focus on how children learn to interpret the meaning of visceral signals (e.g. is this 
gut sensation the butterflies of anxiety or the pangs of hunger?). We use epidemiological methods to 
screen all eligible children via primary care practices to examine the potential impact of our intervention. 
In the R33 phase, we randomize to FBI or parent education to examine clinical and statistical change. The 
control parent education condition provides an added deliverable by providing materials about FAP for use 
in primary care. If we are successful, young children with FAP will experience changes in the viscera as 
fun and fascinating with broad implications for the emergence of emotion awareness and regulation, 
improvement in function, and prevention of disease.
 
Research Summary
State your primary study objectives
Developmental (R21) Phase. We will develop and refine the FBI intervention in 26 child-caregiver dyads.
A1.  Create a developmentally sensitive interoceptive exposure treatment for young children 
with FAP.
A2.  Assess the initial feasibility of FBI.
Hypotheses: HA2 , 
a ≥ 80% of participants enrolled in FBI will complete treatment, 
, ≥ 80% of 
HA2b
participants will complete home-based practice assignments.
A3.  Assess the clinical significance of FBI post-treatment.
Hypothesis : HA3, Children will endorse weekly pain and distress ratings of minimal to none (≤ 2).
 
Pilot-Test (R33) Phase. We will randomize 100 children with FAP to FBI or an active control (parent 
education with standard medical care).
B1.  Determine feasibility of the intervention.
Hypotheses: HB1a, ≥ 80% of participants will complete treatment and 
, homework.
HB1b
B2.  Determine the acceptability of the intervention.

Hypotheses: HB2a, ≥ 80% of parents and children in FBI will endorse Very Much/Extreme positive 
ratings on treatment credibility and 
, satisfaction.
HB2b
B3.  Assess clinically meaningful change in the intervention group compared to control.
Hypotheses: HB3a, Compared to control, children in FBI will endorse: fewer episodes of abdominal pain
,
(Faces Scale)  HB3b, greater reductions in 
 (Children’s Global Assessment Scale)
impairment
State your secondary study objectives
greater improvements in 
 via increased abilities to 
 
Exploratory: 
emotion awareness and regulation
HB3c,
discriminate emotion from pain (via daily diaries) and 
, regulate emotional experience 
HB3d
(laboratory 
mood induction task).
Please select your research summary form:
Standard Research Summary Template
This is the regular (generic) research summary template which is required  for all regular applications (unless 
your protocol fits under the other research summary templates in this category).  Use of these instructions is 
helpful for ensuring that the research summary contains all necessary elements.
 
Standard Research Summary
Purpose of the Study
 
Objectives & hypotheses to be tested
Developmental (R21) Phase. We will develop and refine the FBI intervention in 26 child-caregiver dyads.
A1.  Create a developmentally sensitive interoceptive exposure treatment for young children 
with FAP.
A2.  Assess the initial feasibility of FBI.
Hypotheses: HA2 , 
a ≥ 80% of participants enrolled in FBI will complete treatment, 
, ≥ 80% of 
HA2b
participants will complete home-based practice assignments.
A3.  Assess the clinical significance of FBI post-treatment.
Hypothesis : HA3, Children will endorse weekly pain and distress ratings of minimal to none (≤ 2).
 
Pilot-Test (R33) Phase. We will randomize 100 children with FAP to FBI or an active control (parent 
education with standard medical care).
B1.  Determine feasibility of the intervention.
Hypotheses: HB1a, ≥ 80% of participants will complete treatment and 
, homework.
HB1b
B2.  Determine the acceptability of the intervention.
Hypotheses: HB2a, ≥ 80% of parents and children in FBI will endorse Very Much/Extreme positive 
ratings on treatment credibility and 
, satisfaction.
HB2b
B3.  Assess clinically meaningful change in the intervention group compared to control.
Hypotheses: HB3a, Compared to control, children in FBI will endorse: fewer episodes of abdominal pain
,
(Faces Scale)  HB3b, greater reductions in 
 (Children’s Global Assessment Scale), and, 
impairment
Explora
greater improvements in 
 via increased abilities to 
 
tory: 
emotion awareness and regulation
HB3c,
discriminate emotion from pain (via daily diaries) and 
, regulate emotional experience 
HB3d
(laboratory 
mood induction task).
Background & Significance
Should support the scientific aims of the research

The Duke Tummy Pain (DTP) Study Research Summary
 
R-21 Phase
The Feelings and Body Investigators (FBI): Interoceptive Exposure for Child Abdominal Pain proposes 
to develop (R21) an acceptance-based behavioral treatment intervention for children 5 through 9 years 
old with impairing functional abdominal pain. Functional abdominal pain (FAP) is a frequent somatic 
complaint in young children (approximately 10% of those presenting to primary care) and is 
responsible for distress in the afflicted child and the family; unnecessary health care utilization and 
cost; and interference with schooling. Further, FAP is predictive of future pain disorders, psychiatric 
disorders, and impairment. Despite this prevalent and significant burden, there are currently no 
accepted successful treatments for FAP in young children.
 
The objective of this proposal is to develop an intervention for FAP based on fundamental research on 
aberrant neurodevelopment of the gut-brain axis and subsequent modification by the social 
environment. In brief, this work suggests that FAP results from the influence of pain on the 
neurodevelopment of the gut-brain axis. The gut-brain axis maintains the body’s homeostasis, 
encompassing capacities to sense changes in the viscera and respond adaptively (e.g., responding to 
gut pangs of hunger). Healthy maturation of the gut-brain axis is crucial for the emergence of weight 
and emotion regulation. Further, the interpretation of visceral signals has a developmental course, as 
children learn how to identify, label, and describe body sensations; e.g., whether gut sensations are 
butterflies of anxiety or gut pain. FAP represents a disruption of this normal developmental course. FAP 
may also be exacerbated by environmental influences (e.g., extensive medical diagnostic testing) that 
increase parents’ health anxiety and their children’s fear and distrust of their bodies. We propose to 
intervene directly early in development on these aberrations in gut-brain maturation by training 
eligible child-caregiver dyads to be feelings and body (FBI) investigators using interoceptive exposure 
(the manipulation of visceral sensation) to explore a “body mystery” in a playful, investigative context 
designed to increase curiosity about body function. Sessions are conducted in clinic and home (via web-
camera) to facilitate generalization.
 
Because of limited sample size and the iterative nature of intervention development, criteria for 
success at the R21 Phase are based primarily on clinical rather than statistical criteria. We have 
established goals for compliance, completion, and reduction in physical and psychological distress 
aimed at establishing the feasibility and efficacy of the intervention. We carefully considered statistical 
constraints of pilot investigations by framing outcomes based on clinical but not statistical significance.
 
There are no known physical risks to the child or parent associated with this proposed study.
There are minimal risks such as feeling uncomfortable answering questions.
 
Design & Procedures
Describe the study, providing detail regarding the study intervention (drug, device, physical 
procedures, manipulation of the subject or the subject’s environment, etc.). Discuss justifications for 
placebo control, discontinuation or delay of standard therapies, and washout periods if applicable. 
Identify procedures, tests and interventions performed exclusively for research purposes or more 
frequently than standard of care. Include alternative therapies, concurrent therapies discontinued per 
protocol, risk benefit ratio, and use of tissue/specimens. Discuss monitoring during washout periods if 
applicable. Include brief description of follow-up, if any.
Treatment Procedures/Quality Control for R21
Treatment Procedures: Treatment sessions will be conducted in the Duke Young Child Laboratory (see 
below). For home-based sessions, we use web-cameras so the participants can practice new skills at home 
to facilitate generalization. All families will be given a web-camera, if needed, for this purpose. As with all 
procedures, children lead the sessions (the “FBI missions”) both to maximize their engagement and 
minimize their fears of body-focused exposures. While part of the treatment is gently nudging children to 
do things that produce a somatic sensation, yet it is critical that children feel safe and thus they can 
terminate a session whenever they wish. Our typical approach to such a request is to first attempt to 
titrate the exposure down to a level that is acceptable for the children until they are excited about the 
mission. In the event of continued refusal, we use the session to hone our “observational skills” or go into 
“investigative mode” figuring out why today is such a rough day. Thus, sessions are always productive – 
no matter what the emotional state of the child, but yet always sensitive to the needs of the child.
 
Assessment Procedures
Four separate assessment types occur throughout the study:
                a) 7 days of daily pain diaries (approximately 15 minutes per day)

                b) Parent and child-completed surveys (approximately 1 hour)
                c) Parent interview (approximately 3 hours)
                d) Laboratory mood induction task (approximately 1 hour)
 
All laboratory assessments (and some treatment sessions) will be conducted in our Duke Young Child 
Laboratory in the Center for Developmental Epidemiology, located on bus lines including free public bus 
lines with free parking and available childcare. The laboratory consists of a cheerful playroom where 
children can use toys and a comfortable interviewing room (adjacent to playroom) where parents will 
be interviewed (c) and children will complete the laboratory mood induction task (d). Parents will be 
able to use seating in the playroom during the mood induction task to complete the surveys (b).
 
The daily pain diaries (a) will be given to participants to fill out where ever works best for the 
participants. They will be given these three daily surveys to fill out, within a paper flip booklet which 
the subject will turn in to the researchers after the completing the Daily Pain Diaries.
We also send out a short questionnaire to our subject’s teachers at two time points (which we are 
currently getting permission to do within our main study consent form that the parent fills out and signs, 
along with giving us the teachers name, school, address, e-mail address, and phone number).  First we 
plan to contact the subject’s teacher via e-mail to see if they would be willing to fill out these 
questionnaires, and if they e-mail us back, letting us know that they would like to participate, we will send 
the teacher a questionnaire link, via Duke Qualtrics, prior to the subject starting their investigational 
treatment sessions.  We would then e-mail the teacher a second time, after the subject has completed all 
10 of the treatment sessions, to see if they would be willing to again fill out these questions via a Duke 
Qualtrics link.
 
Assessment Measures:
Feasibility: Hypotheses A.H2
 A.H2 /B.H1 , B.H1 .
a,
b
a
b
We will keep a continuous measure of session attendance with missed sessions that are rescheduled 
within a two-week window (to account for vacations, etc.). Homework practice is recorded by 
therapists at every session (number of practice sessions completed regardless of degree of completion) 
and quality of homework (none, attempt, completed) to provide a continuous measure of treatment 
feasibility.
 
Clinical Significance: Hypotheses A.H3
/B.H3 , B.H3 , B.H3 , B.H3
a 
a
b
c
d
Treatment efficacy is assessed along dimensions of: a) physical pain, b) impairment, and c) emotion-
regulation (exploratory).
 
Pain: Children and their caregivers will be trained to complete pain ratings using a Daily Pain Diary 
which contains a Pain Thermometer to rate pain experienced and the Self-Assessment Manikin (SAM) 
scale to rate emotional experience. Caregivers are trained to use the child’s verbal reports, facial 
expressions, and behaviors to make these ratings. Children make their ratings twice daily: in the 
morning and before dinner. Parents rate their child’s pain three times daily: in the morning, before 
dinner, and at the end of the day. The end of day survey contains additional questions asking about 
the child’s overall pain experience throughout the entire day, as well as their distress and mood. These 
ratings are completed for one week prior to treatment and one week post-treatment, on a daily basis. 
Pain ratings are collected during 2 of the 10 weeks of treatment.
Impairment: Change in function will be assessed by diagnostic interviews and global ratings of clinical 
and functional change by reviewers blind to the randomization on the basis of these interviews, 
functional status as reported in pain/emotion diaries, and medical chart review of frequency of visits 
and physician contacts.
Diagnostic Interviews: Dr. Helen Egger is the leading author of the Preschool Age Psychiatric 
Assessment (PAPA), one of the most widely used and reliable semi-structured interviews for diagnosis 
of young child psychopathology. The caregiver reports on his or her child’s family context, psychiatric 
diagnosis, self-regulatory abilities including sensitivity to sensation, developmental history, and 
impairment. Numerous studies have established its predictive validity and sensitivity to change with 
intervention. Impairment is assessed across multiple domains as well as the perceived cause of 
impairment (e.g. due to physical symptoms). To shorten administration, modules chosen are based on 
frequency of somatic symptoms and include ADHD, somatization, social phobia, separation anxiety, 
generalized anxiety, and depression.
Functioning ratings in daily pain diaries – Parents are asked to provide an assessment of their child’s 
functioning three times per day. In the morning (beginning of day) and afternoon (before dinner), they 
rate their child’s ability to pay attention and have fun whilst experiencing tummy pain. At the end of 
the day, they provide a detailed report of their child’s physical and emotional functioning over the 
course of the day.
Global Ratings: Clinical Response - At pre and post-assessment, clinical status and improvement will 
be rated by blind raters on the eight-point Clinical Global Impression Scale Improvement. Participants 
who are rated as clinically improved or much improved in the area of physical symptoms will be 
considered treatment responders.
Global Ratings: Functioning - Global functioning will be rated by a rater blind to treatment status using 
the Children’s Global Assessment Scale, a 100-point scale with 1 being most impaired and 100 being 

least impaired. A score of 41–50 indicates a moderate degree of interference in functioning in most 
social areas or severe impairment of functioning in one area, whereas a score of 61–70 indicates 
generally functioning well with some difficulty in a single area. Scores of 70 or above will be considered 
responders.
Emotion Regulation: Emotion regulation is measured at pre- and post-treatment with our mood 
induction paradigm and child-reported emotional valence ratings in the daily pain diaries.
 - We employ a standardized mood induction paradigm for young 
Mood induction laboratory paradigm
children (viewing film clips). Additionally, we have children self-report on their emotions, pain, and 
hunger level, as well as changes in body sensation (movement of their heart and gut), throughout the 
task. Figure 4 provides a graphical representation of the mood induction task. To better assess the 
subject’s physiological state while watching these mood inducing video clips, subjects will be hooked 
up to a BioPac machine which will collect the following physiological data:  EEG, ECG, Galvanic Skin 
Response, and Respiration. The film clips include exciting clips,, sad clips, disgusting clips, fearful clips, 
and happy clips. If children have successfully learned to discriminate and regulate emotional 
experiences, they should 1) complete the lab task despite increased emotion, 2) change ratings of 
body sensation and emotion with each clip, but not pain 
 - We have children use the SAM scale in their daily pain diaries to assess 
Child-reported emotional valence
their daily emotional state. By giving daily ratings of their emotional state, their pain state, and combining 
these with parent reports of the same, we can examine increasing segregation of ratings of pain from 
those of emotional experience.
 
R-33 Phase
As of February 2016, we have completed the R-21 phase of The Feeling and Body Investigators (FBI) 
Study (N=26) and have received approval to continue into the R-33 phase of the study.  We are currently 
in the process of analyzing the data collected during the R-21 phase of the study, updating materials 
based on subject feedback, and preparing to begin recruitment of our next 100 subjects (N=100).
 
The R-33 phase, called The Duke Tummy Pain (DTP) Study, will differ from the R-21 phase in that we will 
be comparing our Investigational Treatment (Feeling and Body Investigator Treatment, or FBI) to a control 
treatment (Caregivers in Action Treatment, or CIA). Recruitment, eligibility criteria, and assessment 
strategies will stay the same as they were in the R-21 phase.  Subjects recruited into the R-33 phase will 
be randomized to either the experimental treatment (FBI) or the control treatment (CIA), but both groups 
will receive the same number of treatment sessions (10), with 8 sessions conducted in our lab space and 2 
sessions conducted via Skype.
 
The R33 period will repeat the goals of the R21 period using an improved intervention, a large sample to 
discern statistical and clinical significance, and a randomized design with a parent-psychoeducation 
comparison condition. Endpoints include quantification of whether this intervention can have broad impact: 
using primary care practices to screen and subsequently treat abdominal pain early in the life and disorder 
cycle.
 
Those who receive the FBI Investigational Treatment will still be trained using an improved version of the 
FBI R-21’s interoceptive exposure (the manipulation of visceral sensation) to explore “body mysteries” in a 
playful, investigative context, designed to increase curiosity about body functions.  The CIA (treatment as 
usual) focuses more on the parent, who will receive a psychoeducation comparison condition. Parents will 
receive educational handouts, similar to what they would receive from a Pediatricians office, and the 
therapist will review these materials with the parent, while the child is playing in the room.
 
As of November 2016, Dr. Helen Egger (a Co-PI on this study) has taken a position at NYU and will no 
longer be working with subject’s PHI for this study.  Helen will now be moved to our “Outside Duke Key 
Personnel” and is still involved with Duke, but as an adjunct professor.
 
Lastly, as of January of 2018 we plan to add a small group of 10-year-old children, N=10, as a pilot, to 
test our investigational therapy on an older age group. 
 
April 2018: We have been approved and funded by the NIMH to include a diversity supplement under the 
FBI parent study. Through this supplement, we will be conducting a series of focus groups and interviews 
with Hispanic participants. If the goals of this project are reached, the deliverables from this project will 
include a novel intervention for young children (5-9 years old) with FAP which is tailored to needs of 
families of Hispanic origin. Subjects may only speak Spanish. The focus groups with be translated into 
Spanish. Consent forms have been translated into Spanish. 
 
May 2019: To capture additional data for the diversity supplement, we will recruit parents who would be 
eligible to participate in the focus groups/interviews to complete an online Qualtrics survey instead of 
coming in-person to participate in a focus group or interview. Data collected from these participants will 
help inform the development of the novel intervention tailored to families of Hispanic origin.
 
 
Assignment to Study Group

For the R33 caregiver-child dyads will be randomized into one of two potential treatment groups:  1) 
Feeling and Body Investigators (FBI)- A child focused treatment, or 2) Caregivers In Action (CIA)- a 
parent focused treatment.  Participants who refuse the study at the baseline encounter will also be 
entered into the tracking database to track characteristics of refusals.
 
Treatment Procedures/Quality Control for R-33
Treatment Procedures: Treatment sessions will be conducted either in the Duke Young Child Laboratory 
(see below) or in the Duke Center for Eating Disorders at Lakeview East. For home-based sessions, we use 
web-cameras so the participants can practice new skills at home to facilitate generalization. All families will 
be given a web-camera, if needed, for this purpose.
Those Assigned to FBI: Children will lead the sessions (the “FBI missions”) both to maximize their 
engagement and minimize their fears of body-focused exposures. While part of the treatment is gently 
nudging children to do things that produce a somatic sensation, it is critical that children feel safe and thus 
they can terminate a session whenever they wish. Our typical approach to such a request is to first 
attempt to titrate the exposure down to a level that is acceptable for the children until they are excited 
about the mission. In the event of continued refusal, we use the session to hone our “observational skills” 
or go into “investigative mode”: figuring out why today is such a rough day. Thus, sessions are always 
productive no matter what the emotional state of the child.
Those Assigned to CIA:  These sessions will be focused on the psychoeducation of the parent, but the child 
will be in the room playing while the therapist is reviewing the educational materials with the parent. There 
will be a 10-lesson educational curriculum designed to educate caregivers about the management of their 
child with FAP.  To create the curriculum for CIA, we reviewed patient handouts for exemplary pediatric 
gastrointestinal programs, professional healthcare organizations, and companies that supply the patient 
handouts incorporated into electronic medical record systems (e.g. Maestro). Following the review of these 
materials, we extracted the primary themes and lessons and organized them into a session-by-session 
curricula.
 
Assessment Procedures
**The same as the R-21 Phase, except for adding a 6 month follow up battery of questionnaires which 
will be sent to the parent via an e-mail link using Duke Qualtrics.  These questionnaires will be the 
same as the questionnaires that caregivers fill out during the Lab 1 and Lab 2 portion of this study.
 
Assessment Measures:
Feasibility: Hypotheses A.H2
 A.H2 /B.H1 , B.H1 .
a,
b
a
b
We will keep a continuous measure of session attendance with missed sessions that are rescheduled 
within a two-week window (to account for vacations, etc.) counted (range: 0-10). Homework practice 
is recorded by therapists at every session and rated by two independent blind raters on frequency 
(number of practice sessions completed regardless of degree of completion) and quality of homework 
(none, attempt, completed) to provide a continuous measure of treatment feasibility.
 
Clinical Significance: Hypotheses A.H3
/B.H3 , B.H3 , B.H3 , B.H3
a 
a
b
c
d
Treatment efficacy is assessed along dimensions of: a) physical pain, b) impairment, and c) emotion-
regulation (exploratory).
**All assessments will be the same as in the R-21 Phase**
 
Selection of Subjects
 
List inclusion/exclusion criteria and how subjects will be identified.
The primary care clinic where we recruited during the R-21 sees both privately insured and Medicaid 
children. The staff saw 1798 children between the ages of 5 and 9 years old in a previous study 
conducted at this clinic, The Preschool Anxiety Study. Based on our preschool cohort data (n=918) 
drawn from this primary care clinic, we expect 1) 8% to meet study criteria or 144 children. Assuming 
that 20% refuse to screen (approximately 30), we plan to screen 174 children. For the R33, we need 
to recruit 140 individuals to enroll 100 subjects; it will take 70 weeks to recruit this number (1.3 
years). To get our N of 100 we plan to “consent to screen” close to 2,000 potential subjects. Having 
found that we had recruited most of the eligible subjects from the Picket Road Pediatric Clinic during 
the R-21 phase, we began recruiting from Duke’s Southpoint Pediatric Clinic as well in late 2015.  For 
the R-33 phase we plan to recruit from Duke’s Southpoint Clinic, Durham Pediatrics, and potentially at 
Picket Road Pediatric Clinic once additional potential subjects have aged in. Further, based on our 
cohort data, we expect roughly equal numbers of males, females, ages, and those with a psychiatric 
disorder. We also found that the racial distribution of abdominal pain is roughly equivalent to the racial 

and ethnic distribution of the Raleigh/Durham metropolitan region (45% Caucasian, 45% African-
American, and 10% other underrepresented minorities). Thus, we are able to recruit a representative 
sample and make the intervention available to all who would benefit.
 
Subject Recruitment and Compensation
Describe recruitment procedures, including who will introduce the study to potential subjects. Describe 
how you will ensure that subject selection is equitable and all relevant demographic groups have access 
to study participation (per 45 CFR 46.111(a) (3)). Include information about approximately how many 
DUHS subjects will be recruited. If subjects are to be compensated, provide specific prorated amounts 
to be provided for expenses such as travel and/or lost wages, and/or for inducement to participate.
Recruitment Sampling Frame: The primary care clinic where we will recruit sees both privately insured 
and Medicaid children. The staff saw 1798 children between the ages of 5 and 9 years old in a previous 
study conducted at this clinic, The Preschool Anxiety Study. Based on our preschool cohort data 
(n=918) drawn from this primary care clinic, we expect 1) 8% to meet study criteria or 144 children. 
Assuming that 20% refuse to screen (approximately 30), we plan to screen 174 children. We need to 
recruit 26 individuals for phase 1 and phase 2 of the R21 and it will take us 18 weeks. Further, based 
on our cohort data, we expect roughly equal numbers of males, females, ages, and those with a 
psychiatric disorder. We also found that the racial distribution of abdominal pain is roughly equivalent 
to the racial and ethnic distribution of the Raleigh/Durham metropolitan region (45% Caucasian, 45% 
African-American, and 10% other underrepresented minorities). Thus, we are able to recruit a 
representative sample and make the intervention available to all who would benefit. 
 
Recruitment Sampling Frame: 
The primary care clinic where we recruited during the R-21 sees both 
privately insured and Medicaid children. The staff saw 1798 children between the ages of 5 and 9 years 
old in a previous study conducted at this clinic, The Preschool Anxiety Study. Based on our preschool 
cohort data (n=918) drawn from this primary care clinic, we expect 1) 8% to meet study criteria or 
144 children. Assuming that 20% refuse to screen (approximately 30), we plan to screen 174 children. 
We need to recruit 26 individuals for phase 1 and phase 2 of the R21 and it will take us 18 weeks.  For 
the R33, we need to recruit 140 individuals to enroll 100 subjects; it will take 70 weeks to recruit this 
number (1.3 years). To get our N of 100 we plan to “consent to screen” close to 2,000 potential 
subjects. Having found that we had recruited most of the eligible subjects from the Picket Road 
Pediatric Clinic during the R-21 phase, we began recruiting from Duke’s Southpoint Pediatric Clinic as 
well in late 2015.  For the R-33 phase we plan to recruit from Duke’s Southpoint Clinic, Durham 
Pediatrics, and potentially at Picket Road Pediatric Clinic once additional potential subjects have aged 
in. Further, based on our cohort data, we expect roughly equal numbers of males, females, ages, and 
those with a psychiatric disorder. We also found that the racial distribution of abdominal pain is 
roughly equivalent to the racial and ethnic distribution of the Raleigh/Durham metropolitan region 
(45% Caucasian, 45% African-American, and 10% other underrepresented minorities). Thus, we are 
able to recruit a representative sample and make the intervention available to all who would benefit.
 
Compensation for FBI Study Participants: The parent and child will be compensated up to $310 for their 
participation in the study. The parent will receive $5 a day for each day that they complete all 3 of the 
Daily Pain Diaries, up to $35 for the 1  week of Daily Pain Diaries (pre-treatment) and up to another $35 
st
for the 2
 week of Daily Pain Diaries (post treatment). The parent will also receive $40 for the first mood 
nd
induction laboratory assessment, and $100 for the second mood induction laboratory assessment. The 
parent will receive $35 for each of the parent-interviews (ePAPAs) that they complete (one pre-treatment 
and one post-treatment) and finally, they will receive a $30 gift card for completing the 6 month follow-up 
questionnaires.  Children will receive a prize at the end of each assessment. No monetary compensation 
will be provided for the 10 intervention sessions, but children will be given an assortment of toys at the 
end of each in-person session.
 
Compensation for FBI Study Participants: 
the parent will receive a 
**The same as the R-21 Phase except, 
$30 Amazon gift card for completing a final 6 month follow-up survey.**
 
Compensation for Diversity Supplement Participants:
Both parent and child that participate in this study will be receiving compensation. Upon completion of the 
study parents will receive a $55 pre-loaded ClinCard. Upon the child’s completion of a focus group
/interview session they will receive a small toy. Parents who complete the online Qualtrics survey will be 
sent a $15 Amazon giftcard upon completion.
Consent Process
 

Complete the consent section in the iRIS Submission Form.
Subject’s Capacity to Give Legally Effective Consent
If subjects who do not have the capacity to give legally effective consent are included, describe how 
diminished capacity will be assessed. Will a periodic reassessment occur? If so, when? Will the subject 
be consented if the decisional capacity improves?
Not applicable. Only parents with the capacity to give legal consent will be recruited. 
Study Interventions
If not already presented in #4 above, describe study-related treatment or use of an investigational 
drug or biologic (with dosages), or device, or use of another form of intervention (i.e., either physical 
procedures or manipulation of the subject or the subject’s environment) for research purposes.
See above. 
Risk/Benefit Assessment
Include a thorough description of how risks and discomforts will be minimized (per 45 CFR 46.111(a) (1 
and 2)). Consider physical, psychological, legal, economic and social risks as applicable. If vulnerable 
populations are to be included (such as children, pregnant women, prisoners or cognitively impaired 
adults), what special precautions will be used to minimize risks to these subjects? Also identify what 
available alternatives the person has if he/she chooses not to participate in the study. Describe the 
possible benefits to the subject. What is the importance of the knowledge expected to result from the 
research?
 
B.1) Protection Against Physical Risk
 
Monitoring and Management of Severe GI Pain. It is critical that we have stringent guidelines for the 
appropriate management of varying pain levels in children with FAP to guide therapists in the 
implementation and dissemination of this intervention. The careful development of these 
guidelines will be an important deliverable from this project. To develop these guidelines we 1) 
recruit from primary care to ensure children are under the care of a primary care physician; 2) we 
carefully abstract from medical records throughout the study the medical interventions proscribed and 
number of physician contacts initiated by study participants, and 3) we continually monitor pain from both 
the parent’s perspective of the child and the child’s perspective across study arms. This information is 
shared in weekly case consultation meetings attended by Dr. Zucker, a child psychologist and PI, relevant 
therapists, and when needed Dr. Gary Maslow. The level of monitoring and supervision will be the same 
across treatment arm.  In the experimental arm, our goal is to develop behavioral guidelines to help 
children and caregivers manage abdominal pain. In the intervention, we teach children to quantify 
experience (including pain), the context in which these experiences occur, and the result of the actions 
taken we hope to build mastery in children with medical comorbidity so they can learn when it is 
appropriate to seek help, avoid activities, or gently nudge themselves to participate. Combined, these 
sources of data will be used to create guidelines for therapists managing abdominal pain from a 
psychological perspective to ensure the safety of their patients.
 
B.2a) Protection Against Psychological Risks: Recruitment Site (informed consent and 
screening)
Informed consent. All the data will be collected under proposals approved by the IRB of Duke University 
Medical Center. Brief consent will be obtained in the clinic to administer the short screening items. 
Informed consent will be obtained from the parent by the interviewer on the day of the baseline 

assessment. Separate consents are given for the interview and for having the assessments and treatment 
sessions recorded for coding and quality control. Participants can sign any or all of these separate 
consents. They will be informed that they can refuse to answer any questions they choose, and can have 
the tape recorder/video recorders turned off at any time.
 
Psychological issues that arise during screening. The presence of a responsive and well-established 
pediatric mental health team within the clinic where we are recruiting will support the needs of subjects 
who are identified with possible emotional or behavioral symptoms or disorders that are identified but that 
do not qualify for our intervention study. At any time during our brief screen, the parent or the child may 
discontinue the interview/assessment or choose not to talk about a certain topic. To protect against any 
psychological risk, interviewers are carefully trained. All have a four-year degree. They receive intensive 
training, which includes training in research ethics and confidentiality. All of our interviewers will also have 
experience with and excellent rapport with young children.
 
The interviewers are also trained in procedures for cases where a participant indicates suicidal or homicidal 
thoughts or plans. Cases of suspected suicidal or homicidal ideation are reported to Nancy Zucker, PhD, 
who is a licensed child psychologists on the study faculty. If necessary, a referral will be made to a local 
mental health provider. One of the reasons we chose the Duke Pediatric Clinic as our recruitment site is 
that it has an in-house mental health team led by Dr. Walter, who is also a member of our research team. 
Thus, the parents and children in the study can be referred to Dr. Walter’s team for mental health 
evaluation and treatment. This mental health team, as well as the Duke Child Guidance Clinic, provides 
services for children with and without health insurance. If a child or parent is referred for mental health 
evaluation, a report is filed with the subject’s informed consent forms. Barbara Keith Walter PhD, who 
leads the clinic’s mental health team, will serve as a critical liaison between our research group and the 
clinic. She played this role in the PAPA test-retest study and is currently supervising the study of older 
children (Zucker; RC1-MH-088678). She will help to ensure that we collaborate efficiently and effectively 
with the pediatricians, child psychiatrists and psychologists, nurses, and other clinic staff. She will also 
facilitate mental health evaluations or treatments if they appear necessary at any point in the study. In the 
set-up time at the beginning of the study, we will meet with the clinic staff to introduce ourselves and the 
study protocol and to answer any questions and address any concerns. An information sheet including the 
name of the study, the purpose of the study, and the names, numbers, and e-mail addresses of the 
principal and co-investigators and the study coordinator will be printed on colored cardboard and posted 
throughout the clinic. Critically, Dr. Zucker has collaborative relationships with all these pediatricians due 
to her clinical work with childhood eating and somatic disturbance so lines of communication are both 
familiar and frequently utilized.  
 
B.2b) Protection Against Psychological Risks: Diagnostic Assessments and Treatment
Diagnostic Assessments. At any time, the parent or the child may discontinue the interview/assessment 
or choose not to talk about a certain topic (see above for training of interviewers). The interviewers are 
also trained in procedures for cases where a participant indicates suicidal or homicidal thoughts or plans. 
Cases of suspected suicidal or homicidal ideation are reported to Nancy Zucker, PhD, who is a licensed 
child psychologist on the study faculty. If necessary, a referral will be made to a local mental health 
provider. In practice, our research group, which has more than two decades of experience with 
interviewing parents and children, has found that raising “sensitive” subjects (e.g., depression, suicidal 
ideation) with children or parents for whom this is a problem area serves as a relief to them, providing 
validation that the problem is “real”, and a source of help for it to be made available (see below).
 
Treatment. For protection of the mental health of dyads during treatment, the clinical research team will 
have weekly case consultation meetings. Attending these meetings with be the PI (a child psychologist and 
any relevant study therapists, and, if needed, a pediatrician who works closely with our research group 
(Maslow). Psychological symptoms and pain ratings will be reviewed to monitor the success of current 
therapeutic strategies and to discern the need for referral for additional or alternative sources of care. In 
those cases for which a referral is required, we will carefully document such treatments and will include 
their intervention data up to the point in which this referral was made.
 
B.3. Protection Against Social Risks
Interviewers are trained not to talk to anyone about their interviews and sign confidentiality agreement to 
that effect. All data that would lead to subject identification will be labeled using a research code number 
only so that no names will be used in any of the data. Confidentiality of all subject information will be 
preserved by housing all records and interview tapes in locked files in locked offices. Data will be 

maintained on a computer accessible only to research project staff. Further, all computerized data will be 
maintained in a limited access, password-protected hard drive or on secure backup drives locked in files in 
the research office of study PIs.
 
B.4. Protection Against Legal Risks
Procedures to preserve confidentiality. Interview schedules and tapes will be closely protected at all times. 
After collection, coding, and review for accuracy by the project coordinator, data are entered double-
entered into computer files at our offices at Duke, except for the ePAPA which are computerized and do 
not require double data entry. The schedules and tapes are then stored in locked storage facilities. 
Participant information on the computer files is identified only by a study-specific identification number. 
Only approved research staff has access to the data. All faculty and staff have taken and passed Duke’s 
required training modules on HIPAA regulations for protecting participants’ privacy, and the Center for 
Developmental Epidemiology, where the study records are held, observes all approved security rules to 
protect the data. The Center for Developmental Epidemiology has a full-time staff member, our medical 
information systems manager Jurgen Henn, who oversees our group’s HIPAA compliance.       
Costs to the Subject
Describe and justify any costs that the subject will incur as a result of participation; ordinarily, subjects 
should not be expected to pay for research without receiving direct benefit.
There are no costs to the subjects. 
Data Analysis & Statistical Considerations
Describe endpoints and power calculations. Provide a detailed description of how study data will be 
analyzed, including statistical methods used, and how ineligible subjects will be handled and which 
subjects will be included for analysis. Include planned sample size justification. Provide estimated time 
to target accrual and accrual rate. Describe interim analysis including plans to stop accrual during 
monitoring. Phase I studies, include dose escalation schema and criteria for dose escalation with 
definition of MTD and DLT.
Statistical Methods
Tests of hypotheses will be based on standard binomial models for proportions and Student’s t-test or 
standard ANCOVA regression models as appropriate for continuous measures; ordinal data not meeting 
assumptions of normality will be analyzed using nonparametric Wilcoxon Mann-Whitney procedures or, in 
some cases, generalized linear regression (Poisson, logistic) models. For the R33, evaluations will be 
repeated 6-months post-treatment.
 
Data & Safety Monitoring
Summarize safety concerns, and describe the methods to monitor research subjects and their data to 
ensure their safety, including who will monitor the data, and the frequency of such monitoring. If a 
data monitoring committee will be used, describe its operation, including stopping rules and frequency 
of review, and if it is independent of the sponsor (per 45 CFR 46.111(a) (6)).
Data and Safety Monitoring Board. We have established a DSMB that we have used in our prior clinical 
trials that includes a registered nurse and former member of the Clinical Research Support Office (Sharon 
Minda, RN), a principal investigator of epidemiological trials of child mental health (William Copeland, 
PhD), Kerri Boutelle, PhD, a pediatric clinical trials researcher from the University of California, San Diego 
and Alex Kemper, MD, a former leader in the Duke Pediatric Clinical Trials Network. This committee will 
meet twice annually or as needed to review the conduct of the trial and any unanticipated events. Such 
review will include random review of sessions, investigation of child and parent post-session ratings of 
satisfaction, as well as the screening procedures in primary care. By having clinical staff involved in every 

aspect of this trial from recruitment to treatment, we hope to avoid and address any foreseeable problem 
that should arise.  All study staff is instructed to inform the PIs of any event as soon as possible. Weekly 
staff meetings including review of interview and session tapes also ensures safety.
Privacy, Data Storage & Confidentiality
 
Complete the Privacy and Confidentiality section of the iRIS submission form.
Describe Role of External Personnel:
Outside Duke Key Personnel:
Stephen W. Porges, Greg Lewis, and Maria Isabel Davila Hernandez are helping to analyze the 
Presentation and Acquisition lab data from our Mood Induction Labs. This data does not contain any PHI 
and is labeled by the subject’s study ID numbers.
Helen Egger, M.D is a consultant for our study who has no access to subject’s PHI.
Nancy Spencer is a consultant who will be working with us as a therapist for our Caregiver n Action (CIA) 
Therapy Sessions.  She will have access the following PHI during her work on The Duke Tummy Pain 
Study: Subject names, telephone number, & audio recordings of her therapy sessions with subjects.
July 8, 2019
Kyra Citron:Duke Undergraduate Student volunteer. She will be doing data entry in REDCap. She will NOT 
have access to any PHI.
Bruny Kenou: Duke Undergraduate Student volunteer. She will be doing data entry in REDCap. She will 
NOT have access to any PHI.
Ashley Kelley:Duke Undergraduate Student volunteer. She will be doing data entry in REDCap. She will 
NOT have access to any PHI.
Tejaswi Siripurapu:Student volunteer. She will be doing data entry. She will NOT have access to any PHI.
 
 
Study Scope
Does the subject population contain >50% malignant hematology or oncology patients, or their caregivers?
  Yes   
  No
Are you using a drug, biologic, food, or dietary supplement in this study?
  Yes   
  No
Are you using a medical device, an algorithm (whether computer based or not), an in vitro diagnostic test, or 
using samples to look for biomarkers in this study?
  Yes   
  No
Does this study employ magnetic resonance, including imaging (MRI), spectroscopy (MRS), angiography 
(MRA) or elastography (MRE) beyond the standard of care?
  Yes   
  No
Does this study specify or require the performance of diagnostic procedures using ionizing radiation (x-rays, 
DEXA, CT scans, nuclear medicine scans, etc.) that are beyond the standard of care?
  Yes   
  No

Does this study specify or require the performance of therapeutic procedures using ionizing radiation 
(accelerator, brachytherapy or systemic radionuclide therapy) that are beyond the standard of care?
  Yes   
  No
Will the participant be subjected to increased or decreased ambient pressure?
  Yes   
  No
Do you plan to recruit subjects from Duke Regional Hospital (DRH)?
  Yes   
  No
Do you plan to recruit subjects from Duke Raleigh Hospital (DRAH)?
  Yes   
  No
Does this study utilize the Duke Early Phase Clinical Research Unit (DEPCRU)?
  Yes   
  No
Are you using the Duke logo in any advertisements?
  Yes   
  No
Is this study retrospective, prospective, or both?
"Retrospective" means that data or samples already in existence (collected prior to the study submission) will 
be used.
"Prospective" means there will be data or samples collected in this study for research purposes.
Retrospective 
Prospective 
Retrospective and Prospective 
If the study is both retrospective and prospective: Is this a review soley of information collected for non-
research purposes (i.e. a review of medical records)?
  Yes   
  No
Does this protocol include any research using botulinum toxin, including the FDA-approved clinical product 
(Botox)?
  Yes   
  No
Does this protocol involve the administration of any of the following materials to humans?
   •Any viral vector or plasmid
   •Any cells that have been modified by a viral vector
   •Any other genetically-modified cells
   •Any genetically-modified virus, bacterium, or other agent
   •Any other recombinant or synthetic nucleic acid
  Yes   
  No

 
Subject Population Groups and Enrollment
Population Groups (Select 
 population groups only):
targeted
Note:
If Minors are included, the study will be routed to the Department of Pediatrics for Pediatric Risk 
Assessment. 
Students and Employees over whom Key Personnel have a supervisory role may not be enrolled in this 
study
Adults
Minors who are Wards of State
Minors
Duke Patients
Pregnant Women
Fetuses
Prisoners
Adults incapable of giving consent
Adults with diminished capacity
Handicapped subjects
Students
Employees
Healthy Controls
Deceased subjects
Blanket Protocol
This study will be routed to the Department of Pediatrics for Pediatric Risk Assessment.
Please select any population groups excluded from participation in this study:
Pregnant women
Maximum number of subjects to be consented at Duke:    
Enter a single number. If you anticipate consenting a range of subjects, enter the 
 limit of the range. 
upper
The number should represent the maximum number of subjects for the life of the study.
2000
Maximum number of subjects to be consented at all sites:
Enter a single number. If you anticipate consenting a range of subjects, enter the 
 limit of the range. 
upper
The number should represent the maximum number of subjects for the life of the study.
2000
Maximum number of patient records / samples to be used:   
2000
 
Subject Procedures and Costs
Biobank - Does this study involve the collection, use, tracking, banking (storage) or distribution of human 
biological specimens?

Human biological specimens include blood or its components, healthy or diseased tissue, bodily fluids, DNA
/RNA or human stem cells.
  Yes   
  No
Procedures
Check all the apply:
Genetic Testing
Gene Transfer
DNA Banking
Testing for Reportable Infectious Diseases
Human Cell Banking
*Use of Human Embryonic Stem Cells
*Use of Human-induced Pluripotent Stem Cells
*Use of Other Cells Derived from Human Embryos
*Use of Human/Animal Chimeric Cells
*Specialized Cell Populations for Cell Therapy
Use of Human Tissue
Use of Bodily Fluids
Use of Blood (or its components)
Not Applicable
Will blood be drawn in this study for research purposes?
  Yes   
  No
Will the Operating Room be used in this study?
Include only research time, not clinical care time.
  Yes   
  No
Will there be extra costs to subjects or insurance as a result of the research (e.g. tests, hospitalization)?
  Yes   
  No
Will there be Subject Compensation?
 Yes   
 No
Compensation for Travel / Lost Income (in USD):
380
Other Subject Compensation:
No monetary compensation will be provided for the 10 intervention sessions, but children will be given an 
assortment of toys at the end of each in-person session.
Both parent and child that participate in this study will be receiving compensation. Upon completion of the 
study parents will receive a $55 pre-loaded ClinCard. Upon the child’s completion of a focus group
/interview session they will receive a small toy.
Amendment June 2019: Individuals that participate in the online survey to inform the development of an 
intervention for individuals of Hispanic origin will receive a $25 gift card from Amazon.

 
Subject Recruitment Materials
For each document to be reviewed, use the table below to provide the following information:
Attach a copy of each advertisement that you will be using with this study in the Initial 
Submission Packet. If any Ad will have multiple wording variations, attach a copy of each version 
of the Ad.
All materials that will be used to advertise the study in order to recruit subjects must be approved by the IRB.
Types of subject recruitment materials include, but are not limited to, the following:
Direct Advertising
Posters 
Billboards 
Flyers 
Brochures
Media Advertising
Newspaper Ads 
Magazine Ads 
Radio Ads 
TV commericals / Video 
Internet website
Social Media
Other Types of Advertising
Newsletter 
Email 
Postcards / Letters
(Note: Doctor-to-Doctor letters do not require IRB approval)
Document name
Material category
Location material 
displayed
Has this material 
previously been 
approved by the IRB?
(SV-FT) DTP Chat 
Groups Brochure 
6.1.18
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email  
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Brochure given to 
subject upon screen 
in to study.
  Yes   
  No
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email  
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 

(SV-FT) DTP Chat 
Groups Flyer 5.31.18
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Television" would be 
an appropriate 
response.
Flyer will be posted 
on back of door in 
patient room at 
Duke’s Southpoint 
Clinic and Durham 
Pediatrics.
  Yes   
  No
(EV) DTP Chat 
Groups Flyer 5.31.18
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email  
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Flyer will be posted 
on back of door in 
patient room at 
Duke’s Southpoint 
Clinic and Durham 
Pediatrics.
  Yes   
  No
(EV) DTP Chat 
Groups Brochure 
6.1.18
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email  
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Brochure given to 
subject upon screen 
in to study.
  Yes   
  No
English Version-Flyer 
for Online Study
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email  
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Flyer that will be 
posted in DukeList, 
other community 
listservs, will be 
emailed to 
interested 
participants, and will 
  Yes   
  No

be posted in the 
Lakeview Pavillion 
Waiting Room
Spanish Version-
Flyer for Online 
Study
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email  
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Flyer that will be 
posted in DukeList, 
other community 
listservs, will be 
emailed to 
interested 
participants, and will 
be posted in the 
Lakeview Pavillion 
Waiting Room
  Yes   
  No
 
Consent Process
Attach draft consent forms in the Initial Review Submission Packet.
Consent forms must be MS Word documents and follow the specific format outlined by the IRB. 
 to 
Click here
download a copy of the consent form template.
 Please do not edit the section of the footer that contains the Protocol ID, Continuing Review 
Note:
and Reference Date fields. Those fields will be used to stamp the final consent form when it is approved by the 
IRB. If you want to add an internal version date, please put it in the header.
Who will conduct the consent process with prospective participants? 
Give the person's role in this study (PI, Study Coordinator, etc.):
The study coordinator or senior research assistant. 
 
June 2019: Parents completing the Qualtrics survey for the diversity supplement will read and 
electronically sign the consent form as part of the survey.
Who will provide consent or permission?
(Select all that apply):
Participant
Parent(s) or Legal Guardian(s)
Legally Authorized Representative (LAR)
How much time will the prospective participant (or legally authorized representative) have between being 
 
approached about participating in the study and needing to decide whether or not to participate?  

If you are not giving the person overnight to consider whether or not to participate, please justify.
The parent and child will have anywhere from a few days to a few weeks to decide whether to participate. 
 
June 2019: Participants will have as long as needed to contemplate the consent form as they can access 
the study link  with embedded consent form at any time. 
 
Where will the consent process occur?
Consent for screening will occur in the exam room of a pediatric care practice within the Duke Health 
System. Consent for the treatment will occur in a private testing room in the Duke Center for Eating 
Disorder Research Laboratory in Brightleaf Square. 
 
June 2019: Parents completing the Qualtrics survey for the diversity supplement will be able to read and 
complete the consent form wherever they prefer, but must complete the electronic consent form in order 
to proceed to the online survey.
What steps will be taken in that location to protect the privacy of the prospective participant?
We will conduct consent in a private room with a closed door. This room is in a testing suite in which the 
only individuals present are those participating in the study and thus a low traffic area. 
 
June 2019: For the online portion of the diversity supplement, individuals will choose the setting in which 
they read and sign the consent. 
How much time will be allocated for conducting the initial consent discussion, including presenting the 
information in the consent document and answering questions, with each prospective participant?
A minimum of a day (in between screening and scheduling for the intake visit) but typically a week or 
more. The subject may take as long as needed to consider the consent form and study demands. 
What arrangements will be in place for answering participant questions before and after the consent is 
signed?
During the process of consent, we stop frequently and ask if the participant has any questions and restate 
the language of the consent form using words that are easy to comprehend. The participant is given the 
PI's cell number to call if questions. 
 
June 2019: Study staff contact information will be provided on the electronic consent form for individuals 
completing the diversity supplement Qualtrics survey.
Describe the steps taken to minimize the possibility of coercion or undue influence.
We emphasize the participants right to refuse to participate and that this will not impact their care at 
Duke. 
What provisions will be in place to obtain consent from participants who do not read, are blind or who do not 
read/understand English?
Unfortunately, these individuals would not be eligible for our study as the interventions require the 
capacity to read English. 
As of April 2018 we have been approved and funded by the NIMH to include a diversity supplement under 
the FBI parent study. Through this supplement, we will be conducting a series of focus groups and 
interviews with Hispanic participants. The focus groups will be translated into Spanish. Consent forms have 
been tranlated into Spanish. 
 
June 2019: The online consent form and questions have been translated and back-translated into Spanish. 
 

Do you plan to obtain written consent for the conduct of research?
 Yes   
 No
 
Protected Health Information (PHI)
Indicate how you intend to use potential subjects' Protected Health Information (PHI):
I will review, but not record, PHI prior to consent. 
I will record PHI prior to consent. 
I do not intend to use PHI prior to consent. 
I will record PHI without consent. (decedent research, database repository, chart review) 
 
Review Preparatory to Research (RPR)
Describe the specific PHI that will be reviewed to prepare a research protocol and/or to ascertain and/or 
recruit subjects:
Child's name and age 
Principal Investigator's Affirmation:
The PHI is necessary for the purposes of this activity. 
 Yes   
 No
The PHI will be used solely for this activity.
 Yes   
 No
The PHI will not leave DUHS.
 Yes   
 No
The PHI will not be written down or recorded prior to the subject signing a research consent form.
 Yes   
 No
I will not use the information accessed through this RPR procedure for any other purpose, including for 
presentation or publication.
 Yes   
 No
 
Privacy and Confidentiality
Explain how you will ensure that the subject's privacy will be protected:
Consider privacy interests regarding time and place where subjects provide information, the nature of the 
information they provide, and the type of experience they will be asked to participate in during the research.
We adhere to all Duke procedures for the management of study-related data, keeping this data in locked 
areas accessible only to study personnel. 
Describe how research data will be stored and secured to ensure confidentiality:
How will the research records and data be protected against inappropriate use or disclosure, or malicious or 
accidental loss or destruction? Records and data include, for example, informed consent documents, case 
report forms or study flow sheets, survey instruments, database or spreadsheets, screening logs or telephone 

eligibility sheets, web based information gathering tools, audio/video/photo recordings of subjects, labeled 
specimens, data about subjects, and subject identifiers such as social security number.
All paper documents are kept in locked file cabinets in storage rooms dedicated to the storage of study 
related materials. Databases are kept on a secure folder on a secure drive established by Jurgen Henn, the 
IT consultant for the Department of Psychiatry. Social security numbers are redacted as soon as a 
subject's payment has been processed. 
 
Application Questions Complete
Please click Save & Continue to proceed to the Initial Submission Packet.
The Initial Submission Packet is a short form filled out after the protocol application has been completed.  This 
is an area to attach protocol-related documents, consent forms, and review the application.