Parent Acceptance and Commitment Therapy (PACT) for Parents of Children With Pediatric Feeding Disorder
Phase: NA
Conditions: Pediatric Feeding Disorder, Chronic, Pediatric Feeding Dysfunction, Acute
Sponsor: Children's Mercy Hospital Kansas City

SHORT TITLE: PACT Study 
Page 1 of 30 
 
 
PROTOCOL TITLE:  
Parent Acceptance and Commitment Therapy (PACT) for Parents of Children with 
Pediatric Feeding Disorder 
PRINCIPAL INVESTIGATOR: 
Dana Bakula, PhD 
Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition 
(816) 302-3069 
dmbakula@cmh.edu 
 
IND/IDE NUMBER:  
 
VERSION NUMBER/DATE:  
Version 1.1 (5/2/23))  
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
5/2/23 
Changes per IRB request 
Y 
2 
2/8/24 
Change in exit interview 
Y 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

SHORT TITLE: PACT Study 
Page 2 of 30 
 
Table of Contents 
STUDY INFORMATION 
1.0 Study Summary 
2.0 Objectives 
3.0 Background 
4.0 Study Endpoints 
5.0 Study Design 
6.0 Study Intervention/Investigational Agent 
PARTICIPANT MANAGEMENT 
7.0 Inclusion and Exclusion Criteria 
8.0 Local Number of Participants 
9.0 Screening and Recruitment Methods 
10.0 Procedures 
11.0 Surveys and Psychometric Testing 
12.0 Follow-Up 
13.0 Genetic Analysis Information 
14.0 Sharing of Results with Participants 
15.0 Risks to Participants 
16.0 Potential Benefits 
17.0 Investigator Assessment of Risk/Benefits Ratio 
18.0 Payment, Reimbursement and Tangible Property Provided to Participants 
19.0 Compensation for Research-Related Injury 
20.0 Economic Burden to Participants 
21.0 Parental Permission and Adult Consent Process 
22.0 Assent of Pediatric Participants 
23.0 HIPAA and Confidentiality 
24.0 Provisions to Protect the Privacy Interests of Participants 
25.0 Withdrawal of Participants 
DATA MANAGEMENT 
26.0 Data Collection 
27.0 Adverse Events and Unanticipated Problems 
28.0 Statistical Analysis 
29.0 Data and Specimen Management 

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

SHORT TITLE: PACT Study 
Page 4 of 30 
 
STUDY INFORMATION 
1.0 
Study Summary* 
This is a pilot study of randomized clinical trial of Parent Acceptance and Commitment Therapy 
vs. an attention-control condition (placebo) for improving the mental health of parents of 
children with pediatric feeding disorder. The primary aims of this study are to evaluate 
feasibility and proof-of-concept.  
 
2.0 
Objectives* 
2.1 
Purpose, specific aims or objectives:  Primary Aim: Test the hypothesis 
that PACT will result in clinically meaningful reductions in Mental Health(MH) 
problems among parents of children with Pediatric Feed Disorder (PFD) and 
identify factors that impact the feasibility of intervention delivery.  This pilot 
study will involve conducting recruitment procedures for 4 months (or until 
parent N=30). Participants will be parents of 2- to 6-year-old children with PFD in 
outpatient treatment for their PFD. Parents will be randomly assigned to PACT or 
an attention control condition (control). Secondary aim: Test the hypothesis that 
PACT-F will result in clinically meaningful improvements in parent use of positive 
behaviors at meals, as measured through an observation of a representative 
mealtime.  
2.2 
Hypothesis: We will test the hypothesis that PACT results in clinically 
meaningful change in parent stress and anxiety, and parent use of positive 
mealtime behaviors, using the Reliable Change Index (RCI; success defined as RCI 
> 1.96). We anticipate that these procedures will be feasible, with feasibility 
success defined as recruitment rate above 60%, and retention, assessment 
completion, and intervention completion rate above 80%. Mixed methods data 
collection will identify factors that impact 1) recruitment rate (qualitative 
surveys, % meeting inclusion criteria, # of contact attempts), 2) retention rates 
(qualitative surveys, baseline characteristics; treatment group), 3) assessment 
completion rate (qualitative surveys, measure type), and 4) treatment 
completion rate (qualitative surveys, scheduling, treatment location). 
3.0 
Background* 
Pediatric Feeding Disorder (PFD) is Prevalent, and Parents are Critical to Treatment Success. 
One-third of young children, and up to 80% of children with developmental delays, experience 
pediatric feeding disorder (PFD).1 PFD is characterized by severely restricted volume or variety 
of foods and place children at increased risk for malnutrition.2,3 PFD is also associated with high 
financial burden.6 Interdisciplinary care to address medical and behavioral components of PFD 
is essential,33,34 and often involves a physician, psychologist, dietician, and speech or 
occupational therapists.18 However, treatment success relies on the implementation of 
treatment recommendations at home by parents, including structured family meals, positive 
parent-child interactions at mealtimes, and use of behavioral strategies to reinforce feeding 
behaviors.35 
 
PFD is a Stressor to Parents. Many parents report distress when their child does not eat 
well as feeding is essential to survival.19 Each meal, then (occurring 3-5 times a day), is a 

SHORT TITLE: PACT Study 
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potential stressor for parents of children with PFD. Many parents report “battles” with their 
children at mealtimes over eating.19 Parents across the spectrum of child age report similar 
experiences of mealtime distress.12,19,46   
Parents of Children with PFD are at Higher Risk for Mental Health (MH) Problems. Parents of 
children with PFD are at much higher risk for mental health (MH) problems (depression, 
anxiety, parenting stress, posttraumatic stress) than their peers,7-14 with up to 40% of parents 
endorsing MH problems.12 In qualitative interviews, parents report an enduring emotional 
impact,19 including that difficulties feeding their young children negatively impacts their identity 
development as parents.19 This emotional impact has also been observed biologically, as one 
study found increases in parent cortisol when feeding their child with PFD.47  
Parent MH Problems Impact Health and Feeding Among Children with PFD. Parent MH 
problems are closely linked to poorer health outcomes in children with medical conditions such 
as poorer child quality of life, adherence to medical treatments, and mental health.48-56 Parent 
MH problems have been explicitly linked to problematic child feeding practices.15-17 Further, 
according to the child positive health model,57 an innovative model for understanding child 
health, ecological systems58 such as family factors shape child health. Thus, parent MH 
problems are critical to consider in relation to child health. 
Parent-Focused MH Interventions May Improve Child Outcomes, but Uptake in Clinical 
Settings is Poor. Both pediatric feeding experts and parents have highlighted the need for 
interventions that specifically address parent MH problems in this population.18,19 Multiple 
recent studies have achieved promising results when testing the efficacy of psychological 
interventions (using Cognitive Behavioral Therapy & Problem Solving) for parent MH in other 
medical populations such as cancer.20 However, these interventions are typically time and 
resource intensive (e.g., 6-12 sessions). Even among oncology care, where national standards25 
have declared that parent MH should be addressed with all families, uptake of evidence-based 
parent MH treatments are low.25 Therefore, brief interventions that require minimal resources 
are essential.   
Acceptance and Commitment Therapy (ACT) has the Potential to Radically Improve the 
Uptake of Parent MH Interventions and is Therefore Ideal for Parents of Children with PFD. ACT 
is a transdiagnostic treatment approach that is effective in treating a wide range of adult MH 
problems. Emerging studies have found it can be effective in as few as one session.27 ACT 
focuses on changing how a person perceives and responds to negative thoughts and feelings, 
rather than focusing on challenging and eliminating these thoughts and feelings which can be 
more time intensive. ACT recently was adapted for parents of children with 
neurodevelopmental disorders (PACT), and a series of pilot studies found that PACT 
meaningfully reduced parent depression and anxiety, and improved child behavioral outcomes, 
in just 2-sessions.21,26,27 However, PACT has never been tested in a PFD population (nor has it 
been tested for problems other than anxiety and depression). If effective with parents of 
children with PFD, this brief treatment could radically increase the potential for uptake of 
parent MH treatment in PFD treatment clinics nationally.  
Treatment Adaptations and Feasibility Testing are Critical Next Steps. In order to optimize 
the treatment for parents of children with PFD, our team has adapted PACT to meet the needs 
of parents of children with PFD using formative research methods (IRB# 00002321). Feasibility 
testing and proof-of-concept testing are the essential next steps before proceeding to an 
efficacy study.  
 
4.0 
Study Endpoints 
 
Parents will complete the standard study battery at baseline, post-intervention, and 3-month 
follow-up.  
 
Quantitative Measures. Feasibility success is defined as recruitment rate above 60%, and 
retention, assessment completion, and intervention completion rate above 80%. 

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Demographics. Parents will provide information on their own and child’s age, sex/gender, 
race/ethnicity, education, and socioeconomic status. 
• Parent Mental Health (MH) Measures.  
o PHQ-9.  A 9-item self-report measure of depressive symptoms. Scores of 10 or 
more indicate probable depression.  
o GAD-7. A 7-item self-report measure of anxious symptoms. Scores of 10 or more 
indicate probable anxiety.87  
o IES-R. A 22-item self-report measure of posttraumatic stress symptoms. Scores 
of 33 or more indicate clinically significant posttraumatic stress.  
o PSS. A 10-item self-report measure of perceived stress. Scores of 14 or more 
indicate clinically significant stress.  
o AAQ-2. A 7-item self-report measure of psychological flexibility and experiential 
avoidance, which are targets of the behavioral treatment.  
• Child Health.  
o PedsQL 4.0 (Generic).  A 23-item parent-proxy measure of child quality of life, 
with versions specific to child age (2-4 years, 5-7 years) that each result in 
standardized total scores and domain-specific scores of physical functioning, 
emotional functioning, social functioning, and school functioning.  
o BPFAS. A 35-item parent-proxy report of child mealtime and feeding behavior.  
• Qualitative Measures. Qualitative sruveys will be completed by parents at the 3-month 
follow-up, focused on factors that impact feasibility. Feasibility of 1) recruitment 
procedures, 2) intervention procedures, and 3) measure completion. 
• Observational Behavioral Coding. Parents will record a representative family mealtime 
over Microsoft Teams at baseline, post-intervention, and at 3-month follow-up. A 
research assistant will facilitate the recordings over Microsoft Teams using procedures 
routinely employed in Dr. Davis's prior RCTs. The recordings will be coded using the 
Dyadic Interaction Nomenclature for Eating (DINE) coding scheme. The DINE is a well-
established measure of mealtime behavior that has been studied in a variety of 
populations and has good psychometric properties.74 The DINE measures parent-child 
interactions by coding three subscales: parent behaviors, child behaviors, and child 
eating behaviors. DINE coding will be completed by research assistants trained by the PI. 
The research assistants will be blinded to the intervention condition. Each video will be 
double-coded, and discrepancies will be resolved by meetings between the two coders 
and consultation with the PI.  
 
5.0 
Study Design* 
Study Design. This feasibility pilot study. 
 
 
6.0 
Study Intervention/Investigational Agent* 
Active Treatment (PACT-F) and Control Interventions. Parents randomized to PACT-F will complete 
two 90-minute PACT-F sessions individually with a study interventionist, 2-weeks apart. Parents 
randomized to the control group will complete two 90-minute sessions individually with a study 
interventionist, 2-weeks apart (focused on nutrition education). The control intervention will be parallel 

SHORT TITLE: PACT Study 
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to the PACT-F intervention, equal in the number of interactive components and duration of face-to-face 
time with health professionals (interventionists). Interventionists for both conditions will be individuals 
with at least master’s-level training in mental health or a related field. Based on guidance from our 
parent consultants, we will deliver intervention sessions through Microsoft Teams to reduce barriers to 
participation (e.g., travel, childcare).  
PACT-F. PACT-F is a 2-session intervention based on the Focused Acceptance and Commitment 
Therapy treatment literature14,30 and the two-session PACT approach utilized by Brown16 and 
Whittingham15 with parents of children with neurodevelopmental conditions. PACT-F content includes 
1) education about parent MH problems among parents of children with PFD, 2) interactive learning of 
FACT skills, including cognitive defusion, mindfulness, and value-based decision making, and 3) 
education about the importance of positive parent-child interactions at mealtime and how to apply 
PACT-F skills to their mealtime interactions with their child with PFD. Each session lasts 90 minutes and 
will be conducted remotely via Microsoft Teams.  
Control. The content of the control intervention covers a range of nutrition and healthy lifestyle 
topics including USDA’s MyPlate. The control condition has equivalent face-to-face time with the 
interventionists.  
2.3 
Drugs or Biologics:  N/A 
2.4 
Medical Devices.  N/A 
2.5 
Behavioral Intervention: Both the active and control conditions are 
behavioral interventions. See description above.  
 
PARTICIPANT MANAGEMENT 
7.0 
Inclusion and Exclusion Criteria* 
3.1 
Eligibility Criteria:  
Inclusion Criteria 
• 1) Must be a parent aged 18+ (primary caregiver) of 2-6-year-old child with PFD  
• 2) Child must be receiving outpatient PFD treatment at CMH 
• 3) The parent must have a clinically significant elevation on at least one measure 
of parent MH (using established clinical cutoffs). Parents will be included 
regardless of whether the child has a new diagnosis or established diagnoses 
Exclusion Criteria 
• 1) Parent has significant cognitive impairments  
• 2) Parent does not speak English 
• Parent unable to obtain high speed internet at home 
3.2 
Equitable Selection:  We are excluding non-English speaking participants 
because we are providing a behavioral intervention and do not have a translated 
version of the intervention available. In the future, we hope to translate this 

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intervention for non-English speaking patients but are unable to do this for the 
present study.  
3.3 
Vulnerable Populations: Check any vulnerable populations that are being 
targeted for enrollment into the study: (Members of the following populations 
may not be included as participants in the research unless selected here.) 
☒ Children/Minors (under 7 years of age) 
☐ Children/Minors (7-17 years of age) 
☐ Neonates (infants less than 30 days old) 
☐ Neonates of Uncertain Viability (infants 
less than 30 days old) 
☐ Non-Viable Neonates (infants less than 
30 days old) 
☐ Wards of the State 
☐ Fetuses 
☐ Pregnant Women  
☐ Adults with impaired decision-making 
capacity         
☐ CM Employees 
☐ CM Students/Residents/ Fellows 
☐ Economically or Educationally 
Disadvantaged Persons 
☐ Prisoners 
 
 
• Children with pediatric feeding disorder will be enrolled, and 
adequate provisions will be made to solicit the informed consent of 
parents and/or guardians. Informed consent of children in this study 
would not be appropriate because children enrolled are under the 
age of 6 years and many of these children have developmental 
delays. Parents will be given sufficient time to decide if the study is 
right for them and will be given all the options during the consent 
conversation. Participants will be informed that they can withdraw 
from the research at any time.  
 
8.0 
Local Number of Participants 
4.1 
 
 
Total consented 
(before meeting 
inclusion criteria) 
Group 1 
(Active 
treatment) 
Group 2 
(Control) 
 
Total (meet criteria 
and randomized)  
Enrollment Goal: 
Number of participants to be enrolled = the 
number of participants to be consented or to 
be screened for chart reviews. 
80 
20 
10 
30 
Approximately 60% of subjects consented will not meet inclusion criteria after taking 
quantitative measures and so 80 subjects will need to be enrolled to meet 30 
randomized subjects.  If number of randomized subjects reaches 30 prior to 80 being 
enrolled, enrollment will cease. 

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Page 9 of 30 
 
 
9.0 
Identification and Recruitment of Potential Participants* 
4.2 
Identification of Potential Participants:   
How will participants be identified? (Check all that apply) 
 
☒ Chart reviews  
 
☒ By their treating physician who will then provide the study team’s contact 
information to the potential participant/family 
☒ By their treating physician who will obtain patient/family permission to share 
contact information with the study team 
☐ Self-refer in response to IRB approved advertisements or websites  
☐ Through Cerner or other CM sources (e.g. databases, billing records, 
pathology reports, admission logs, etc.) May involve access of records by 
individuals not involved in the patient’s care. 
☐ List of candidates provided through the Data Report Request Form  
☐ Registry of individuals interested in research opportunities   
☐ Past participant list 
☐ Participants will roll-over from another research study: Study # 
☐ Other:  
 
4.3 
Pre-Screening prior to HIPAA Authorization 
Will any of the identification methods checked above involve 
access to Protected Health Information (PHI) prior to obtaining 
HIPAA Authorization? 
☒ Yes 
 
☐ No 
• If yes, a “Partial Waiver of HIPAA Authorization” is required.  Be sure to 
make this selection in the “HIPAA & Confidentiality” section below and 
complete Addendum E: Waiver/Alteration of HIPAA Authorization 
 

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4.4 
Recruitment of Potential Participants:   
Parents will be screened at outpatient clinic visits to the CMH feeding clinic. Parents 
who agree to participate will then complete parent MH measures via REDCap on a 
tablet during the clinic visit. No PHI will be collected at this time.  Potential subjects that 
meet inclusion criteria after completing the screening tool will be asked to participate in 
the study.  At that time a ICF will be given to them and reviewed.  All questions will be 
answered and adequate time will be given for a decision. 
 
•  
10.0 Procedures 
Parents who meet inclusion criteria and sign consent will be randomized to either PACT-
F or an attention control (control) condition using block randomization, such that an 
equal number of patients presenting for a new diagnosis and with an established 
diagnosis are randomized to each group. Participants will be blind to treatment 
condition (single blind study). See Figure 1 below for procedures. Intervention. Parents 
randomized to PACT-F will complete two 90-minute PACT-F sessions individually with a 
study interventionist, 2- weeks apart (see Table 2 for intervention content). Parents 
randomized to the control group will complete two 90-minute sessions individually with 
a study interventionist, 2-weeks apart (focused on nutrition education). The control 
intervention will be parallel to the PACT-F intervention in all ways, including interactive 
components and the face-to-face time with health professionals (interventionists). The 
control condition intervention has already been developed by Dr. Davis’s research team 
and covers a range of nutrition and healthy lifestyle topics including USDA’s MyPlate. 
Interventionists for both conditions will be individuals with at least master’s degree 
training in mental health or a related field. The interventions will take place remotely via 
telehealth.  The team has expertise in remote delivery of therapy in both clinical and 
research environments. Both arms of the intervention will be manualized and 
interventionists in both arms will be trained using didactics and role playing with the PI. 
Intervention fidelity will be monitored by audio recording all sessions. The PI (Dr. 
Bakula) will review video recordings each week and conduct weekly supervision. 
 
Due to the nature of the study, the participants will be blinded to the group assignment 
during treatment.  This is necessary as knowledge of whether they are in the treatment 
or control group may change behaviors of the participants.  We will therefore not be 
able to give specific descriptions of the treatments in each group in the Informed 
consent form.  Participants will be informed of their group assignment after they have 
completed the 3-month follow up and if they were in the control group be given the 
opportunity to participate in the treatment group.  There is no difference in risk for 
either group. 
 
Once the 3-month follow up is complete the subjects will be contacted and unblinded 
and control subjects will be offered the active treatment.   

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Figure 1 
 
 
 
 
5.2 Blood and Other Specimen Collection: 
N/A 
 
11.0 Surveys and Psychometric Testing: 
• Parent Mental Health (MH) Measures.  
o PHQ-9.  A 9-item self-report measure of depressive symptoms. 
Scores of 10 or more indicate probable depression.  
o GAD-7. A 7-item self-report measure of anxious symptoms. 
Scores of 10 or more indicate probable anxiety.87  

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Page 12 of 30 
 
o IES-R. A 22-item self-report measure of posttraumatic stress 
symptoms. Scores of 33 or more indicate clinically significant 
posttraumatic stress.  
o PSS. A 10-item self-report measure of perceived stress. Scores 
of 14 or more indicate clinically significant stress.  
o AAQ-2. A 7-item self-report measure of psychological 
flexibility and experiential avoidance, which are targets of the 
behavioral treatment.  
• Child Health.  
o PedsQL 4.0 (Generic).  A 23-item parent-proxy measure of 
child quality of life, with versions specific to child age (2-4 
years, 5-7 years) that each result in standardized total scores 
and domain-specific scores of physical functioning, emotional 
functioning, social functioning, and school functioning.  
o BPFAS. A 35-item parent-proxy report of child mealtime and 
feeding behavior.  
• Observational Behavioral Coding. Parents will record a representative 
family mealtime over Teams at baseline, post-intervention, and at 3-
month follow-up. A research assistant will facilitate the recordings 
over Teams using procedures routinely employed in Dr. Davis's prior 
RCTs. The recordings will be coded using the Dyadic Interaction 
Nomenclature for Eating (DINE) coding scheme. The DINE is a well-
established measure of mealtime behavior that has been studied in a 
variety of populations and has good psychometric properties.74 The 
DINE measures parent-child interactions by coding three subscales: 
parent behaviors, child behaviors, and child eating behaviors. DINE 
coding will be completed by research assistants trained by the PI. The 
research assistants will be blinded to the intervention condition. Each 
video will be double-coded, and discrepancies will be resolved by 
meetings between the two coders and consultation with the PI.  
• Exit survey:  Parents will complete an exit survey at the 3 month visit 
via RedCap on their feelings about the study and offer a chance to 
give feedback on their experiences. 
 
12.0 Follow-up 
13.0 Genetic Analysis Information 
5.1 
N/A 
 
14.0 Sharing of Results with Participants 
5.2 
A study summary of individual results will be offered to all 
subjects when they complete the study. 
 

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15.0 Risks to Participants* 
5.3 
This study is minimal risk, and the only foreseeable risk is the loss 
of confidentiality in the event of a data breach. Precautions have been 
taken to ensure data confidentiality, such as data storage in a secure 
REDCap database, with only trained/approved study staff having access 
to the data.  
 
16.0 Potential Benefits* 
5.4 
Parents may find these sessions helpful in managing their own 
stress, as the protocol used has been shown to be effective in reducing 
parent distress in other pediatric populations. Additionally, the 
information shared by these subjects has the potential to help other 
families in the future.  
 
17.0 Investigator Assessment of Risk/Benefits Ratio*  
17.1 
Please provide an assessment of risk and benefits in the table below.  
Note, the IRB makes the final determination based upon responses in the two 
preceding sections. 
 
Select as applicable: 
Pediatric Risk Category: 
☒ 
Category 1  Research not involving greater than minimal risk  
(45 CFR §46.404 and 21 CFR §50.51)   
☐ 
Category 2 
Research involving greater than minimal risk but 
presenting the prospect of direct benefit to the 
individual participants. (45 CFR §46.405 and 21 CFR 
§50.52) 
☐ 
Category 3 
Research involving greater than minimal risk and no 
prospect of direct benefit to individual participants, 
but 
likely to yield generalizable knowledge about the 
participant's disorder or condition.  
(45 CFR §46.406 and 21 CFR §50.53) 
☐ 
Category 4 
Research not otherwise approvable which presents 
an opportunity to understand, prevent, or alleviate a 
serious problem affecting the health or welfare of 
children. (45 CFR §46.407 and 21 CFR §50.54) 
Select if applicable: 
Adult Risk Category: 
☒ 
Not Greater than Minimal Risk 
☐ 
Greater than Minimal Risk 
 
 

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18.0 Payment, Reimbursement and Tangible Property provided to 
participants*  
Is payment, reimbursement, or tangible property part of the study?  
☒  Yes                 ☐  No (If No, delete the following subsections) 
Payment to Participants: If providing payment for participation (e.g. cash 
equivalent for participation, payment for time off work), select the form 
of payment: 
Study Activity 
Payment 
Screening measures 
$ 5 
Baseline forms 
$30 
Post-treatment measures 
$ 40 
3-month follow up measures 
$ 50 
Total  
$ 125 
 
☒  Gift card 
☐  Prepaid Merchant Gift Card: (Merchant:_____________) 
☒  e-Gift card 
☐  Other: __________ 
 
 
5.5 
 Reimbursement:  N/A 
          
5.6 
Tangible Property:  N/A 
 
19.0 Compensation for Research-Related Injury 
5.7 
N/A 
 
20.0 Economic Burden to Participants 
6.1 
N/A. Intervention sessions will be scheduled at times convenient 
to the family so they should not interfere with work schedules. 
Telehealth is being utilized to reduce burden and eliminate travel costs. 
No clinical fees associated with study procedures will be incurred for 
parents who take part in this clinical trial.  
 
21.0  Parental Permission and Adult Consent Process* 
 

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21.1 
For screening purposes, we will give the parents an information sheet 
explaining that we are asking them to complete questionnaires to see if they 
meet criteria to participate in the main part of the study and will answer any 
questions they have. We are requesting a waiver of the documentation of 
permission/consent for this.  The parent completing the questionnaires will be 
considered implied consent.  
 
If parent meets inclusion/exclusion they will then be presented the consent 
document and consent discussion for the main part of the study will happen.  If 
they do not meet inclusion/exclusion they will be thanked for their participation. 
 
 
Waiver of Documentation of Permission/Consent 
Permission/Consent form provided but signature will NOT be obtained (e.g. verbal consent) 
Must complete Addendum A: Waiver of Documentation of Permission/Consent 
 
☒ Waiver of written documentation of permission of parent/LAR for pediatric 
participants  
Study group(s) to which this method applies: This only applies to the screening 
section of the study  
☒ Waiver of written documentation of consent of adult participants  
 
Study group(s) to which this method applies: This only applies to the screening 
section of the study 
☐ Waiver of written documentation of consent of participants turning 18  
 
21.2  Permission/Consent/Consent at 18 Discussion: N/A – no pediatric subjects 
will be turning 18 during their enrollment in the study. Children enrolled in the 
study are under the age of 6 and therefore are not close to their 18th birthday. 
Individual data will be deidentified once the study is complete. We will not 
access patient data after the child is 18 years of age. 
 
21.3  Documentation of Permission/Consent/Consent at 18:  N/A 
 
21.4  Identification of participants turning 18:  N/A 
 
 
22.0 Assent of Pediatric Participants 
 
22.1 
Select the option(s) that apply to the study: 
 

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Page 16 of 30 
 
☐ Assent of pediatric participants WILL BE SOUGHT following assessment of 
ability to assent. 
 
☒ Obtaining assent of pediatric participants is NOT POSSIBLE due to: 
☒  The capability of the participants (considering the ages, maturity, physical 
and/or psychological state) is so limited that they cannot reasonably be 
consulted. 
☐  The intervention or procedure involved in the research holds out a prospect 
of direct benefit that is important to the health or well-being of the 
participants and is available only in the context of the research. 
 
☒ Obtaining assent of pediatric participants is NOT PRACTICAL given the 
context of this study (e.g., minimal risk, no direct contact with participants). 
Must complete Addendum B: Waiver/Alteration of 
Permission/Assent/Consent 
 
☐ 
22.2  Assessment of Ability to Assent:  N/A   
 
22.3  Assent Discussion: N/A 
 
22.4  Documentation of Assent or Inability to Assent:  N/A 
 
 
23.0 HIPAA and Confidentiality 
HIPAA regulations apply to this study if the data used or accessed relates to: 
• The past, present or future physical or mental health or condition of an 
individual; 
• The provision of health care to an individual; OR 
• The payment for the provision of health care, AND 
identifies the individual or for which there is a reasonable basis to believe it can 
be used to identify the individual. 
 
23.1 
HIPAA Authorization  
Select all applicable methods of HIPAA Authorization that apply to this 
study.   
☒  Full Written HIPAA Authorization will be obtained (within the p/a/c form or 
standalone form) 
 

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☒ Partial Waiver of HIPAA Authorization (e.g. waiver for recruitment and pre-
screening purposes only) 
Must complete Addendum E: Waiver/Alteration of HIPAA Authorization 
 
a) PHI accessed for pre-screening/recruitment will be name and 
medical record number . 
☐ Alteration of HIPAA Authorization (some but not all required elements of an 
Authorization are present, e.g. signature will not be obtained) 
Must complete Addendum E: Waiver/Alteration of HIPAA Authorization 
 
a) Describe which proposed elements to be altered. 
 
☐ Waiver of HIPAA Authorization (authorization will NOT be obtained) 
 
☐ If Other, explain: 
 
23.2 Specify the PHI for which accessing (“viewing”) or recording 
(“writing down”) is necessary for the purpose of this research: 
To minimize risks, only the minimum necessary identifiable data should be 
accessed/viewed and/or recorded/written down.  
 
PHI 
Accessed Only 
Recorded 
1. Name/Initials 
☐ 
☒ 
2. All elements of date (except year) directly 
related to an individual (e.g. date of birth, 
admission date, discharge date, date of 
death) 
☐ 
☒ 
3. Medical record number 
☒  
☐  
4. Account number 
☒  
☐  
5. Health plan identification number 
☐  
☐  
6. Social Security Number 
☐  
☐  
7. Device identifiers and serial number 
☐  
☐  
8. Certificate/License number 
☐  
☐  
9. Telephone number 
☐  
☒  
10. Fax number 
☐  
☐  
11. Email addresses 
☐  
☒  
12. Web addresses (URLs); Internet IP addresses 
☐  
☐  
13. Street address, city, county, precinct, zip 
code or equivalent geographical codes 
☐  
☐  

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14. Full face photographic images and any 
comparable images (this includes use of 
video recordings via Teams) 
☐  
☐  
15. Biometric identifiers, including finger and 
voice print (this includes recorded Teams 
audio) 
☐  
☐  
16. Vehicle identifiers and serial numbers, 
including license plate number 
☐  
☐  
17. Any other unique identifying number, 
characteristic or code that may help identify 
individual participants including their initials 
(e.g. student or employee ID number) 
☐  
☐  
18. Elements of date, including year, for persons 
90 years or older 
☐  
☐  
19. Other: 
☐  
☐  
 
23.3 
Only necessary PHI will be recorded to ensure the participant’s 
confidentiality is protected.  All PHI and data recorded will be, aside from 
the hard copy of the consent form, stored in a secure drive that only 
study personnel have access.  
 
23.4 
A certificate of confidentiality has not been issued for this study.  
 
24.0 Provisions to Protect the Privacy Interests of Participants* 
24.1 
Steps will be taken to protect the participant’s privacy. The consent 
discussion will occur during a private meeting with the parent, and identifiable 
information will not be shared outside of the study team.  
24.2 
Efforts will be made to make the parents feel at ease with the research 
situation such as informing parents all procedures and questions are optional, 
and they can choose not to participate in any aspect of the research with no 
impact to their care in the RUBI clinic or at CM.  
24.3 
The research team will access the Interdisciplinary Feeding and 
Swallowing program schedule through the EMR and will screen patients’ EMR 
data to determine if they are eligible for participation. This will be possible 
through a partial HIPAA waiver. Steps will be taken to ensure the participant’s 
confidentiality is protected, and data will be stored in a secure drive that only 
study personnel have access. 
 
25.0 Withdrawal of Participants* 

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7.2 
There are no anticipated circumstances which subjects with be 
withdrawn from the research without their consent. Subjects may 
voluntarily withdraw by informing the study coordinators.  
7.3 
In the event of voluntary withdraw, data that has previously been 
collected with be retained, and future data collected during the RUBI 
Clinic will not be used for study purposes.  
 
DATA MANAGEMENT 
26.0 Data Collection* 
8.1 
We will collect questionnaire data from parents enrolled in the 
study. We will have parents video record a mealtimes with them and 
their child through a facilitated Microsoft Teams call. PHI accessed in the 
medical record will include patient Name, MRN, DOB, and Visit Date, 
phone number, address, and email address.  
8.2 
The PHI from the medical records will be abstracted by chart 
review. Questionnaires will be collected via REDCap survey. Mealtimes 
will recorded via a facilitated Microsoft Teams call. All data will be 
securely stored as outlined in the Data Management plan below.  
8.3 
Sensitive Data:  We are not collecting sensitive data.  
☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐
☐☐☐☐☐☐☐☐☐☐☐ 
 
27.0 Adverse Events and Unanticipated Problems* 
9.1 
Monitoring:  Participating parents will be able to reach study staff at any 
time if they experience distress and will have ongoing contact with the RUBI 
team during their regular course of care. We will monitor parent responses to 
the depression screening measure (PHQ-9) as the responses are submitted. If a 
parent endorses clinically significant depression or endorses a positive response 
on the item asking about suicidal ideation, the PI (a licensed psychologist) will 
contact the parent to conduct a safety assessment and provide the parent with 
appropriate referrals for intervention as indicated (e.g., emergency room).  
9.2 
Reporting:  We will follow Policy 5.11 Reportable Events of the CM 
Research Program Policies and Procedures in regard to reporting adverse events 
and other unanticipated problems to the CM IRB.   
 
28.0 Statistical Analysis* 
10.1 
Data will be analyzed using SPSS. We will conduct descriptive 
statistics to evaluate the research endpoints of this study. We will 

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conduct correlations between demographic factors and endpoints to 
evaluate relationships that may influence these endpoints.  
10.2 
Quantitative Feasibility Analyses. Descriptive statistics (frequency 
counts, %s) will determine recruitment, retention, assessment, and 
intervention delivery success and will be compared to identified 
benchmarks of success (recruitment rate above 60%, and retention, 
assessment completion, and intervention completion rate above 80%). 
Factors that may impact success will be evaluated in relation to these 
outcomes using t- and chi-squared tests.  
10.3 
Qualitative Feasibility Analyses. Parent free text responses to 
feasibility questions will be imported into NVivo 12 software for coding. A 
coding tree will be developed a priori and periodically revised to include 
relevant inductive codes as emergent themes arise. Qualitative responses 
will then be double coded by PI and a graduate research assistant. 
Interrater reliability will be coded, with the goal of achieving 80% 
interrater reliability. PI mentor will provide direct supervision for data 
collection and analysis.  
10.4 
Proof of concept analyses. We use the Reliable Change Index (RCI; 
success defined as RCI > 1.96) to determine if there is a reliable signal of 
change for participants who are in the PACT (active treatment) group 
from baseline to post-treatment and follow-up. The RCI is a psychometric 
criterion used to evaluate whether change is significant at the level of the 
individual. An RCI will be calculated for each participant in the PACT 
(active treatment) group, using the following formula: RCI = observed 
difference score between measurements divided by the standard error of 
measurement of the difference. We will assess proof of concept for 
change in parent stress, parent anxiety, and parent behavior at meals 
(measured by the DINE).  
10.5 
Given the feasibility and proof-of-concept nature of this study, we 
are interested in seeing if these study procedures are feasible and if there 
are meaningful improvements (e.g., several points of improvement on 
rating scales) rather than statistical significance. The sample size was 
therefore selected to ensure that a large enough group of participants 
can be evaluated to be reflective of a heterogeneous group of parents. 
10.6 
Recruitment rate is the indicator of recruitment feasibility (# 
consented/total # eligible per week). We will track factors that may impact 
recruitment from both those who do and do not consent to participate 
(baseline characteristics, contact methods). Retention: The % of parents 
who are retained through the final measurement will be the indicator of 
retention success. Assessment: % missing data will be the indicator of 
assessment success. We will track factors that may impact assessment 
success (measure factors, baseline characteristics). Intervention delivery: 

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session completion rate will be the indicator of success. We will monitor 
factors that may impact intervention delivery (baseline characteristics, 
scheduling procedures).  
 
 
29.0 Data and Specimen Management* 
11.1 
Data Management:  Data will be collected and stored via REDcap. 
Data will include the endpoints in addition to data accessed from the 
medical record. Only study team members approved by the IRB will have 
access to the data. The data will be stored until the study is complete or 
until the youngest participant turns 18. Study coordinators will be 
responsible for the receipt of this data. Study team members will access 
these data through CM Institutional REDcap access.  
11.2 
Specimen Management: N/A 
11.3 
Biosafety Information 
Will this study involve handling, transporting, or shipping any 
potentially hazardous biological material at/from a Children’s 
Mercy location (e.g., blood, stool, saliva, tissue)? 
☐ Yes 
☒ No 
Will this study involve processing any potentially hazardous 
biological material at a Children’s Mercy location (e.g., blood, 
stool, saliva, tissue)? 
☐ Yes 
☒ No 
If processing potentially hazardous biological materials, where will 
this work be conducted? 
☐ Pediatric Clinical Research Unit (PCRU) 
☐ Children's Mercy Research Institute Biorepository (CRIB) 
☐ Children’s Mercy Research Institute labs (mySafety 
ID#:__________) 

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☐ Other location 
If “Other location,” identify the location and mySafety ID# of the 
corresponding IBC protocol: 
Location: ____________________ 
mySafety ID#: ___________________________  
 
30.0 Storing of Data and/or Banking of Specimens for Future Research 
12.1 
If this study involves storing of data or banking of leftover 
specimens for future research, indicate how the use will be managed: 
☐  Contributing data and/or leftover specimens to an existing CM 
repository protocol (myIRB#___________________________) 
☐  Contributing data and/or leftover specimens to an existing non-CM 
repository (Institution/Repository Name: _________________________) 
☒  Not contributing to an existing repository for the management of 
data/specimens for future research use.   
☐  Other: 
 
31.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
N/A. This study does not involve more than Minimal Risk and therefore 
this section is not required.  
13.1 
In addition to the Principal Investigator, which individual or group 
will be responsible for monitoring the data and safety for this study? 
 
☐ Sponsor or Sponsor Designee (including the Sponsor CRO) 
☐ Data and Safety Monitoring Board (DSMB) or Data Safety Monitoring 
Committee (DSMC)  
☐ Independent Monitor (s) 
☐ Internal Committee at CM 
☐ Other: ____________ 
 
13.2 
Data Safety Monitoring Plan: N/A 
 
STUDY MANAGEMENT 

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32.0 Setting & Locations* 
14.1 
All visits will take place either during a MDC feeding clinic visit at 
Adelle Hall in the Gastroenterology outpatient clinics or via tele-video 
conferencing using Microsoft Teams with the participant at home.  
Measures completion will be done via redcap system. 
14.2 
As this study is focused on the mental health of caregivers, 
psychological resources will be readily available for caregivers if 
necessary. As there are no physical procedures being done a need for 
medical resources are not expected. 
 
33.0 Multi-Site or Collaborative Research 
Choose ALL relationship types that apply:  
☐    Multi-Site Research: Multiple sites will be engaged in this human research 
project. Sites will use the same protocol to conduct the same human research 
activities (except for minor variations due to local context considerations).   
☐    Collaborative Research: Multiple sites will be engaged in this human 
research project. Sites will not be performing the same research activities. The 
Site submission will specify the specific research activities each site will perform.  
REQUIRED: Enter summary of site-specific activities that differ from the 
overall protocol: Click or tap here to enter text.  
☐    Student(s):  Student(s) will help with this project and will be engaging their 
home institution.  
☐    Visiting Resident(s) / Visiting Fellow(s):  Visiting Resident(s) / Visiting 
Fellow(s) will help with this project and will be engaging their home institution.  
 
Is Children’s Mercy (CM) acting as the single IRB of Record (sIRB)? 
☐    No, each site is getting their own IRB approval.  
☐    Yes, some or all sites will rely on the CM as the sIRB.  
• Reliance is required for non-Exempt NIH or other Federally 
Funded research where: 
o The institution's employees or agents intervene or 
interact with human subjects for research purposes;     
o The institution's employees or agents obtain 
individually identifiable private information or 
identifiable biospecimens about human subjects for 
research purposes; or     

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o The institution receives a direct HHS award to conduct 
human subjects research, even where all activities 
involving human subjects are carried out by a 
subcontractor or collaborator.  
If CM is sIRB for another site, complete the chart for that site(s) (Add a new row 
for each site relying on the CM IRB, delete chart if not acting as sIRB): 
Site Name 
Enrollment Goal for 
Site(s) 
Choose One 
Relying on CM IRB?  
Insert Site Name 
☐  Site Enrollment 
Goal: Insert # 
 
☐  Site will not enroll  
☐  External Site will rely on the CM IRB as 
the IRB of Record using a reliance 
agreement. () 
☐  Not Applicable. Site will not interact or 
intervene with human participants or their 
identifiable data / identifiable biospecimens. 
Site is also not a primary NIH or federal 
grant recipient.   
 
 
 
 
34.0 International Research 
15.1 
N/A 
 
 
Addendum A: Waiver of Documentation of Permission/Consent 
(for screening only_ 
 
Regulatory Criteria: To qualify for a waiver of documentation of parental permission or 
adult consent, the study must fit into at least one of the three scenarios below. Indicate 
which scenario(s) applies. 
 
☐ The only record linking the participant and the research would be the 
permission/consent form and the principal risk is potential harm resulting from a 
breach of confidentiality. Each parent/LAR or adult participant will be asked whether 
they want documentation linking the participant with the research, and the 
parent/LAR’s or adult participant’s wishes will govern. 
 
OR 
 

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☒ The research presents no more than minimal risk of harm to participants and 
involves no procedures for which written parental permission or adult consent is 
normally required outside of the research context. 
 
OR 
 
☐ The parent(s)/LAR or adult participants are members of a distinct cultural group or 
community in which signing forms is not the norm, the research presents no more 
than minimal risk of harm to participants and an appropriate alternative mechanism 
for documenting that informed parental/LAR permission or adult consent was 
obtained will be provided. Describe the alternative mechanism provided: 

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Addendum B: Waiver/Alteration of Permission/Assent/Consent 
 
What’s the difference between a “waiver” and an “alteration” of parental permission, 
child assent, or adult consent?   
 
• A “waiver” of parental permission, child assent, or adult consent is when all 9 
required elements of permission/consent are waived. If the IRB approves a 
waiver then the study team does not need to obtain the parental permission or 
adult consent in order to include a participant in the study. 
 
• An “alteration” of parental permission, child assent, or adult consent is when 
one or more of the 9 required elements are waived because they are not 
relevant to the research activity. If the IRB approves an alteration, then the study 
team must still obtain parental permission or adult consent in order to include a 
participant in the study, but certain elements may not be required in the 
form/discussion. 
 
 
 
NOTE: If requesting a waiver of parental/LAR permission because parental permission is 
not a reasonable requirement to protect the participants [e.g. research on neglected or 
abused children], contact irb@cmh.edu to discuss additional regulatory requirements. 
 
Regulatory Criteria: To qualify for a waiver or alteration of parental permission or adult 
consent, ALL of the following must apply.  Explain how the study meets each of the 
regulatory criteria below.   
 
Criteria 
Explain how the study meets the criteria 
The research involves no more 
than minimal risk to the 
participants 
 
The research could not 
practicably be carried out 
without the requested 
waiver/alteration (i.e., explain 
why the study could not be 
done if 
permission/assent/consent 
were required) 
 
If the research involves using 
identifiable private 
information or identifiable 
 

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biospecimens, the research 
could not practicably be 
carried out without using such 
information or biospecimens 
in an identifiable format 
The waiver/alteration will not 
adversely affect the rights and 
welfare of the participants 
 
Whenever appropriate, the 
participants or legally 
authorized representatives 
will be provided with 
additional pertinent 
information after participation 
 
 
Proposed Alteration (if applicable):  
Select which required elements of permission are to be omitted. 
☐ A statement that the study involves research, an explanation of the purposes of 
the research and the expected duration of the participant's participation, a 
description of the procedures to be followed, and identification of any 
procedures that are experimental; 
 
☐ A description of any reasonably foreseeable risks or discomforts to the 
participant; 
 
☐ A description of any benefits to the participant or to others that may reasonably 
be expected from the research; 
 
☐ A disclosure of appropriate alternative procedures or courses of treatment, if any, 
that might be advantageous to the participant; 
 
☐ A statement describing the extent, if any, to which confidentiality of records 
identifying the participant will be maintained; 
 
☐  For research involving more than minimal risk, an explanation as to whether any 
compensation and an explanation as to whether any medical treatments are 
available if injury occurs and, if so, what they consist of, or where further 
information may be obtained; 
 
☐  An explanation of whom to contact for answers to pertinent questions about the 
research and research participants' rights, and whom to contact in the event of a 
research-related injury to the participant; 
 

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☐  A statement that participation is voluntary, refusal to participate will involve no 
penalty or loss of benefits to which the participant is otherwise entitled, and the 
participant may discontinue participation at any time without penalty or loss of 
benefits to which the participant is otherwise entitled; and 
 
☐  One of the following statements about any research that involves the collection 
of identifiable private information or identifiable biospecimens: 
 
☐  A statement that identifiers might be removed from the identifiable private 
information or identifiable biospecimens and that, after such removal, the 
information or biospecimens could be used for future research studies or 
distributed to another investigator for future research studies without 
additional informed consent from the participant or the legally authorized 
representative, if this might be a possibility; or 
 
☐  A statement that the participant's information or biospecimens collected as 
part of the research, even if identifiers are removed, will not be used or 
distributed for future research studies. 
 
Provide the rationale for omitting the item(s) selected: 
 
 
 

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Addendum E: Waiver/Alteration of HIPAA Authorization 
 
 
What’s the difference between a “waiver” and an “alteration” of HIPAA 
Authorization? 
 
• A “waiver” of HIPAA Authorization is when the requirement to obtain 
authorization is completely waived. If the IRB approves a waiver then the study 
team does not need to obtain HIPAA Authorization in order to include a 
participant in the study. 
 
• An “alteration” of HIPAA Authorization is when one or more of the required 
elements of authorization are waived.  If the IRB approves an alteration then 
the study team must still obtain HIPAA Authorization in order to include a 
participant in the study, but certain elements may not be required in the 
form/discussion.  The study team should still verify the identity of the participant 
as part of the process.  For an online survey, for example, this could be 
accomplished by having the participant type in their name. 
 
 
 
Regulatory Criteria: To qualify for a waiver/alteration of HIPAA Authorization, ALL of the 
following must apply to a study. Explain how the study meets each of the regulatory 
criteria below.   
 
Criteria 
Explain how the study meets the 
criteria 
The use or disclosure of PHI involves no 
more than minimal risk to the privacy of 
individuals based upon the following:  
a. Plan to protect PHI from 
improper use and disclosure: 
b. Plan to destroy PHI at the 
earliest opportunity, unless 
there is a health or research 
justification for retaining the 
PHI: 
c. Assurance that PHI will not be 
reused or disclosed to any 
other person or entity: 
 
A partial waiver of HIPAA 
authorization is being used only to 
identify potential research 
subjects.  No PHI will be recorded 
in the research record. Name will 
be recorded in enrollment log and 
for payment purposes. The 
RedCap database with answers to 
the questionnaires will be de-
identified.  Any PHI will not be 
reused or disclosed to any other 
person or entity. 

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The research cannot practicably 
be conducted without the 
waiver/alteration, i.e. explain why 
a signature for HIPAA 
Authorization cannot be obtained. 
It would not be practicable to get 
HIPAA authorization from 
potential study participants prior 
to determining if they even meet 
study criteria.  It would cause PHI 
to be recorded that would not be 
recorded otherwise. 
The research cannot practicably 
be conducted without access to 
and use of the PHI, i.e. explain 
why access to PHI is needed for 
this study. 
We need access to PHI in order to 
identify potential subjects that 
nominally meet study criteria.