Integrative Training Program for Pediatric Sickle Cell Pain (I-STRONG for SCD): Optimizing Feasibility and Acceptability
Phase: NA
Conditions: Sickle Cell Disease
Sponsor: Emory University

Study Protocol 
 
 
 Integrative Training Program for Pediatric Sickle Cell Pain (I-STRONG for 
SCD): Optimizing Feasibility and Acceptability 
 
 
Protocol Date: January 24, 2024 
 
 
NCT06110754 

Protocol Title: Integrative Training Program for Pediatric Sickle Cell Pain 
 
 
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PROTOCOL TITLE:   Integrative Training Program for Pediatric Sickle Cell Pain (I-STRONG for 
SCD): Optimizing Feasibility and Acceptability  
EXTERNAL (NON-EMORY) COLLABORATORS  
Lori Crosby, PsyD, Behavioral Medicine and Clinical Psychology, Cincinnati Children’s Hospital 
Medical Center 
Susmita Kashikar-Zuck, PhD, Behavioral Medicine and Clinical Psychology, Cincinnati Children’s 
Hospital Medical Center 
Charles Quinn, MD, Pediatric Hematology/Oncology, Cincinnati Children’s Hospital Medical 
Center 
Lindsey Cohen, PhD, Children’s Healthcare of Atlanta, Georgia State University, Department of 
Psychology  
PRINCIPAL INVESTIGATOR: 
Soumitri Sil, PhD, ABPP 
Department of Pediatrics 
Telephone Number 
 
  
EMORY CO-INVESTIGATORS: 
Shasha Bai, PhD 
Nitya Bakshi, MD 
Carlton Dampier, MD 
Gregory Myer, PhD 
Anjanette Nunez, PT, DPT 
Trisha Kesar, PhD 
Cynthia Sinha, PhD 
VERSION: 2.0 
FUNDING SOURCE: National Institutes of Health, National Center for Complementary and 
Integrative Health R61 AT012421-01 
 

Protocol Title: Integrative Training Program for Pediatric Sickle Cell Pain 
 
 
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REVISION HISTORY 
 
Revision # 
Version 
Date 
Summary of Changes 
1.1 
1/3/23 
Procedures Involved: Including option for participants to 
complete qualitative interviews in-person. Demographics 
survey will include questions about medical and non-
pharmacological treatments.  
2.0 
7/25/23 
Aims and Procedures Involved: Including the next phase of 
I-STRONG intervention development and adaptation – Aim 
2, a pilot feasibility study. Procedures include study 
assessments, treatment sessions, qualitative exit 
interviews, and continued stakeholder advisory board 
meetings to optimize intervention adaptations. Updated 
potential risks, protections to protect against potential 
risks, and compensation. Inclusion of additional data 
analyses.  
2.1 
1/23/24 
Provisions to Monitor the Data to Ensure Safety of 
Participants: updates to clarify the frequency and 
responsibilities of tasks undergoing independent 
monitoring per DSMP requirement 
 
 
 
 
 
 
 
 
 

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Table of Contents 
 
1. 
Study Summary .................................................................................................................... 4 
2. 
Objectives............................................................................................................................. 4 
3. 
Background .......................................................................................................................... 5 
4. 
Study Endpoints ................................................................................................................... 6 
5. 
Study Intervention/Design ................................................................................................... 6 
6. 
Procedures Involved ............................................................................................................ 6 
7. 
Sharing of Results with Participants .................................................................................. 13 
8. 
Study Timelines .................................................................................................................. 13 
9. 
Inclusion and Exclusion Criteria ......................................................................................... 14 
10. 
Population .......................................................................................................................... 14 
11. 
Vulnerable Populations ...................................................................................................... 15 
12. 
Local Number of Participants............................................................................................. 15 
13. 
Recruitment Methods ........................................................................................................ 15 
14. 
Withdrawal of Participants ................................................................................................ 16 
15. 
Risk to Participants............................................................................................................. 17 
16. 
Potential Benefits to Participants ...................................................................................... 18 
17. 
Compensation to Participants ........................................................................................... 18 
18. 
Data Analysis, Management and Confidentiality .............................................................. 18 
19. 
Provisions to Monitor the Data to Ensure the Safety of Participants . Error! Bookmark not 
defined. 
20. 
Provisions to Protect the Privacy Interest of Participants ................................................. 20 
21. 
Economic Burden to Participants ...................................................................................... 23 
22. 
Informed Consent .............................................................................................................. 25 
23. 
HIPAA ................................................................................................................................. 26 
24. 
Setting ................................................................................................................................ 27 
25. 
Resources Available ........................................................................................................... 27 
26. 
Multi-Site Research When Emory is the Lead Site ............................................................ 27 
27. 
References ......................................................................................................................... 28 
28. 
Protocol Checklist .............................................................................................................. 33 
 
 
 
 
 

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1. Study Summary 
 
Study Title 
Integrative Training Program for Pediatric Sickle Cell 
Pain: Development and Adaptation of I-STRONG for 
SCD 
Study Design 
Mixed-methods study and single-arm feasibility study 
Primary Objective 
Adapt and refine the integrative components of the 
FIT Teens intervention to develop a new culturally 
tailored I-STRONG intervention for youth with chronic 
SCD pain to refine in a single-arm feasibility study  
Secondary Objective(s) 
N/A 
Research 
Intervention(s)/Interactions 
I-STRONG for SCD is proposed as a group-based, 16-
session multi-component intervention that includes 
mind-body, cognitive-behavioral, and neuromuscular 
movement training. Semi-structured interviews will 
inform intervention adaptation and refinement to 
tailor I-STRONG for chronic pain in SCD. A single-arm 
feasibility study will optimize the feasibility and 
acceptability of I-STRONG. 
Study Population 
Adolescents with sickle cell disease (SCD) aged 12-18 
and their parents  
Sample Size 
45 adolescents and their parents  
Study Duration for 
individual participants 
1-6 months 
Study Specific 
Abbreviations/ Definitions  
SCD: Sickle Cell Disease 
I-STRONG for SCD: Integrative Strong Body and Mind 
Training for Sickle Cell Disease  
FIT Teens: Fibromyalgia Integrative Training for Teens 
Funding Source (if any) 
NIH/NCCIH 1 R61 AT012421-01  
 
2. Objectives 

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Our objectives are to partner with patient and family stakeholders to adapt and refine an existing, 
evidence-based intervention (the FIT Teens program) to target the unique needs and preferences 
of families managing chronic SCD pain. We will then iteratively optimize and refine the feasibility 
and acceptability of the newly adapted intervention. Our central hypothesis is that disrupting the 
complex interplay of biopsychosocial factors that exacerbate chronic SCD pain will ameliorate 
health outcomes in youth with SCD.  
Aim 1: Adapt and refine the integrative components of the FIT Teens intervention to develop a 
new culturally tailored I-STRONG intervention for youth with chronic SCD pain. We will conduct 
mixed method approaches and purposive sampling to collect qualitative feedback informed by 
patient and family lived experiences regarding intervention content, format, perceived benefits, 
and barriers/facilitators to engagement from 15 patients (12-18 years) with chronic SCD pain and 
their parents and about 8 adolescents and 8 parents to participate in stakeholder advisory 
boards. Community stakeholder advisory boards and iterative design will inform intervention 
adaptation and refinement to enhance clinical implementation. 
Aim 2: Assess feasibility and acceptability of I-STRONG intervention for youth with chronic SCD 
pain. We will conduct a single-arm proof-of-concept study of the I-STRONG intervention with 12 
adolescents (12-18 years) to iteratively optimize the feasibility and acceptability of I-STRONG in 
youth with chronic SCD pain. Feasibility will be demonstrated by rates of study enrollment, 
retention, and adherence (target goals set at ≥ 75%). Acceptability will be demonstrated by 
treatment burden, satisfaction, and tolerability. Qualitative feedback about the program format 
and content will inform additional intervention optimization, refinement, and enhance feasibility 
and acceptability. 
3. Background 
Pain is the hallmark feature of sickle cell disease (SCD), a life-limiting chronic illness that 
disproportionately affects African Americans SUI. Well-documented racial disparities complicate 
effective pain control and the under-treatment of pain experienced by Black Americans with SCD 
(2-4). Approximately 20% of youth with SCD develop chronic pain and experience significant 
functional impairment, diminished quality of life, and comorbid depression and anxiety that can 
worsen over time (5, 6). Youth with chronic SCD pain often are stuck in a vicious cycle of pain, 
functional impairment, and pain-related fear of movement that contributes to activity avoidance 
and exacerbates pain (7, 8). The most effective chronic SCD pain management requires 
multicomponent, interdisciplinary treatment approaches that include integrative mind-body 
treatments (9). Mind-body approaches, specifically diaphragmatic breathing, progressive muscle 
relaxation, and guided imagery, can improve outcomes for youth with chronic pain (10). 
However, multicomponent interventions tailored for chronic SCD pain have never been 
established. Most pain interventions are developed and studied largely with white youth, do not 
address cultural influences, and consequently have limited generalizability for minoritized 
populations that experience health disparities like SCD (11, 12). There is a critical need for 
effective, culturally tailored, integrative pain management approaches to address health 
disparities and improve outcomes for youth with SCD whose chronic pain can persist into 
adulthood.  

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To address this unmet need, we will leverage an existing innovative intervention designed for 
juvenile fibromyalgia, the Fibromyalgia Integrative Training for Teens (FIT Teens) (13). Recent 
clinical practice guidelines for SCD pain identified fibromyalgia as most closely aligned with 
chronic pain in SCD to inform treatment recommendations; thus, FIT Teens is well-suited for 
adaptation and testing for SCD (9). FIT Teens is an 8-week (16 session) group-based telehealth 
intervention that combines mind-body, cognitive-behavioral, and neuromuscular movement 
approaches. Early trials of FIT Teens found excellent patient engagement, and medium to large 
effects on reducing disability, pain, depressive symptoms, and fear of movement without adverse 
effects of pain exacerbation (14). An ongoing multicenter trial of FIT Teens has excellent patient 
retention (>80%, n=300 enrolled). The mind-body, cognitive-behavioral, and neuromuscular 
movement treatment components will form the basis of a new multicomponent integrative 
intervention tailored for SCD, Integrative Strong Body and Mind Training (I-STRONG) for SCD. We 
will utilize our successful experience engaging with community stakeholders and applying the 
ADAPT-ITT and RE-AIM models to guide cultural adaptation of interventions for patients with 
SCD.  
4. Study Endpoints 
Aim 1: The primary study endpoints include stakeholder (patient, parent, community health 
workers) derived treatment preferences, barriers, and facilitators to engaging in a 
multicomponent behavioral intervention for chronic SCD pain management.  
 
Aim 2: The primary study endpoints include feasibility and acceptability metrics including 
treatment adherence, completion of group-based sessions, intervention fidelity, treatment 
acceptance, treatment satisfaction, and assessment of primary outcome.  
 
5. Study Intervention/Design  
The overarching study design is guided by the ORBIT model, a systematic framework for 
behavioral treatment development that features a flexible and progressive process with 
ongoing optimization (15). In Phase I (Aim 1) we will solicit patient and parent perspectives 
through formative qualitative research about the FIT Teens program to inform intervention 
adaptation and tailoring. Treatment adaptation  will be guided by a) the ADAPT-ITT model to 
ensure the integrity of the core evidence-based content (16), b) the RE-AIM  model to enhance 
implementation (17, 18), and c) community partnership (12). We will prepare and refine 
treatment manuals and procedures in partnership with community stakeholder advisory boards 
to develop a new culturally tailored multicomponent intervention, Integrative Strong Body and 
Mind (I-STRONG) for SCD. I-STRONG for SCD will then be primed for feasibility testing in Phase II 
(Aim 2), a single-arm proof-of-concept feasibility study. The within-subjects design will 
longitudinally follow patients from baseline, 8-week intervention immediate post-treatment, 
and 3-month follow-up. 
 
6. Procedures Involved 
 

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Aim 1. We will use mixed-method approaches using questionnaires and semi-structured 
interviews to collect qualitative feedback informed by patient and family lived experiences 
regarding content of the I-STRONG for SCD program, usability, perceived benefits, and 
barriers/facilitators to engagement. 
 
Measures. Consistent with the NIH Helping to End Addiction Long-term (HEAL) Initiative 
Common Data Element (CDE) program(19), we will collect required demographic information 
leveraging self-report measures from the PhenX Toolkit, Sickle Cell Disease protocol along with 
assessment of social determinants of health. All measures within the PhenX Toolkit SCD 
collection were determined by an expert review panel as a core set of high-priority, well-
established, and low-burden measures intended for inclusion in studies involving individuals 
with SCD(20).  The following measures will be collected including but not limited to: date of 
birth, patient and caregiver age, sex at birth, gender identity, ethnicity and race, educational 
attainment, caregiver employment status, relationship status, annual household income; health 
insurance coverage, applied for disability insurance; birthplace of patient, parents, and 
grandparents, years living in the U.S. for those born overseas; patient pain duration, frequency 
of sickle cell pain episodes per year, hemoglobin characterization, history of transfusion, 
pediatric school performance, and opinions and experience with medical and non-
pharmacological treatments.  
 
Semi-structured interviews. Obtaining child and parent perspectives are vital for intervention 
development, will ensure that the intervention content is grounded in decisions that families 
make and barriers they face, and will maximize the acceptability, implementation, and 
dissemination of the intervention. The interview guide will be developed in partnership with 
our Community Health Workers. We will assess aspects of RE-AIM (Table 1) within individual 
qualitative interviews including discussions on: potential barriers to treatment (Reach); 
preferences for intervention content and the unique needs of adolescents with chronic SCD 
pain (Efficacy); and preferences for intervention delivery (individual, group), frequency (weekly, 
biweekly), and innovative methods to enhance teens’ treatment engagement (use of phone 
apps or biofeedback cards to support skills at home) (Implementation). Semi-structured 
qualitative interviews will last 60-75 minutes and will be conducted virtually, by phone, or in-
person (depending on family preference) with support from a member of Emory’s Qualitative 
Research Core (Drs. Sinha, Bakshi) and trained psychology graduate students, fellows, or 
research study members. About 15-20 semi-structured qualitative interviews will be conducted 
for adolescents and caregivers separately to allow open discussion. Semi-structured qualitative 
interviews for children are recommended because it allows interviews to match their 
developmental needs (21). Additional qualitative interviews will be conducted until saturation 
of themes is achieved. 
All interviews will be audio-recorded as digital files and transcribed for analysis by a 
professional transcription service for qualitative research that offers a secure, HIPPA-compliant 
platform. Audio recordings will be saved for up to 6 years following completion of the study and 
saved via password-protected computer that is only accessible to the PI to ensure security. No 

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audio recordings will be used for educational or presentation purposes. The research design 
does not require subjects to be deceived.  
 
 
 
Developing culturally tailored content: We will develop a culturally tailored intervention based 
on feedback from families with SCD, community partnership, and related literature of culturally 
adapted family-focused treatments for adolescents (22-25). Although most patients with SCD in 
the U.S. are African American, we will strive to understand intra-ethnic cultural differences that 
will influence how patients and families manage pain based on varying socioeconomic classes 
and national origins through purposive sampling. For example, sociocultural and environmental 
factors may influence pain experiences differently based on regional origins among African 
Americans and African immigrants in the U.S and require greater consideration of sociocultural 
factors in intervention design, such as the meaning of pain and how it is interpreted, how pain 
education and interventions are taught and communicated, patient-provider ethnicity 
concordance, or availability of social network and support (26). Interview guides will be 
finalized in consultation with stakeholder advisory boards (described below) comprised of 
patients with chronic SCD pain and their caregivers representing intra-ethnic diversity from our 
SCD clinics. Research suggests consideration of the following tailoring strategies (which will be 
explored in qualitative interviews): experiences of racism or mistrust related to pain treatment 
or with healthcare providers (e.g. treatment may build communication skills about pain); 
recognizing the importance of family (e.g., allowing family members to be present when 
teaching coping strategies); supporting racial pride and spirituality; recognizing children’s 
respect of elders (e.g., asking parent’s permission for teens to disagree to maintain respect of 
parents); using the family’s strengths; and validating racial-related stressors (22-25, 27).  
Table 1. RE-AIM Planning Approach to Enhance Translation and Dissemination 
Dimensions for Dissemination 
Strategies to Enhance Translation and 
Dissemination  
Reach (Proportion of the target population 
that participated in the intervention)  
• Formative evaluation with potential users and 
nonusers 
• Identify and reduce participation barriers; Use varied 
recruitment strategies 
Efficacy (Success rate in improving 
targeted heath outcome in which benefits 
outweigh harm) 
• Incorporate tailoring to individuals 
• Evaluate quality of life 
Adoption (Proportion of settings or 
practices that will adopt the intervention) 
• Develop recruitment materials, outline program 
benefits and resources 
• Develop interventions to fit specific workflow of the 
setting 
Implementation (Extent to which the 
intervention is implemented as intended in 
the real world) 
• Participatory research methods to enhance 
acceptability for target group 
• Provide clear and detailed intervention protocols and 
training to delivery agents 
Maintenance (Extent to which intervention 
effects and program is sustained over time) 
• Conduct follow-up assessments and interviews to 
characterize success  
• Continuing contact with participants; Consider 
incentives and policy supports 

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Stakeholder Advisory Boards: We will assemble separate patient and caregiver advisory boards 
including our Community Experts to review qualitative feedback, proposed intervention 
adaptation and materials, and undergo a theater test. Adaptations to intervention content will 
be reviewed by the interdisciplinary research team to ensure safety and tolerability for patients 
with SCD pain. Theater testing will pre-test intervention components (Table 2) with the target 
audience to examine attitudes towards the intervention format and content and receive 
feedback to improve acceptability of the material, content, format, and delivery of the 
intervention. We will review treatment modules that capture core mind-body, cognitive-
behavioral, and neuromuscular movement elements of the intervention. After each module, 
advisory board members will complete brief surveys that contain open- and closed-ended 
questions to elicit reactions regarding the applicability of the content and materials. Additional 
discussion will elicit feedback and recommendations on the relevance of the content. Any new 
treatment content or adaptations developed based on qualitative feedback will undergo 
additional theater testing. 
 
Adaptation and Optimization of Treatment Manual: Intervention content, delivery style, and 
Table 2. Proposed I-STRONG intervention session content to be modified by findings from Aim 1  
 
Session 
(P=Parent; 
T=Teen) 
Mind-Body & Cognitive-Behavioral 
Neuromuscular Movement 
Week 
1 
Session 1 (P, T) 
Introduction to I-STRONG program  
Introduce training equipment 
Session 2 (P, T) 
Education about pain, meaning, and 
interpretation 
Education about muscle 
strength, fatigue, and pain 
Week 
2 
Session 3 (P, T) 
Parental guidelines, in vivo practice for 
parents on how to support teen 
Level 1 Holding movement  
Session 4 (T) 
Diaphragmatic breathing, progressive 
muscle relaxation  
Level 1 Holding movement  
Week 
3 
Session 5 (T) 
Mini relaxation  
Level 2 Creating movement  
Session 6 (T) 
Guided imagery   
Level 2 Creating movement  
Week 
4 
Session 7 (T) 
Pleasant activity scheduling    
Level 2 Creating movement  
Session 8 (P, T) 
Open session, review progress and 
adherence to training 
Level 2 Creating movement  
Week 
5 
Session 9 (T) 
Activity pacing; school planning   
Begin Level 3 Resisting 
movement  
Session 10 (T) 
Impact of thoughts and beliefs on pain 
perception    
Level 3 Resisting movement  
Week 
6 
Session 11 (T) 
Using positive affirmations     
Level 3 Resisting movement  
Session 12 (T) 
Thinking traps, cognitive reframing    
Level 3 Resisting movement  
Week 
7 
Session 13 (T) 
Problem solving, Improving 
communication about pain       
Begin Level 4 Functional 
movement  
Session 14 (T) 
Maintenance Planning (Pain Action 
Plan)   
Level 4 Functional movement  
Week 
8 
Session 15 (P, T) 
Review skills and progress with parents 
Level 4 Functional movement  
Session 16 (P, T) 
Review Pain Action Plan and problem 
solving 
Level 4 Functional movement; 
Introduction to home practice  

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materials will be adapted for optimization based on analyses of qualitative feedback from semi-
structured interviews, theater tests, and our interdisciplinary team of experts (draft 1). We will 
seek feedback on the treatment protocol from 5 external topical experts, such as patient and 
caregiver stakeholders as well as physicians and behavioral scientists with significant expertise in 
SCD pain, pediatric chronic pain, and mind-body interventions, which will be integrated for 
adaptation (draft 2). Readability testing (Flesch-Kincaid) will be applied to ensure protocol 
content is below a fourth-grade reading level to enhance health literacy, comprehension, and 
facilitate use and acceptability (draft 3). The treatment manual will then be ready for preliminary 
testing and optimization in Aim 2.  
Aim 2. We will use mixed-method approaches using administration of questionnaires, semi-
structured interviews, performance-based assessment (i.e., 6-minute walk test), and ecological 
momentary assessment via actigraphy to optimize I-STRONG for SCD. We will conduct 2-3 groups 
of 4-6 patients in each group with protocol refinements and optimization after completion of 
each group. Additional groups may be conducted to optimize feasibility and acceptability.  
Measures. Consistent with the NIH HEAL Initiative Common Data Element (CDE) program (19), 
we will collect the nine core pain domains via recommended questionnaires along with 
supplemental measures (see Study Measures table below). All measures have evidence of 
reliability and validity in youth with chronic pain or SCD in this age range and include core 
measures recommended for pediatric pain clinical trials(28). The primary treatment outcome will 
be pain intensity. Secondary outcomes will include pain interference, depressive symptoms, pain-
related fear of movement, pain catastrophizing, and health-related quality of life. Exploratory 
outcomes include objective measures of physical activity. Physical activity will be monitored for 
7 days during assessment time points using actigraphy. Assessments will occur at baseline (T1), 
post-treatment (T2), and 3-month follow-up (T3). At T2-T3, families will rate treatment 
acceptability and satisfaction. We will monitor changes in medical or psychiatric treatment during 
the study using a CRF.  
Study Questionnaires  
Measure 
Description of Measure 
T=Teen Report, P=Parent-Report 
NIH HEAL 
CDE 
T1 
T2 
T3 
 
Screening and Demographics 
 
 
 
 
PhenX Toolkit - Sickle Cell 
Disease Protocol  
Demographics, social determinants of 
health, SCD history(20) (T, P) 
X 
X 
 
 
Pediatric Pain Screening Tool  
Pain risk severity and allocation of 
treatment needs(29) (T) 
 
X 
 
 
 
Primary outcome measures 
 
 
 
 
Brief Pain Inventory (BPI) 
Pain severity  
Pain intensity ratings survey (T) 
X 
X 
X 
X 
 
Secondary outcome measures 
 
 
 
 
Brief Pain Inventory (BPI) – 
Pain Interference  
Functional interference due to pain 
(T) 
X 
X 
X 
X 
Patient Health Questionnaire 
(PHQ-8) 
Depressive symptoms in past 2 
weeks(30) (T, P) 
X 
X 
X 
X 

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General Anxiety Disorder 
(GAD-2) 
General worry in past 2 weeks (T, 
P)(31) 
X 
X 
X 
X 
Pain Catastrophizing Scale 
Exaggerated worried thoughts of 
pain(32, 33) (T, P) 
X 
X 
X 
X 
Pediatric Quality of Life 
Inventory (PedsQL)  
Health-related quality of life and 
impact on child and family in the past 
month(34, 35) (T, P) 
X 
X 
X 
X 
Adolescent Sleep-Wake Scale  Sleep quality and duration(36) (T) 
X 
X 
X 
X 
NIDA Modified Assist Tool-2 
Substance Use Screener past 3 
months(37) (T) 
X 
X 
 
X 
Opioid Use 
Self-report of analgesics consumed 
(yes/no) for 7 days in conjunction 
with daily pain diary  
X 
X 
X 
X 
Patient Global Impression of 
Change (PGIC) 
Overall rating of efficacy of 
treatment(28) (T) 
X 
 
X 
X 
Treatment Evaluation 
Inventory 
Treatment acceptance and 
satisfaction (T, P)(38) 
 
 
X 
X 
Tampa Scale of 
Kinesiophobia  
Fear of movement related to fear of 
pain(39) (T)   
 
X 
X 
X 
 
Exploratory outcome measures 
 
 
 
 
6-minute walk test  
Distance patient can walk over a total 
of six minutes on a hard, flat surface 
(T)(40) 
 
X 
 
X 
Physical activity via 
actigraphy  
Peak and Total daily physical activity, 
categorized into light, moderate, and 
vigorous activity(41, 42) 
 
X 
 
X 
Healthcare utilization  
Total # ED visits, admissions for pain 
for 6-months via medical chart 
review in compliance with HIPPA 
 
X 
 
X 
 
I-STRONG Intervention. In addition to usual care, youth will receive the I-STRONG intervention 
consisting of 16 group-based telehealth sessions (90 min/session) held twice per week over 8 
weeks. Group size will vary with up to 4-6 patients with SCD per group, which was found to be 
the ideal group size based on our pilot work. Parents will be included in at least 6 of the 16 
sessions and will receive education about I-STRONG, instruction on how to support teen behavior 
change to enhance generalizability at home, and have opportunities for social support and 
networking with other parents of youth with SCD. Participants will have the opportunity to 
interact with other participants during group sessions as well as two shared interventionists (a 
behavioral coach and movement coach). As is common for behavioral interventions in clinical 
trials, treatment completion is defined as attending at least 75% of sessions. 
The intervention will be delivered jointly by a behavioral health coach (e.g., doctoral-level 
psychology provider) and movement training coach (e.g., trained physical therapist, exercise 
physiologist) using a restricted password-protected, HIPPA compliant audio-video virtual 
platform (e.g., Zoom Business). As described in Table 2, the behavioral health coach will deliver 
mind-body and cognitive-behavioral strategies for the first 30 mins of each session to reduce 

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comorbid depressive symptoms and fear of movement. Patients will learn to apply the mind-
body skills, such as diaphragmatic breathing, progressive muscle relaxation, guided imagery, and 
mindfulness techniques, in-vivo as they learn increased body awareness and strengthening and 
progress through increasing levels of challenge in the movement training. The movement training 
coach will deliver specialized progressive neuromuscular movements using available household 
items (e.g., pillow, chair, wall) for the latter 30 mins of each session. The movement training will 
begin with an introduction to the specific movements with education about proper form and 
technique, benefits of each movement, and relationship of each movement with improved ability 
for performing daily activities (e.g., climbing stairs, walking briskly, sitting in class, waiting in line, 
bending to pick up an object). Movement training will follow a specialized protocol that employs 
phasic progression based on the different muscle actions and their associated likelihood for 
induced muscle pain and soreness during and after movement. The four phase protocol is 
systematically progressed from Level 1: Holding Movement, Level 2: Creating Movement, Level 
3: Resisting Movement, to Level 4: Functional Movement and has been published in detail(43) 
and provided in the appendices. The prescribed movements, sets, and repetitions will be 
individualized in intensity and difficulty based on patient’s baseline ability so that they are 
attainable for each patient and modified as needed. Initial volume selection will be low to allow 
patients with SCD to learn how to perform each movement while integrating learned mind-body 
and cognitive-behavioral skills, enhancing body awareness and emotional regulation, and shifting 
self-perception of their capability to maintain proper form. Movements will only progress after 
patients can properly perform the movement at the prescribed intensity and difficulty. The 
movement coach is skilled in recognizing proper technique and will provide constructive 
feedback to support learning. Participant feedback on movement exercises and modifications 
will be monitored throughout the intervention to inform subsequent protocol adaptations.  
Maintenance phase. After the 8-week active treatment phase, we will have 1 group-based 
booster session timed to occur at the mid-point between post-treatment and 3-month follow-
up. The booster session will problem-solve any difficulties teens or parents may have had with 
using skills learned via I-STRONG at home or school. 
 
Intervention Fidelity. Behavioral health and movement coaches from all sites will attend a two-
day in-person workshop led by the PI (Dr. Sil), Dr. Kashikar-Zuck, and experienced lead 
interventionists at Cincinnati. Written intervention manuals promote quality assurance and 
include materials for training, supervision, and fidelity monitoring (see appendices). Following a 
procedural training plan, coaches will conduct role-plays of content until they demonstrate 
proficiency on delivering content. Once the trial is underway, continued training, feedback, and 
monitoring will occur over monthly coach teleconferences. Coaches will receive weekly onsite 
supervision by Drs. Sil and Crosby to minimize drift. Treatment sessions will be video recorded. A 
random sampling of 20% of sessions will be reviewed to ensure standardization and monitor 
protocol adherence via fidelity checklist monitoring. Examples of fidelity monitoring include 
monitoring of homework assignment and completion, daily diary review, instruction in the use 
of coping skills, instruction in neuromuscular movement exercises, and developing a plan to 
practice skills outside of sessions. Fidelity checklists will be completed by a trained independent 
rater. Participant attendance at group sessions will be tracked via study session forms.  

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Study Intervention Adherence. Adherence to treatment will be assessed based on patient 
attendance at treatment sessions and patient self-report of home practice of mind-body, 
cognitive-behavioral, and movement skills. Participants who miss sessions will have the 
opportunity to catch up individually with their coaches prior to the next group session (e.g., 30 
minutes before the next session for patient and/or parent who missed previous session) to 
ensure timely delivery of intervention content to all group members. Participants will not be 
integrated into a different group to ensure maintenance of group cohesion. If a patient is 
hospitalized during the treatment phase and there are no medical contraindications for their 
participation in treatment sessions, patients will be provided a opportunity to participate in 
sessions to the extent possible (e.g., join via iPad to learn mind-body or cognitive-behavioral 
strategies and observe or modify neuromuscular movement to their ability).  
Semi-structured qualitative exit interviews. At the end of the treatment program, caregivers and 
patients will be asked for feedback in separate one-on-one interviews lasting up to 90 minutes. 
The interviews will elicit participants’ impression of the program, how well they could do mind-
body, cognitive-behavioral, and movement skills in session, feedback about the difficulty level of 
movement and progression of movements. Participant feedback about content and format of 
sessions will also be solicited including how they liked the program, how well the content was 
integrated, interest level, length of sessions and format, size and cohesion of group-based 
sessions, and any suggestions or changes to the materials or format. Information from these 
interviews will be used to refine and optimize I-STRONG for SCD. Interviews will be conducted by 
telehealth and will be audio recorded as digital files and transcribed for analysis. 
Stakeholder Advisory Boards: We will reconvene our existing patient and caregiver advisory 
boards assembled to support the intervention adaptation to review qualitative feedback from 
exit interviews and proposed intervention adaptation and refinements. An iterative process 
allows for continued optimization to ensure feasibility and promote acceptability(15). 
 
7. Sharing of Results with Participants 
Patients and parents may elect to receive aggregate data on the study findings at the 
completion of the study (e.g., via study newsletter, email, or mailed letter). 
 
8. Study Timelines 
Aim 1. Patients and parents who provide consent/assent for Aim 1 will participate up to 6 
months (between 1-6 study visits). Patients and parents who only complete the qualitative 
interview will participate for 1 study visit; patients and parents who are part of the stakeholder 
advisory boards will participate for up to 6 study visits.  
Aim 2. Patients and parents who provide consent/assent for Aim 2 will participate up to 5 
months (20 study visits), including 3 study assessments, 16 intervention sessions, 1 booster 
session, and qualitative exit interview combined with post-treatment assessment. 
 
 

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9. Inclusion and Exclusion Criteria 
 
Inclusion criteria:  
(a) 12-18 years old (the developmental period when chronic pain is prevalent among youth (44)), 
(b) diagnosed with SCD (any genotype),  
(c) score at least 3 (indicating medium to high risk for chronic pain) on the Pediatric Pain 
Screening Tool (29, 45). 
(d) stable disease-modifying treatments, if applicable, as defined by no newly initiated or 
significantly increased dosasges (mg/kg) in the past 3 months (Aim 2 only) 
(e) English fluency (Aim 2 only) 
 
Exclusion criteria:  
(a) comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., 
rheumatologic disorders or inflammatory bowel disease);  
(b) significant cognitive or developmental limitations, as per their healthcare provider or parent, 
which would impair completion of self-report measures or engagement in mind-body 
interventions. 
(c) presence of a condition(s) or diagnosis, either physical or psychological, or physical exam 
finding that precludes participation (e.g., severe avascular necrosis with limited or non-weight 
bearing restrictions, significant cognitive or developmental limitations, active suicidal ideation) 
(Aim 2 only) 
(d) Adolescent receiving active treatment (e.g., weekly appointments with a provider) for 
nonpharmacological therapies (e.g, structured behavioral pain management, physical therapy, 
or acupuncture program) that overlap with the active phase of the study intervention (Aim 2 
only) 
 
For Aim 2, participants will be screened for access to necessary resources for participating in a 
technology-based intervention (i.e., computer, smartphone, internet access). Reliable resources 
(e.g., device, wireless hotspot) will be provided to participants in need of them.  
 
 
10. Population 
The participant population will include parents and adolescents with SCD aged 12-18 years, which 
represents the developmental period when chronic pain is prevalent among youth. Patients who 
are 18 years old may participate without a parent or caregiver, although parent participation is 
preferred. Individuals who are not able to clearly understand English will be included in Aim 1 
qualitative interviews with the support of a medical language interpreter.  
Using the same eligibility criteria described above, we will assemble separate patient and 
caregiver advisory boards comprising up to 8 patients with chronic SCD pain and 8 caregivers to 
support decision-making regarding intervention adaptations and further refinements. We 
maintain collaborative working relationships with young adults with SCD who have transitioned 
from our programs into adult care to engage ongoing community education and support through 

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structured programs and events (e.g., SCD education day) and community health workers 
through the SCD Foundation of Georgia. We will solicit their partnership as advisory board 
stakeholders to amplify the voices and real-world needs of young adults with SCD to inform 
successful pain management into adulthood.  
 
11. Vulnerable Populations 
The research involves children under 21 who have not attained the legal age for consent to 
treatments or procedures involved in research. This study involves no greater than minimal risk 
to children. It presents the prospect of anticipated direct benefit to individual participants by 
teaching coping skills that may help improve pain management. Parental permission of one 
parent will be obtained and assent will be obtained from children to ensure voluntary 
participation. Parental permission, parental consent, and child assent will be documented.    
12. Local Number of Participants 
Participants will be recruited from two pediatric centers with large SCD patient populations: 
Emory/Children’s Healthcare of Atlanta (CHOA) and Cincinnati Children’s Hospital Medical 
Center.  
For Aim 1, approximately 15 patient-caregiver dyads will be recruited to complete qualitative 
interviews (8 from Atlanta, 7 from Cincinnati). Patients (n=8) and caregivers (n=8) will also 
participate in stakeholder advisory boards (8 from Atlanta, 8 from Cincinnati). Additional dyads 
will be recruited as needed to achieve saturation of themes. 
For Aim 2, approximately 12 patient-caregiver dyads will be recruited to complete the group-
based I-STRONG intervention to optimize feasibility and acceptability (approximately 6 enrolled 
at Atlanta and 6 at Cincinnati). Additional dyads will be recruited as needed to iteratively 
optimize intervention feasibility and acceptability.  
Estimates of sex and race inclusion are derived from our sites’ sickle cell disease clinic database. 
Based on these data, it is expected that approximately 60% of the adolescents enrolled will be 
female and approximately 90% of parent participants will be female. The higher percentage of 
female patients is consistent with evidence in the literature on pediatric chronic pain. This high 
percentage of mothers reflects the nature of pediatric research and statistics from similar studies 
which also show significantly higher participation of mothers than fathers.  
Patients and parents of any race and ethnicity will be recruited for the proposed aims. Based on 
our sites’ sickle cell disease clinic database, it is expected that children and adolescents along 
with their parents will be 98% Black or African-American, 2% biracial or multiracial, and 2% of 
Black participants will be Hispanic or Latino. The predominance of Black or African-American 
patients in this cohort is also consistent with the racial distribution of sickle cell disease.  
13. Recruitment Methods 
Based on prior success, existing clinic registries will be screened for eligibility by the local study 
investigator. Based on previous feedback from families, we will prioritize initial in-person contact 
about the study from a trusted healthcare professional directly known to the patient. Each site 

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will also contact participants in their research database who have agreed to be contacted for 
future studies either with a phone call, mailed letter and infographic describing the study in a 
“who, what, where, and why” format, or in-person during scheduled clinic visits. Mailed letters 
will be followed up with a personal phone call to the family to describe the study in further detail 
and determine interest and eligibility. All potentially eligible patients will be approached and 
screened during their routine outpatient SCD appointment. If youth and caregivers are interested 
in learning more, study staff will provide details, opportunities for questions, and seek informed 
consent and assent. Designated research coordinators who are racially representative of the 
patient population will conduct screening procedures and remain the primary research study 
contact during the family’s study participation. We will track the number of eligible patients 
screened by phone or in-person, enrolled, and reasons for refusal.  
 
We will use purposive sampling to recruit a representative sample of a broad patient population 
based on patient age, sex, SCD genotype, national origin (e.g., African, Caribbean, African 
American), and family socioeconomic status. Our sites have used the following strategies to 
achieve 80-95% recruitment rates for qualitative interview participation and proactively manage 
scheduling challenges: (1) survey families for good dates/times; (2) schedule sessions virtually or 
at hospital campus locations closest for families; (3) obtain endorsement from trusted medical 
staff; (4) respectful face-to-face, phone, and written communication from consistent study team 
members highlighting the importance of family involvement to improve SCD care; (5) 
transportation vouchers and child care during interviews to allow sustained attention and 
participation; (6) meals and/or activities to engage all family members; and (7) anticipate 
facilitators/barriers to participation to refine planning and marketing strategies (46). We will 
optimize these recruitment strategies based on iterative stakeholder feedback.  
Iterative patient, parent, and community expert stakeholder engagement through qualitative 
interviews and advisory board involvement will optimize and enhance these retention strategies:  
• Identify 2 contact persons knowledgeable of participants’ updated contact information to 
minimize loss to follow-up due to relocation  
• Obtain email addresses for patient and parent to optimize communication if cellular 
service is limited 
• Offer electronic device or hotspot to participants in need of reliable device access and 
network connectivity  
• Continued frequent mailings (e.g., newsletters, birthday cards) to foster study 
engagement  
• Email and text message reminders of upcoming visits and assessments  
• 24-hour follow up on “incomplete” sessions or assessments to facilitate timely 
completion 
• Development and distribution of study tokens (e.g., magnets, keychains) to enhance 
study recognition and engagement   
 
14. Withdrawal of Participants 

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Participants have the right to leave the study at any time without penalty. If participants choose 
to leave the study before the final planned study visit, participants may be asked to have some 
final study procedures completed including but not limited to qualitative exit interviews to 
inform reasons for leaving the study and addressing any barriers to participation.  
Study personnel may stop participant involvement in the study without participant consent for 
any reason to maintain the best interest of the participant or if participants object to any future 
changes that may be made in the study plan.  
 
15. Risk to Participants 
Questionnaire Data:  Study questionnaires may contain potentially sensitive questions 
concerning demographics, which may elicit emotional discomfort.  Completion of questionnaire 
assessments may produce fatigue in some participants and burden related to length of 
assessments will be kept at a minimum.  
Individual Interviews: The potential risk to participants is minimal.  Potential risks for participants 
include feelings of emotional discomfort when discussing their/their child’s experiences with 
sickle cell disease and pain management and loss of confidentiality. Completion of individual 
qualitative interviews may produce fatigue in some participants. Procedures to protect against 
these risks are detailed in the Provisions to Protect Individuals section below. Overall, the 
interview discussions do not significantly increase the participants’ risk of harm beyond those 
risks that are inherent in ordinary daily living. 
Distress, Pain, or Fatigue:  There is a possibility that they may feel uncomfortable when discussing 
experiences with SCD, pain management strategies, pain-related mood changes, or engaging in 
neuromuscular movement training. The only potential risks/discomforts related to the 
neuromuscular movement training is that participants may experience temporary increase in 
muscle pain/soreness and/or fatigue since many of them may have been quite sedentary prior 
to the program. So far, participants have not reported any distress related to the assessments or 
the treatment, or had any injuries or pain flares. They report slight temporary soreness with the 
neuromuscular movement training as expected but this resolved within a day or two with rest 
and use of heat if needed.  
Inconveniences: There should be minimal discomfort related to the length of sessions (about 90 
minutes). The only foreseen inconveniences are participating in telehealth treatment sessions 2 
times per week for 8 weeks (subject to modification based on Aim 1 results) or wearing the wrist-
mounted accelerometer.   
Confidentiality:  There is a small risk to confidentiality about identifiable information on the self-
report questionnaires. I-STRONG sessions are expected to be conducted in a group setting (4-6 
participants per group) and there is some risk that confidential information about participants 
may be shared with those outside of the group, by group members.  Also, there is a small risk to 
confidentiality about identifiable health information on the self-report questionnaires. 
 
 

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16. Potential Benefits to Participants 
Participation in this qualitative study and feasibility study may or may not directly benefit 
participants. Information collected will provide useful data regarding adaptations and cultural 
tailoring of intervention content to meet the unique needs identified by adolescents with chronic 
SCD pain and their parents along with their treatment preferences. Participants may find some 
benefit through sharing their experiences and insights during interviews and treatment sessions. 
This will provide critical knowledge for the optimization of I-STRONG in this population. The 
potential risks of participation to participants are considered to be minimal in relation to the 
potential gain.  
17. Compensation to Participants 
 
Aim 1. Participants will receive compensation after completion of qualitative interviews ($100). 
Stakeholder engagement will include a variety of activities, such as surveys, phone calls, virtual 
or in-person meetings. Patient and parent stakeholders will be compensated a consistent 
$100/hour rate for their time. Stakeholders will be compensated at a prorated rate if activities 
require less than an hour (e.g., pay per the quarter hour).  
 
Aim 2. Participants will receive financial compensation for the time commitment necessary for 
their study participation (assessments, treatment sessions, actigraphy, qualitative interviews). 
Participants (patient and caregiver) will each receive $30 compensation after completion of each 
assessment (baseline, post-treatment, 3-month follow-up), $60 after completion of each 
treatment session, and $100 after completing the qualitative exit interview. Patients will also 
receive $10 per day for wearing an actigraph up to 7 consecutive days per assessment time point.  
All compensation will be prorated appropriately as per IRB guidelines. Participant compensation 
will be provided in the form of Clincards. There will be no cost to the child, parent, or their 
insurance company for participation in the study.  
 
18. Data Analysis, Management and Confidentiality 
Aim 1: Qualitative and Quantitative Data Analysis Plan. Past research involving semi-structured 
interviews of children and adolescents with SCD and their families achieved saturation of themes 
with 11-15 participants (47-50). We anticipate our proposed 15 participants will be feasible to 
achieve saturation, and more interviews will be convened if needed. Inductive data collection 
methods will contribute to iterative refinements to the interview guide. Interviewers will engage 
in verbal debriefings after interviews and listen to interview recordings to identify key issues 
raised or any new or surprising information and identify areas that need follow-up in additional 
interviews. The core interview topics and questions will remain the same, with refinements and 
additional probes to questions as warranted. Collectively, these strategies help gain a deeper 
understanding of the topics, guide purposive sampling, and inform when saturation of 
information is achieved. Interviews will be audio-taped as digital files and transcribed for analysis 
as they are completed. Transcripts will be actively reviewed repeatedly with the use of memoing 
to enhance familiarization with the information while remaining aware of existing ideas and 
understanding of chronic pain and SCD, and open to innovative ideas and unique perspectives. 

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We will discuss and compare memos to develop a preliminary codebook, which will contain code 
definitions and coding rules and will be refined on an ongoing basis. We will use a grounded 
theory-informed constant comparative approach for qualitative coding to develop a coding 
system for thematic domains and a coding scheme for intervention preferences (including 
cultural and developmental considerations)(51). Qualitative data will be analyzed using 
MAXQDA. Data will be analyzed on an ongoing basis to guide subsequent data collection and 
adjustments to recruitment and interview guide. Interview data will be coded by two 
independent reviewers to enhance confirmability and dependability of conceptual domains (52, 
53). Reviewers will meet to discuss coding discrepancies, reach consensus, and refine the 
codebook and definitions to enhance reliability of coding. An embedded concurrent mixed 
methods design will allow qualitative interviews to complement and expand inferences from 
quantitative demographic and survey data to examine feedback about each treatment module 
from theater testing(54). Group-level qualitative data will be analyzed with individual 
quantitative contributors taken into consideration. Descriptive statistics will be calculated and 
integrated with qualitative findings. This will result in a systematic approach to intervention 
adaptation to enhance relevance and acceptability.  
 
Aim 2. Feasibility and Acceptability  
Feasibility will be characterized with descriptive statistics (means, standard deviations), 
frequency counts, and percentages to determine enrollment (percent of eligible participants that 
consent), retention rates (percent of patients completing the study at primary endpoint of 3-
months follow-up), completion of primary outcome assessments (percent of primary outcome 
assessments completed), and treatment completion (percent of planned or makeup treatment 
sessions completed). We anticipate with iterative refinement to achieve the following target 
goals: ≥30% of eligible patients approached will consent, ≥75% retention rates, ≥90% completion 
of primary outcome assessments at 3-month follow-up assessment (primary endpoint), and 
≥75% treatment completion (attending at least 75% of planned or makeup sessions). Treatment 
engagement will examine the rate of homework completion with goals of 75% “some” homework 
completion. Safety will be assessed throughout the study as described in Section 8.2. Iterative 
adaptation and refinement will optimize achievement of feasibility goals. 
Acceptability will be determined by qualitative analysis of individual interviews at the end of 
treatment to elicit perceptions about treatment content (utility, appropriateness) and format 
(convenience, number and length of sessions). We will also use the Treatment Evaluation 
Inventory. Total scores range from 9-45. Scores ≥ 27 indicate “moderate” treatment 
acceptability(38). Descriptive statistics (means, standard deviations), frequency counts, and 
percentages will characterize treatment satisfaction and primary and secondary outcomes. We 
will use the qualitative analytic approach described in Section 9.4.1 to identify key themes from 
interviews and optimize I-STRONG for testing in a randomized clinical trial. 
 
Exploratory Analysis. Descriptive statistics including means, standard deviations, frequency 
counts, and percentages will characterize performance-based measures (6-minute walk test) and 
healthcare utilization per medical chart review.  
 

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Objective measures of physical activity via actigraphy will be characterized by descriptive 
statistics, including frequency counts, percentages, means, and standard deviations. Feasibility 
metrics will include participant adherence to wearing the actigraphs (e.g., percent of time during 
the day, percent of days per week).  A “complete” day of data will be defined as ≥ 80% of monitor-
wearing time. Descriptive statistics will characterize average activity counts per minute during 
daytime hours, peak activity, and average time (in minutes) spent in sedentary, light, moderate, 
and vigorous activity per day during daytime hours.  
 
19. Provisions to Monitor the Data to Protect the Safety of Participants 
We recognize the need to provide a plan to ensure the scientific integrity and safeguard the well-
being of study participants. The study team is highly qualified to lead the qualitative interviews 
and behavioral intervention.  All study interventionists will be trained to conduct the 
interventions using a manualized protocol and will monitor the comfort and safety of participants 
at each session.  The PI and study interventionists will have regular monthly meetings to discuss 
the progress of the study, the integrity of the treatment delivery, and discuss any adverse events.  
Internal monitoring of the trial for protocol compliance and data accuracy will be the 
responsibility of the Research Administration QA/QI Analyst. The trial will be monitored for 
completion of the informed consent forms, clinical data capture forms, IP dispense logs and 
treatment-related adverse events not related to SCD. In addition, the credentials, delegation of 
authority and training logs will be monitored for study member. The monitoring will occur 
according to the following schedule: 
 
• 
At least every six months while participants are receiving intervention and 
• 
Annually while participants are in follow-up 
• 
Close-Out Study Visit 
  
Additional monitoring may be performed in the event of Serious Adverse Events if deemed 
necessary by the monitoring committee or if requested by the Principal Investigator. 
  
This study will be conducted in compliance with the Aflac Cancer & Blood Disorders Center Data 
Safety Monitoring Board (DSMB) for Phase 1 and 2 pediatric studies. In brief, the role of the Data 
Safety Monitoring Board (DSMB) is to protect the interests of subjects and the scientific integrity 
for all Phase 1 and 2 studies. The DSMB consists of 7 members including a chair, a statistician, a 
pharmacist, and at least one external member. 
  
The DSMB meets on a quarterly basis to review current study results, as well as data available to 
the DSMB from other related studies. The DSMB will provide recommendations for each study 
reviewed to change the study or to continue the study unchanged and will determine the 
frequency of future meetings. 
  
Data and Safety Board reports for Institutional Review Boards will be prepared. The Principal 
Investigator assumes responsibility for assuring that the study is carried out in accordance with 
the DSMP. 

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DSMP Requirement 
How this Requirement is Met 
Frequency 
Responsible Party(ies) 
Site Monitoring at pre-
determined intervals: The 
Principal Investigator has a 
responsibility to ensure that 
the study is following all 
aspects of the protocol. 
There should be a standard operating 
procedure to review data (whether a 
sample or 100%) at pre-determined 
intervals to ensure that there is 
adequate documentation of critical 
elements such as eligibility criteria. 
Monitoring is required at the 
following timepoints (but may be 
done more frequently): 
• 
study initiation  
• 
at least every six months 
while participants are 
receiving intervention and 
• 
annually while participants 
are in follow-up 
At a minimum, a 
review is required 
annually when no one 
has been enrolled or 
the study is in long 
term follow up. 
Additional interim 
monitoring at least 
once every 12-24 
weeks based on the site 
activity, and more as 
needed, to include the 
possibility of remote 
monitoring. 
Delegate a responsible 
party for each 
requirement below*. Self-
assessment is NOT 
acceptable. An 
experienced, 
knowledgeable 
person who is 
independent of the study 
team should serve as 
monitor. A Contract 
Research Organization 
(CRO) may be used. 
Consult the IRB Office 
regarding acceptable 
qualifications for the 
independent monitor, if 
not using an outside 
expert such as a CRO. 
  
Real-time review of 
participant data during 
initial data collection. 
Inclusion/Exclusion Checklist is 
completed by the CRC via 
RedCap  
This is completed 
when patients 
enroll 
Study team and PI 
100% review of 
regulatory files 
Regulatory binder will be 
created to house all Regulatory 
documents for review. 
Regulatory files will be reviewed 
by monitor at monitoring visits. 
Start of study, close 
out and as 
necessary in 
between 
Team coordinators, 
QA/QI Analyst 
100% review of consent 
forms 
Per Aflac policy, all consents are 
reviewed in real time by 2 
separate coordinators.  The first 
review is within 5 days of the 
consent. The next review is 
within 5 days of the first review 
but within 10 days of the 
consent date. Consents will be 
reviewed by monitor at 
monitoring visits. 
As consents are 
signed 
Team coordinators, 
QA/QI Analyst 
Review of credentials, 
training records, the 
delegation of 
responsibility logs (if 
applicable) 
Study training logs are kept in 
the Regulatory Binder for review 
with the upkeep of the 
coordinators. This information 
will be reviewed by monitor at 
monitoring visits. 
Reviewed every 
time there is a new 
staff added to the 
study as well as 
study amendments 
Team coordinators, 
QA/QI Analyst 

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Comparison of case 
report forms (CRF) to 
source documentation 
for accuracy and 
completion 
Data will be stored via Redcap. 
CRF documentation will be 
reviewed by monitor at 
monitoring visits.  
Yearly Review 
Principal Investigator, 
QA/QI Analyst 
Review of 
documentation of all 
adverse events 
The PI will have oversight on the 
documentation of AE’s which 
will be logged and tracked by 
the study Coordinator and kept 
in the subject’s chart. AE 
documentation will be reviewed 
by monitor at monitoring visits. 
Every time an AE 
occurs the Study 
Coordinator will log 
it. Monitor will 
review at specified 
monitoring 
intervals. 
Principal Investigator, 
Team Coordinators, 
and QA/QI Analyst 
Monitoring of critical 
data points (eligibility, 
study endpoints, etc.) 
Data Collection and data points 
is captured via RedCap and is 
the responsibility of the study 
coordinators under the 
supervision of the principal 
investigator to make sure all 
questionnaires are completed. 
The coordinators are 
responsible for ensuring 
accuracy, completeness, 
legibility, and timeliness of the 
data reported. The PI will have 
oversight over all data collected 
for the study. The monitor will 
review critical data points at 
monitoring visits. The PI will 
review all monitoring reports 
upon the completion of a 
monitoring visit. 
Eligibility will be 
done at time of 
patient enrollment. 
Study endpoint will 
be reviewed at end 
of each treatment 
period 
  
Principal Investigator 
and Team 
Coordinators, and 
QA/QI Analyst 
For FDA regulated 
studies, the following 
requirements apply: 
How this Requirement is Met 
Timing, frequency, 
and intensity of 
monitoring 
Responsible Party(ies) 
Monitoring methods 
(may include centralized, 
on-site, and self-
monitoring) 
The QA/QI Analyst will be 
monitoring this study going 
forward. 
As per protocol 
QA/QI Analyst  
*For international studies, you are required to engage a CRO that is working in the site country and/or to consult with 
Emory’s legal counsel regarding compliance with the country’s clinical research regulations. 
 
 

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20. Provisions to Protect the Privacy Interest of Participants 
General: To help reduce any uneasiness or discomfort about answering questions about their 
health, the research protocol includes standardized measures that have been widely used in 
other research of youth in this age range with SCD without adverse effects. Participants will be 
allowed to skip any questions that they do not feel comfortable answering and will have 
opportunities for breaks to minimize fatigue. Participants will be informed of their right to 
terminate their participation in any part of data collection at any time and will be given phone 
numbers of the PI as well as the IRB if they would like to issue a complaint or desire any additional 
information regarding the study. 
Electronic Daily Pain Diary: Participants will be consented and informed that pain intensity data 
collected through the 1-week pain diary during assessment time points is not a means of 
communicating with their provider, but only as a reporting tool for the study. Data will be 
reviewed a minimum of once weekly during data entry. Participants with high pain scores (pre-
determined at time of enrollment) may be contacted by a research staff member to ensure that 
participants have sought care for pain-related concerns with their healthcare provider. Research 
staff members will not provide medical advice. The consent form will clearly indicate that data 
collected in the study is for reporting purposes only and not as a means to inform their healthcare 
provider of pain needs or seek medical attention. Given the minimal risk of the electronic pain 
diary, we do not anticipate concerns with its use.  
Distress, Pain, or Fatigue: The neuromuscular movement training component of I-STRONG will 
be conducted by a highly trained master’s level exercise physiologist or physical therapist closely 
supervised by the PhD level co-Is (Myer, Kesar) who are experts in neuromuscular training and 
rehabilitation. The neuromuscular movements have been carefully designed to take into account 
participants’ baseline abilities and the difficulty level will be modified accordingly.  Participants 
will be allowed to take rest breaks during sessions. The Site Hematologist PIs will be available to 
address any reports of increased pain or discomfort arising from neuromuscular movement 
training that may need medical attention.  The intervention protocol has been specifically 
designed to minimize delayed-onset muscle soreness and facilitate functional movement 
required in daily life (e.g., bending to pick up an object, climbing stairs). 
Depression Screening: In the event that one of the procedures reveals indicators of significant 
depressive symptoms or suicidal ideation, a standard suicide-risk plan will be implemented.  Drs. 
Sil, Kashikar-Zuck, and Crosby (PI and Co-Is, respectively) and their research staff are already 
trained in a standard risk assessment protocol that has been successfully implemented in their 
prior studies. Research staff will check child and parent responses to the self-report 
questionnaires after completion to determine whether depressive symptoms fall in the clinical 
range. In the event that a participant endorses clinically significant depressive symptoms, suicidal 
ideation, or reveals a history of abuse on questionnaires or during interviews or treatment 
sessions, research staff will notify the Site PI (or a designated covering investigator, if Site PI is 
not available) who will conduct a risk assessment, either by phone or in person, using several 
screening measures (Ask Suicide-Screening Questions, ASQ; Brief Suicide Safety Assessment, 
BSSA).  Drs. Sil, Kashikar-Zuck, and Crosby are licensed clinical psychologists and will be available 
24 hours a day to be called via cell phone to address crisis questions at their site. Psychiatric or 

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other life crises that are high risk and imminent will be acted upon immediately with staff linking 
participants to appropriate crisis services (e.g., a referral to the ED, if necessary, community 
agencies for ongoing care). These are reviewed immediately with the clinically responsible PI. 
Lower risk and less imminent crises will result in an attempt to help the participant devise a plan 
for treatment and/or safety.  For example, major stresses, availability of social supports, access 
to treatment, and plans for safety will be discussed in detail with the participant, and appropriate 
referrals for treatment will be provided. These cases will be reviewed within 24 hours by the 
clinically responsible PI. All actions taken will be documented on a case report form. Based on 
our prior experience in similar psychosocial pain research in SCD, we anticipate this risk to be 
very low. 
Inconveniences: To minimize inconveniences of participating in the study, we will integrate 
patient and caregiver stakeholder feedback to inform intervention design and adaptation. With 
key stakeholder feedback, inconveniences to treatment engagement will be minimized to 
optimize feasibility and acceptability. The number of treatment sessions is similar to the 
frequency of prescribed physical therapy visits in most clinical settings for pain/rehabilitation and 
therefore not thought to be unduly burdensome compared to usual clinical care. We will take 
care to schedule the group sessions at times convenient to the participants (including after-
school hours) so that they are able to attend sessions regularly. Sessions will be held via 
telehealth to offer ease of access from the patient’s home. Our past studies indicate minimal 
discomfort reported by patients wearing a wrist-mounted accelerometer.  
Confidentiality: This study will have several protections in place to minimize risk to loss of 
participant confidentiality. The participant’s identity, research records, and personal health 
information will be safeguarded using secure password-protected services. Primary sources of 
data from questionnaires and digital audio-video files will be stored on a secure password-
protected database that is protected by the highest standards for electronic data safety. The 
research staff will utilize a variety of safeguards to protect the study from loss of data. All data 
will be coded with participant ID and no personal identifiers will be associated with these data. 
Only the study PI and other members of the research team will be able to access participant data. 
The list of identifying information linking subjects to their ID numbers will be kept in a restricted 
electronic file.  
Every effort will be made to assure that the data from the qualitative interviews and treatment 
sessions are kept confidential. At the onset of each qualitative interview and treatment session, 
participants will be reminded of audio recording and will be asked to refrain from revealing 
personal information that could result in identifying them to protect anonymity and 
confidentiality. The audio recordings produced from the interviews and sessions will be used only 
for the purposes of the study. Participants will be asked to keep all comments made in the group 
sessions confidential. Each participant will be assigned an anonymous study code number in the 
transcript of the audiotape. Once transcribed, the computer data files will be password-
protected, and these data files will have no personal identifiers and contain no information 
linking an individual participant with their study code. These protections will be explained in the 
consent form.  
 

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21. Economic Burden to Participants 
There are no direct costs to participants who decide to take part in this study.  There are the 
indirect costs related to transportation or parking if there are any in person meetings for the 
advisory board and assessments.  All other participation will take place at standard clinic visits, 
virtually or on the telephone. 
 
22. Informed Consent  
Research staff will screen interested participants for eligibility via phone or in person during 
clinic visits. During the screening, research staff will share a 1-page study infographic and 
explain the study procedures, study risks/benefits, and assurances of a participant’s right to 
discontinue the study at any time. If children and parents are interested in participating, study 
staff will provide parents and children with electronic or hard copies of the consent and assent 
forms for them to review. Names and phone numbers of the PI and the Institutional Review 
Board will be provided in these consent forms. The PI or research coordinator will review the 
Child Assent Form in detail with each child to ensure full understanding of the study by asking 
children to repeat the procedures back to the staff.  Each child will be given the opportunity to 
ask questions about the study and discuss their decision to participant with their parent(s). The 
same process and explanation will be repeated separately with parents to ensure they fully 
understand the study. Parents will provide permission for their child’s participation as well as 
consent for their own participation.  Parental permission for one parent will be required even if 
the other parent is alive, known, competent, reasonably available, and shares legal 
responsibility for the care and custody of the child. The original consent forms will be kept in a 
locked file cabinet in the Clinical Research Office, separate from all other data and PHI. For 
participants completing consent and assent by phone, electronic consent and assent forms will 
be sent via a web link to an online consent form via CHOA’s REDCap platform, which is a secure 
platform compliant with 21 CFR part 11. Once these documents are received by the participant, 
the coordinator will call the subject and have the consent discussion over the phone as 
described above. The participant will electronically sign the consent form. The fully executed 
signed consent forms will be uploaded into the participant’s REDCap record and emailed to 
participants for their records. The coordinator will document the telephone consent via a 
Telephone or Research Encounter Note in the patient’s research record. 
 
Separate consent and assent forms will be available for study procedures related to Aim 1 
(Development and Adaptation) and Aim 2 (Optimizing Feasibility and Acceptability). Separate 
consent and assent forms for Aim 1 and for Aim 2 were informed by patient and parent 
stakeholder feedback to simplify the consent and assent process and to ensure clarity in study 
procedures. Although most of the eligibility criteria for Aims 1 and 2 are similar, the additional 
criteria required for Aim 2 is best clarified in separate consent/assent forms to ensure 
participants are consenting and assenting to study procedures for which they are eligible. 
Lastly, eligible participants may enroll in the study procedures for either Aim 1 or Aim 2 or both.  
  
Non-English-Speaking Participants   

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It is possible that some patients meeting eligibility criteria for Aim 1 only may be non-English 
speaking or their parents may be non-English speaking, including but not limited to Spanish. 
Although we anticipate the frequency of non-English-speaking participants meeting eligibility 
criteria to be low, we acknowledge the importance of having procedures in place to ensure 
their participation. Participants who do not speak English will be enrolled for qualitative 
interviews to elicit stakeholder experiences and feedback. All written information will be 
translated to participant’s preferred language (e.g., Spanish) and an interpreter will be used for 
consent, assent, and qualitative interviews.  
 
23. HIPAA 
A HIPAA Wavier will be requested for the use of PHI for screening potential participants.  The 
use or disclosure of this PHI involves no more than a minimal risk to the privacy of individuals, 
based on, at least, the presence of the following elements: 
• 
Our previously described plan to protect the identifiers from improper use and 
disclosure (see section 20. 
Provisions to Protect the Privacy Interest of Participants). 
• 
Identifiable information will be destroyed at study closeout or withing 5 years 
(whichever is later).  De-identified study data will be kept indefinitely; 
The protected health information (PHI) that we will use and/or disclose (share) for the main 
research study includes: 
• Demographic data for you and your parent. 
• Medical information about you including your medical history and present/past 
medications. 
We will use and share PHI for the conduct and oversight of the research study.  We will also use 
and share PHI to conduct normal business operations.  We may share PHI with other people 
and places that help us conduct or carry out the study, such as laboratories, data management 
centers, data monitors, contract research organizations, Institutional Review Boards (IRBs) and 
other study sites. We will require caregiver authorization to use PHI to participate in the 
research study.  
The research team will utilize a variety of safeguards to protect the study from loss of data. 
Data will be collected using electronic or hard-copy versions of measures and will only be 
identified with the participant ID number. The codes that link the name of the participant to the 
study ID will be kept confidential in a secured cabinet. Collected forms will be electronically 
transferred and hard copies will be transported to the Clinical Research Office. Transcripts of 
qualitative interviews will be reviewed by an independent transcriber. Qualitative data will be 
coded by independent reviewers and any discrepancies will be discussed to reach consensus 
during research team meetings.  Research staff will receive standardized training on 
administration of assessments. 
 

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24. Setting 
Participants will be recruited from two pediatric centers with large SCD patient populations: 
Emory/Children’s Healthcare of Atlanta (CHOA) and Cincinnati Children’s Hospital Medical 
Center. Our experience with psychosocial studies and clinical trials in SCD suggests that Emory/ 
CHOA and Cincinnati Children’s Hospital Medical Center are adequate for recruiting the sample 
size needed while offering geographic diversity. We have conservatively planned enrollment 
based on our preliminary work and available patient population. CHOA is comprised of 3 separate 
campuses located across the metro Atlanta area: Egleston, Scottish Rite, and Hughes Spalding.  
Research procedures, including qualitative interviews and stakeholder feedback via advisory 
board meetings, will be performed remotely via telehealth or phone. Survey assessments will 
be completed electronically or via paper-and-pencil forms during clinic visits or at patient’s 
home, depending on family preference. Study assessments and treatment sessions will 
primarily occur remotely with the exception of physical assessments that will be conducted in-
person. Study procedures will offer flexibility in completion remotely versus in person based on 
family’s preference as appropriate. 
 
25. Resources Available 
Participants will be recruited from two pediatric centers with large SCD patient populations: 
Emory/Children’s Healthcare of Atlanta (CHOA) and Cincinnati Children’s Hospital Medical 
Center that collectively cares for over 2500 youth with SCD to obtain geographically diverse 
perspectives. The patient populations at these centers provide care to about 300 patients with 
chronic SCD pain who are likely eligible for recruitment for this project based on proposed 
eligibility criteria described below (250 from CHOA, 50 from Cincinnati). Study funding supports 
dedicated personnel effort of the PI, Co-Investigators, and study team to direct towards 
research activities. The research team has well-developed plans and resources to support 
psychological and behavioral human research (see Provisions to Protect Individuals section for 
additional information).  
Research coordinators and assistants will complete and maintain CITI certification and undergo 
training to use REDCap for data collection and management.  The PI will train research 
personnel in the process of screening eligible participants, recruitment, and the consenting 
process.  Research personnel also will receive standardized training on the administration and 
scoring of measures using REDCap as well as paper-pencil measures.  The research staff also will 
be trained in a specific procedural plan for identifying potential psychological distress and 
contacting a psychologist (Drs. Sil, Crosby) to conduct follow-up assessment at the site of data 
collection. Research team members will be trained in conducting semi-structured individual 
interviews to ensure scientific rigor and consistency.  Professional transcription services will be 
utilized for transcription. Members of the Emory Qualitative Research Core will complete 
coding of qualitative data under the supervision of the PI and qualitative methods expert (Dr. 
Sinha).  
26. Multi-Site Research When Emory is the Lead Site 

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Study-Wide Number of Participants 
Up to 45 adolescents and their caregivers will be accrued across sites. This 
includesapproximately 15-20 dyads for qualitative interviews or until saturation of themes is 
achieved, 8 patients and 8 caregivers for stakeholder advisory board, and 15 dyads for the 
feasibility study. Additional dyads may be recruited to optimize feasibility and acceptability.  
 
Study-Wide Recruitment Methods 
Participant recruitment methods are described in detail above under the Recruitment section 
and will remain under the control of the local site. Site PIs will have regularly scheduled 
meetings (e.g., weekly) to ensure communication among sites. All sites will have the most 
current version of the protocol, consent document, and HIPAA authorization. All required 
approvals (initial, continuing review, and modifications) will be obtained at each site (including 
approval by the site’s IRB of record). Routine research study meetings will allow for ongoing up-
to-date communication, including assurance that all IRB modifications have been 
communicated to sites and approved (including approval by the site’s IRB of record) before the 
modification is implemented. All engaged participating sites will safeguard data, including the 
secure transmission of data, as required by local information security policies. All local site 
investigators conduct the study following applicable federal regulations and local laws. All non-
compliance with the study protocol or applicable requirements will be reported following local 
policy. 
 
Regularly scheduled study team meetings via video-conferencing and/or phone will allow open 
communication among participating sites to discuss problems (inclusive of reportable events), 
interim results (e.g., impressions of emerging qualitative themes), and activities leading to the 
closure of a study. 
 
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Sankyo, Ionis, Ironwood, Medtronic, Pfizer, and Sysmex; and has received grants and personal 
fees from Surface Oncology. A.D.M. has received grants from Argenx, Baxalta, Eisai, Eli Lilly & 
Daiichi Sankyo, Ionis, Ironwood, Medtronic, Pfizer, and Sysmex; has received personal fees from 
AstraZeneca; and has received grants and personal fees from Surface Oncology. A.U.Z. has 
received personal fees from Novartis; is on a speakers bureau and has received grants and 
personal fees from Global Blood Therapeutics; and has received personal fees from Emmaus 
Medical. M.U.C. has received grants and personal fees from Bayer, Biomarin, Global Blood 
Therapeutics, HEMA Biologics, Kedrion, Octapharma, Pfizer, Roche/Genentech, 
Sanofi/Bioverativ, Spark Therapeutics, and Takeda. 
42. 
Ward DS, Evenson KR, Vaughn A, Rodgers AB, Troiano RP. Accelerometer use in physical 
activity: best practices and research recommendations. Medicine and science in sports and 
exercise. 2005;37(11 Suppl):S582-8. Epub 2005/11/19. doi: 
10.1249/01.mss.0000185292.71933.91. PubMed PMID: 16294121. 
43. 
Thomas SM, Sil S, Kashikar-Zuck S, Myer GD. Can Modified Neuromuscular Training 
Support the Treatment of Chronic Pain in Adolescents? Strength & Conditioning Journal. 
2013;35(3). 
44. 
Brattberg G. Do pain problems in young school children persist into early adulthood? A 
13-year follow-up. European Journal of Pain. 2004;8(3):187-99. doi: 
10.1016/j.ejpain.2003.08.001. 
45. 
Simons LE, Smith A, Ibagon C, Coakley R, Logan DE, Schechter N, Borsook D, Hill JC. 
Pediatric Pain Screening Tool: rapid identification of risk in youth with pain complaints. Pain. 
2015;156(8):1511-8. Epub 2015/04/24. doi: 10.1097/j.pain.0000000000000199. PubMed PMID: 
25906349; PMCID: Pmc4504741. 
46. 
Mitchell M, Crosby LE, Hines J, Bloom J, editors. Recruiting and retaining African 
American children and families in clinical research studies. 9th Annual Child Mental Health 
Conference; 2004; Tampa, FL. 
47. 
Middleton J, Calam R, Ulph F. Communication with children about sickle cell disease: A 
qualitative study of parent experience. Br J Health Psychol. 2018;23(3):685-700. Epub 
2018/06/10. doi: 10.1111/bjhp.12311. PubMed PMID: 29885041. 

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48. 
Gesteira ECR, Szylit R, Santos MRD, FariaIchikawa CR, Oliveira PP, Silveira EAA. Family 
management ofchildren who experience sickle cell disease: a qualitative study. Revista 
brasileira de enfermagem. 2020;73(suppl 4):e20190521. Epub 2020/09/24. doi: 10.1590/0034-
7167-2019-0521. PubMed PMID: 32965419. 
49. 
Hawkins LM, Sinha CB, Ross D, Yee MEM, Quarmyne MO, Krishnamurti L, Bakshi N. 
Patient and family experience with chronic transfusion therapy for sickle cell disease: A 
qualitative study. BMC pediatrics. 2020;20(1):172. Epub 2020/04/20. doi: 10.1186/s12887-020-
02078-w. PubMed PMID: 32305060; PMCID: PMC7165370. 
50. 
Sil S, Cohen LL, Dampier C. Chronic pain expeirence in pediatric sickle cell disease: A 
qualitative examination. Annals of Behavioral Medicine. 2020;54:S791. 
51. 
Charmaz K. Constructing Grounded Theory. 2nd ed. London: Sage Publications Ltd; 
2014. 
52. 
Teddlie C, Tashakkori A. Foundations of mixed methods research: Integrating 
quantitative and qualitative approaches in the social and behavioral sciences. Thousand Oaks, 
CA: Sage Publications Inc; 2009. 
53. 
Lincoln YS, Guba EG. Naturalistic Inquiry. Newbury Park, CA: Sage Publications 1985. 
54. 
Creswell JW, A.C. K, Clark VLP, K.C. S. Best Practices for Mixed Methods Research in the 
Health Sciences. In: Research OoBaSS, editor. Washington, D.C.: National Institutes of Health; 
2011. 
 
28. Protocol Checklist 
Please note that protocol sections with an asterisk (*) should always be included in the protocol; if the section does not 
have an asterisk, and you have not included the section in the protocol, the IRB will consider it your attestation that 
the section does not apply to your study. 
 
Protocol Section 
Added to 
the 
protocol? 
External Collaborators- if applicable, add each external collaborator information and 
indicate whether that institution’s IRB will review (or has already reviewed) that individual’s 
engagement in human participants research activities)   
☐ Yes 
Funding Source*: Include the information for the funding entity for this study.  Please 
explain if this study is covered by a sub-award or other pertinent information. Say 
“department” if you do not have any other funding. 
☐ Yes 
Objectives*: Describe the purpose, specific aims, or objectives and state the hypotheses to 
be tested 
☐ Yes 
Background*: Describe the relevant prior experience and gaps in current knowledge. 
Describe any relevant preliminary data. Provide the scientific or scholarly background for, 
the rationale for, and significance of the research based on the existing literature and how 
will it add to existing knowledge.  Describe any relevant preliminary data or knowledge to 
be built upon in this study. Examples of issues to address are cultural expectations, political 
conditions, economic conditions, disease prevalence/incidence, environmental factors. 
Provide the scientific or scholarly background for, the rationale for, and significance of the 
research based on the existing literature and how will it add to existing knowledge. 
☐ Yes 

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Include any other non-research rationale for the work, if this study is a mix of non-research 
and research 
Study Endpoints: Sample: provide some information about the data set that the research 
team will be analyzing. 
☐ Yes 
 
Study Intervention/Design*: Describe the study intervention that is being evaluated, and/or 
the nature of interactions proposed. 
☐ Yes 
Procedures involved*: Describe and explain the study design in more detail. 
Describe all research procedures being performed and when they are performed, including 
procedures being performed to monitor participants for safety or minimize risks. 
Procedures performed to lessen the probability or magnitude of risks. 
☐ Yes 
Procedures-Source Records*: The source records that will be used to collect data about 
participants. (Attach all surveys, scripts, and data collection forms in the smartform on the 
“Study-Related Documents” page under “Other Attachments.” If unable to attach data 
collection instruments due to copyright requirements, include a description of the 
instrument in the protocol document 
☐ Yes 
Procedures-Data collection*: What data, specifically, will be collected during the study, and 
how that data will be obtained. If audio/video-recordings will be generated, describe 
processes for transcribing audio/video recordings.  Will audio-recordings be destroyed after 
transcription?  If so, how long after transcription?  If not, how will they be kept secure?  If 
video-recordings will be used beyond the current research procedures for 
educational/presentation purposes. 
☐ Yes 
Procedures- Long Term Follow Up*: If there are plans for long-term follow-up (once all 
research-related procedures are complete), what data will be collected during this period.  
☐ Yes 
Procedures-Deception: Does the research design require subjects to be deceived? Describe 
and justify the need for deception. Describe the plan to debrief participants after study 
participation is completed.  Will the subjects be exposed to any stress?  Describe and justify 
the need for stress. 
☐ Yes 
 
Data and Specimen Banking: If data or specimens will be banked for future use, describe 
where the data or specimens will be stored, how long they will be stored, how the data or 
specimens will be accessed, and who will have access to the data or specimens.  List the 
data to be stored or associated with each specimen. Describe the procedures to release 
☐ Yes 

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data or specimens, including the process to request a release, approvals required for 
release, who can obtain data or specimens, and the data to be provided with specimens. 
Sharing of Results with Participants*: Describe whether results (study results or individual 
subject results, such as results of investigational diagnostic tests, genetic tests, or incidental 
findings) will be shared with participants or others (e.g., the subject’s primary care 
physicians) and if so, describe how the results will be shared. 
☐ Yes 
Study timelines*: Describe the duration of an individual subject’s participation in the study, 
the duration anticipated to enroll all study participants, and the approximate total duration 
of the overall study 
☐ Yes 
Population and Inclusion/Exclusion Criteria*: Describe how individuals will be screened for 
eligibility; the criteria that define who will be included or excluded in your final study 
sample; and indicate specifically whether you will include or exclude each of the following 
special populations:  
• Adults unable to consent 
• Individuals who are not yet adults (infants, children, teenagers) 
• Pregnant women 
• Prisoners 
Note: you cannot exclude people with limited English proficiency unless you can 
demonstrate the scientific need for such exclusion. 
Community Participation: For studies aimed at addressing issues that affect a certain 
community or group: How, if at all, will this study involve people from the target community 
in the design of the study? Conduct of the study? How will the results of the research be 
shared with the participants and/or the target community/ies?   
☐ Yes 
Research with pregnant women, fetuses, or neonates: review this checklist to verify you 
have provided enough information to ensure the safety and well-being of this population. 
☐ Yes  
Research with neonates of uncertain viability: review this checklist to verify you have 
provided enough information to ensure the safety and well-being of this population. 
☐ Yes 
Research involving prisoners: review this checklist to verify you have provided enough 
information to ensure the safety and well-being of this population. 
☐ Yes  
Research involving children: review this checklist to verify you have provided enough 
information to ensure the safety and well-being of this population. 
☐ Yes  

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Research involving cognitively impaired adults: review this checklist to verify you have 
provided enough information to ensure the safety and well-being of this population. 
☐ Yes  
Research involving economically or educationally disadvantaged persons: describe the 
additional safeguards that have been included in the study to protect the rights and welfare 
of these subjects 
☐ Yes  
Local Number of Participants*: Indicate the total number of participants to be accrued 
locally. If applicable, distinguish between the number of participants who are expected to 
be enrolled and screened, and the number of participants needed to complete the research 
procedures (i.e., numbers of participants excluding screen failures.)  
Provide your projected enrolling goals, including the percentage of participants according to 
sex and race.    
☐ Yes 
Recruitment Methods*: Describe when, where, and how potential participants will be 
recruited, who will make initial contact and how, and if physicians or staff refer participants. 
Describe the source of participants. Describe the methods that will be used to identify 
potential participants. Describe materials that will be used to recruit participants. (Attach 
copies of these documents in Smartform on the “Study-Related Documents” page under 
“Recruitment material templates.”  with the application. For advertisements, attach the 
final copy of printed advertisements. When advertisements are taped for broadcast, attach 
the final audio/videotape. You may submit the wording of the advertisement before taping 
to preclude re-taping because of inappropriate wording, provided the IRB reviews the final 
audio/videotape.) How will eligibility be determined? Provide a detailed description of any 
eligibility screening done before enrolling the subject (including whether any identifiers will 
be recorded – note that IP address is an identifier). If recruiting online, describe how 
potential participants would be directed to your recruitment information and study 
description.   
If using contests or raffles as an incentive, you must offer entry to all potential participants, 
not just those who enroll in the study/complete study-related procedures, per Georgia State 
Law. 
If recruiting online, describe how potential participants would be directed to your 
recruitment information and study description.  
All research recruitment through social media needs to follow this guidance, which does not 
allow the use of personal social media accounts for some recruitment activities 
☐ Yes 
Withdrawal of Participants*: Describe anticipated circumstances under which participants 
will be withdrawn from the research without their consent. Describe procedures that will be 
followed when participants withdraw from the research, including partial withdrawal from 
procedures with continued data collection. 
☐ Yes 

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Risk to Participants*: List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the participants related to the participant's participation in the research. 
Include as may be useful for the IRB’s consideration, a description of the probability, 
magnitude, duration, and reversibility of the risks. Consider physical, psychological, social, 
legal, and economic risks. Include risks of loss of privacy or breach of confidentiality. 
If applicable, indicate which procedures may have risks to the participants that are currently 
unforeseeable. 
If applicable, indicate which procedures may have risks to an embryo or fetus should the 
subject be or become pregnant. 
If applicable, describe risks to others who are not participants. 
Do not state that there are no risks. 
☐ Yes 
Potential Benefits to Participants*: Describe the potential benefits that individual 
participants may experience  
Indicate if there is no direct benefit. Do not include benefits to society or others. 
Describe areas of knowledge that would be strengthened. 
Compensation should NOT be stated as a benefit. 
☐ Yes 
Compensation to Participants*: Describe if/how subjects will be compensated for 
participation in this study. Indicate what method compensation will be delivered (e.g. cash, 
gift card, school credit).  
Describe the amount and timing of any payments to participants.  How much?  What kind?  
Is tax information required? (if so, must be reflected in the informed consent form). Will 
payments be pro-rated if a participant withdraws early? 
☐ Yes 
Data Analysis, Management and Confidentiality*: Describe the data analysis plan, including 
any statistical procedures or power analysis. Describe the steps that will be taken to secure 
the data (e.g., training, authorization of access, password protection, encryption, physical 
controls, certificates of confidentiality, and separation of identifiers and data) during 
storage, use, and transmission. Describe any procedures that will be used for the quality 
control of collected data.  
☐ Yes 
Describe how data or specimens will be handled study-wide*: What information will be 
included in that data or associated with the specimens? 
• Where and how data or specimens will be stored? 
• How long the data or specimens will be stored? 
• Who will have access to the data or specimens? 
• Who is responsible for receipt or transmission of the data or specimens? 
• How data or specimens will be transported? 
☐ Yes 
Data Monitoring and Participants Safety  
☐ Yes 

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(if this study is no more than minimal risk, this section is not required) 
• 
Ensure that you review our Data and Safety Monitoring plan guidance for specific 
details about this section, and examples of what the IRB will be requiring according to 
the level of risk. 
• 
If a DSMB is needed, please describe the composition of the board (if not already 
detailed in the protocol).  Review this guidance for more information.  If the sponsor 
protocol does not contain all required information, please in this section.  
• 
Describe the plan to periodically monitor the data at the site level, and if you have 
international sites.  
• 
Description of the plan for notifying the IRB of reportable events; whether the sponsor 
requires reporting above and beyond the Emory IRB reporting requirements, and if so, 
a description of the requirements and plan for meeting them.  
• 
Please address the specific details below. If deemed not applicable, please provide 
rationale: 
• 
Subject safety: 
o Specific subject safety parameters  
o Frequency of subject safety observations 
o Individual responsible for safety monitoring 
o Subject stopping rules – under what conditions will a subject be removed 
from study participation and who will make the decision? 
o Study stopping rules - under what conditions will the study be modified or 
stopped and who will make the decision? 
o Reporting mechanisms (i.e. Deviations, adverse events, UPs) 
• 
Data Integrity: 
o Specific data elements to be reviewed 
o Frequency of monitoring data, points in time, or after a specific number of 
participants 
o Individual responsible for data monitoring 
Provisions to Protect the Privacy Interests of Participants*:  
• Describe the steps that will be taken to protect participants’ privacy interests. “Privacy 
interest” refers to a person’s desire to place limits on whom they interact with or whom 
they provide personal information. 
• Describe what steps you will take to make the participants feel at ease with the 
research situation in terms of the questions being asked and the procedures being 
performed. “At ease” does not refer to physical discomfort, but the sense of 
☐ Yes 

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intrusiveness a participant might experience in response to questions, examinations, 
and procedures. 
• Indicate how the research team is permitted to access any sources of information about 
the participants. 
Economic Burden to Participants*: Describe any costs that participants may be responsible 
for because of participation in the research. 
☐ Yes 
Informed Consent*: Describe where the consent process will take place, any waiting period 
available between informing the prospective subject and obtaining the consent; and the 
process to ensure ongoing consent. 
Describe the role of the individuals listed in the application as being involved in the consent 
process; the time that will be devoted to the consent discussion; steps that will be taken to 
minimize the possibility of coercion or undue influence; and steps that will be taken to 
ensure the participants’ understanding. 
Note: If you are planning to obtain consent via electronic signature, please review this 
document. Additional guidance on consent documentation and process can be found on our 
website, under the consent toolkit.  
☐ Yes 
Consent Process-Non-English-Speaking Participants*:  
Indicate what language(s) other than English are understood by prospective participants or 
representatives. 
If participants who do not speak English will be enrolled, describe the process to ensure that 
the oral and written information provided to those participants will be in that language. 
Indicate the language that will be used by those obtaining consent. 
If you checked N/A, please provide reasoning of why subjects with limited English 
proficiency are excluded.  
Note: if you stated that subjects with LEP will be enrolled, you are approved for the use of 
the Emory IRB short forms.  Please read the guidance about the use of short forms here. 
☐ Yes 
Consent Process-Children: After determining if the subject is a child per GA law (or if 
enrolled outside GA, per state/country law), please describe whether parental permission 
will be obtained from: 
• Both parents unless one parent is deceased, unknown, incompetent, or not reasonably 
available, or when only one parent has legal responsibility for the care and custody of 
the child. 
• One parent even if the other parent is alive, known, competent, reasonably available, 
and shares legal responsibility for the care and custody of the child. 
☐ Yes  

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Describe whether permission will be obtained from individuals other than parents, and if so, 
who will be allowed to provide permission.  Describe the process used to determine these 
individuals’ authority to consent to each child’s general medical care. 
When assent of children is obtained describe whether and how it will be documented per 
Emory Policies and Procedures 
Consent Process-Cognitively Impaired Adults:  describe the process to determine whether 
an individual is capable of consent. The IRB allows the person obtaining assent to document 
assent on the consent document and does not routinely require assent documents and does 
not routinely require children to sign assent documents. 
☐ Yes 
 
Consent Process-Adults Unable to Consent:  List the individuals from whom permission will 
be obtained in the order of priority. (E.g., durable power of attorney for health care, a court-
appointed guardian for health care decisions, spouse, and adult child.) 
For research conducted in the state, review “46 LEGALLY AUTHORIZED REPRESENTATIVES 
AND SURROGATE CONSENT” to be aware of which individuals in the state meet the 
definition of “legally authorized representative.” 
For research conducted outside of the state, provide information that describes which 
individuals are authorized under applicable law to consent on behalf of a prospective 
subject to their participation in the procedure(s) involved in this research.  
Describe the process for the assent of the participants. Indicate whether: 
• Assent will be required of all, some, or none of the participants. If some, indicated, 
which participants will be required to assent and which will not. 
• If assent will not be obtained from some or all participants, an explanation of why not. 
Describe whether the assent of the participants will be documented and the process to 
document assent. The IRB allows the person obtaining assent to document assent on the 
consent document and does not routinely require assent documents and does not routinely 
require participants to sign assent documents 
☐ Yes 
 
Waiver or Alteration of Consent and HIPAA authorization (consent will not be obtained, 
required information will not be disclosed, or the research involves deception)  
Review the Emory IRB waiver document to ensure you have provided sufficient information 
for the IRB to make these determinations. 
If the research involves a waiver of the consent process for planned emergency research, 
please review the Emory P&Ps, Chapter 48, WAIVERS OF, AND EXCEPTIONS FROM, 
INFORMED CONSENT FOR PLANNED EMERGENCY RESEARCH to ensure you have provided 
sufficient information for the IRB to make these determinations. 
☐ Yes 

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Setting*: Describe the sites or locations where your research team will conduct the research 
including where the subject will be identified and recruited, where the research procedures 
will be performed, and if you will involve a community advisory board.  For research 
conducted outside the organization and its affiliates describe the site-specific regulations or 
customs affecting the research outside the organization and the local scientific and ethical 
review structure outside the organization. 
☐ Yes 
Resources Available*: Describe the resources available to conduct the research such us the 
feasibility of recruiting the required number of suitable participants within the agreed 
recruitment period; describe the time that you will devote to conducting and completing 
the research; describe the availability of medical or psychological resources that participants 
might need as a result of an anticipated consequences of the human research; describe your 
process to ensure that all persons assisting with the research are adequately informed 
about the protocol, the research procedures, and their duties and functions. 
☐ Yes 
Multi-Site Research when Emory is the Lead Site 
Study -Wide Number of Participants: indicate the total number of participants to be accrued 
across all sites. 
Study-Wide Recruitment Methods: If this is a multicenter study and participants will be 
recruited by methods not under the control of the local site (e.g., call centers, national 
advertisements) describe those methods.   
Describe when, where, and how potential participants will be recruited. 
Describe the methods that will be used to identify potential participants. 
Describe materials that will be used to recruit participants.  
Describe the processes to ensure communication among sites. See “WORKSHEET: 
Communication and Responsibilities (HRP-830).” All sites have the most current version of 
the protocol, consent document, and HIPAA authorization. 
All required approvals (initial, continuing review and modifications) have been obtained at 
each site (including approval by the site’s IRB of record). 
All modifications have been communicated to sites and approved (including approval by the 
site’s IRB of record) before the modification is implemented. 
All engaged participating sites will safeguard data, including secure transmission of data, as 
required by local information security policies. 
All local site investigators conduct the study in accordance with applicable federal 
regulations and local laws.  
All non-compliance with the study protocol or applicable requirements will reported in 
accordance with local policy 
Describe the method for communicating to engaged participating sites (see “WORKSHEET: 
Communication and Responsibilities (HRP-830)”): 
• Problems (inclusive of reportable events). 
• Interim results. 
☐ Yes 

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• The closure of a study 
If this is a multicenter study where you are a participating site/investigator, describe the 
local procedures for maintenance of confidentiality. (See “WORKSHEET: Communication and 
Responsibilities (HRP-830).”) 
• Where and how data or specimens will be stored locally? 
• How long the data or specimens will be stored locally? 
• Who will have access to the data or specimens locally? 
• Who is responsible for receipt or transmission of the data or specimens locally? 
• How data and specimens will be transported locally?