Evaluation of an Interdisciplinary Decision Guide for Infant Feeding Assessment
Phase: NA
Conditions: Premature Birth, Feeding and Eating Disorders of Childhood
Sponsor: University of North Carolina, Chapel Hill

 
Evaluation of an Interdisciplinary Decision Guide for Infant Feeding 
Assessment 
 
 
 
NCT number NCT04850794 
Document Date 02/18/2022 
Document Type Protocol 
 

Evaluation of Interdisciplinary Decision Guide for 
Infant Feeding Assessment 
Protocol Number: 20-2786 
National Clinical Trial (NCT) Identified Number:  NCT04850794 
Principal Investigator: Kelsey Thompson, MS, CCC-SLP 
Sponsor: N/A 
Funded by: National Center for Advancing Translational Sciences (NCATS), 
National Institutes of Health, through Grant Award Number UL1TR002489 
Version Number:  1.00 
18 February 2022 
 
 
Summary of Changes from Previous Version: 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
 
 
 
 
 
 

  
 
ii 
Table of Contents 
STATEMENT OF COMPLIANCE ....................................................................................................................................... 1 
1 
PROTOCOL SUMMARY ...................................................................................................................................... 1 
1.1 
Synopsis .................................................................................................................................................. 1 
1.2 
Schema ................................................................................................................................................... 2 
1.3 
Schedule of Activities (SoA) .................................................................................................................... 4 
2 
INTRODUCTION ................................................................................................................................................. 4 
2.1 
Study Rationale ...................................................................................................................................... 4 
2.2 
Background ............................................................................................................................................. 4 
2.3 
Risk/Benefit Assessment ........................................................................................................................ 5 
2.3.1 
Known Potential Risks ......................................................................................................... 5 
2.3.2 
Known Potential Benefits ................................................................................................... 5 
2.3.3 
Assessment of Potential Risks and Benefits ....................................................................... 5 
3 
OBJECTIVES AND ENDPOINTS ........................................................................................................................... 5 
4 
STUDY DESIGN ................................................................................................................................................... 9 
4.1 
Overall Design ........................................................................................................................................ 9 
4.2 
Scientific Rationale for Study Design ...................................................................................................... 9 
4.3 
Justification for Dose .............................................................................................................................. 9 
4.4 
End of Study Definition........................................................................................................................... 9 
5 
STUDY POPULATION ......................................................................................................................................... 9 
5.1 
Inclusion Criteria..................................................................................................................................... 9 
5.2 
Exclusion Criteria .................................................................................................................................. 10 
5.3 
Lifestyle Considerations ....................................................................................................................... 10 
5.4 
Screen Failures ..................................................................................................................................... 10 
5.5 
Strategies for Recruitment and Retention ........................................................................................... 10 
6 
STUDY INTERVENTION .................................................................................................................................... 10 
6.1 
Study Intervention(s) Administration ................................................................................................... 10 
6.1.1 
Study Intervention Description ......................................................................................... 11 
6.1.2 
Dosing and Administration ............................................................................................... 12 
6.2 
Preparation/Handling/Storage/Accountability .................................................................................... 12 
6.2.1 
Acquisition and accountability .......................................................................................... 12 
6.2.2 
Formulation, Appearance, Packaging, and Labeling ......................................................... 12 
6.2.3 
Product Storage and Stability ........................................................................................... 12 
6.2.4 
Preparation ....................................................................................................................... 12 
6.3 
Measures to Minimize Bias: Randomization and Blinding ................................................................... 12 
6.4 
Study Intervention Compliance ............................................................................................................ 12 
6.5 
Concomitant Therapy ........................................................................................................................... 12 
6.5.1 
Rescue Medicine ............................................................................................................... 12 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL ............. 12 
7.1 
Discontinuation of Study Intervention ................................................................................................. 13 
7.2 
Participant Discontinuation/Withdrawal from the Study .................................................................... 13 
7.3 
Lost to Follow-Up ................................................................................................................................. 13 
8 
STUDY ASSESSMENTS AND PROCEDURES ....................................................................................................... 13 
8.1 
Efficacy Assessments ............................................................................................................................ 13 
8.2 
Safety and Other Assessments ............................................................................................................. 14 
8.3 
Adverse Events and Serious Adverse Events ........................................................................................ 14 
8.3.1 
Definition of Adverse Events (AE) ..................................................................................... 14 

  
 
iii 
8.3.2 
Definition of Serious Adverse Events (SAE) ...................................................................... 15 
8.3.3 
Classification of an Adverse Event .................................................................................... 15 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up .................................. 16 
8.3.5 
Adverse Event Reporting .................................................................................................. 16 
8.3.6 
Serious Adverse Event Reporting...................................................................................... 16 
8.3.7 
Reporting Events to Participants ...................................................................................... 16 
8.3.8 
Events of Special Interest.................................................................................................. 16 
8.3.9 
Reporting of Pregnancy .................................................................................................... 16 
8.4 
Unanticipated Problems ....................................................................................................................... 16 
8.4.1 
Definition of Unanticipated Problems (UP) ...................................................................... 16 
8.4.2 
Unanticipated Problem Reporting .................................................................................... 17 
8.4.3 
Reporting Unanticipated Problems to Participants .......................................................... 17 
9 
STATISTICAL CONSIDERATIONS ....................................................................................................................... 17 
9.1 
Statistical Hypotheses .......................................................................................................................... 17 
9.2 
Sample Size Determination .................................................................................................................. 19 
9.3 
Populations for Analyses ...................................................................................................................... 19 
9.4 
Statistical Analyses ............................................................................................................................... 19 
9.4.1 
General Approach ............................................................................................................. 19 
9.4.2 
Analysis of the Primary Efficacy Endpoint(s) .................................................................... 19 
9.4.3 
Analysis of the Secondary Endpoint(s) ............................................................................. 19 
9.4.4 
Safety Analyses ................................................................................................................. 20 
9.4.5 
Baseline Descriptive Statistics .......................................................................................... 20 
9.4.6 
Planned Interim Analyses ................................................................................................. 20 
9.4.7 
Sub-Group Analyses .......................................................................................................... 20 
9.4.8 
Tabulation of Individual participant Data ......................................................................... 20 
9.4.9 
Exploratory Analyses ........................................................................................................ 20 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ...................................................... 21 
10.1 
Regulatory, Ethical, and Study Oversight Considerations .................................................................... 21 
10.1.1 
Informed Consent Process ................................................................................................ 21 
10.1.2 
Study Discontinuation and Closure ................................................................................... 21 
10.1.3 
Confidentiality and Privacy ............................................................................................... 22 
10.1.4 
Future Use of Stored Specimens and Data ....................................................................... 22 
10.1.5 
Key Roles and Study Governance ..................................................................................... 22 
10.1.6 
Safety Oversight ................................................................................................................ 23 
10.1.7 
Clinical Monitoring ............................................................................................................ 23 
10.1.8 
Quality Assurance and Quality Control ............................................................................. 23 
10.1.9 
Data Handling and Record Keeping .................................................................................. 23 
10.1.10 
Protocol Deviations ........................................................................................................... 23 
10.1.11 
Publication and Data Sharing Policy ................................................................................. 24 
10.1.12 
Conflict of Interest Policy .................................................................................................. 24 
10.2 
Additional Considerations .................................................................................................................... 24 
10.3 
Abbreviations ....................................................................................................................................... 26 
10.4 
Protocol Amendment History ............................................................................................................... 27 
11 
REFERENCES .................................................................................................................................................... 28 
 

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STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with International Conference on Harmonisation Good Clinical 
Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR 
Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812)  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the Institutional Review Board (IRB) for review and approval.  Approval of both 
the protocol and the consent form must be obtained before any participant is enrolled.  Any 
amendment to the protocol will require review and approval by the IRB before the changes are 
implemented to the study.  In addition, all changes to the consent form will be IRB-approved; a 
determination will be made regarding whether a new consent needs to be obtained from 
participants who provided consent, using a previously approved consent form.] 
 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Evaluation of an Interdisciplinary Decision Guide for Infant Feeding 
Assessment 
Study Description: 
This study will determine if a decision support tool changes clinical 
practice recommendations when used by speech language pathologists 
and occupational therapists. We hypothesize the support tool will change 
whether providers will recommend specialist referral.   
Objectives: 
 
Primary objectives are the degree of concordance in feeding therapy, 
referral, and specific specialist referral recommendations between 
therapists using and not using the tool. Secondary objectives include 
degree of concordance between feeding therapy frequency and therapy 
target recommendations as well as acceptability, appropriateness, and 
feasibility of the tool.  
 
 
Endpoints: 
The endpoint is when the provider has finished reading the case study. 
Study Population: 
56 speech language pathologists and occupational therapists with at least 
two years of feeding experience and currently practicing in North Carolina 
Phase: 
N/A 
Description of 
Sites/Facilities Enrolling 
Participants: 
This study will occur through an online survey. Survey recruitment will be 
based out of UNC-Chapel Hill.   
Description of Study 
Intervention: 
The study intervention is a decision support tool, which is a checklist of 
signs and symptoms of feeding problems.  
Study Duration: 
The estimated duration is 6 months. 

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Participant Duration: 
Participants will take about 20 minutes to complete an initial interest 
survey and then the full survey. 
 
 
1.2 
SCHEMA 
 

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Screening
Ongoing
•Total n=70
•Screen potential participants by inclusion and exclusion criteria through an 
online survey
Randomization
Ongoing
•Case A, then Case B group (n=28)
•Case B, then Case A group (n=28)
Study Intervention
Ongoing
•Participants complete informed consent
•Participants complete survey and demographic information 

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1.3 
SCHEDULE OF ACTIVITIES (SOA) 
 
Procedures 
Screening 
Day -7 to -1 
Enrollment/Baseline 
Day 1 
Survey  Day 1 – Day 14 
Screening 
X 
 
 
Randomization 
 
X 
 
Informed Consent 
 
 
X 
Administer study intervention 
 
 
X 
Demographic Information 
 
 
X 
 
 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
While it is now recognized that pediatric feeding disorder (PFD) involves medical, nutritional ,feeding 
skill, and/or psychosocial domains [1], in early intervention (EI) in North Carolina, individual providers 
(speech language pathologists (SLPs) or occupational therapists (OTs), are tasked with individually 
assessing and treating infants with PFD. While trained in feeding skills and sensory processing, these 
professionals are also expected to screen the medical, nutritional, and psychosocial domains, and make 
appropriate external referrals, despite these areas being outside of their scope of practice. The 
importance of a thorough, systematic evaluation and referral process is particularly important at the 
transition to solid foods, a critical developmental juncture as feeding demands increase and nutritional 
needs shift [15,16]. SLPs and OTs in EI need a tool that facilitates timely referrals and communication 
with multidisciplinary feeding teams, or individual specialists, when assessing infants with PFD. 
 
2.2 
BACKGROUND  
Pediatric feeding problems fall within the scope of many professionals; speech-language pathologists 
(SLPs), occupational therapists (OTs), nurses, dietitians, gastroenterologists, pediatricians, and 
psychologists/behavior analysts may be involved in evaluation and treatment. In 2019, a consensus 
definition of pediatric feeding disorder (PFD) was published, providing these professionals with common 
diagnostic criteria [1]. Preterm infants (1 in 10 live births in North Carolina), are particularly at risk for 
long-term PFD, representing up to 40% of children seen at feeding disorder clinics [2,3]. Th resulting 
economic impact is significant; even insured families report an average loss of $125,645 in income 
caring for their child with PFD [4]. 
 
While it is now recognized that PFD involves medical, nutritional, feeding skill, and/or psychosocial 
domains, in early intervention (EI) in NC, individual SLP or OT providers assess and treat infants with 
PFD. While trained in feeding skills and sensory processing, these providers are also expected to screen 
the medical, nutritional, and psychosocial domains and make appropriate referrals, despite these areas 
being outside of their scope of practice. The importance of a multi-domain, systematic evaluation and 
referral process is particularly important for preterm infants. Preterm infants are likely to present 
symptoms relevant to multiple professionals including gastroesophageal disorders, physiologic 

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instability, nutritional deficits, and behavior problems into early childhood [5–12]. This is particularly 
true at the transition to solid foods, a critical developmental juncture as feeding demands and 
nutritional needs shift [13,14]. EI SLPs and OTs need a tool to facilitate timely referrals and 
communication with other specialists when assessing preterm infants with PFD. 
 
We propose the development of a decision-making tool for the evaluation of preterm infants with PFD 
by SLPs and OTs in EI to facilitate appropriate external referrals.  This tool is specific to children at the 
solid food level (6mo-3years) and is called the Clinical Feeding Guide (CFG). We have developed a list of 
observational items through examination of existing tools and a literature review. To achieve our goal of 
developing a feasible clinical tool, we will pursue the following specific aims. Aim 1:  Establish content 
validation using the Delphi Technique to generate a screening and decision-making tool.  Aim 2:  
Complete pilot testing of the tool to determine feasibility, acceptability, and change from current 
standard practice. 
2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
 
There are no known risks of using the intervention, as it is being used on mock case studies. There is the 
potential for participants to experience emotional distress or consequences of a breach of 
confidentiality. Although the likelihood of a breach of confidentiality is low, the data collected could 
yield information about participants’ behaviors and demographics that could cause emotional distress if 
confidentiality were breached. Professionals may also experience fatigue, frustration, or stress will 
reading case studies. However mock case studies have been determined to yield the least stress over 
considering real cases or viewing videos of real children.  
 
2.3.2 KNOWN POTENTIAL BENEFITS  
This study does not have any potential for direct benefit to the individual subjects in this study. 
However, we do hope that the tool developed will benefit infants and professionals in the future by 
improving clinical practice and the accurate and timely diagnosis and treatment of feeding disorders in 
infants and children.  
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
This study will contribute to our understanding about how SLPs and OTs make appropriate external 
referrals during clinical feeding evaluations. It is necessary for SLPs and OTs to test this tool in order to 
understand its potential impact. Risks to participants have been minimized by de-identifying participant 
responses, reporting participant responses as an aggregate, and having participants read short, mock 
case studies while using the tool. These limited risks outweigh the value of the information to be gained, 
which would assist professionals in making better clinical decisions thereby improving the treatment of 
feeding problems in infants.  
 
3 
OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Degree of Concordance Between 
Therapists’ Feeding Therapy 
Recommendations 
 
 
After reading a feeding case study, 
early intervention professionals will 
answer the question "Would you 
recommend feeding therapy?" with 
two choices: yes or no. Difference in 
agreement between early 
intervention professionals using the 
decision support tool and those not 
will be calculated and compared for 
cases A and B. 
To determine whether 
using the tool, which 
helps identify feeding 
problem symptoms, 
changes decisions 
therapists make 
around recommending 
therapy for a child. 
Degree of Concordance Between 
Therapists’ Referral 
Recommendations  
After reading a feeding case study, 
early intervention professionals will 
answer the question "Would you 
refer this family to any other 
providers/specialists for 
evaluation/treatment?" with two 
answer choices: yes or no. Difference 
in agreement between early 
intervention professionals using the 
decision support tool and those not 
will be calculated and compared for 
cases A and B. 
 
To determine whether 
using the tool, which 
helps identify feeding 
problem symptoms by 
discipline with the 
explicit purpose of 
facilitating referrals, 
changes decisions 
therapists make 
around recommending 
referral to a specialist. 
Degree of Concordance Between 
Therapists’ Specific Specialist 
Referral Recommendations  
After reading the feeding case study, 
early intervention professionals will 
answer the question "What other 
professionals would you refer this 
child to? Check all that apply." with 
the following choices: 
nutritionist/dietician, 
gastroenterologist, otolaryngologist 
(ENT), aerodigestive clinic, 
pulmonologist, occupational 
therapist, speech language 
pathologist, psychologist/social 
worker, applied behavior analyst 
(ABA), or allergist. Difference in 
agreement between early 
intervention professionals using the 
decision support tool and those not 
will be calculated and compared for 
cases A and B. 
To determine whether 
the tool, which lists 
feeding problem 
symptoms by specialist 
discipline, changes the 
specialists a therapist 
refers to. 
Secondary 
 
 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Degree of Concordance Between 
Therapists’ Feeding Therapy 
Frequency Recommendations 
 
After reading the feeding case study, 
early intervention professionals who 
recommended feeding therapy will 
answer the question "With what 
frequency would you recommend 
therapy?" with three choices: 2 times 
per week or more, 1 time per week, 
less than one time per week. 
Difference in agreement between 
early intervention professionals using 
the decision support tool and those 
not will be calculated and compared 
for cases A and B. 
 
To determine whether 
using the tool, which 
helps identify feeding 
problem symptoms, 
changes decisions 
therapists make 
around recommending 
a specific frequency of 
therapy for a child. 
Degree of Concordance Between 
Therapists’ Intervention Target 
Choices 
After reading the feeding case study, 
early intervention professionals who 
recommended feeding therapy will 
answer the question "What therapy 
targets might you include for this 
child?" and may check all that apply 
from the following choices: oral 
motor skills, sensory, behavioral, 
medication, modification of 
food/liquid, modification of 
equipment (seating, utensils, etc.), 
modification of environment 
(location, distractions, routine, etc.), 
parent coaching, or other. Difference 
in agreement between early 
intervention professionals using the 
decision support tool and those not 
will be calculated and compared for 
cases A and B. 
To determine whether 
using the tool, which 
helps identify feeding 
problem symptoms by 
area of concern, 
changes decisions 
therapists make 
around recommending 
a specific intervention 
target for a child. 
Decision Support Tool Acceptability 
Score 
The Acceptability of Intervention 
Measure (AIM) will be used to 
measure acceptability of the decision 
support tool. This tool includes four 
items, rated on a five-point Likert 
scale from completely disagree to 
completely agree, and will be 
quantified with a score of 0 for 
completely disagree, 1 for disagree, 2 
for neither agree nor disagree, 3 for 
agree, and 4 for completely agree. 
The average score across the four 
items will be calculated, with higher 
To determine if this 
intervention is 
acceptable to 
practicing therapists.  

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
scores indicating higher acceptability 
of the decision making tool. The 
minimum score is 0 and the 
maximum score is 20. Items on this 
measure include: (Intervention) 
meets my approval; (Intervention) is 
appealing to me; I like (Intervention) 
and I welcome (Intervention). 
Decision Support Tool 
Appropriateness Score 
The Intervention Appropriateness 
Measure (IAM) will be used to 
measure appropriateness of the 
decision support tool. This tool 
includes four items, rated on a five-
point Likert scale from completely 
disagree to completely agree, and 
will be quantified with a score of 0 
for completely disagree, 1 for 
disagree, 2 for neither agree nor 
disagree, 3 for agree, and 4 for 
completely agree. The average score 
across the four items will be 
calculated, with higher scores 
indicating higher acceptability of the 
decision making tool. The minimum 
score is 0 and the maximum score is 
20. Items on this measure include: 
(Intervention) seems fitting; 
(Intervention) seems suitable; 
(Intervention) seems applicable; 
(Intervention) seems like a good 
match. 
To determine if 
practicing therapists 
feel this intervention is 
appropriate for the 
preterm, early 
intervention 
population and to the 
therapists. 
Decision Support Tool Feasibility 
Score 
The Feasibility of Intervention 
Measure (FIM) will be used to 
measure feasibility of use of the 
decision support tool. This tool 
includes four items, rated on a five-
point Likert scale from completely 
disagree to completely agree, and 
will be quantified with a score of 0 
for completely disagree, 1 for 
disagree, 2 for neither agree nor 
disagree, 3 for agree, and 4 for 
completely agree. The average score 
across the four items will be 
calculated, with higher scores 
indicating higher acceptability of the 
To determine if 
therapists feel this 
intervention is feasible 
to use in clinical 
practice. 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
decision making tool. The minimum 
score is 0 and the maximum score is 
20. Items on this measure include: 
(Intervention) seems implementable; 
(Intervention) seems possible; 
(Intervention) seems doable; 
(Intervention) seems easy to use. 
Tertiary/Exploratory  
 
 
N/A 
N/A 
 
N/A 
 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
This is a randomized crossover pilot study. It will be conducted online through one site, UNC Chapel Hill. 
The study intervention is the ‘Clinical Feeding Tool’ also known as the decision support tool. Our 
hypothesis is that clinicians will change their recommendations for feeding therapy and specialist 
referral when using the tool compared to when they do not use the tool. Clinicians will be randomly 
assigned to respond to either Case A or Case B without using the tool (2 groups). Then, they will respond 
to the other case using the tool. Total participation time is estimated at 20 minutes.  
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
We have selected a crossover design for this pilot study in order to directly compare use of the tool to 
no use of the tool among a small group of participants. Therefore, participants will serve as their own 
control group. This was chosen given the varying experience of the participants with feeding.  
 
4.3 
JUSTIFICATION FOR DOSE 
All therapists will view the full tool in the survey in order to directly compare use of the tool to no use of 
the tool. 
 
4.4 
END OF STUDY DEFINITION 
A participant is considered to have completed the study if he or she has completed the survey. 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Provision of signed and dated informed consent form 
2. Stated willingness to comply with all study procedures and availability for the duration of the 
study  
3. Male or female, aged 18 or older 
4. Speech language pathologist or occupational therapist 

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5. At least 2 years of experience evaluating and treating pediatric feeding 
6. Have worked in Early Intervention in the last 5 years 
7. English proficiency 
8. Currently reside in NC 
 
5.2 
EXCLUSION CRITERIA 
 
An individual who meets any of the following criteria will be excluded from participation in this study: 
 
1. Less than 2 years of experience 
2. Have not worked in Early Intervention in the last 5 years 
3. Does not currently reside in NC  
5.3 
LIFESTYLE CONSIDERATIONS 
Not applicable 
 
5.4 
SCREEN FAILURES 
Screen failures are defined as participants who express interest in participating in the clinical trial but 
are not subsequently randomly assigned to the study intervention or entered in the study. A minimal set 
of screen failure information is required to ensure transparent reporting of screen failure participants, 
to meet the Consolidated Standards of Reporting Trials (CONSORT) publishing requirements and to 
respond to queries from regulatory authorities. Minimal information includes screen failure details, 
eligibility criteria, and any serious adverse event (SAE). 
 
 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
The target sample size is 56 participants with 28 SLPs and 28 OTs. We anticipate one site will be used – 
UNC Chapel Hill; although the study will be completed virtually by participants. Target enrollment will 
not be stratified for age, gender, or race/ethnicity for this pilot study, but future studies will control for 
these variables. Because participants are expected to be practicing in early intervention, participants will 
be recruited from private practices (which contract with early intervention) and from the early 
intervention system in North Carolina. Participants will be recruited through web search, the Child 
Developmental Services Agency, and word of mouth. Potential participants will be emailed through 
these groups and will be directed to an interest survey where they will complete a screening. If eligible 
and interested, they will provide their name and email. In the order of entry, the PI will email them a link 
to the survey.  
 
Because the fields of occupational therapy and speech language pathology are majority female, specific 
female recruitment is not necessary. For this pilot study, participants will not be specifically selected for 
race/ethnicity, but this will be pursued in future, larger studies. 
 
Participants who complete the full survey will receive a $25 gift card as an incentive.  
 
6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION(S) ADMINISTRATION 

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6.1.1 STUDY INTERVENTION DESCRIPTION 
The study intervention is a checklist that was developed with feeding specialists at UNC Health through 
Delphi surveys. The checklist contains four headings: gastrointestinal, nutritional, behavioral, and 
aerodigestive. Under each heading there is a list of observable symptoms that may warrant referral to a 
specialist provider in that area.  
 
The main heading says, “Feeding Assessment Referral Guide”. The main subheading says, “Use the 
following checklist during the feeding evaluation to observe symptoms that may warrant referral to 
specialists.” 
 
Under gastrointestinal, the observable symptoms are: 
• 
Frequent spitting up/vomiting during meal 
• 
Fussiness, crying, or arching during meal 
• 
Wheezing, stridor, cough, or hoarseness while eating 
• 
Gagging during meal 
• 
Burps frequently while eating 
• 
Drools while eating 
• 
Avoidance or prioritizing of certain food textures 
Under aerodigestive, the observable symptoms are: 
• 
Gets red in the face while eating 
• 
Coughs during meal 
• 
Food/liquid comes out nose while eating 
• 
Gets tired and cannot finish eating 
• 
Breathes harder/faster while eating 
• 
Evidence of stridor v. stertor 
• 
Needs to pause during meal to catch breath 
• 
Watery eyes while eating 
Under behavioral, the observable symptoms are: 
• 
Refuses to eat 
• 
Whines, cries, or tantrums during meal 
• 
Insists on food being offered a specific way 
• 
Throws or pushes food away 
• 
Will not stay seated during meal 
• 
Throws or spits food 
• 
Parent has to do something special to get child to eat 
• 
Parent and child have conflict during feeding 
• 
The parent appears stressed and overwhelmed during feeding 
Under nutrition, the observable symptoms are: 
• 
Appears underweight 
• 
Exclusion of entire food group 
• 
Eating only one texture of food during evaluation  
 
At the bottom, the checklist says, “If the child has demonstrated any of these signs/symptoms while 
eating, referral to a medical specialist, in addition to your treatment, may be warranted.”  

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6.1.2 DOSING AND ADMINISTRATION 
Each provider will view the checklist to use during one case study. 
 
6.2 
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
 
6.2.1 ACQUISITION AND ACCOUNTABILITY 
The intervention is a checklist.  
 
6.2.2 FORMULATION, APPEARANCE, PACKAGING, AND LABELING 
 
The intervention is a checklist provided both within the body of a survey, and as a PDF.  
 
6.2.3 PRODUCT STORAGE AND STABILITY 
N/A 
 
 
6.2.4 PREPARATION 
N/A 
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
14 OTs and 14 SLPs will receive case A first; 14 OTs and 14 SLPs will receive case B first. There are two 
versions of the survey – one where case A is presented first and one where case B is presented first. 
Providers will be sent the link to the version to which they are assigned. 
 
Assignment will be based on the order of study entry. For example, the first SLP to enroll will receive 
case A first, the second SLP to enroll will receive case B first, etc. Similarly, the first OT to enroll will 
receive case A first, the second OT to enroll will receive case B first, etc. 
 
The PI will complete all randomization computations. There will not be blinding. Blinding is considered 
unnecessary in this case because the researchers will not have direct interaction with participants, 
participants will complete the full survey and intervention independently without interaction with the 
researchers.  
 
6.4 
STUDY INTERVENTION COMPLIANCE 
This study is a survey. Thus, as long as the participant completes the assigned survey, they will have 
adhered to the study protocol.  
 
6.5 
CONCOMITANT THERAPY 
N/A 
 
6.5.1 RESCUE MEDICINE 
N/A 
 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 

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7.1 
DISCONTINUATION OF STUDY INTERVENTION 
Participant responses will be monitored for concerning responses. If there are repeated concerning 
responses about the survey or intervention, the study will be discontinued. Participants can also stop 
participating in the survey at any time.  
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue or withdraw a participant from the study for the following reasons: 
• 
Participant does not complete the intervention within the designated time frame 
The reason for participant discontinuation or withdrawal from the study will be recorded on the Master 
Participant list. Subjects who sign the informed consent form and are randomized but do not receive the 
study intervention may be replaced.  Subjects who sign the informed consent form, and are randomized 
and receive the study intervention, and subsequently withdraw, or are withdrawn or discontinued from 
the study, will be replaced. 
7.3 
LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if he or she fails to complete the survey within the 
specified time frame and is unable to be contacted by the study site staff.  
 
The following actions must be taken if a participant fails to complete the survey: 
• 
The site will attempt to contact the participant via email with a survey reminder and ascertain if 
the participant wishes to and/or should continue in the study. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make at least 
two emails to the participant. These contact attempts should be documented in the 
participant’s medical record or study file.  
• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
EFFICACY ASSESSMENTS  
To test intervention efficacy, the participant will be asked to answer a set of clinical questions after 
reading the case study. They will first do this without the intervention and then read another case study 
using the intervention. This will be administered through Qualtrics in survey form. 
 
The questions include: 
• 
Would you recommend feeding therapy to this child? Yes/No 
o If yes, “With what frequency would you recommend therapy?” 
 
2 times per week, 1 time per week, Less than one time per week 
o If yes, “What therapy target areas might you include for this child?” (select all that 
apply) 

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 
Oral motor skills, sensory, behavioral, medication, modification of food/liquid, 
modification of equipment (seating, utensils, etc.), modification of environment 
(location, distractions, routine, etc), parent coaching, other (fill in) 
o If yes, “What would be the recommended length of treatment for this child?” 
 
Less than 6 months, 6-12 months, More than 12 months 
• 
What diagnosis would you give this child? 
• 
Would you refer this family to any other providers/specialists for evaluation/treatment? Yes/No 
o If yes, “What other professionals would you refer this child to? Check all that apply.” 
 
Nutritionist/dietician, gastroenterologist, otolaryngologist (ENT), aerodigestive 
clinic, pulmonologist, occupational therapist, speech language pathologist, 
psychologist/social worker, applied behavior analyst (ABA), allergist, 
multidisciplinary feeding team, other (list) 
In addition to the clinical questions, the following questions will be asked in order for the participant to 
evaluate the tool: 
• 
With a likert scale of completely agree, agree, neither agree nor disagree, disagree, completely 
disagree 
o The Clinical Feeding Guide meets my approval 
o The Clinical Feeding Guide is appealing to me 
o I like the Clinical Feeding Guide 
o I welcome the Clinical Feeding Guide 
o The Clinical Feeding Guide seems fitting 
o The Clinical Feeding Guide seems suitable 
o The Clinical Feeding Guide seems applicable 
o The Clinical Feeding Guide seems like a good match 
o The Clinical Feeding Guide seems implementable 
o The Clinical Feeding Guide seems possible 
o The Clinical Feeding Guide seems doable 
o The Clinical Feeding Guide seems easy to use 
• 
If you could make changes to the CFG you would (check all that apply): 
o Make it shorter, make it longer/more comprehensive, change the format, add items, 
remove items, I wouldn’t make any changes, I wouldn’t use it 
• 
Please list 1-2 strengths of the CFG 
• 
Please list 1-2 changes you would make to the CFG to make it more useful for clinical practice 
• 
I would use the CFG in clinical practice (5pt likert scale from strongly agree to strongly disagree) 
o If Strongly, somewhat, or neither agree/disagree is selected: “Please describe why you 
would use the CFG in clinical practice” 
o If somewhat disagree, strongly disagree or neither agree/disagree is selected: “Please 
describe why you would not use the CFG in clinical practice” 
 
8.2 
SAFETY AND OTHER ASSESSMENTS 
While no obvious safety concerns are expected, provider responses to the survey will be monitored 
weekly for any concerning responses.  
   
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
 

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Adverse event means any untoward medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either the 
investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse 
event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital 
anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the participant and may require medical or surgical intervention to prevent one of 
the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do 
not result in inpatient hospitalization, or the development of drug dependency or drug abuse. 
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
 
8.3.3.1 SEVERITY OF EVENT 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines 
will be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”.] 
 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION 
All adverse events (AEs) must have their relationship to study intervention assessed by the PI who 
communicates with the participant about the concerning survey response and evaluates its relationship 
with the intervention. The degree of certainty about causality will be graded using the categories below. 
In a clinical trial, the study product must always be suspect.  
 
• 
Related – The AE is known to occur with the study intervention, there is a reasonable possibility 
that the study intervention caused the AE, or there is a temporal relationship between the study 
intervention and event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study intervention 
and event onset, or an alternate etiology has been established. 
 
8.3.3.3 EXPECTEDNESS  

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The PI will be responsible for determining whether an adverse event (AE) is expected or unexpected.  An 
AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent with 
the risk information previously described for the study intervention. 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during weekly review of survey responses. 
 
All AEs will be captured on the appropriate case report form (CRF). Information to be collected includes 
event description, date and time of survey response, PI’s assessment of severity, and relationship to 
study product. All AEs occurring while on study must be documented appropriately regardless of 
relationship. All AEs will be followed to adequate resolution. 
 
The PI will record all reportable events with start dates occurring any time after informed consent is 
obtained until study participation is complete.  Events will be followed for outcome information until 
resolution. 
 
8.3.5 ADVERSE EVENT REPORTING  
AEs will be reported to the IRB and NCTraCS within 3 days of their identification.  
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
The study PI will immediately report to the sponsor any serious adverse event, whether or not 
considered study intervention related, including those listed in the protocol and must include an 
assessment of whether there is a reasonable possibility that the study intervention caused the event. 
Study endpoints that are serious adverse events must be reported in accordance with the protocol 
unless there is evidence suggesting a causal relationship between the study intervention and the event. 
In that case, the investigator must immediately report the event to the sponsor. 
 
All serious adverse events (SAEs) will be followed until satisfactory resolution or until the site 
investigator deems the event to be chronic or the participant is stable. Other supporting documentation 
of the event may be requested by the study sponsor and should be provided as soon as possible. 
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
N/A 
 
8.3.8 EVENTS OF SPECIAL INTEREST  
N/A 
 
8.3.9 REPORTING OF PREGNANCY  
N/A 
 
 
8.4 
UNANTICIPATED PROBLEMS 
 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 

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The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to 
participants or others to include, in general, any incident, experience, or outcome that meets all of the 
following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
participant population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
8.4.2  UNANTICIPATED PROBLEM REPORTING  
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB) and to the IRB and study sponsor. The UP report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number; 
• 
A detailed description of the event, incident, experience, or outcome;  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP;  
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB and to the study sponsor 
within 7 days of the investigator becoming aware of the event.  
• 
Any other UP will be reported to the IRB and to the study sponsor within 7 days of the 
investigator becoming aware of the problem.  
• 
All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and the Office for 
Human Research Protections (OHRP) 7 days of the IRB’s receipt of the report of the problem 
from the investigator. 
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
N/A 
 
9 
STATISTICAL CONSIDERATIONS  
 
9.1 
STATISTICAL HYPOTHESES 
• 
Primary Efficacy Endpoint(s):  
o Degree of concordance between therapists’ feeding therapy recommendations 
 
Null Hypothesis: There is no difference in therapists’ feeding therapy 
recommendations when using v. not using the tool 

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 
Alternative Hypothesis: There is a difference in therapists’ feeding therapy 
recommendations when using v. not using the tool 
 
Non-inferiority comparison  
 
Time period: After reading the case study 
o Degree of concordance between therapists’ referral recommendations 
 
Null Hypothesis: There is no difference in therapists’ referral recommendations 
when using v. not using the tool 
 
Alternative Hypothesis: There is a difference in therapists’ referral 
recommendations when using v. not using the tool 
 
Non-inferiority comparison  
 
Time period: After reading the case study 
o Degree of concordance between therapists’ specific specialist referral recommendations 
 
Null Hypothesis: There is no difference in who the therapists recommend 
referral to when using v. not using the tool 
 
Alternative Hypothesis: There is a difference in who the therapists recommend 
referral to when using v. not using the tool  
 
Non-inferiority comparison  
 
Time period: After reading the case study 
 
• 
Secondary Efficacy Endpoint(s): 
o Degree of concordance between therapists’ feeding therapy frequency 
recommendations 
 
Null Hypothesis: There is no difference in therapists’ feeding therapy frequency 
recommendations when using v. not using the tool 
 
Alternative Hypothesis: There is a difference in therapists’ feeding therapy 
frequency recommendations when using v. not using the tool  
 
Non-inferiority comparison  
 
Time period: After reading the case study 
o Degree of concordance between therapists’ intervention target choices 
 
Null Hypothesis: There is no difference in therapists’ feeding therapy 
intervention target choices when using v. not using the tool 
 
Alternative Hypothesis: There is a difference in therapists’ feeding therapy 
intervention target choices when using v. not using the tool 
 
Non-inferiority comparison  
 
Time period: After reading the case study 
o Decision Support Tool Appropriateness 
 
Null Hypothesis: The decision support tool is not appropriate. 
 
Alternative Hypothesis: The decision support tool is appropriate. 
 
Superiority 
 
Time period: After using the tool 
o Decision Support Tool Acceptability  
 
Null Hypothesis: The decision support tool is not acceptable. 
 
Alternative Hypothesis: The decision support tool is acceptable 
 
Superiority 
 
Time period: After using the tool 
o Decision Support Tool Feasibility 
 
Null Hypothesis: The decision support tool is not feasible. 
 
Alternative Hypothesis: The decision support tool is feasible. 

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 
Superiority 
 
Time period: After using the tool 
 
9.2 
SAMPLE SIZE DETERMINATION 
This is a pilot study. Sample size was selected based on available funding and to achieve equal numbers 
in each group (group 1: case A then case B; group 2: case B then case A) as well as equal numbers of 
SLPs and OTs per group (group 1: 14 SLP, 14 OT. Group 2: 14 SLP, 14 OT).  
 
9.3 
POPULATIONS FOR ANALYSES 
All participants who completed the full survey will have their data included in analysis. Partial survey 
responses will not be included.  
 
9.4 
STATISTICAL ANALYSES 
 
9.4.1 GENERAL APPROACH 
 
For descriptive statistics, counts and percentages will be reported.  
For inferential tests, two-tailed tests will be used. Test statistics, p-values, and effect sizes will be 
reported. 
Covariates will be assessed to determine if they should be included in the statistical model. These will 
include years of experience and being an OT v SLP.  
Due to the small sample size and categorical variables, only nonparametric tests will be used. 
 
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
For the following primary outcomes: degree of concordance between therapists’ feeding therapy 
recommendations and degree of concordance between therapists’ referral recommendations we have 
categorical data (2 groups – using tool and not using tool; 2 answers – yes or no). This is a repeated 
measure (therapists answer once for case A and once for case B). Each case will be analyzed separately. 
Due to the categorical data and small sample, reporting will be descriptive. Chi square tests will also be 
run if determined to meet the required assumptions. For chi-square tests, p value and effect size will be 
reported. These will be independent and therefore, adjustment for multiple comparisons will not be 
pursued.  
 
For the third primary endpoint, degree of concordance between therapists’ specific specialist referral 
recommendations, descriptive statistics will be used due to the multiple categories, small counts, and 
small sample size. The percentage of therapists recommending a particular provider will be compared 
among therapists using and not using the tool.  
 
Across all analyses, missing data will be reported but not corrected for due to the small sample size. 
Participants who did not complete all survey items will not be included in analysis. Adjustment for 
multiple comparisons is considered unnecessary due to the small sample size and minimal use of 
inferential statistics.  
 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 

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For degree of concordance between therapists’ feeding therapy frequency recommendations we have 
categorical data (2 groups – using and not using the tool; 3 response categories – 1xweek, 2xweek, less 
than 1 time per week). This is a repeated measure (therapists answer once for case A and once for case 
B). Each case will be analyzed separately. Due to the categorical data and small sample, reporting will be 
descriptive. Chi square tests will also be run if determined to meet the required assumptions. For chi-
square tests, p value and effect size will be reported.  
 
For degree of concordance between therapists’ intervention target choices, descriptive statistics will be 
used due to the multiple categories (categorical data), small counts, and small sample size. The 
percentage of therapists recommending a particular provider will be compared among therapists using 
and not using the tool. This will be analyzed separately for case A and for case B.  
 
For decision support tool acceptability, appropriateness, and feasibility, we have ordinal data (Likert 
scale). Additionally, each score (acceptability, appropriateness, feasibility) has 4 Likert scale items that 
form the score for that subscale. This is a single endpoint. The mean across the 4 items will be calculated 
for each participant to achieve a mean acceptability, appropriateness, and feasibility score. Then, the 
mean and standard deviation will be calculated across participants to result in an overall mean rating for 
acceptability, appropriateness, and feasibility.  
 
Across all analyses, missing data will be reported but not corrected for due to the small sample size. 
Participants who did not complete all survey items will not be included in analysis. Adjustment for 
multiple comparisons is considered unnecessary due to the small sample size and minimal use of 
inferential statistics.  
 
9.4.4 SAFETY ANALYSES 
Survey responses will be monitored for any concerns responses and these will be reported.  
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
Intervention groups will be compared on the basis of years of experience (in feeding, early intervention, 
and overall clinical practice), and years since graduation with their clinical degree. Due to the small 
sample size, inferential statistics will be trialed (i.e. Mann-Whitney U), but may not be used if 
assumptions are not met for their appropriate use.  
 
9.4.6 PLANNED INTERIM ANALYSES  
N/A 
 
9.4.7 SUB-GROUP ANALYSES 
The primary and secondary endpoints will not be analyzed based on age, sex, or race/ethnicity for this 
pilot study due to the small sample size.  
 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
Individual participant data will not be listed. 
 
9.4.9 EXPLORATORY ANALYSES 
No exploratory analyses are planned. 
 

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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
Consent forms describing in detail the study intervention, study procedures, and risks are viewed by the 
participant and documentation of informed consent is required prior to starting 
intervention/administering study intervention.  The following consent materials are submitted with this 
protocol Online Consent form. 
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be Institutional 
Review Board (IRB)-approved and the participant will be asked to read and review the document. 
Interested participants will view an online version of the consent form via Qualtrics. They will be 
prompted to email the PI with any questions they have about the study. The professional will e-sign the 
consent form via Qualtrics to consent to participants. 
 
The consent forms and processes will include information about the legal obligations of researchers that 
may, in rare instances, require a disclosure of confidential information. Professional participants will 
receive an emailed copy of their signed consent; original signed consent forms will be downloaded from 
Qualtrics and stored securely and separately from subject data on a secure UNC server.  
 
Given the nature of the consent process, the research subjects will have time to read and think over the 
consent and whether they would like to participate, before signing. They will be offered the opportunity 
to ask the PI any questions before signing.  
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to study participants, investigator, funding agency, and 
regulatory authorities.  If the study is prematurely terminated or suspended, the Principal Investigator 
(PI) will promptly inform study participants, the Institutional Review Board (IRB), and sponsor and will 
provide the reason(s) for the termination or suspension.  Study participants will be contacted, as 
applicable, and be informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 

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Study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the sponsor, and/or IRB. 
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, and the sponsor(s) and their interventions. Therefore, the study protocol, documentation, data, 
and all other information generated will be held in strict confidence. No information concerning the 
study or the data will be released to any unauthorized third party without prior written approval of the 
sponsor.  
 
The study monitor, other authorized representatives of the sponsor, representatives of the Institutional 
Review Board (IRB), or regulatory agencies may inspect all documents and records required to be 
maintained by the investigator, including but not limited to, study records for the participants in this 
study. 
 
The study participant’s contact information will be securely stored on OneDrive for internal use during 
the study. At the end of the study, all records will continue to be kept in a secure location for as long a 
period as dictated by the reviewing IRB, Institutional policies, or sponsor requirements. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored on UNC OneDrive. This will not include the participant’s contact or 
identifying information. Rather, individual participants and their research data will be identified by a 
unique study identification number. The study data entry and study management systems used will be 
secured and password protected.  
 
Certificate of Confidentiality  
 
To further protect the privacy of study participants, a Certificate of Confidentiality will be issued by the 
National Institutes of Health (NIH).  This certificate protects identifiable research information from 
forced disclosure. It allows the investigator and others who have access to research records to refuse to 
disclose identifying information on research participation in any civil, criminal, administrative, legislative, 
or other proceeding, whether at the federal, state, or local level. By protecting researchers and 
institutions from being compelled to disclose information that would identify research participants, 
Certificates of Confidentiality help achieve the research objectives and promote participation in studies 
by helping assure confidentiality and privacy to participants. 
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
This study does not involve storage of specimens for future unspecified research.  
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Principal Investigator 
Faculty Advisor 
Kelsey Thompson, MS, CCC-SLP 
Cara McComish, PhD 
UNC Chapel Hill  
UNC Chapel Hill  
321 S Columbia Street Chapel Hill, 
NC 
321 S Columbia Street Chapel 
Hill, NC 
919-966-1007 
919-966-1007 

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Kelsey_thompson@med.unc.edu 
Cara_mccomish@med.unc.edu 
 
 
10.1.6 SAFETY OVERSIGHT 
Because this study does not have any obvious safety concerns, provider responses to the survey 
will be monitored weekly for any concerning responses. Additionally, providers will be informed 
they should not yet use this tool in clinical practice.  
 
10.1.7 CLINICAL MONITORING 
 
This study will be completed virtually and is low-risk (a survey). Clinical site monitoring will include 
monitoring of data entry. A random 20% of participant entries will be audited to ensure data is correctly 
transferred from the Qualtrics survey into data records for analysis.   
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
The PI will manage all quality assurance and control. The survey will not be changed during the study 
unless approved by the IRB. Data will be downloaded and recorded by the PI and checked by a RA as 
necessary. QA and QC errors that are identified will be addressed by the PI.  
 
10.1.9 DATA HANDLING AND RECORD KEEPING  
 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
investigator. The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
 
Clinical data (including adverse events (AEs) will be saved in a file within the secure OneDrive system 
which is maintained by UNC. Data will also be stored within Qualtrics until the study is complete. Then 
this data will be downloaded to OneDrive and the surveys containing identifiable data in Qualtrics will 
be deleted.  
 
10.1.9.2 STUDY RECORDS RETENTION  
Study documents should be retained for a minimum of 2 years after the last approval of a marketing 
application in an International Conference on Harminosation (ICH) region and until there are no pending 
or contemplated marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the study intervention. These documents should be 
retained for a longer period, however, if required by local regulations. No records will be destroyed 
without the written consent of the sponsor, if applicable. It is the responsibility of the sponsor to inform 
the investigator when these documents no longer need to be retained. 
 
10.1.10 
PROTOCOL DEVIATIONS  

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A protocol deviation is any noncompliance with the clinical trial protocol, International Conference on 
Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 
It is the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 5 working days of identification of the protocol deviation, or within 5 working days of 
the scheduled protocol-required activity.  All deviations must be addressed in study source documents, 
reported to NCTraCS Program Official.  Protocol deviations must be sent to the reviewing Institutional 
Review Board (IRB) per their policies. The site investigator is responsible for knowing and adhering to 
the reviewing IRB requirements.  
 
10.1.11 
PUBLICATION AND DATA SHARING POLICY 
 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals.  Data from this study may be requested from other researchers 2 years after the 
completion of the primary endpoint by contacting Kelsey Thompson.  
 
 
10.1.12 
CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence is critical.  Therefore, any actual 
conflict of interest of persons who have a role in the design, conduct, analysis, publication, or any aspect 
of this trial will be disclosed and managed. Furthermore, persons who have a perceived conflict of 
interest will be required to have such conflicts managed in a way that is appropriate to their 
participation in the design and conduct of this trial.  The study leadership in conjunction with NCTraCS 
and UNC have established policies and procedures for all study group members to disclose all conflicts 
of interest and will establish a mechanism for the management of all reported dualities of interest.] 
 
10.2 ADDITIONAL CONSIDERATIONS 
N/A 

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10.3 ABBREVIATIONS 
 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
EI 
Early Intervention 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Conference on Harmonisation  
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
OT 
Occupational Therapist 
PFD 
Pediatric Feeding Disorder 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
SLP 
Speech language pathologist 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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10.4 PROTOCOL AMENDMENT HISTORY 
 
Version 
Date 
Description of Change  
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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