SCThrive: Improving Self-Management in Adolescents With Sickle Cell Disease
Phase: NA
Conditions: Sickle Cell Disease
Sponsor: Children's Hospital Medical Center, Cincinnati

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Protocol Title:  
SCManage: Improving Self-Management in Adolescents with 
Sickle Cell Disease  
 
Protocol Number: 
 
2016-1282 
 
Version: 
 
 
5.0 
 
Date:  
 
 
March, 2017 
 
Principal Investigator: 
Lori E. Crosby, Psy.D. 
 
 
 
 
Division of Behavioral Medicine and Clinical Psychology 
 
 
 
 
Patient and Family Wellness Center 
Cancer and Blood Diseases Institute 
Cincinnati Children’s Hospital Medical Center 
 
Funding: 
 
 
1R21HD084810-01A1  
NCT#:  
 
 
NCT02851615 
 
 
 
 
 
 
 
 
 
 
 
 
Confidentiality Statement: Information contained within this document is not to be disclosed in 
any way without prior permission of the Principal Investigator and NICHD.  
 
 
 
 
 

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Table of Contents 
1. 
ABSTRACT ......................................................................................................................... 4 
2. 
PURPOSE OF STUDY ....................................................................................................... 5 
3. 
BACKGROUND .................................................................................................................. 5 
4. 
STUDY DESIGN ................................................................................................................. 9 
5. 
DURATION ........................................................................................................................11 
6. 
SELECTION & RECRUITMENT OF PARTICIPANTS ........................................................11 
7. 
PROCESS OF OBTAINING CONSENT .............................................................................12 
8. 
STUDY PROCEDURES .....................................................................................................13 
9. 
DATA ANALYSIS/METHODS ............................................................................................15 
10. 
FACILITIES & PERFORMANCE SITES .........................................................................16 
11. 
POTENTIAL BENEFITS .................................................................................................16 
12. 
POTENTIAL RISKS, DISCOMFORTS, INCONVENIENCES, AND PRECAUTIONS ......16 
13. 
RISK/BENEFIT ANALYSIS.............................................................................................18 
14. 
DATA SAFETY & MONITORING ....................................................................................18 
15. 
PRIVACY & CONFIDENTIALITY ....................................................................................18 
16. 
COST OF PARTICIPATION ...........................................................................................19 
17. 
PAYMENT FOR PARTICIPATION .................................................................................19 
18. 
REFERENCES ...............................................................................................................22 
 
 
 
 
 

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1. ABSTRACT 
Background: Sickle cell disease (SCD) is the most common life-shortening genetic disorder 
and affects primarily African American youth in the U.S.12 In addition to the progressive 
biological impact of SCD, which requires a higher level of disease self-management, 
adolescence is also a time when parents/caregivers begin transferring responsibility for disease 
management. Adolescents with chronic diseases have some of the lowest adherence rates17,18 
and for those with SCD, minority race and economic disadvantage compound the risk.19 Crucial 
for the success of any self-management intervention is behavioral activation (BA), which is the 
knowledge, skills, readiness to change, and self-efficacy, needed to make effective decisions to 
manage health.1 No existing interventions address broader BA skills that underlie many of the 
specific health behaviors and lifestyle changes that are required for effective self-management 
of SCD and its impact. Furthermore, to effectively motivate and engage AYAs with SCD in 
sustainable health behavior change, the social context (e.g. connection with peers) is 
developmentally important, but has not been considered in existing programs. Objective: In this 
study, we will refine and test an innovative, technology-enhanced, group self-management 
intervention, SCThrive, which uses a mixed in-person and online format and is supported by a 
tailored mHealth tool, iManage. The objective of the current proposal is to determine the 
feasibility and acceptability of SCThrive, and to evaluate its initial efficacy for increasing BA in 
adolescents with SCD. Methods: We will achieve our objective via two specific aims: Aim 1: we 
will conduct a small pilot to determine the feasibility and acceptability of the SCThrive 
intervention for adolescents and young adults with SCD (N = 8; 4 adolescents ages 13-17; 4 
young adults ages 18-21). Aim 2: we will conduct a small single-site, randomized control trial (N 
= 64) to determine whether the refined SCThrive intervention is superior to attention control in 
improving BA in adolescents and young adults (AYAs) with SCD ages 13-21. We hypothesize 
that SCThrive will be engaging, beneficial, increase BA in adolescents with SCD, and, 
ultimately, change health behaviors (long-term goal) that result in improved quality of life, 
decreased SCD symptoms, and decreased acute care visits (i.e. emergency room); in other 
words, participation in the intervention will help adolescents with “sickle cell thrive.” 
Conclusions/Next Steps: Results from this developmental/exploratory project will lay the 
foundation for a competitive R01 application to examine SCThrive’s efficacy in a fully powered 
randomized multisite trial. 
 
 

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2. PURPOSE OF STUDY 
The objective of this study is to determine the feasibility and acceptability of SCThrive, an 
innovative, technology-enhanced, group self-management intervention that uses a mixed in-
person and online format and supported by a tailored mHealth tool, iManage. The study will also 
evaluate the initial efficacy of SCThrive for increasing behavioral activation (BA) in adolescents 
with Sickle Cell Disease (SCD) ages 13 to 21. We will achieve our objective through two specific 
aims: 
 
Aim 1: Determine the feasibility and acceptability of the SCThrive intervention for adolescents 
and young adults with SCD (N = 8; 4 adolescents ages 13-17; 4 young adults ages 18-21).  
 
Aim 2: Conduct a pilot randomized trial (N = 64) to determine whether the refined SCThrive 
intervention is superior to attention control in improving BA in AYAs with SCD ages 13-21. 
Hypothesis 1: Participants in the SCThrive group will show greater BA (primary outcome) at 
post-treatment than the attention control group.  
Hypothesis 2: Participants in the SCThrive group will continue to show significantly greater BA 
at the six week follow-up compared to the attention control group.  
 
Exploratory Aim: Explore whether SCThrive is associated with greater improvements in self-
management behaviors and quality of life (secondary outcome) compared to attention control at 
the six-week follow-up assessment.  
 
3. BACKGROUND 
Adolescents and young adults (AYAs) with SCD have poor health outcomes. SCD is the 
most common genetic disorder in the U.S. affecting approximately 100,000 individuals, the 
majority of whom are African-American (approximately 1 in 400 African-American births).24 SCD 
is first identified during infancy, but the AYA years are a particularly vulnerable time when 
complications (e.g. chronic pain due to organ or bone damage, pulmonary hypertension, renal 
and cardiac dysfunction, or stroke) increase.11,25,26 SCD pain is severe, unpredictable, and 
recurrent, and accounts for the majority of Emergency Room (ER) visits and hospitalizations.15 
AYAs with SCD have more ER visits than other age groups of SCD patients(3.61 per patient per 
year vs. 2.59 per patient per year).27 SCD accounts for approximately 100,000 hospitalizations 
per year (estimated $488 million in healthcare costs).28,29 AYAs with SCD have higher 30 day 
and 14 day re-hospitalization rates than other SCD patients (41.1% and 28.4% respectively).15 
Mortality rates for AYAs are also high, ranging from 6-20 percent. 30,31 Approximately, 11% of 
AYAs with the most severe genotype (Hb SS) are at risk for over strokes.32 Silent strokes are 
frequent in all genotypes (37% of patients age 14 or older).33 Regrettably, the risk of stroke 
increases into adulthood and 50% of adults with SCD with no documented history of stroke 
have neurocognitive limitations.33-36 Furthermore, empirical studies confirm that AYAs with SCD 
are at risk for depression and anxiety, impairments in quality of life, and delays in social 
functioning.37-39 
Behavioral Activation (BA) is a potentially important mechanism for improving disease self-
management and preventing poor outcomes. Effective disease self-management is critical to 
decreasing complications and early mortality in SCD. BA (also referred to as “patient activation” 
or “patient engagement in health behaviors”) plays an intermediary role in improving self-
management behaviors.1,40,41 BA is composed of several different constructs (knowledge, self-
efficacy, skills, and readiness for change1) that are linked to health outcomes in SCD and other 
chronically painful conditions.2-4 Although individual components of BA have shown links with 
health outcomes, the direct association between the larger construct of BA and health outcomes 

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is understudied (Table 1 summarizes SCD and BA research). Studies suggest that increased 
BA precedes improvements in self-management.1 Moreover, high levels of BA are associated 
with positive health outcomes (i.e. healthy eating, exercising, medication adherence, fewer EF 
visits and hospitalizations).1,41-43 Our prior research and extensive clinical experience suggests 
that AYA with SCD lack the skills components of BA: goal setting, self-monitoring, 
communication, and action planning.53,54 
 
Table 1. Summary of Prior Research on BA Constructs in SCD 
BA Construct 
Research Findings 
 
Knowledge 
Maternal disease knowledge associated with positive health outcomes for 
AYA with SCD; increased disease knowledge may improve self-efficacy 
in children with SCD.44,45 
 
 
Self-Efficacy 
Lower self-efficacy associated with high pain severity, healthcare 
utilization and physical and psychological symptoms in adults with SCD. 
Higher self-efficacy associated with better quality of life in adults with 
SCD; lower self-efficacy associated with adverse physical and 
psychological symptoms and poor transition (self-management) 
outcomes in adolescents.2,46-49 
 
 
Readiness to 
Change 
AYA with SCD demonstrate poor preparation for self-management and 
transition (low readiness); higher levels of readiness for self-management 
or transition associated with high HRQL; Negative attitudes about the 
transition process of self-management associated with disease 
severity.3,50-52 
 
BA is particularly important during the AYA years when the demands for self-management 
increase and have a significant impact on health. Although AYAs are expected to be more 
independent, many AYAs with chronic conditions have not developed the self-regulation skills 
(e.g. daily monitoring of health status) needed to manage their illness.55,56 Furthermore, self-
management rates are especially low for AYAs with limited exposures to healthy behavior role 
models and who lack access to health resources due to risk factors such as minority race and 
economic disadvantage, like our proposed sample.57 Likewise, the complexity and demands of 
the SCD treatment regimen present unique challenges that may undermine BA. For example, 
AYAs with severe disease may be required to take daily medications (e.g. hydroxyurea), receive 
monthly blood transfusions, and/or frequent lab draws (4-12 times per year) all of which require 
strong healthcare navigation skills,58 and yet, data suggest that families of youth with SCD 
identify these skills as a significant barrier to care.59 In addition, the episodic and unpredictable 
nature of SCD may contribute to AYAs feeling unprepared when a flare-up occurs and reinforce 
inaccurate beliefs about the consequences of non-adherence (low motivation).  
The SCD research community has called for intervention to increase activation and self-
efficacy during AYA to improve self-management.5,6 SCD Transition and Centers for Disease 
Control guidelines recommend the development of broad-based self-management skills for 
patients with SCD, particularly AYA.5-7 Moreover, self-management research in pediatric chronic 
disease and SCD shows that multicomponent interventions are superior to those focusing on a 
single domain of self-management.8,9,49 Additionally, public health research supports the use of 
peer-based intervention to effectively engage and motivate AYA to sustain health behavior 
changes.60 Nevertheless, existing SCD self-management interventions have focused on a single 
dimension of self-management (e.g. adherence), used an individual approach rather than 
including peers, and been primarily designed by investigatorys.2 While these interventions have 
shown some positive effects (such as increased daily functioning and decreased school 

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absences); they assume a high level of motivation and engagement and fail to address the full 
range of behaviors required to manage SCD.2,61 
We developed and prototyped a novel, tailored, group-based BA intervention, SCThrive, 
supported by an mHealth self-monitoring tool co-designed by AYAs with SCD (iManage), that 
works to systematically target BA constructs knowledge, self-efficacy, skills, readiness to 
change) and influencing factors (mood, family/social support, resources; see Figure 1). The 
SCThrive intervention gives patients a structure for sharing their illness narrative (builds 
importance and confidence which promotes readiness for change), choosing self-management 
goals and developing action plans to achieve them (self-efficacy), setting reminders to complete 
action plans (skills), tracking daily symptoms (build knowledge through iManage), and receiving 
support from others on goals and action plans (family/social support from peers and caregivers). 
SCThrive uses evidence-based, developmentally appropriate, interactive teaching methods 
including brainstorming, video vignettes, skills-training methods (modeling, role-playing, and 
rehearsal), small group exercises, large group discussions (sharing action plans) and social 
reinforcement via iManage.62 
AYAs with SCD are a particularly vulnerable group at risk for serious disease complications 
that could be minimized or prevented with effective self-management. The new SCThrive 
intervention is a multicomponent, developmentally tailored intervention to increase BA with the 
potential to significantly improve their quality of life and health outcomes.   
 
3.1 Preliminary Data Informing the Proposed Study Design  
Data from our preliminary studies as well as the larger literature highlight the persistence of 
motivational and environmental barriers to self-management in AYAs with SCD5,49,72,73 and 
support the need for an intervention focused on BA. Preliminary data from 33 AYAs with SCD 
confirmed that they have an elevated risk for self-management difficulties due to environmental 
or psychosocial barriers such as lack of family social support, family medical/behavioral 
problems, and parental stress ( as measured by the Psychosocial Assessment Tool 2.0; 
M=1.32; SD = .68).74 In partnerships with University of Cincinnati (UC) design students, the PI 
used qualitative and design thinking research methods to identify barriers to self-management 
Model is informed by research on patient and consumer activation, the Wagner chronic care 
model, health action process approach and self-determination theories40,63-68 

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for AYAs with SCD ages 16-24. Eighteen AYAs with SCD (M age = 20.4; 61.11% female; SS 
type 77.77%) and eight SCD providers completed in-depth interviews and co-creation 
(validation) session. The following barriers emerged: 1) inaccurate beliefs about the 
consequences on non-adherence (low SCD knowledge and self-efficacy); 2) negative 
perceptions of overall health status (low readiness to change, low mood); and 3) lack of self-
management support (from peers, family, and the healthcare team) and lack of self-
management resources (educational resources).75 SCThrive addresses these barriers by 
targeting BA constructs to increase the likelihood of engaging AYA in self-management.  
 
Development of the iManage tool. In another collaboration with US design students, eight AYAs 
with SCD (m age=19; 60% male) and six SCD providers participated in interviews, focus 
groups, and visit observations.82 Results revealed that AYA desired a self-management tool that 
would educate them about the impact of SCD, help monitor progress on self-management 
goals, send reminders to complete self-management goals (e.g. take daily medications, drink 
fluids, develop a medication list), facilitate communication with healthcare team and other AYAs 
with SCD. These themes informed the development of the iManage app, which was refined with 
patient and provider input. Usability testing (N=5 AYA with SCD) found that iManage is easy to 
use, increases AYA knowledge about SCD, facilitates peer communication and tracking 
progress on self-management goals.75 
Self-management online portal. As part of her K-Award, the PI designed a web-based portal and 
examined the feasibility and preliminary efficacy of a six-week intervention to promote portal use 
in AYA with SCD aged 16-24.83 Data from 42 AYAs indicated that 95% found the portal easy to 
use, 90% found it beneficial, 98% reported that the portal increased SCD knowledge, and 95% 
reported that it improved their self-management. Yet, outcome data for BA and other measures 
were not impressive (pretest PAM-13 M=72.0; posttest PAM-13 M=65.6; i.e. no significant 
reduction in BA) suggesting that online-only interventions were unlikely to lead to measureable 
behavior change.  
In-Person Delivery of SM Intervention for AYAs with SCD. The PI also conducted a pilot study of 
a six-week in-person group self-management intervention (Chronic Disease Self-Management 
Program – CDSMP)84 with 74 AYAs with SCD aged 16-24. Intervention participants were highly 
satisfied with the CDSMP (9.05 out of 10), yet barriers to regular attendance at sessions posed 
a strong impediment to study participation.85,86 Session completion was defined as 4/6 sessions; 
34% of completers attended less than six sessions and another eight participants who started 
the intervention dropped out due to illness or family issues (e.g. hospitalization, family member 
ill). Participants rated sessions focused on physical activity and exercise, managing difficult 
emotions, and communicating with healthcare providers as most beneficial and reported that 
interacting with other AYA with SCD enhanced their ability to learn and continue to use self-
management skills. Multivariate analyses found significant improvement from pre to post on 
AYA confidence in: 1) using exercise to deal with health problems (p = .005), 2) keeping fatigue 
from interfering with pleasurable activities (p = .020), and 3) exercising three times per week (p= 
.057). Study findings are highly promising and suggest that in-person interventions have strong 
potential to improve AYA self-efficacy for self-management.   
In summary, our pilot work underscores the need for multicomponent, peer-based 
interventions that include easily accessible technology enhanced tools combined with at least 
some in-person contact to enhance knowledge, peer support, and self-monitoring, but also to 
produce greater engagement and clinically significant changes in self-management in AYA with 

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SCD. SCThrive uses a mixed format (online and in-person sessions) to overcome participation 
barriers, but also maintain engagement. For example, results from a pilot study of three 
SCThrive online sessions with four AYA with SCD found high ratings on engagement (4.5/5 on 
returning for another session) and skills (4.75/5 on improving their management of SCD).  
4. STUDY DESIGN 
Aim 1: We will conduct a mixed-methods study (quantitative and qualitative). Eight AYA with 
SCD ages 13-21 will participate in the SCThrive six-week, mixed format (in-person and online) 
intervention. Participants will complete measures at baseline and post-intervention to assess 
feasibility and acceptability of data collection and management procedures. We will also obtain 
qualitative feedback (via focus groups) from participants about SCThrive content, format, 
feasibility and acceptability. Data will be used to refine and finalize the intervention protocol.  
Aim 2: We will conduct a pilot 2-arm randomized controlled trial to test the initial efficacy of 
SCThrive in improving BA relative to an Attention Control in AYAS with SCD ages 13.21. AYA 
with SCD will first be dichotomized by age (13-17 and 18-21) and disease severity (severe/non-
severe). Participants will be categorized as severe if they have a history of acute chest 
syndrome, prior stroke or more than three hospitalizations for vaso-occlusive crises in the prior 
3 years. Participants will be categorized as not severe if these complications are not present. 
Participants within each of the 2 (age; 13-17 years or18-21 years) by 2 (disease severity; severe 
or not severe) cells will be randomized into the SCThrive intervention arm or an attention control 
arm (e.g., stratifying participants based on age and disease severity prior to random 
assignment).  
Study participation includes a baseline assessment, after which participants will be 
randomized to the SCThrive intervention arm or attention control arm. This is followed by 6 
weeks of intervention (SCThrive) and post-treatment assessment. Given the grant timeline, only 
a subset of participants will be followed in the post-treatment period. Fourteen SCThrive 
intervention arm participants will complete an online/in-person booster session at 6 weeks post-
treatment and 14 attention control participants (N=14) will receive a follow-up phone call at 6 
weeks post-treatment. These participants will also complete a follow-up assessment 6 weeks 
after treatment ends. 
 
 
Our primary outcome will be for participants in the SCThrive group to demonstrate greater 
BA at post-treatment than the attention control group. Our secondary outcome and exploratory 
aim will be greater improvements in self-management behaviors and quality of life at the six-
week follow-up.  
 
Aim 2 Study Design 

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SCThrive Intervention: SCThrive consists of six weekly group sessions. Three sessions will be 
held in-person at CCHMC while the other three will be held online via Skype for Business or 
Zoom™, group video chat programs. To promote engagement during video chats, therapists will 
call AYAs by name to join in discussions and brainstorms consistent with the intervention. In 
addition, AYAs will designate another individual (most likely their caregiver) to receive reminders 
about their action plans. Two therapists (doctoral level clinical psychologists or graduate 
students) trained in delivering SCThrive and in cultural sensitivity will co-facilitate all sessions 
(see Table 2 for information on Intervention Sessions). SCThrive incorporates several 
components of culturally-sensitive clinical interventions with African-Americans including its 
emphasis on becoming an active member of the healthcare team (advocacy), assessment of 
stress related to SES and ethnic minority status (PAT 2.0), flexible and home-based design, and 
inclusion of culturally-relevant content (AYA with SCD co-designed iManage; use of culturally 
sensitive and age appropriate book on SCD management, Hope and Destiny Jr.87; 
developmentally appropriate scenarios/exercises for the 13-17 and 18-21 age groups).88 
Participants will also receive the Living a Healthy Life with Chronic Conditions book. 89  
The 
iManage app is accessible on smartphone or tablet; it is an essential component of the 
intervention because it: 1) visually reinforces the connection between SCD symptoms and self-
management behaviors; 2) provides visual feedback on self-management goal progress; 3) 
facilitates peer support for self-management; and 4) allows AYA to track daily pain, fatigue and 
mood symptoms. We will ask participants in the first three SCThrive groups to participate in 
usability testing to ensure the iManage app is easy to navigate and that that is it having the 
desired result. Pilot group participants reported that they would need the ipad to log on for the 
8th session so we changed the 8th session to an in-person session so they could turn in their 
ipads at that session. Since feedback from the pilot group was so informative and beneficial, we 
have asked two young adults from the pilot group to participate as members of the Intervention 
Development Team (we will enroll up to 4 to ensure that at least 2 can attend meetings 
regularly). They will be responsible for advising on study recruitment and retention, study 
procedures and dissemination of study results. They will be compensated for their participation 
and sign a consent form. These team members will also be asked to pilot accelerometers to 
evaluate whether they would be a value add to the SCThrive intervention and should be 
incorporated in future iterations (next grant application).They will be asked to sign an 
accelerometer use agreement. 
 
Table 2. Intervention Target by Treatment Sessions 
Week  
(Location) 
Topics 
Behavioral Activation (BA) Target 
1 
(in-person) 
SCD Knowledge, Self-Monitoring, Action 
Planning 
Knowledge, Self-Efficacy, Readiness for 
Change, Family/Social Support 
2 
(in-person) 
Communication, Problem Solving, Action 
Planning 
Skills, Self-Efficacy, Family/Social Support 
3 
(online) 
Pain Management, Mood Management, Action 
Planning 
Mood, Self-Efficacy, Skills, Family/Social 
Support 
4 
(online) 
Cognitive Restructuring, Action Planning 
Self-Efficacy, Skills, Family/Social Support 
5 
(online) 
Managing Emergencies, Treatment Adherence, 
Action Planning 
Knowledge, Skills, Self-Efficacy, 
Resources, Family/Social Support 
6 
(in-person) 
Decision Making, SCD Health Behaviors, Action 
Planning 
Skills, Knowledge, Self-Efficacy, 
Resources, Family/Social Support 
Booster 
(in-person/online) 
Review of skills, Progress Updates, Action 
Planning 
Self-Efficacy, Readiness to Change, 
Family/Social Support 
 
 

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Attention control arm: Additional trained therapists (not conducting SCThrive) will conduct the 
attention control intervention which consists of 6 weekly 15-20 minute individual phone calls and 
a follow-up up phone call on the following educational topics: Session 1: What is Sickle Cell 
Disease?; Session 2: It’s in the Genes; Session 3: SCD Complications; Session 4: Treatments 
for SCD; Session 5: Healthy Living with SCD; and Session 6: Navigating Health Insurance.91-93 
 
5. DURATION 
The project will begin in April 2016 and conclude in March 2018. Figure 2 displays the project 
timeline. 
 
Figure 2. Study Timeline 
 
 
 
6. SELECTION & RECRUITMENT OF PARTICIPANTS 
 
Study Population 
 
The study population will consist of 72 AYAs with SCD recruited from the CCHMC Sickle Cell 
Clinic. Eight (8) participants will be recruited for Aim 1 (feasibility, acceptability, intervention 
refinement) and 64 participants for Aim 2 (pilot two-arm randomized trial comparing efficacy of 
SCThrive to Attention Control) with the goal of retaining 54 for analyses (see recruitment 
strategies). 
 
Inclusion Criteria 
 
We will use the following inclusion criteria for study participants: 
1) Patient of CCHMC Sickle Cell Clinic. 
2) Confirmed diagnosis of SCD with SS, SB0Thal or SC genotype. 
3) 13-21 years of age.  
4) On or eligible for disease-modifying therapies. 
5) Caregiver (or AYA > 18 years) consent that the participant will be the sole user of the 
tablet, report immediately if it is damaged or lost, return it at the end of the study, and log 
on to sessions from a private location.  
Exclusion Criteria 

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We will use the following exclusion criteria for study participants: 
1) another chronic disease (which would complicate measurement of behavioral activation);  
2) Non-English-speaking (<5% of the target population); or  
3) cognitive or psychiatric disorder that the physician or study therapists believe would 
impair study participation. Patients who desire participation but are not eligible will be 
referred to the SCD Clinic social worker for assistance with self-management as this is 
the usual procedure. 
 
Recruitment 
 
Potentially eligible AYAs will be identified through CCHMC’s electronic medical record (EMR). 
Those meeting entry criteria will be sent a letter and flyer signed by the PI and the hematology 
clinical director telling them about the study and offering them the opportunity to call if 
interested. A trained clinical research coordinator will follow-up with a phone call to eligible 
participants to describe the study, answer any questions and schedule a time for interested 
participants to come in for a baseline visit. Eligible participants with a scheduled clinic visit will 
be approached to see if they would like to enroll during the visit. Eligible patients who are 
hospitalized will be approached only if the medical team feels it is appropriate or the patient 
requests more information about the study. After written informed consent/assent is obtained, 
AYAs and caregivers will complete baseline measures.  
 
We will screen 85-100 AYAs with SCD (eligible pool) with the goal of recruiting 64 new AYAs 
with SCD (did not participate in Aim 1) using Aim 1 inclusion/exclusion criteria. After baseline 
assessment, we will review EMR data to determine disease severity (severe = history of acute 
chest syndrome, prior stroke or more than three vaso-occlusive crises in the past three years; 
not severe = these complications are not present) 90.  
 
The study statistician will use computer-generated randomization tables. Participants will be 
blocked on age (ages 13-17; ages 18-21) and disease severity (severe/not severe) and then 
randomized to one of the study arms to ensure equal distribution across groups. 
 
Retention 
 
To promote retention, AYAs will provide emails, all phone numbers, and contact information for 
others (i.e. parent-guardian, grandparents) in case they cannot be reached. In addition, 
participants will receive a calendar of study visits and electronic appointments. To facilitate 
communication, study staff will use a dedicated texting enabled cell phone.  
 
7. PROCESS OF OBTAINING CONSENT 
Written informed consent/assent will be obtained by trained research staff when this is not 
possible phone consent will be obtained and written consent faxed or mailed to the CRC. All 
pertinent aspects of consent/assent will be covered including study purpose, risks/benefits, 
confidentiality, and right to withdraw. Patients will be informed that their care at CCHMC will not 
be affected by whether they choose to participate in the study. Caregivers and/or patients and 
study staff (co-investigators or research assistants) will sign and date the consent and 
permission form to document the informed consent process. Caregivers and/or patients will 
receive a copy of the signed and dated consent form to keep. Patients under age 18 will be 
asked to sign an assent form that is written at the 7th grade reading level or below. 

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8. STUDY PROCEDURES 
Aim 1: We will conduct two successive groups of 4 AYAs with protocol refinements after the first 
group and further refinements after completion of the second group. These AYAs will participate in 
focus groups at the end of treatment to provide additional information about SCThrive’s format, 
content and acceptability. Participants will also complete measures at baseline and post-treatment 
(see Table 3).  
 
All SCThrive participants will receive a Wi-Fi enabled, insured, tablet computer with a cellular 
data plan that will facilitate: 1) standardization of intervention delivery; 2) consistent access to a 
computer and internet service; and 3) study personnel monitoring of tablet use. During the first 
session, AYAs will be assigned a unique username and password for the iManage tool and sign 
a iPad use agreement (see epas). The CRC will provide instructions, demonstrate system 
features, and assist AYAs in starting their patient profile, selecting a self-management goal 
(action plan), and scheduling reminders. The CRC will be available by cell phone for 
troubleshooting. 
 
After obtaining consent, a member of the research team will schedule the first study visit with 
the participants. Subsequent study visits will be scheduled via phone, e-mail, or in-person 
contact with a member of the research team. All study visits will last approximately one to two 
hours and will be conducted in a conference room in the D building, Behavioral Medicine and 
Clinical Psychology clinic space or online. 
 
Aim 2: Participants will complete two or three study visits as part of this study. Study visits will 
occur at baseline (screening), post-intervention, 2 weeks post-intervention (week 8), and 4 
weeks- post-intervention (week 12). The SCD population has a high rate of no-shows and 
cancellations due to psychosocial factors that interfere with access to treatment but to increase 
the likelihood of participant retention while minimizing participant burden, measures can be 
completed within a one month window of each study visit date. To minimize participant burden, 
follow-up study visits will be coordinated with SCD clinic appointments when possible or 
scheduled at another time convenient for the participant and their family. To maximize 
attendance at study visits, a member of the research team will remind the participants of 
upcoming research visits via phone call, text, or e-mail as preferred by the participant. 
 
SCThrive arm. Four successive groups with four to eight participants per group will be 
conducted. Participants will receive the finalized six-week SCThrive intervention sing 
procedures described in Aim 1. To encourage retention and skill maintenance, participants will 
receive one online/in-person booster session two weeks after treatment ends. Based on 
feedback from the Intervention Development Team we will allow participants who cannot attend 
the in-person session due to illness or other factors to attend online via ZOOM. We will also 
allow participants to review a missed session recording before the next session with the CRC. 
 
Attention control arm. Additional trained therapists (not conducting SCThrive) will conduct the 
attention control intervention which consists of six weekly 15-20 minute individual phone calls 
via Zoom. Participants will receive one online booster session two weeks after treatment ends.  
 
Assessment Strategy. AYAs will complete questionnaires assessing BA, self-management 
behaviors (including healthy lifestyle behaviors), quality of life, and depressive symptoms (which 
can impact BA; Beck Depression Inventory-II)94, at baseline, post-treatment, and six-weeks after 
treatment (see Table 3). Caregivers or AYAs > age 18 will complete demographic (e.g. parental 

Page | 14  
 
education, family income), psychosocial (Psychosocial Assessment Tool – PAT 2.0 
General)74,95, barriers to care (Barriers to Care Questionnaire – BCQ)96 measures at baseline. 
Caregivers will also complete a quality of life measure at baseline and post-treatment. We will 
collect ER visits, disease severity, and hospitalization data from the EMR. SCThrive satisfaction 
and usefulness will be assessed after each session. Feasibility, acceptability, and iManage 
usage measures will be completed at post-treatment. The iManage tool will provide usage data 
on the number and frequency of logins, pages visited, time spent on each page, and number 
and time of action plan reminders. Based on feedback from the pilot group, we added a health 
motivation measure (Treatment Self-Regulation Questionnaire – TSRQ109) to capture the social 
support and healthcare knowledge and skills participants reported were significant benefits of 
participating in the intervention. In addition, since our original submission an SCD-specific 
measure of self-management/ transition readiness has been published110-111. We have now 
added these two measures to the battery and will increase our compensation accordingly. We 
also added a feasibility measure for the SCHealthEd treatment and a qualitative interview for 
the SCThrive treatment to help us better understand participant perceptions and experiences 
with the intervention.  
Table 3.  Assessment Strategy 
Construct 
Measure 
Brief Description/Score Used/ Psychometrics 
Primary Outcome Measure 
Behavioral Activation 
(BA) 
(AYA report) 
PAM-1397 
Measures skills, knowledge, confidence and readiness for self-management; 
Total Score; used in many studies of BA and self-management22,40,98,99; α = .87 
Secondary and Exploratory Outcome Measures 
Self-management 
behaviors 
(AYA report) 
TRAQ-5100 ; Youth Risk 
Behavior Survey items101 
Measures managing medications and appointments, tracking symptoms, 
provider communication, daily interference and physical activity, eating, 
sleeping and fluid intake; TRAQ Total Score (α = .82-.92) and Youth Risk 
Behavior Survey item mean scores; N/A 
Self-management 
behaviors 
(clinician rating) 
TRxANSIT Scale V4102 
Semi-structured interview that assesses knowledge of chronic health 
condition, medications, adherence, nutrition, self-management skills, 
insurance, and finding a new health care provider); Knowledge of Chronic 
Health Condition, Medications, Adherence, Self-Management Skills 
Subscales;  r = .71 
Medication Adherence 
(clinician rating) 
Medical Adherence 
Measure (MAM)103 
Semi-structured interview with four general modules to assess adherence 
with medication, diet, exercise, and clinic attendance; Medication Domain; r = 
−.40; r =.89 
SCD-specific quality of 
life 
(Caregiver & AYA 
report) 
Peds-QL SCD Module90 
Measures several domains of health-related quality of life including pain 
impact, fatigue, pain management, emotions, communication and treatment 
adherence; Total Score; α = .95  
SCD Knowledge  
(AYA report) 
SCD Knowledge 
Questionnaire10 
Measures SCD knowledge including pathophysiology, treatments and self-
management; Total Score; α = .79 
SCD Self-Efficacy 
(AYA report)  
Sickle Cell Self-Efficacy 
Scale4 
SCD self-efficacy scale validated in adolescents with SCD; Total Score;  α = 
.87 
Self-Regulation (AYA 
Report) 
Treatment Self-
Regulation 
Questionnaire (TSRQ) 
Measures the degree of motivation an individual has towards 
changing/maintaining health behaviors; Total Score; α > .73. 
SCD Transition 
Readiness 
Transition 
Intervention Program 
Readiness for Transition 
(TIP-RFT) 
Measures healthcare knowledge and skills, education and vocation planning, 
social support skill set, and independent living skills. 
SCD Readiness to 
Change 
(AYA  report)  
SCD Readiness to 
Change for Self-
Management Scale3 
Measures amount of prior thought, knowledge, interest, anticipated difficulty 
and perceived importance about self-management; Mean Scores; N/A 
Covariates 
Medical Covariates 
(EMR review) 
Medical Background 
Case Report Form 
ER visits, Hospitalizations, Treatment type 
Demographic 
Covariates 
(AYA or Caregiver) 
Demographics Form 
AYAs age, gender, SES, SCD type, parental education, family income level 
Treatment barriers 
(AYA or Caregiver) 
Barriers to Care 
Questionnaire (BCQ)68 
Sociobehavioral factors that interfere with successful interaction with the 
health care system 
 

Page | 15  
 
Table 3.  Assessment Strategy 
Construct 
Measure 
Brief Description/Score Used/ Psychometrics 
Psychosocial barriers 
(AYA or Caregiver) 
Psychosocial 
Assessment Too 74,95* 
Assesses level of psychosocial risk for families of patients with a chronic 
illness  
Feasibility & Acceptability 
Feasibility/ 
Acceptability/ 
Satisfaction 
(AYA report) 
SCThrive Feasibility & 
Acceptability 
SCThrive Satisfaction  
Survey 
SCThirve Follow-up 
Questionnaire 
SCHealthED Feasibility 
& Acceptability 
AYA opinion regarding the format, content, satisfaction and usefulness of 
SCThrive and SCHealthEd 
Feasibility/ 
Acceptability/ 
Satisfaction 
(AYA report) 
iManage Feasibility & 
Acceptability Survey 
iManage Usage Survey 
App characteristics, usefulness and computer/internet use 
iManage Usability  
Internet Background 
Questionnaire &  Post 
Questionnaire  
Assesses usability of the iManage app  
SCThrive Group 
Qualitative Interview 
SCThrive Feasibility 
Interview 
Assesses usefulness and satisfaction with SCThrive in an interview format 
*Psychosocial Assessment Tool:  Patients complete this annually during clinic visits in hematology. We will get permission from 
participants to use this data. We will only administer it if it has not been completed in the last 12 months. To decrease participant 
burden, we will then provide the PAT data to the clinic (so the participant will not have to complete it again – see consent form). 
 
Independent evaluators. Trained independent evaluators blinded to treatment assignment 
(doctoral psychology graduate students) will administer self-management and treatment 
adherence measures (clinician ratings); one evaluator will review 25% of intervention sessions 
for fidelity. 
9. DATA ANALYSIS/METHODS 
Analytic Plan. We will use Mplus (Version 7.20)104 to conduct our analyses. Descriptive 
statistics (e.g. proportions for dichotomous variables, means, and standard deviations) will be 
calculated for all measures of interest. Outliers will be examined and kept in final analyses, 
unless substantial evidence is available for their deletion (e.g., data errors). When testing 
statistical hypotheses, statistical model assumptions will be examined.  
Aim 1: Determine the feasibility and acceptability of the SCThrive intervention for 
adolescents and young adults with SCD. Feasibility of SCThrive will be assessed by the 
proportion of eligible patients approached for the study who consent to participate and attend at 
least 4/6 sessions. Acceptability will be assessed by qualitative analysis of focus groups at the 
end of treatment. The focus groups will elicit the AYAs overall impression of the program, the 
mixed format, how well they perform skills, and the progression of activities, as well as content- 
and format-specific feedback on the integration of iManage and SCD content, interest level, and 
length of sessions. 
Aim 2: Conduct a pilot randomized trial (final N=54 assuming 15% attrition) to determine 
whether the refined SCThrive intervention is superior to attention control in improving 
BA in AYAs with SCD ages 13-21. A 2 (group; treatment vs. control) by 2 (time; Pre-/Post-test) 
mixed ANCOVA analysis will be used, with BA (PAM-13) as our primary outcome, time and 
group as main effects, and a time*group intervention effect, to determine the needed effect size 
estimates. The statistical test of the interaction will be the primary tests of the efficacy of the 
SCThrive intervention. If statistically significant, the group*time interaction would indicate BA 
changed differently across time between the two groups and effect sizes (d) will be calculated 

Page | 16  
 
for all significant simple main effects and simple comparison effect size calculations described 
above.  
Exploratory Aim: A MANOVA will be used to test for significant group (SCThrive vs. attention 
control) differences on improvements in self-management behaviors and quality of life scores at 
three months. A significant omnibus test will be followed with simple comparisons and 
computation of effect size estimates (d). 
Power Analysis. We chose the PAM-13 (BA) as our primary outcome for power estimates 
because the General Linear Modeling analyses found a significant improvement in PAM-13 
means from pre-test to post-test for the in-person self-management versus the self-
management online portal groups, whereas the responsiveness of the other measures (e.g. 
SCD quality of life) may require a longer time-frame. The average effect size (eta-squared) for 
the change in BA was η^2= 0.14, which is a large effect. A 2 (treatment vs. control) by 2 (pre-
test, post-test) mixed effects ANCOVA power analysis was conducted using the internal Monte 
Carlo simulation capabilities of Mplus (Version 1.20)104 under the following assumptions: 1) the 
attention control arm will show a d = 0.30 effect size improvement in BA from pre-test to post-
test, 2) based on the effect size obtained from pilot data analyses (i.e., η^2= 0.14), the SCThrive 
intervention arm will show a d = 0.90 effect size improvement from pre-test to post-test, 3) 
participants assigned to the SCThrive intervention arm will show in incremental effect of (0.90 – 
0.30 = 0.60) d = 0.60 over participants assigned to the attention control arm, and 4) the 
inclusion of two control covariates (treatment type and baseline healthcare utilization), together 
with blocking on participant age and disease severity prior to randomization, will explain 40% 
(i.e., R2 = 0.40) of post-test BA score variance. Results from the Monte Carlo simulation 
analyses based on 5,000 simulated datasets showed power will be > 0.80 to detect the d = 0.60 
anticipated incremental improvement for the SCThrive intervention arm if recruitment, N = 64, 
results in a post-attrition N = 54 (N =27 per group) available for statistical analysis.  
10. FACILITIES & PERFORMANCE SITES 
The research will take place in the following locations: 
a. Location D Conference Rooms 
b. Location A – CBDI clinic, day hospital, inpatient rooms 
c. Location T -  BMCP or CRC conference rooms 
 
11. POTENTIAL BENEFITS 
Based on our prior work with group self-management interventions, we expect that SCThrive 
participants will most likely experience direct benefits including improved behavioral activation, 
self-management, better ability to cope and improved mood and functioning. In addition, all 
participants may receive some benefit from completing disease self-management measures. If 
successful, this line of research has the potential to significantly impact clinical care for all AYAs 
suffering from SCD and improve their psychological and physical health outcomes.  
 
12. POTENTIAL RISKS, DISCOMFORTS, INCONVENIENCES, AND PRECAUTIONS  
Overall, this study presents minimal risk to participants. To further minimize risks and protect 
participants’ confidentiality, all members of the study team will have completed mandated 
training procedures and certifications. Specific risks are noted below. 
 

Page | 17  
 
1. Emotional/clinical distress. Asking AYA with SCD to complete self-report measures 
about their symptoms, physical and psychological functioning typically does not result in 
distress. However, some AYA may report depressive affect or suicidal thoughts or 
become emotionally distressed when discussing their disease self-management. 
2. Hassles/frustrations. It is possible that teens may not like the iManage app or receiving 
messages (electronic reminders) from other group members or the individual they 
designate for their secondary reminder. 
3. Confidentiality & Privacy. The primary risk of this study is the loss of confidentiality in 
three main ways: 1) considering focus groups and the group-based intervention involve 
collaboration and support among the participants, there is an inherent loss in privacy 
between group members; 2) loss of confidentiality or privacy that may occur if 
participants log onto to the group video chat from a public or semi-public location; 3) 
inadvertent and unauthorized release of PHI to individuals outside the study or research 
team.  
 
 
Protections Against Risk  
 
1. Emotional Distress. In the event that a participant becomes emotionally distressed 
during their study participation or a participant reveals severe depressive symptoms or 
suicidal ideation (e.g. on the Beck Depression Inventory-II), the PI (Dr. Crosby, a 
licensed psychologist) will be immediately notified. A risk assessment, including detailed 
information about suicidal ideation, intent and/or plans, access to means to hurt 
themselves, major stresses, availability of social supports, access to treatment, and 
plans for safety will be discussed in detail with the subject. The assessment will be 
conducted by either the PI or Dr. Joffe, also a licensed clinical psychologist, with 
extensive experience in the treatment of SCD patients. A referral to the Emergency 
Room (if necessary), and/or a referral to the Psychiatry Division or our outpatient 
Psychology clinic, as appropriate, will be made. All actions taken will be documented in 
the participant’s confidential folder. The SCThrive intervention will be delivered by a 
highly trained psychologist (Dr. Joffe) and an experienced clinical psychology graduate 
student (Ms. McCuistian) supervised by the PI (Dr. Crosby) who is an expert in cognitive 
behavioral and self-management interventions. 
2. Hassles/Frustrations.  During the consent process, participants are told of the possible 
hassle/frustration caused by the receipt of reminders to complete self-management 
goals and action plans. Study personnel will be trained to give participants the proper 
instructions to change the frequency, alter the sound (new ringtone, vibrate), or delete 
the reminders at any time. Additionally, the participant is given the contact information of 
a research coordinator who is able to assist them in making necessary changes to 
reminders.  
 
3. Confidentiality & Privacy. All personnel will participate in training on protecting the 
rights and welfare of human participants in research. Personnel will all complete an 
online tutorial and satisfactorily complete an electronically-administered examination 
testing knowledge and application of the ethical principles and Federal regulations 
protecting human participants in research as described in the Belmont Report and Title 
45 Code of Federal Regulations Part 46. 
 
Adverse events will be reported to the IRB during continuing review, while serious adverse 
events will be reported to the IRB within 24 hours. 
 

Page | 18  
 
13. RISK/BENEFIT ANALYSIS 
Based on a risk/benefit judgement and our knowledge of the study procedures, the risk of 
adverse effects is minimal. The potential benefits to participants such as improved ability to self-
manage, which lead to overall improved quality of life may outweigh any minimal risks 
participants may experience. The potential benefits of this study including improvement of 
knowledge of SCD, self-management, and quality of life in adolescents with SCD serve as 
justification for the minimal risks associated with this study.  
14. DATA SAFETY & MONITORING  
This project includes a small scale clinical trial in Phase 2 and we recognize the need to provide 
a plan to ensure scientific integrity and safeguard the well-being of study participants. As such, 
the PI and research team will plan regular monthly meetings to monitor the progress of the 
study, the integrity of the treatment and safety monitoring, including a review of any adverse 
events. If participants experience any adverse events, investigators will follow up participants 
and provide treatment until the event has subsided. Investigators will be available 24 hours via 
pager. The PI will report any significant study-related or unanticipated adverse events to the 
Institutional Review Board and to the study sponsor based upon institutional and sponsor 
guidelines. Given that this study is an initial exploratory study with a single treatment arm, it is 
felt that monitoring at the level of the PI and research team, with oversight from the IRB and 
study sponsor, is sufficient. 
15. PRIVACY & CONFIDENTIALITY  
The informed consent process will address various aspects of participant privacy including the 
level of control over the circumstances and extent of sharing one’s personal information. As 
stated above, participants will only be approached by study personnel after initial interest is 
obtained through their provider. The nature of the intervention (e.g. group self-management 
sessions) leads to a loss of privacy as participants will be able to identify each other.  They may 
also be identified by others if a participant logs onto the group video chat in a public location. 
This will be explained to participants as a compromise of the security of the data and part of the 
consent form. If a participant logs on from a public place, the clinical research coordinator will 
end the call with the participant and call them individually to problem solve an alternate location. 
If a suitable private location cannot be found, the participant will be asked to turn off their 
webcam and participate by phone or set an appointment to review the recorded session at a 
later date. During the informed consent process, the study personnel will explain these risks and 
the nature of the interaction with other participants. At that time, the potential participant may 1) 
decline to participate or 2) agree to participate with the understanding that they may withdraw at 
any time. This will give the participant control over the circumstances of sharing their personal 
information. To minimize privacy risks, all participants will also be required to sign an agreement 
that the AYA will log on to sessions from a private location. Study personnel will screen all 
questionnaires for completeness; participants are allowed to skip any survey questions they do 
not wish to answer, thereby providing additional control over the extent of sharing personal 
information. 
15.1 Data De-Identification 
All data will be de-identified with the use of unique assigned study identifier codes. Study 
identifier codes will be used on study measures for data entry and adherence electronic monitor 

Page | 19  
 
data download. No other identifying data such as date of birth, address, phone numbers, social 
security number, or zip code will be entered on electronic measures. Electronic data files 
(including downloads of data from REDCap or DDC measures) will only identify participants via 
study identifier codes and will be password protected. Electronic data files will be maintained on 
CCHMC hard drives.  
15.2 
Data Storage 
Informed consent documents will be maintained in locked storage cabinets within Dr. Crosby’s 
locked office at CCHMC. Consent and permission forms will be kept separate from participant’s 
data. Only the study investigative team will have access to the keys to the cabinets. Medical 
chart data will be collected by trained study staff under the supervision of the PI. These risk 
protection methods have been effectively used by the PI and her mentors and consultants for 
numerous studies. 
Individual data will not be available to anyone not directly associated with the study. All study 
personnel have been trained in data safety and monitoring, privacy and confidentiality, 
minimizing risks related to loss of privacy and confidentiality.  We will closely monitor 
performance of our research personnel to ensure the strictest standards. Study-related 
information will not be released without written permission of the participant (and parent or legal 
guardian, when applicable). 
16. COST OF PARTICIPATION  
No payment from participants will be required to participate in this study. Participants will be 
responsible for the usual costs of medical care. 
17. PAYMENT FOR PARTICIPATION  
 
17.1 Assessments (baseline, post-intervention, 2 weeks post-intervention, 6 weeks post-
intervention) 
 
Compensation for baseline measure completion (est. completion time: 50 minutes) is set at $35 
based on previous studies. The goal is that baseline questionnaires will be completed directly 
following a clinic visit, but subsequent study visits may require additional trips to CCHMC so a 
graduated incentive schedule will be used. SCThrive Pilot Group, SCThrive Intervention Arm, 
and Attention Control Arm participants will be compensated $35 for the baseline assessment, 
$55 for the post-treatment (week 6), and $60 for the week 12 assessment ($150 total). All 
payments will be in the form of a reloadable debit card (ClinCard) and participants will receive a 
handout that will explain how to use the card. Money will be loaded onto their cards after each 
visit based on the schedule listed below. 
 
Assessment Compensation  
Visit Type 
Compensation 
Baseline Measure Completion 
$35 
Post-Treatment Measure Completion 
$55 ($25 if 
complete 
SCThrive 
qualitative 
interview for a 
total of $80) 

Page | 20  
 
12 week Measure Completion 
$60 
 
 
 
17.2 Intervention Compensation 
 
Intervention Development Team:  
 
$360 for attending the majority of the study meetings by phone/in-person as well piloting new 
intervention tools and completing measures. These measures will help us evaluate the 
usefulness of the intervention tools. 
 
Participants will be compensated for their time and participation in SCThrive sessions and 
Attention Control phone calls ($35 per session/phone call). Based on feedback from the 
intervention development team, we will clearly identify the portion of the compensation that is for 
tracking pain/mood via the iManage app for SCThrive Intervention Arm participants. If all 6 
sessions/phone calls are completed, participants will receive a total of $245. Attention control 
participants will receive $35 for the booster phone call (making the total possible 
$245).SCThrive Intervention Arm participants will be asked to return their tablet at the 8th 
session (booster session); therefore, this treatment session offers a significantly higher 
compensation rate of $60. All payments will be in the form of a reloadable debit card (ClinCard) 
and participants will receive a handout that will explain how to use the card. Money will be 
loaded onto their cards after each visit based on the schedule listed below.  
 
Pilot and Intervention Studies Compensation 
Visit Type 
Compensation 
Total  
SCThrive Pilot Group 
$210  
 
 
Intervention Study 
 
   SCThrive Intervention Arm (6 sessions +1 booster) 
$270 
   Attention Control Arm (6 sessions + 1 booster) 
$245  
 
 
 
 
 
17.3 Transportation 
Many families report that transportation is a barrier to participation. Therefore, participants will 
receive compensation for their travel to complete assessments (baseline, post and 3-month). 
Data from our previous 6 week group self-management intervention indicates that 
approximately 25% of participants needed taxi cabs. On average, taxi roundtrip transportation is 
< $35. The participants not using taxi services also required transportation assistance for gas or 
to pay a family member/friend for gas. Pilot group participants reported that $10 was sufficient 
for transportation reimbursement given current gas prices. 
 
To minimize transportation needs, we will have participants in the SCThrive pilot group and 
SCThrive Intervention arm complete the post-assessment on the same day as their last 
intervention session.  
 
1. The SCThrive pilot group will consist of 8 participants who will have 3 in-person visits 
(session 1, session 2 & session 6/post-assessment). We are planning that 25% (3) of 

Page | 21  
 
participants in the SCThrive pilot group will require taxi compensation for study visits, 
and the other 75% (5) of participants will require $10 for transportation compensation. 
 
2. The SCThrive Intervention Arm will consist of 32 participants who will have 3 in-person 
visits (sessions 1, 2 & 6), 14 of whom will have an additional 2 in-person visits (booster 
session and 3 month follow up). We are planning that 25% (8) of participants in the 
SCThrive Intervention Arm will require taxi compensation for study visits, and 75% (24) 
of participants will require $10 for transportation compensation.  
 
3. The Attention Control Arm will consist of 32 participants who will have 1 in-person visit 
for their post-assessment. We are planning that 25% (8) of participants in the Attention 
Control Arm will require taxi compensation for study visits, and 75% (24) of participants 
will require $10 for transportation compensation. 
 
All payments will be in the form of a reloadable debit card (ClinCard) and participants will 
receive a handout that will explain how to use the card. Money will be loaded onto their cards 
based on the parameters described above. 
 
 

Page | 22  
 
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