Online Modules to Help Children Manage Medical Stress After an Injury: Recovery After Stress Toolkit (ReSeT) Pilot Study
Phase: NA
Conditions: Post-traumatic Stress Disorder
Sponsor: Children's Hospital Medical Center, Cincinnati

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Setting Families on a Positive Path to Recovery after Pediatric TBI: 
Road-to-Recovery, A Randomized Control Trial 
IRB/Protocol Number: 2022-0221  
Clinicaltrials.gov Number: NCT04830839    
Unique Protocol ID: R24 HD096350 
 
Principal Investigator: Shari Wade, PhD 
Funded by: The National Institute on Disability and Rehabilitation Research (NIDILRR) 
Version 8 
August 14, 2024 

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Table of Contents 
 
1. 
Background Information and Scientific Rationale .............................................................................. 4 
1.1 
Background Information .............................................................................................................. 4 
1.2 
Rationale ....................................................................................................................................... 5 
2. 
Objectives and Purpose........................................................................................................................ 5 
3. 
Study Design ......................................................................................................................................... 6 
3.1 
Overview ....................................................................................................................................... 6 
3.2 
Infrastructure ............................................................................................................................... 6 
3.3 
Study Measures ............................................................................................................................ 6 
3.4 Eligibility Criteria .................................................................................................................................. 8 
3.4.1 
Study Subjects .......................................................................................................................... 8 
3.4.1.1 
Participant Inclusion Criteria ............................................................................................... 8 
3.4.1.2 
Participant Exclusion Criteria ............................................................................................... 8 
3.5 
Recruitment Procedures .............................................................................................................. 8 
4. 
Study Procedures ................................................................................................................................. 9 
4.1.1 
Screening .................................................................................................................................. 9 
4.1.2 
Enrollment/Baseline................................................................................................................. 9 
4.1.2.1 
Obtaining Consent .............................................................................................................. 10 
4.1.3 
R2R-TBI Intervention .............................................................................................................. 10 
4.1.4 
Follow-up/Final Study Visit .................................................................................................... 12 
4.1.5 
Participant Withdrawal or Termination ................................................................................ 12 
4.1.5.1 
Reasons for Withdrawal or Termination ........................................................................... 12 
4.1.5.2 
Handling of Participant Withdrawals or Termination ....................................................... 13 
5. 
Statistical and Analytical Approaches ............................................................................................... 13 
5.1 
Statistical and Analytical Plans .................................................................................................. 13 
6. 
Data Management.............................................................................................................................. 15 
6.1 
Data Safety and Monitoring Plan............................................................................................... 15  
7. 
Quality Assurance and Quality Control ............................................................................................. 15 
7.1 
Quality Control Procedures ........................................................................................................ 15 
8. 
Human Subject Considerations .......................................................................................................... 15 
8.1 
Potential Risks ............................................................................................................................ 15 
8.2 
Potential Benefits ....................................................................................................................... 15 
9. 
Compensation and Costs .................................................................................................................... 15 
9.1 
Compensation ............................................................................................................................ 15 
9.2 
Costs ............................................................................................................................................ 16 
 
 
 
 
 
 
 

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Key Personnel 
Study PI 
Shari L. Wade, PhD, Professor 
Cincinnati Children’s Hospital Medical Center, 3333 Burnet Avenue, MLC 4009 
Cincinnati, Ohio 45229 
513-636-7480 
Shari.Wade@cchmc.org 
 
Site PI 
Kelly McNally, PhD, Assistant Clinical Professor of Pediatrics 
Nationwide Children’s Hospital, Psychology, 700 Children’s Drive 
Columbus, OH 43205 
(614) 722-4700 
kelly.mcnally@nationwidechildrens.org 
 
Co-Investigator 
Stacey P. Raj, PhD, Assistant Professor 
Xavier University, School of Psychology, Elet Hall, 3800 Victory Parkway 
Cincinnati, OH 45207 
(513) 745-4260 
rajs@xavier.edu 
 
Consultant 
Matthew Schmidt, PhD, Associate Professor of Educational Technology 
University of Florida, 2423 Norman Hall, Gainesville, FL 32611 
(352) 273-4241 
matthew.wchmidt@coe.ufl.edu 
 
Statistician 
Paul Horn, PhD, Professor 
Cincinnati Children’s Hospital Medical Center, 3333 Burnet Avenue 
Cincinnati, Ohio 45229 
513-803-3256 
Paul.Horn@cchmc.org 
 
 
 
 
 

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1. Background Information and Scientific Rationale 
1.1 
Background Information 
 
Traumatic brain injury (TBI) is a leading cause of acquired disability in childhood, 
impacting long-term health and functioning. Hospitalizations and rehabilitation visits 
leave families with worries, guilt, and questions regarding longer-term issues. The 
impact of pediatric TBI on caregivers and families is clearly documented, with numerous 
studies showing poorer psychological functioning, greater stress, and more family 
problems among caregivers of children with TBI relative to caregivers of non-injured 
children (e.g., Aitken et al., 2009; Hawley et al., 2003; Rashid et al., 2014). Mounting 
evidence has supported the critical role of parent/family functioning and parent-child 
interactions in child recovery following TBI (Yeates et al., 1997; Taylor et al., 2001, 
Gerring & Wade, 2012), and recent investigations have continued to underscore the role 
of the family and home environment in the child’s recovery. 
 
Risk factors for poorer recovery include nonmodifiable factors such as greater severity 
of injury (Catroppa et al., 2008; Rassovsky et al., 2015), younger age at injury (Catroppa 
et al., 2008; Keenan et al., 2019), and lower household income (Cohen-Zimerman et al., 
2019). However, there is a growing body of research documenting the critical role of 
caregiver and family functioning on child recovery following pediatric TBI (e.g., Ryan et 
al., 2016). Poor caregiver psychological functioning and family dysfunction have been 
found to exacerbate child behavior problems following injury (e.g., Raj et al., 2014a; 
Taylor et al., 2001). This association is particularly notable given that parents of children 
with TBI report more family problems, higher rates of depression and anxiety, and 
greater levels of stress than parents of non-injured children (e.g., Aitken et al., 2009; 
Hawley et al., 2003; Rashid et al., 2014). The influence of caregiver functioning is 
apparent in the initial months post injury, with poorer caregiver psychological health 
predicting more adolescent externalizing behavior problems, and more positive parent-
adolescent communication predicting fewer behavior problems (Raj et al., 2014a). 
 
To our knowledge, there are no interventions specifically targeting caregiver needs and 
well-being, and/or positive parenting in the acute phase following injury. Indeed, there 
is a general lack of interventions for families impacted by pediatric TBI (Brown et al., 
2013). A number of existing interventions focus on chronic needs, and not on 
functioning in the immediate weeks after injury (McLaughlin et al., 2013, Wade et al., 
2017). Parents of infants and toddlers may be especially unlikely to receive support; 
Keenan and colleagues (2019) found that more than 25% of parents of young children 
with TBI reported developmental concerns, yet only 5% of these children received early 
childhood intervention services.  
 
Numerous factors can hamper intervention efforts with parents impacted by pediatric 
TBI. Parents already burdened with increased child needs may have not have time, 
resources, or inclination to seek supports for themselves (e.g., Roscigno & Swanson, 
2011). Both traditional barriers to help seeking, such as perceived stigma (Corrigan, 
2004), and logistical challenges such as living in rural areas or lack of transportation and 
financial resources (Syed et al., 2013) render traditional in-office psychological services 
difficult to access. 
 

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1.2 
Rationale 
 
The early recovery period constitutes a critical window to set families on a positive road-
to-recovery by supporting parental self-care, positive parent-child interactions, and 
awareness of potential longer-term concerns. The latter would facilitate parental 
recognition of behavioral and psychosocial needs that might otherwise go unmet. 
 
Recognizing that (1) caregivers of children who have sustained TBI are at risk of 
worsening psychological health and that (2) caregiver functioning and parenting 
behaviors have a direct impact on child recovery and outcomes; intervening and 
supporting caregivers in the acute phase following injury may set children and families 
on a positive path to recovery. Intervening at the acute phase may reduce the cascading 
effects of parental burden/distress and concomitant negative parent-child interactions 
on child recovery and functioning over time.  
 
Because families of children with TBI and other chronic health conditions may have 
difficulty accessing services due to transportation and cost issues, particularly lower 
income families (Syed et al., 2013), the R2R-TBI program is designed to be accessed via 
any web-enabled device (e.g., smartphone, computer, tablet) with any form of internet 
connection. We will also offer the intervention (via tablet) to parents while they wait for 
their child to complete outpatient therapies (e.g., speech, physical, and occupational 
therapy). Delivery of web-based behavioral health interventions may reduce barriers to 
help-seeking and promote evidence-based interventions that are both accessible and 
efficient (e.g., Linardon et al., 2019; Luxton et al., 2011). The PEW Research Center 
(2019) indicates that about 92% of US adults ages 30-49 years and 96% of adults ages 
18-29 years own a smartphone. Importantly, the common practice of seeking health 
information online (PEW Research, 2015) is correlated with changes in medical decision 
making, suggesting that online information seeking affects subsequent health-related 
decisions (Chen et al., 2018). Among 151 caregivers of children with TBI, 71% rated a 
self-guided online treatment format as convenient (versus only 18% who rated face-to-
face treatment as convenient), providing further support for the acceptability of this 
approach (Wade et al., 2019).  
 
2. Objectives and Purpose 
 
The overarching aims of this project are to: (1) refine and enhance the R2R-TBI 
intervention, and (2) examine the efficacy of the R2R-TBI intervention in a randomized 
control trial. 
 
Findings from our pilot usability trial were largely positive and are described in Raj et al., 
(2021). The R2R-TBI program targets caregiver psychological functioning, parenting 
behaviors, and family functioning in the first three months following pediatric TBI. 
Research shows that the impact of parent functioning and behaviors on child outcomes 
are apparent in the initial months following injury (e.g., Raj et al., 2014a), and 
intervening during this acute phase may serve a protective function to children and 
families. This project is unique as it shifts the emphasis on recovery and neuroprotection 
that is typically delivered exclusively to the child, to the caregiver/family. Moreover, 
intervening in the acute phase post-TBI may provide a new opportunity for preventative 

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behavioral health care and set families on a positive path to recovery. 
 
3. Study Design  
3.1 
Overview 
 
This study has two main goals: 1) to refine and enhance the R2R-TBI intervention; and 2) 
to examine the efficacy of the R2R-TBI intervention in a randomized control trial. To 
achieve the second goal, we will employ a between-groups randomized treatment 
design with repeated measures at baseline, one-month post-randomization, and at a 
six-month follow-up. The two conditions will be: a) usual medical care plus access to 
internet resources regarding pediatric brain injury (Internet Resources Comparison 
group, IRC), and b) usual medical care plus the R2R-TBI intervention (Road-to-Recovery 
group, R2R-TBI).  
 
3.2 
Infrastructure 
 
Participants will be recruited from Cincinnati Children’s Hospital Medical Center 
(CCHMC) and Nationwide Children’s Hospital (NCH). CCHMC and NCH are fully 
accredited by the Association for the Accreditation of Human Research Protection 
Programs (AAHRPP), which promotes the highest quality research. To earn 
accreditation, organizations must provide tangible evidence – through policies, 
procedures, and practices – of their commitment to scientifically and ethically sound 
research and to continuous improvement. Potential participants will also be recruited 
through sharing of study information and study flyer at other hospitals and through 
organizations and associations serving children/families impacted by pediatric TBI. 
 
3.3 
Study Measures 
 
Participants will complete the following self-report measures at baseline, one-month 
post-baseline, and six-month follow-up. The measures described below were chosen 
based on the following criteria: 1) brevity (to minimize respondent burden), 2) high 
levels of reliability and evidence of validity with this population, 3) sensitivity to the 
effects of TBI, and 4) sensitivity to the effects of intervention. All data will be collected 
online via REDCap. 
 
Family demographics: Parents will complete a demographic survey that includes items 
related to annual family income, child and parent race/ethnicity, relationship to child, 
and services child is receiving.  
 
Parent mental health functioning: The Patient-Reported Outcomes Measurement 
Information System (PROMIS) Anxiety Measure 4a (4 items) will be used to assess 
parent anxiety. The Center for Epidemiological Studies Depression Scale (CES-D; 10-
items), will be used to measure parent depression. The CESD-10 is the short form of the 
original 20 item CES-D (Radloff, 1977). The Primary Care PTSD Screen for DSM-5 (PC-
PTSD-5) will be used to asses for parent post-traumatic stress symptoms. The measure 
consists of 5-items (Prins, et al., 2015). 
 
Parent wellbeing: Parent resilience will be assessed using the Connor-Davidson 

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Resilience Scale (10 items, Connor and Davidson, 2003) and parent self compassion and 
self-care behaviors will be assessed using the Mindful Self-Care Scale – Brief (24 items, 
Cook-Cottone, C. P. (2015) 
 
Perceived parenting efficacy. The Caregiver Self-Efficacy Scale (CSES) is a 25 item self-
report scale that measures parenting confidence and efficacy. Parents rate how 
comfortable they are in aspects of parenting, including their ability to control their 
child’s behavior, praise their child, and say no to their child. Scores on the measure 
range from 25 to 100, with higher scores indicating greater perceived parenting efficacy. 
The CSES is a reliable and valid measure and has been shown to be sensitive to the 
effects of online, family-centered interventions for TBI (Wade et al., 2014). 
 
Family functioning. Family functioning will be assessed using the 12 item Global 
Functioning Scale of the McMaster Family Assessment Device (FAD-GF, Epstein et al., 
1983), a self-report measure of family functioning with established reliability and 
validity (Miller et al., 1985). Primary caregivers will rate their level of agreement (i.e., 
strongly agree, agree, disagree, strongly disagree) to statements reflecting their family’s 
functioning. Scores on the FAD-GF range from 1 to 4 with higher scores indicating 
poorer family functioning. The FAD-GF is recognized by the Pediatric Common Data 
Elements (CDE) workgroup as a core measure of family functioning following TBI 
(McCauley et al., 2012). 
 
Child/adolescent socioemotional functioning. Caregivers will complete the Pediatric 
Quality of Life Inventory (PedsQL – Short Form, for ages 2-18 years; Varni et al., 1999) or 
the Pediatric Quality of Life Infant Scales (for ages 1-24 months; Varni et al., 2011). The 
PedsQL is a reliable, valid, and widely used measure of child/adolescent quality of life 
and socioemotional functioning (Varni et al., 1999, 2011), with established validity and 
reliability in pediatric TBI samples (McCarthy et al., 2005). The measure provides a total 
scale score as well as two summary scores - physical health and psychosocial health. The 
psychosocial health summary score will be used as an outcome measure and the 
physical health summary score will be used to describe the sample. Scale scores are 
reported as mean scores for each scale, with higher scored indicating better functioning. 
 
Burden of injury. The Family Burden of Injury Interview (FBII, Burgess et al., 1999) will be 
used to assess injury-related stress in the domains of child functioning and behavior, 
spousal relationship, and relationship with other members of the family in the acute 
phase following injury. The FBII is a reliable and valid assessment measure of injury-
related burden for families affected by TBI (Burgess et al., 1999).  
 
Feasibility and satisfaction. Ease of use of the program will be assessed by several 
measures of feasibility including usage analytics (i.e., trace data that captures time spent 
using the intervention, number of modules completed, time spent in each section/page 
of the intervention, keyboard input, etc.), as well as the System Usability Scale (SUS; 
Brooke, 1996). The SUS is an industry-standard scale consisting of 10 items with five 
Likert-scale response categories (strongly agree to strongly disagree). The SUS is easy to 
administer, widely used, and produces reliable and valid results (Bangor et al., 2008; 
Lewis, 2018). Parents will also complete an intervention satisfaction survey that has 
been adapted from prior web-based intervention studies (e.g., Kurowski et al., 2018; 

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Wade et al., 2012). The satisfaction survey captures both satisfaction with the content 
as well as with the web-delivery of the intervention. Caregivers will also provide 
qualitative feedback and suggestions via telephone and in-person interviews.  
 
3.4 
Eligibility Criteria 
3.4.1 
Study Subjects 
3.4.1.1 Participant Inclusion Criteria 
Caregivers will be eligible if they are over 18 years of age, and if their child meets all of 
the following criteria: 
• 
Ages 3 months to 18 years at time of discharge from hospital 
• 
Sustained a complicated mild to severe TBI as defined by a Glasgow Coma Scale 
(GCS) of 13-15 with imagining abnormalities or GCS 3-12 with or without 
imaging abnormalities 
• 
Admitted overnight to the hospital 
• 
0-3 months post-discharge  
 
3.4.1.2 Participant Exclusion Criteria 
The caregiver will be excluded from participation if any of the following occur: 
• 
Child did not survive the injury 
• 
Child’s head trauma was self-inflicted 
• 
Child does not reside with parent/caregiver for study duration 
• 
English is not primary language spoken in the home 
 
3.5 
Recruitment Procedures 
 
Up to 200 participants will be enrolled in this RCT. Potential participants will be 
identified and recruited from the CCHMC and NCH Trauma Registry, inpatient units, and 
outpatient clinics such as rehabilitation clinics. Potential participants will also be 
recruited through sharing of study information and study flyer at other hospitals and 
through organizations and associations serving children/families impacted by pediatric 
TBI. 
 
Recruitment at CCHMC and NCH 
 
Parents/caregivers who are eligible to participate will receive the study brochure or flyer 
while they are at the hospital, when their child is discharged from the hospital and/or at 
follow-up visits or clinics. Eligible parents/caregivers may also receive the study 
brochure or flyer via mail and or email (see recruitment email). The study brochure and 
flyer includes a QR code to a website that has the information sheet for the study. 
Research personnel will connect with families at the hospital (e.g., at follow-up clinics or 
discharge) or via phone (see phone /in-person recruitment script). Parents will be 
provided information about the study during this contact and will have the opportunity 
to review the information sheet/consent form and ask questions. Study staff will 
document this consent process on a form that will be included in the study binder.  
 
Recruitment through sharing of study information and flyer 
 

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Potential participants may also reach out to the study staff and request to be screened 
for the study. Study staff at CCHMC will screen potential participants for eligibility and 
families who meet criteria will be provided information about the study during this 
contact and will have the opportunity to review the information sheet/consent form 
and ask questions (see Road-to-recovery telephone script for potential participants who 
self refer). Study staff will document this consent process on a form that will be included 
in the study binder  
 
For all 
 
If the parent or individual is not interested, they will be thanked for their time and no 
further contact about the study will be made. If interest in the study is expressed, the 
parent will be sent a link to the study REDCap site. Parents will also be given the option 
to meet with study staff via videocall to orient the parent to the REDCap and/or study 
site and provide technical support. The study REDCap site opens with the study 
information sheet that provides contact details for study personnel. Participants who 
choose to participate will indicate consent by clicking a button at the bottom of the 
REDCap information sheet that reads, “YES, I acknowledge that I have viewed the 
information sheet and am voluntarily choosing to participate in this study.” Participants 
who click “YES” will then begin the baseline questionnaires. Participants who choose not 
to participate with click the “NO, I acknowledge that I have viewed the information 
sheet and I do not wish to participate in this study,” and they will receive a notification 
thanking them for their time and they will not be able to access the questionnaires.  
 
After baseline measures have been completed, the predetermined randomization 
sequence will be used to randomize caregivers into one of the two conditions (R2R-TBI 
vs. IRC). Stratified randomization will be used to achieve balance in child’s age (< 5 
years; ≥ 5 years) and injury severity. The randomization sequence will be based on a 
design with blocks of four or six chosen randomly within the sequence with equal 
probability. A pseudorandom number generator in R will be used, and the 
randomization sequence will be maintained by the statistician. Randomly varying block 
size reduces the chance that research staff will guess the next group assignment, 
minimizing unconscious bias. Block randomization with randomly mixed block sizes will 
then be performed with equal probabilities of assigning a participant to one of the two 
intervention groups.  
 
4. Study Procedures 
4.1.1 
Screening 
During the initial contact, potential participants will be informed about the study 
and will be asked whether they would like to be screened for the study (see 
telephone/in-person recruitment script and telephone script for potential 
participants who self-refer). Parents/caregivers who are eligible will then be 
provided further information about the study as detailed in the recruitment 
procedures. 
 
4.1.2 
Enrollment/Baseline 
Eligible caregivers who provide consent via REDCap will be presented with the 
baseline survey queue on REDCap. The baseline forms are expected to take about 

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45 minutes to complete. Once study staff receive complete baseline forms, 
participants will be randomly assigned to either IRC or R2R-TBI and will be sent a 
link, password, and instructions on how to access the R2R-TBI application or IRC 
website.  
 
4.1.2.1  Obtaining Consent  
Study staff will review the consent form with prospective participants (via phone or 
in-person; see phone/in-person recruitment script) and parents will have the 
opportunity to ask questions. Study staff will document this consent process on a 
form that will be included in the study binder. A waiver of documentation of 
consent will be requested for this study and study staff will accept participant 
acknowledgement on REDCap as consent for the study. (i.e., participants clicking 
“YES, I acknowledge that I have viewed the information sheet and am voluntarily 
choosing to participate in this study”). The consent form/information sheet will be 
viewable on REDCap prior to beginning baseline measures. All pertinent aspects of 
the study will be included in the information sheet, including, contact information of 
the researcher, study purpose, risks/benefits, confidentiality, and right to withdraw.  
 
4.1.3 
Study Groups 
4.1.3.1 R2R-TBI Intervention 
Caregivers assigned to the R2R-TBI intervention will receive a link to the web-based 
intervention as well as a username and password. Caregivers will receive weekly 
text, email, or phone reminders (participants will choose their preferred method of 
contact) to engage with the website. Time caregivers spend on the intervention as 
well as details on how often they log-on and devices used when accessing the 
intervention will be recorded.  
 
The R2R-TBI intervention was developed to be interactive and encourage active 
participation. Caregivers choose their own navigation paths through the web 
platform, allowing them to tailor the program to their specific needs. To encourage 
active engagement, caregivers have opportunities to practice skills taught in the 
intervention (e.g., questions with multiple responses and immediate feedback) and 
the format of these activities is varied. Each of these different components were 
tested in the usability testing sessions, and caregivers reported ease of use.  
 
Figure 1 provides a brief overview of the R2R-TBI modules. Each module is designed 
to take less than 20 minutes to complete and parents have access to all modules 
when they access the site. While we will encourage caregivers to move sequentially 
through the first four modules before selecting supplemental modules, feedback 
from the pilot trial suggests that caregivers benefit from flexibility to navigate to 
content that is most relevant for them. For example, parents with immediate school 
concerns or greater relationship concerns may want to access that content earlier. 
Note that participants in both conditions will continue to receive usual care. 
 
Figure 1. Summary of R2R-TBI modules 
 MODULE 1: WHAT TO EXPECT? 

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Parents often desire information about potential outcomes and benefit from ongoing information which may 
help reduce parental distress (Savage et al., 2005, Prigatano & Gray, 2007). In this module, caregivers are 
provided information about TBI and common sequelae of injury. Caregivers may select and learn more about 
symptoms that their child is experiencing. 
 
Problem-solving therapy approaches show promise in improving outcomes among children and families 
impacted by chronic health conditions (Law et al., 2014). As parent/guardians adjust to their new normal, this 
module teaches skills and a problem-solving framework that has been successfully used by caregivers of 
children with TBI (e.g., Wade et al., 2014; 2018).  
 
Parents learn positive parenting skills such as how to set their child up for success, and strategies to 
strengthen the parent-child relationship, set boundaries, and manage externalizing behaviors. Parents are 
able to select information that is specific to their child’s age and developmental level. 
 
Caregivers experience a lot of stress in the acute phase post injury, which can persist for many years. In this 
module, parents are taught stress management strategies such as progressive muscle relaxation, relaxed 
breathing, and guided imagery.  
 
Parent perspectives of quality of communication with their child’ school during re-entry and affects child 
outcomes (Andersson et al., 2016). In this module, parents learn how to work collaboratively with the school 
to support their child’s re-entry and needs. Information about services/supports (e.g., IEP, 504-Plan) is 
provided.  
 
Parents of children with TBI often experience feelings of guilt and grief (Aitken et al., 2009; Kirk et al., 2015). 
This module works to normalize feelings of guilt and grief and shares experiences of other caregivers. Parents 
are provided strategies to manage difficult emotions and information on respite care and other 
services/support.  
 
Parents learn about common relationship stressors following pediatric TBI (e.g., differing parental 
expectations, poor communication, financial concerns, etc.; Kirk et al., 2015). Parents also learn tips for 
improving communication with their spouse/partner and practice effective talking/listening skills. 
 
Many children with TBI experience sleep difficulties (Sumpter et al., 2013). This module covers possible 
reasons for their child’s sleep issues, and strategies for supporting healthy sleep for both child and parent.  
 
Siblings of children with TBI are at risk of poorer psychological functioning and reduced quality of life 
(Sambuco et al., 2008). In this module, parents learn about typical sibling reactions and strategies they can use 
to support all their children. Parents are also taught to differentiate between normal sibling reactions and 
warning signs of more serious problems, as well as resources on services/supports for siblings. 
 
This module is for parents of children with post-TBI challenges transitioning out of high school. It contains 
information on their child’s legal rights around education and job training and links to organizations that 
MODULE 2. PROBLEM SOLVING YOUR CHILD’S RECOVERY 
MODULE 3. POSITIVE PARENTING 
MODULE 4. TAKING CARE OF YOURSELF 
MODULE 10. AFTER HIGH SCHOOL 
MODULE 9. PARENTS AND SIBLINGS 
MODULE 8. SLEEP ISSUES 
MODULE 7. PARENTAL COMMUNICATION 
MODULE 6. GUILT, GRIEF, AND CAREGIVING 
MODULE 5. WORKING WITH YOUR CHILD’S SCHOOL 

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support transition, such as the State Vocational Rehabilitation Agency. 
 
4.1.3.2 Internet Resources Condition (IRC) 
Caregivers in the web-based resources condition will be provided with a link and 
password to a website that provides links to a range of resources on pediatric TBI 
including local, state, and national brain-injury associations. These resources will 
also be provided to families in the R2R-TBI intervention. Essentially, families in the 
IRC condition will have access to the same links to resources without the specific 
intervention content/modules. This will enable us to equate the groups with regard 
to access to information and resources available on the internet. Parents in this 
group will also have access to technical support as well as the opportunity to 
contact the researchers with any questions/concerns.  
Participants in both conditions will continue to receive usual care. 
 
4.1.4 
Check-ins  
Study staff will check-in with study participants at regular intervals during their 
participation in the study via phone calls, texts and/or emails. These check-ins will 
allow study staff to keep participants engaged and to provide reminders to use the 
website.  
 
4.1.5 
Follow-ups 
Follow-up 1 (30 – 45 days after receiving study login) 
Approximately 30 to 45-days after receiving their login, parents will be contacted via 
phone, email, and/or at follow-up clinics and will be provided a link to the REDCap 
site to complete the post-intervention questionnaires. Participants will also be given 
the option to meet with study staff via videocall if they would like to orient the 
participant to the REDCap site and provide technical support.  
 
Follow-up 2 (6 months after baseline) 
Approximately 6 months after receiving their login, parents will be contacted via 
phone, email, and/or at follow-up clinics and will be provided a link to the REDCap 
site to complete the long-term follow-up measures. Participants will also be given 
the option to meet with study staff via videocall if they would like to orient the 
participant to the REDCap site and provide technical support. 
 
Brief interview 
A subset of participants may be contacted via phone, email, and/or at follow-up 
clinics to complete a brief qualitative interview (10-15 minutes) about their 
experience with the intervention that may be audio recorded. This interview will be 
conducted anytime after follow-up 1 and may be done via email, phone, or in-
person. 
 
4.1.6 
Participant Withdrawal or Termination 
4.1.6.1 Reasons for Withdrawal or Termination 
Participants are free to withdraw from the study at any time upon verbal or 
written request.  
An investigator may terminate participation in the study if: 

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• 
Any adverse event, medical condition, or situation occurs such that 
continued participation in the study would not be in the best interest of the 
participant 
• 
The participant meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation 
4.1.6.2 Handling of Participant Withdrawals or Termination 
Participants are free to withdraw from the study at any time upon verbal or 
written request.  If a family indicates they would like to withdraw, they will be 
given the option to discontinue intervention modules but remain in the study 
for follow-up or discontinue from the intervention modules and future follow-
up. Existing data will remain in the study database.  If a participant wishes to 
have all research being conducted on his/her data stopped, the data will not be 
included in the analysis. 
 
5. Statistical and Analytical Approaches  
5.1 
Statistical and Analytical Plans 
Caregiver functioning is examined as the primary and most proximal outcomes of the 
R2R-TBI intervention. Through targeting caregiver functioning, we expect the R2R-TBI 
intervention to have downstream effects (through reductions in caregiver depression 
and distress) on the secondary outcomes of child recovery and family functioning. We 
further anticipate that the same risk and protective factors that have been shown to 
moderate child recovery and the efficacy of other family-centered interventions for 
pediatric TBI, such as household income and baseline family functioning, will moderate 
the efficacy of the R2R-TBI intervention (e.g., Antonini et al., 2014; Raj et al., 2014b; 
Wade et al., 2012, 2015). Specifically, we anticipate that the R2R-TBI intervention will be 
most effective among low-income families and among caregivers with high levels of 
baseline distress. Our hypotheses are as follows: 
 
 
Hypothesis 1: Caregivers receiving the R2R-TBI intervention will report lower levels of 
depression, anxiety, post-traumatic stress, and higher levels of caregiver self-efficacy 
and mindful self-care at follow-up, compared to caregivers in the IRC condition, after 
controlling for baseline levels.  
 
The R2R-TBI intervention is designed to promote caregiver psychological well-being and 
positive parenting in the acute phase post-injury. This hypothesis represents an 
important test of whether the intervention is successful in improving these areas of 
functioning that are targets of the intervention. To evaluate this hypothesis, we will 
examine group difference in caregiver depression (CES-D-10, Radloff, 1977), anxiety 
(PROMIS Anxiety 4a), post traumatic stress (PC-PTSD-5, Prins et al., 2015), caregiver self-
efficacy (CSES, Boothroyd & Evans, 1997), and mindful self-care (MSCS-25; Cook-
Cottone, 2015) at one and six-months post-baseline, controlling for baseline scores. 
Given the challenges in the acute phase post-injury, we expect caregivers in the R2R 
intervention to report stable functioning while caregivers in the IRC group to report 
increasing levels of depression and distress at both one and six-month follow-ups.   
 
Hypothesis 2: Caregivers receiving the R2R intervention will report better child and 
family functioning at follow-up, compared to caregivers in the IRC condition, after 
controlling for baseline functioning.  

14 
 
 
We anticipate that the R2R-TBI intervention will be effective in both ameliorating 
problems evident at baseline and in preventing emergence of additional problems in 
family and child functioning at one and six-months post-baseline. To test this 
hypothesis, we will examine group differences in family functioning (FAD-GF, Epstein, 
Baldwin, & Bishop, 1983), family burden of injury (FBI, Burgess et al., 1999) and child 
socioemotional functioning (PedsQL Psychosocial Summary Score, Varni et al., 1999) at 
one and six-months post-baseline. 
 
Hypothesis 3: We hypothesize that treatment effects will be moderated by household 
income and level of caregiver distress at baseline.  
 
We expect families with greater social disadvantage (lower income, more stress) will 
benefit most from the R2R-TBI intervention. This hypothesis is consistent with previous 
research findings (e.g., Antonini et al., 2014; Raj et al., 2014b; Wade et al., 2012, 2015).   
 
Variable distributions will be examined before carrying out inferential statistical 
procedures, and transformations will be made in cases where distributions are skewed 
or fail to meet the assumptions of normality. Non-parametric procedures will be 
employed in cases where transformations would be inappropriate or where analysis of 
frequencies is justified. Preliminary work will also involve computation of reliabilities 
and creation of derived variables that summarize performance on measures that are 
highly inter-correlated. To evaluate potential attrition bias, caregivers who drop out 
(i.e., those who access < 3 modules and/or who do not complete baseline or follow-up 
measures) will be compared to those who remain in follow-up on background 
characteristics as well as on outcomes measured prior to dropout. Factors related to 
dropout will be included as covariates in the analysis.  
Analytic plan for hypotheses 1 and 2. The primary analysis will consist of a linear mixed-
effect models used to examine changes in caregiver, family, and child functioning 
among participants in the R2R-TBI intervention and IRC groups from baseline to 6-
months post-baseline. In addition, the one-month data will be included in a mixed 
model repeated measures analysis. This model allows for flexible modeling of the 
pattern of change in outcomes over time and uses all the data for a given participant, 
even if that participant is not seen at all assessments, allowing us to retain participants 
with missing assessments.  
Analytic plan for hypothesis 3. Existing literature and findings from our other studies 
suggest that demographic factors such as household income as well as baseline 
caregiver functioning impact adaptation to injury, and we hypothesize that these factors 
will moderate the efficacy of the intervention. Hierarchical multiple regression analyses 
which include the interaction of group, moderator (household income, baseline 
functioning), and time in the model will be used to test hypothesis 3. Variable selection 
using backward elimination will be used to remove non-significant higher- and then 
lower-order terms. In order to avoid selection bias, bootstrapping will be used on the 
backward elimination process (Austin, 2008). Post hoc analyses will be used to compare 

15 
 
treatment groups on each outcome at different levels of the moderators at 1 and 6-
months post-baseline.  
6. Data Management  
6.1 
Data Safety and Monitoring Plan 
 
Risks to the patient and family’s privacy are minimal, and every effort will be made to 
safeguard confidentiality according to HIPAA specifications. Personnel involved in data 
collection will be instructed regarding the importance of confidentiality and the steps 
that must be taken to protect it. Confidentiality of participant’s names will be ensured 
by replacing names with subject numbers. The master list linking the two will be kept in 
a locked file drawer.  
 
A licensed psychologist and staff trained in working with families of children and teens 
with TBI will be conducting this study. Participants and their families will be able to 
reach the study PI or designee to report any adverse effects or concerns. 
 
Participants will complete a W9 form embedded in the REDCap survey to obtain 
compensation. After a participant completes the W9, this information will be uploaded 
to Cincinnati Children’s Hospital Medical Center secured G: Drive and deleted from 
REDCap. All data will be presented and published in aggregate form without identifying 
information.  All paper and pencil data will be secured in locked file cabinets and on-line 
data will be password protected and encrypted using 128-bit encryption software. 
Should participants disclose any unnecessary PHI on the questionnaires; the PHI will be 
redacted using black permanent marker and will be initialed and dated by the 
coordinator noting redacted PHI. PHI will also be edited out in audio recordings as well 
as resultant transcripts. 
 
7. Quality Assurance and Quality Control  
7.1 
Quality Control Procedures  
Regular meetings of the PI and project staff will serve to review recruitment, baseline, 
and follow-up assessment scheduling and completion, to address questions regarding 
administration and scoring of assessments, and to evaluate progress toward study 
milestones.  
 
8. Human Subject Considerations 
8.1 
Potential Risks 
Participants will encounter no more than minimal risks due to enrollment in this study.  
All of the questionnaire measures have been used extensively in previous research with 
no negative psychological reactions reported.  
8.2 
Potential Benefits 
Regardless of the intervention condition the participant is assigned to, they will be 
provided links to resources on pediatric TBI that may be helpful.  
 
9. Compensation and Costs 
9.1 
Compensation 
Participants will be compensated as follows:  
• 
$50 after completing the first set of online questionnaires (baseline) 

16 
 
• 
$50 after participating in the online self-guided intervention (or control 
condition) and completing the 1 to 1.5 month online questionnaires 
• 
$50 after completing the 6-month follow-up online questionnaires 
• 
$25 to parents who participate in the qualitative interview 
 
9.2 
Costs 
There are no costs to participants or their insurance providers. 
 
 
 

17 
 
References  
 
Aitken, M. E., McCarthy, M. L., Slomine, B. S., Ding, R., Durbin, D. R., Jaffe, K. M., ... & MacKenzie, E. J. 
(2009). Family burden after traumatic brain injury in children. Pediatrics, 123(1), 199-206. 
 
 
Brown, F. L., Whittingham, K., Boyd, R., & Sofronoff, K. (2013). A systematic review of parenting 
interventions for traumatic brain injury: Child and parent outcomes. The Journal of Head Trauma 
Rehabilitation, 28(5), 349-360. 
 
Burgess, E. S., Drotar, D., Taylor, G. H., Wade, S., Stancin, T., & Yeates, K. O. (1999). The family burden of 
injury interview: reliability and validity studies. The Journal of Head Trauma Rehabilitation, 14(4), 394-
405. 
 
Catroppa, C., Anderson, V. A., Morse, S. A., Haritou, F., & Rosenfeld, J. V. (2008). Outcome  
and predictors of functional recovery 5 years following pediatric traumatic brain injury  
(TBI). Journal of Pediatric Psychology, 33(7), 707–718. https://doi.org/10.1093/jpepsy/jsn006 
 
Chen, Y. Y., Li, C. M., Liang, J. C, Tsai, C. C. (2018). Health information obtained from the internet and 
changes in medical decision making: Questionnaire development and cross-sectional survey. Journal of 
Medical Internet Research, 20(2):e47. https:doi.org/10.2196/jmir.9370 
 
Cohen-Zimerman, S., Kachian, Z. R., Krueger, F., Gordon, B., & Grafman, J. (2019). Childhood  
socioeconomic status predicts cognitive outcomes across adulthood following traumatic brain injury. 
Neuropsychologia, 124, 1–8. https://doi.org/10.1016/j.neuropsychologia.2019.01.001 
 
Connor, K. M., & Davidson, J. R. (2003). Development of a new resilience scale: The Connor‐Davidson 
resilience scale (CD‐RISC). Depression and anxiety, 18(2), 76-82.  
 
Cook-Cottone, C. P., & Guyker, W. M. (2017). The Development and Validation of the Mindful Self-Care 
Scale (MSCS): an Assessment of Practices that Support Positive Embodiment. Mindfulness, 1-15. 
Corrigan, P. (2004). How stigma interferes with mental health care. American Psychologist, 59(7), 614. 
 
Epstein, N. B., Baldwin, L. M., & Bishop, D. S. (1983). The McMaster family assessment device. Journal of 
Marital and Family Therapy, 9(2), 171-180. 
 
Hawley, C. A., Ward, A. B., Magnay, A. R., & Long, J. (2003). Parental stress and burden following 
traumatic brain injury amongst children and adolescents. Brain Injury, 17(1), 1-23. 
 
Keenan, H. T., Clark, A. E., Holubkov, R., Cox, C. S., & Ewing-Cobbs, L. (2019). Psychosocial  
and executive function recovery trajectories one year after pediatric traumatic brain  
injury: The influence of age and injury severity. Journal Of Neurotrauma, 35(2), 286– 
296. https://doi.org/10.1089/neu.2017.5265 
 
Kindon, S. L., Pain, R., & Kesby, M. (2007). Participatory action research approaches and  
methods: Connecting people, participation and place. (Eds.) Routledge studies in human geography, (p. 
9-18). Routledge. 
 

18 
 
Lessenberry, B. M., & Rehfeldt, R. A. (2004). Evaluating stress levels of parents of children with 
disabilities. Exceptional Children, 70(2), 231-244. 
 
Linardon, J., Cuijpers, P., Carlbring, P., Messer, M., & Fuller-Tyszkiewicz, M. (2019). The  
efficacy of app-supported smartphone interventions for mental health problems: a meta- 
analysis of randomized controlled trials. World Psychiatry, 18(3), 325–336. 
https://doi.org/10.1002/wps.20673 
 
Luxton, D. D., McCann, R. A., Bush, N. E., Mishkind, M. C., & Reger, G. M. (2011). mHealth for mental 
health: Integrating smartphone technology in behavioral healthcare. Professional Psychology: Research 
and Practice, 42(6), 505. 
 
McCarthy, M. L., MacKenzie, E. J., Durbin, D. R., Aitken, M. E., Jaffe, K. M., Paidas, C. N., ... & Ding, R. 
(2005). The Pediatric Quality of Life Inventory: an evaluation of its reliability and validity for children 
with traumatic brain injury. Archives of Physical Medicine and Rehabilitation, 86(10), 1901-1909. 
https://doi.org/10.1016/j.apmr.2005.03.026 
 
McCauley, S. R., Wilde, E. A., Anderson, V. A., Bedell, G., Beers, S. R., Campbell, T. F., ... & Levin, H. S. 
(2012). Recommendations for the use of common outcome measures in pediatric traumatic brain injury 
research. Journal of Neurotrauma, 29(4), 678-705. 
 
McLaughlin, K. A., Glang, A., Beaver, S. V., Gau, J. M., & Keen, S. (2013). Web-based training in family 
advocacy. The Journal of Head Trauma Rehabilitation, 28(5), 341-348. 
 
Miller, I. W., Epstein, N. B., Bishop, D. S., & Keitner, G. I. (1985). The McMaster family assessment 
device: reliability and validity*. Journal of Marital and Family Therapy, 11(4), 345-356. 
 
Pew Research Center (2015). The Smartphone Difference. Retrieved on 28 Mar 2016 from 
http://www.pewinternet.org/2015/04/01/us-smartphone-use-in-2015/ 
 
Pew Research Center. (2019). Mobile technology and home broadband. 
https://www.pewresearch.org/internet/2019/06/13/mobile-technology-and-home-broadband-2019/ 
 
Prigatano, G. P., & Gray, J. A. (2007). Parental concerns and distress after pediatric traumatic brain 
injury: A qualitative study. Brain Injury, 21(7), 721-729. 
 
Prins, A., Bovin, M. J., Kimerling, R., Kaloupek, D. G, Marx, B. P., Pless Kaiser, A., & Schnurr, P. P. (2015). 
Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) [Measurement instrument]. Available from 
https://www.ptsd.va.gov  
 
Raj, S. P., Schmidt, M. Moscato, E. L., Guzman-Gomez, A., Rodriguez, B., Seid, C. S., & Wade, S. L. (2021). 
Road-to-Recovery-TBI: Pilot trial of an eHealth intervention for caregivers after pediatric brain injury. 
Clinical Practice of Pediatric Psychology, 9(2), 167-179. doi: 10.1037/cpp0000398 
 
Savage, R. C., DePompei, R., Tyler, J., & Lash, M. (2005). Pediatric traumatic brain injury: A review of 
pertinent issues. Pediatric Rehabilitation, 8(2), 92-103. 
 

19 
 
Radloff, L. S. (1977). The CES-D scale a self-report depression scale for research in the general 
population. Applied Psychological Measurement, 1(3), 385-401. 
 
Rashid, M., Goez, H. R., Mabood, N., Damanhoury, S., Yager, J. Y., Joyce, A. S., & Newton, A. S. (2014). 
The impact of pediatric traumatic brain injury (TBI) on family functioning: a systematic review. Journal of 
Pediatric Rehabilitation Medicine, 7(3), 241-254. doi: 10.1089/neu.2017.5265 
 
Rassovsky, Y., Levi, Y., Agranov, E., Sela-Kaufman, M., Sverdlik, A., & Vakil, E. (2015).  
Predicting long-term outcome following traumatic brain injury (TBI). Journal of Clinical & Experimental 
Neuropsychology, 37(4), 354–366. https://doi.org/10.1080/13803395.2015.1015498 
 
Raj, S. P., Wade, S. L., Cassedy, A., Taylor, H. G., Stancin, T., Brown, T. M., & Kirkwood, M. W. (2014). 
Parent psychological functioning and communication predict externalizing behavior problems after 
pediatric traumatic brain injury. Journal of pediatric psychology, 39(1), 84-95. 
 
Rivara, F. P., Koepsell, T. D., Wang, J., Temkin, N., Dorsch, A., Vavilala, M. S., ... & Jaffe, K. M. (2011). 
Disability 3, 12, and 24 months after traumatic brain injury among children and 
adolescents. Pediatrics, 128(5), e1129-e1138. https://doi.org/10.1542/peds.2011-0840 
 
Roscigno, C. I., & Swanson, K. M. (2011). Parents’ experiences following children’s moderate to severe 
traumatic brain injury: A clash of cultures. Qualitative Health Research, 21(10), 1413-1426. 
https://doi.org/10.1177/1049732311410988 
 
Ryan, N. P., van Bijnen, L., Catroppa, C., Beauchamp, M. H., Crossley, L., Hearps, S., & Anderson, V. 
(2016). Longitudinal outcome and recovery of social problems after pediatric traumatic brain injury 
(TBI): Contribution of brain insult and family environment. International Journal of Developmental 
Neuroscience, 49, 23-30. https://doi.org/10.1016/j.ijdevneu.2015.12.004 
 
Syed, S. T., Gerber, B. S., & Sharp, L. K. (2013). Travelling towards disease: Transportation  
barriers to health care access. Journal of Community Health, 38, 976-993. 
https://doi.org/10.1007/s10900-013-9681-1 
 
Taylor, H. G., Yeates, K. O., Wade, S. L., Drotar, D., Stancin, T., & Burant, C. (2001). Bidirectional child–
family influences on outcomes of traumatic brain injury in children. Journal of the International 
Neuropsychological Society, 7(06), 755-767. 
 
Varni, J. W., Limbers, C. A., Neighbors, K., Schulz, K., Lieu, J. E., Heffer, R. W., ... & Alonso, E. M. (2011). 
The PedsQL™ Infant Scales: Feasibility, internal consistency reliability, and validity in healthy and ill 
infants. Quality of Life Research, 20(1), 45-55. 
 
Varni, J. W., Seid, M., & Rode, C. A. (1999). The PedsQL™: measurement model for the pediatric quality 
of life inventory. Medical Care, 126-139. 
Wade, S. L., Taylor, H. G., Drotar, D., Stancin, T., & Yeates, K. O. (1998). Family burden and adaptation 
during the initial year after traumatic brain injury in children. Pediatrics, 102(1), 110-116. 
 
Wade, S. L., Cassedy, A. E., McNally, K. A., Kurowski, B. G., Kirkwood, M. W., Stancin, T., & Taylor, H. G. 
(2019). A randomized comparative effectiveness trial of family-problem–solving treatment for 
adolescent brain injury: Parent outcomes from the Coping with Head Injury through Problem Solving 

20 
 
(CHIPS) study. The Journal of Head Trauma Rehabilitation, 34(6), E1-E9. http://doi: 
10.1097/HTR.0000000000000487