GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
Phase: NA
Conditions: Pediatric Pain, Chronic Pain, Widespread, Musculoskeletal Pain
Sponsor: Laura E Simons

 
Simons Single Site Clinical Protocol v1.8 21Jan2021 
 
GET Living: Graded Exposure Treatment for 
Children and Adolescents with Chronic 
Musculoskeletal Pain 
 
Clinical Protocol 
 
Principal Investigator: 
Dr. Laura Simons, PhD 
 
Associate Professor 
Department of Anesthesiology, Perioperative, and Pain Medicine 
Stanford University School of Medicine 
 
Funded by: 
The National Institute for Arthritis and Musculoskeletal and Skin Diseases 
 
National Clinical Trial Identifier: NCT03699007 
Protocol Number: R21 AR072921-01A1 
Version Number: v.1.8 
January 21st, 2021 
 
 
 

 
 
2 
Summary of Changes from Previous Version:  
Affected Section(s) 
Summary of Revisions Made 
Rationale 
9.4 Interim Analyses and 
Stopping Rules 
Addition of interim analysis plan 
To provide procedures for stopping 
the trial if overwhelming futility or 
efficacy is proven. 

 
 
3 
 
Table of Contents 
STUDY TEAM ROSTER ............................................................................................................................................... 5 
PARTICIPATING STUDY SITES .................................................................................................................................... 6 
PRÉCIS ...................................................................................................................................................................... 7 
1.1 
Primary Objective ........................................................................................................................................ 8 
2. BACKGROUND AND RATIONALE ................................................................................................................. 8 
2.1 
Background and Significance ........................................................................................................................ 8 
2.2 
Study Rationale ......................................................................................................................................... 10 
3. STUDY DESIGN ...................................................................................................................................................... 11 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS ..................................................................................... 12 
4.1 
Inclusion Criteria ........................................................................................................................................ 12 
4.2 
Exclusion Criteria ....................................................................................................................................... 13 
4.3 
Study Enrollment Procedures ..................................................................................................................... 13 
5. STUDY INTERVENTIONS ............................................................................................................................ 13 
5.1 
Interventions, Administration, and Duration .............................................................................................. 13 
    5.1.2             Compensation                      18 
5.2 
Handling of Study Interventions ................................................................................................................. 18 
5.3 
Concomitant Interventions ........................................................................................................................ 18 
5.3.1 
Allowed Interventions        19 
5.3.2 
Required Interventions 
19 
5.3.3 
Prohibited Interventions 19 
5.4 
Adherence Assessment .............................................................................................................................. 19 
6. STUDY PROCEDURES ................................................................................................................................ 20 
6.1 
Schedule of Evaluations ............................................................................................................................. 20 
6.2 
Description of Evaluations ......................................................................................................................... 21 
6.2.1 
Screening Evaluation 
 
 
21 
6.2.2 
Enrollment, Baseline, and Randomization 
21 
6.2.3 
Blinding  
 
 
 
23 
6.2.4 
Treatment Measures 
 
 
23 
6.2.6 
Follow-Up Assessments 
 
 
23 
7. SAFETY ASSESSMENTS .............................................................................................................................. 23 
7.1 
Specification of Safety Parameters ............................................................................................................. 24 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters ....................................... 24 
7.3 
Adverse Events and Serious Adverse Events ............................................................................................... 24 
7.4 
Reporting Procedures ................................................................................................................................ 25 
7.5 
Follow-up for Adverse Events ..................................................................................................................... 25 

 
 
4 
7.6 
Safety Monitoring ...................................................................................................................................... 25 
8. INTERVENTION DISCONTINUATION .......................................................................................................... 26 
9. STATISTICAL CONSIDERATIONS ................................................................................................................ 26 
9.1 
General Design Issues ................................................................................................................................ 26 
9.2 
Sample Size and Randomization ................................................................................................................. 27 
9.3  
Definition of Populations ........................................................................................................................... 28 
9.4 
Interim Analyses and Stopping Rules ......................................................................................................... 28 
9.5 
Outcomes .................................................................................................................................................. 28 
9.5.1 
Primary Outcome  
28 
9.5.2 
Secondary Outcomes 
28 
           9.5.3 
Additional Outcomes   
27 
           9.5.4 
Exploratory Outcomes 
27 
           9.5.5 
Feasibility Measures 
27 
9.6 
Data Analyses ............................................................................................................................................ 30 
10. DATA COLLECTION AND QUALITY ASSURANCE ....................................................................................... 31 
10.1 
Data Collection Forms ................................................................................................................................ 31 
10.2 
Data Management ..................................................................................................................................... 31 
10.3 
Quality Assurance ...................................................................................................................................... 31 
10.3.1 
Training  
 
 
31 
10.3.2 
Quality Control Committee 
32 
10.3.3 
Metrics  
 
 
32 
10.3.4 
Protocol Deviations 
 
32 
10.3.5 
Monitoring 
 
 
32 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ......................................................................................... 32 
11.1 
Institutional Review Board (IRB) Review .................................................................................................... 32 
11.2 
Informed Consent Forms ............................................................................................................................ 32 
11.3 
Participant Confidentiality ......................................................................................................................... 33 
11.4 
Study Discontinuation ................................................................................................................................ 33 
12. COMMITTEES ......................................................................................................................................... 33 
13. PUBLICATION OF RESEARCH FINDINGS ................................................................................................... 33 
14. REFERENCES ........................................................................................................................................... 34 
 
 
 

 
 
5 
STUDY TEAM ROSTER  
Principal Investigator - Laura Simons, PhD 
Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine; 1070 
Arastradero Rd. Suite 300, Palo Alto, CA, 94304, phone (650) 736-0838, fax (650) 724-8692, 
lesimons@stanford.edu  
 
Co-Investigator - Korey Hood, PhD 
Department of Pediatrics, Department of Psychiatry and Behavioral Sciences, Lucile Packard Children’s Hospital; 
780 Welch Rd., CJ320G, Palo Alto, CA, 94304, kkhood@stanford.edu  
 
Co-Investigator - Michael Orendurff, PhD 
Motion & Sports Performance Laboratory, Stanford Children’s Health; 1195 W. Fremont Ave., Sunnyvale, CA 
94087, phone (408) 426-8128, fax (408) 426-8124, morendurff@stanfordchildrens.org 
 
Biostatistician- Derek Boothroyd, PhD 
Department of Medicine and Quantitative Sciences Unit, Stanford University School of Medicine; 1070 
Arastradero Rd. 3C3101, Palo Alto, CA, 94304, phone (650) 498-9243, derekb@stanford.edu  
 
Consultant - Johan Vlaeyen, PhD 
Department of Health Psychology, University of Leuven; Tiensestraat 102, 3000 Leuven, Belgium, phone +32 1632 
5915, fax +32 1632 6144, johannes.vlaeyen@kuleuven.be  
 
Consultant – Rikard Wicksell, PhD 
Department of Behavioral Medicine Pain Treatment Service, Karolinska University Hospital; Karolinska vägen, 171 
76 Solna, Sweden, phone +46 (0) 8 – 524 823 08. rikard.wicksell@ki.se  
 
Clinical Research Coordinator  
Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine; 1070 
Arastradero Rd. Suite 300, Palo Alto, CA, 94304, phone (650) 497-9562, pedspainlab@stanford.edu 
 
Treatment Provider (Psychologist) 
Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University School of Medicine; 1070 
Arastradero Rd. Suite 300, Palo Alto, CA, 94304 
 
Treatment Provider (Physical Therapist)  
Center for Rehabilitation Services, Stanford Children’s Health, Lucile Packard Children’s Hospital; 725 Welch Road, 
Suite 350, Palo Alto, CA, 94304, phone (650) 206-0190, fax (650) 479-8491 
 
Safety Monitoring Committee (Medical Expertise) – Lonnie Zeltzer, MD  
Pediatric Pain and Palliative Care Program, David Geffen School of Medicine at UCLA; 5041 Valjean Ave, Encino, 
CA 91436. lzeltzer@mednet.ucla.edu 
 
Safety Monitoring Committee (Clinical Psychology Expertise) – Soumitri Sil, PhD  
Aflac Cancer and Blood Disorders Center, Children’s Healthcare of Atlanta, Emory University School of Medicine; 
2015 Uppergate Drive, Rm 426H Atlanta, GA 30322. soumitri.sil@emory.edu 
 
Safety Monitoring Committee (Physical Therapy Expertise) –Tarcisio De Campos, PT  
Department of Health Professions, Macquarie University; Ground Floor, 75 Talavera Rd 
Macquarie University, NSW 2109, Australia. tarcisio.decampos@mq.edu.au 
 
 

 
 
6 
Study Abbreviations 
 
Acronym 
Expanded Term 
Section(s) 
ACT 
Acceptance and Commitment Therapy 
10.3.1 
AE 
Adverse Event  
7.3, 7.4 
ANOVA 
Analysis of Variance 
9.1 
BAS 
Baseline study visit  
3, 6.2.2, 9.1, 9.5.5 
CBT 
Cognitive Behavioral Therapy  
2.1, 5.1, 10.3.1 
CHOIR 
Collaborative Health Outcomes Information 
Registry  
3 
CITI 
Collaborative Institutional Training Initiative  
10.3.1 
DD 
Daily Diary  
3, 9.1 
DSMP 
Data Safety Monitoring Plan  
7.6 
EAP 
Exposure Action Plan 
2.2, 5.1 
eCRF 
Electronic Case Report Form 
6.2.2, 7.4, 10.3.4 
FAM 
Fear Avoidance Model  
5.1 
FDA 
Food and Drug Administration  
11.3, 11.4 
FDI 
Functional Disability Inventory 
3, 6.2.2, 9.1, 9.5.2, 9.5.5 
FOPQ-SF 
Fear of Pain Questionnaire – Short Form 
4.1 
GCP 
Good Clinical Practice  
10.3.1 
GET Living 
Graded in-vivo Exposure Treatment  
1.1, 2.1, 2.2, 3, 4.3, 5.1, 
5.2, 5.4, 6.2.1, 6.2.2, 
6.2.5, 9.1, 9.2, 9.6, 
10.3.1 
HBE 
Home-Based Exposure  
5.1 
IFAM 
Interpersonal Fear Avoidance Model  
2.1, 5.1 
ICH 
International Conference on Harmonisation  
10.3.1 
IRB 
Institutional Review Board  
7.4, 7.5, 7.6, 10.3.4, 
11.1, 11.3, 11.4 
JFM 
Juvenile Fibromyalgia 
2.1 
MSPL 
Motion and Sports Performance Laboratory 
10.2 
NIAMS 
National Institute of Arthritis and Musculoskeletal 
and Skin Diseases  
7.4, 10.3.4, 11.3, 11.4 
NIH 
National Institutes of Health  
10.3.1, 13 
OHRP 
Office for Human Research Protections  
11.3, 11.4 
PA 
Physical Activity 
2.1 
PD 
Protocol Deviation 
10.3.4 
PHODA-YE 
Photographs of Daily Activities – Youth English 
2.2, 5.1, 9.5.1, 9.5.5 
PI 
Principal Investigator  
7.4, 8, 10.3.2, 10.3.4, 12 
PID 
Participant Identification Number  
11.3 
PPMC 
Pediatric Pain Management Clinic  
3, 5.1, 6.2.1 
PROMIS 
Patient-Reported Outcomes Measurement 
Information System  
4.1 
PSY 
Psychology/Psychologist  
5.1, 10.3.1 
PT 
Physical Therapy/Therapist  
3, 5.1 
RC 
Research Coordinator  
6.2.1, 6.2.2 
REDCap 
Research Electronic Data Capture 
6.2.2, 7.4, 10.1, 10.2 
SAE 
Serious Adverse Event  
7.3, 7.4 
SCH 
Stanford Children's Health  
3, 5.1, 6.2.1, 10.2 
S.M.A.R.T. 
Specific, Measurable, Achievable, Relevant, Time-
Bound  
5.1 
SMC 
Safety Monitoring Committee  
7.4, 7.6, 10.3.4 
TPM 
Typical Pain Management  
1.1, 2.1, 3, 4.3, 5.1, 
6.2.2, 6.2.5, 9.1, 9.2, 9.6 
SR 
Self-Report  
3 
UP 
Unanticipated Problem  
7.3, 7.4 
WILD 
Willingness, Importance, Likelihood of Success, 
Degree of Difficulty  
2.2, 5.1 
 
PARTICIPATING STUDY SITES 
The study will be conducted at Stanford Children’s Health Facilities.   

 
 
7 
PRÉCIS   
Study Title  
GET Living: Graded Exposure Treatment for Adolescents with Chronic Musculoskeletal Pain 
Objectives  
Reducing elevated pain-related fear promotes participation in daily activities1-4. When patients experience 
how disengagement from safety behaviors does not lead to catastrophic consequences, their 
misinterpretations are challenged and disconfirmed, enabling them to correct their fear expectancies5-7. GET 
Living is the first program to explicitly targeted pain-related fear and associated disability in adolescents. 
Currently, most rehabilitative treatments for adolescents with chronic pain involve promoting pain coping 
strategies via psychology with separate physical therapy prescribed. Unfortunately, the debilitating influence 
of pain-related fear can stymy progress in both domains resulting in continued high healthcare utilization 
without symptomatic improvement. 
Design and Outcomes   
This study will be a randomized control trial (RCT) including approximately 74 children, ages 8-18, with 
musculoskeletal pain who present for treatment at Stanford Children’s Health (SCH).  
A “participant” in this study is defined as a child and at least one parent. The term “patient” is used to 
describe the child participant only. Participants will attend an initial baseline assessment (BAS) to perform 
consent/asset, undergo a biomechanical assessment by the Motion and Sports Performance Laboratory of 
SCH, and complete self-report questionnaires. Child participants will also be given an Actigraph and will be 
introduced to the daily diaries. Following BAS, participants will undergo a pre-treatment baseline period 
where daily diaries will be collected and Actigraphy monitoring will occur. After the baseline period, 
participants will be randomly assigned to a treatment group, Graded Exposure Therapy (GET Living) or Typical 
Pain Management (TPM) stratified on their fear and disability scores. Participants in the GET Living 
intervention group (n=37) will engage in 1-hour sessions of GET Living for 12 sessions jointly facilitated by a 
pain psychology therapist and physical therapist. Participants randomized into the TPM treatment group (n = 
37) will engage in 6 sessions of cognitive behavioral therapy and 6 sessions of physical therapy following BAS. 
Parents enrolled into the TPM arm will engage in 3 parent-only sessions with the child’s cognitive-behavioral 
therapist. All participants complete a Daily Diary during treatment.  
At treatment discharge for the GET Living intervention group and TPM treatment, participants will undergo a 
second biomechanical assessment and complete self-report questionnaires. After completion of the second 
assessment evaluation, participants are contacted for follow-up evaluation, which includes completion of the 
Daily Diary for a 7-day window and self-report questionnaires at each follow-up time point (3 and 6 months 
post-second assessment). 
 
Interventions and Duration  
The GET Living intervention will be compared to Typical Pain Management (TPM) provided at Stanford 
Children’s Health. Each participant will be enrolled in the study for up to 40 weeks – Starting with the BAS 
visit, 2 weeks (on average) of a pre-treatment baseline period, approximately 6 weeks of active treatment, 
Discharge Assessment, and 3 and 6-month post-discharge follow-up. (See Figure 3 for a break-down of the 
study milestones and expected timeline.) 
 
Sample Size and Population  
An ideal recruitment site, Stanford houses a tertiary care pediatric pain management treating approximately 
300 unique patients in the clinic each year. Patients who meet eligibility criteria will be informed of the 
study by their pain clinicians at clinic appointments and provided a study brochure. We aim to recruit a total 
of 74 participants into the study.  

 
 
8 
1.1 
Primary Objective 
1a. To evaluate pain-related fear outcomes between GET Living and TPM. Hypotheses: Compared to TPM, 
the GET Living group will (1) have significantly less pain-related fear avoidance (adolescent, parent) at 
discharge, with continued gains at 3 and 6-month follow-up; Exploratory: (2) have fewer number of days to 
pain-related fear avoidance improvement via daily diaries. 
 
1b. To evaluate disability and parent responses to pain outcomes between GET Living and TPM. Hypotheses: 
Compared to TPM, adolescents receiving GET Living will have (1) significantly less functional disability and 
protective parent responses at discharge, with continued gains at 3 and 6-month follow-up; Exploratory: (2) 
fewer number of days to achieve decreased functional disability and protective parent responses, assessed 
via daily diaries; (3) significantly better adolescent joint kinetics at discharge, assessed via motion analysis; 
and (4) demonstrate significantly greater increases in daily physical activity levels at discharge via Actigraphy. 
We will also examine treatment response correlates: age, pain, gender, diagnosis, and readiness to change. 
 
2. To characterize feasibility and acceptability of GET Living compared to TPM to inform implementation of 
a large multi-site RCT. Hypotheses: GET Living participants will have (1) high treatment satisfaction ratings 
(mean score ³ 40 of 60; reflective of satisfied or very satisfied); Secondary: (2) ³ 80% sessions completed on-
schedule, ≤ 20% attrition rate, ³ 80% adolescent and parent daily diary adherence; Exploratory: (3) fewer 
health care costs at 3 and 6-month follow-up compared to TPM.  
2. BACKGROUND AND RATIONALE 
2.1 
Background and Significance 
Overall Scientific Premise. Chronic musculoskeletal pain in adolescence is a significant public health concern 
with median prevalence rates of 11 to 38%8,9, with 3 to 5% of adolescents suffering from significant pain-
related disability10,11, costing society $19.5 billion annually in the US alone12. Notwithstanding the personal 
suffering and persistent physical and economic consequences for families, chronic pain in adolescence can 
predispose the development of adult chronic pain13. Fear avoidance is a particularly salient influence on pain 
outcomes14-17 and is a risk factor for less treatment responsiveness18.  Typical Pain Management (TPM) yields 
only modest improvements in functional disability and no change in pain-related fear avoidance19. These 
findings underscore the need to specifically target pain-related fear avoidance in adolescents to potentially 
avert sustained pain-related disability. Thus, the current exploratory randomized controlled trial (RCT) tests 
graded in-vivo exposure treatment (GET) for adolescents with chronic musculoskeletal pain (GET Living). 
While TPM focuses on pain control via pain management psychology and impairment-based physical 
therapy, GET Living is jointly delivered by a pain psychologist and physical therapist targeting functional 
improvement through exposing participants to activities previously avoided due to fear avoidance of pain or 
re-injury. Implementing GET Living will represent a significant treatment paradigm shift by focusing on a key 
mechanism (pain-related fear avoidance) rather than on pain itself. Knowing that RCTs of GET are successful 
in adults with chronic musculoskeletal pain2,3,20-24 and with compelling preliminary results from our pilot 
work of GET Living, this exploratory RCT will provide the necessary findings to support or refute a large 
multi-site RCT serving as the basis for potential large-scale implementation of GET Living nationwide and 
ultimately expand effective, tailored treatment options for adolescents struggling with persistent 
musculoskeletal pain, fear, and disability. 
 
Scientific premise for GET Living. Reducing elevated pain-related fear promotes participation in daily 
activities1-4. When patients experience how disengagement from safety behaviors does not lead to 
catastrophic consequences, their misinterpretations are challenged and disconfirmed, enabling them to 
correct their fear expectancies5-7. GET Living is the first program in the United States to explicitly targeted 
pain-related fear and associated disability in adolescents. Currently, most rehabilitative treatments for 
adolescents with chronic pain involve promoting pain coping strategies via psychology with separate physical 

 
 
9 
therapy prescribed. Unfortunately, the debilitating influence of pain-related fear can stymy progress in both 
domains resulting in continued high healthcare utilization without symptomatic improvement.  
 
Scientific premise for addressing pain-related fear in adolescents and parents. Adolescent pain-related fear is 
associated 
with 
disability, 
depressive 
symptoms, and school impairment24,25. 
Recent work has identified that it is equally 
important to assess and address parental 
fears. Parent emotional responses serve as 
key guides to a child’s learning of safety and 
danger, in turn influencing subsequent 
behavior26,27. Growing evidence supports 
parent pain catastrophizing and protective 
behavior in prioritizing pain control28, higher 
functional 
disability29,30 
and 
school 
dysfunction31 in youth with pain. Building 
from the Fear Avoidance Model of Pain32-34, 
we 
developed 
and 
validated 
the 
Interpersonal Fear Avoidance Model of Pain (IFAM) (Figure 1)35. Within the IFAM, parents interpret an 
adolescent’s pain expression through the lens of their own catastrophic appraisals and pain-related fears, and 
are more likely to engage in maladaptive parenting behaviors (i.e., protective responses), in turn negatively 
influencing adolescent pain-related function.  
 
Scientific premise for biomechanical assessment and physical activity monitoring. A cycle of fear of 
movement, activity avoidance, and abnormal movement patterns (kinesics) in adolescents with chronic pain 
can lead to decreased tolerance to physical activity that persists into adulthood37. Abnormal kinesics, such as 
asymmetry in range of motion, or timing of muscle activation or joint motions, commonly exist as a 
compensatory mechanism in (adult) chronic pain38,39 and potentially amplified by pain-related fear40. 
Adolescents with juvenile fibromyalgia (JFM) have higher fear of movement and greater variability in lower 
extremity mechanics during gait assessment and drop landing compared to healthy controls37. Moreover, in 
a small pilot trial (n=11) of CBT and neuromuscular training in JFM, improvements were observed in walking 
gait (stride length) and functional performance (drop vertical jump)41. Building from work in JFM, examining 
biomechanics of gait and functional movements among a diverse group of chronic pain patients in this RCT 
allows us to precisely define the joint motions and forces that are altered by chronic pain, and the changes 
that occur with TPM compared to GET Living. 
 
In order to understand the impact of altered biomechanics observed in the laboratory, this trial includes real 
world objective physical activity (PA) monitoring via a wrist-worn actigraph. Actigraphy is particularly useful 
as self-report measures can be prone to response shift and reporter bias42,43. Unlike laboratory-based 
objective measures of physical activity, such as timed walks and peak oxygen consumption during exercise, 
actigraphy provides high ecological validity with unobtrusive measurement of activity levels during daily 
life44. Adolescents with chronic pain have lower mean and peak activity levels compared to healthy peers43. 
Although changes in physical activity via actigraphy have not been demonstrated for adolescent 
fibromyalgia patients using cognitive-behavioral therapy alone45, it is hypothesized that the integrated GET 
Living approach will increase mean and peak physical activity levels.  
 
Significance of the expected research contribution: (1) targeting pain-related fear, a key mechanism 
associated with pain-related dysfunction, (2) addressing parent distress and behavior to enhance adolescent 
Child pain 
catastrophizing 
Child pain-
related fears
Child avoidant 
behaviors
Declines in child 
functioning 
Parent pain-
related fears
Pain stimulus
Child pain 
experience 
Path of acceptance 
and confrontation
Parent pain 
catastrophizing 
Child pain 
expression
Parent 
interpretation 
Parent 
(protective) 
behavior
Parent 
consequences 
(depression, 
interference of 
personal goals)
Figure 1. IFAM  

 
 
10 
fear eradication, and (3) providing proof-of-principle of innovative daily tracking and biomechanical measures 
to define clinical endpoints and assess treatment progress within this clinical trial.     
2.2 
Study Rationale 
Preliminary Studies/Progress Report  
Over the past 10 years we have executed a line of research focused on pain-related fear avoidance in children 
spanning assessment and treatment intervention development. 
 
We have implemented the first US pilot of graded in-vivo exposure for youth with chronic pain (GET Living; 
NCT:01974791). GET Living was designed in close consultation with Johan Vlaeyen, PhD, developer of GET 
and consultant on this application. The pilot was designed as a sequential replicated and randomized single-
case experimental design with multiple measures with no comparator arm.  
 
Preliminary Clinical Endpoints without Controls. As displayed in Table 1, patients reported significant 
improvements in disability, fear, avoidance (large effects). Moreover, parent fear, avoidance, and protective 
behavior were also impacted (large effects). These results suggest that  
1) GET Living treatment results in significant improvements in primary (disability) and  
secondary/mechanistic (fear, avoidance) endpoints, 2) gains continue at 3 and 6-months follow-up, and 3) this 
approach is particularly effective for parents on fear, avoidance, and protective behavior. 
In addition to standard questionnaires, patients 
complete the Photographs of Daily Activities-Youth 
English (PHODA-YE)46, a diagnostic tool we validated to 
determine perceived harmfulness of activities and 
movements. 
The 
PHODA-YE 
is 
administered 
electronically with a photograph for each activity. 
Treatment providers receive a detailed PHODA-YE 
report that is shared with the patient to develop an exposure hierarchy prior to the start of exposures. 
Examining PHODA-YE outcomes (Figure 2), 
patients report significant decreases in activity-
engagement worries (large effect sizes across 
domains), 
with 
largest 
sports 
activity 
engagement improvements. These results 
suggest that specifically targeting worrisome 
activities in GET Living treatment results in 
appreciable improvements at end of treatment 
that are maintained.  
The proposed study focuses on evaluating an 
innovative treatment adolescents with pain-
related disability and fear. GET is successful and empirically supported for reducing disability in adults with 
substantial pain-related fear. However, the efficacy of exposure-based treatment for children with chronic 
pain has not been tested.  
Feasibility and Acceptability Data. A total of 37 patients (Mean 
age=13.7; 82% female) enrolled. Of the 34 patients who began 
treatment (3 dropped out during baseline), 28 completed (18% 
attrition rate) and 27 have reached 3-months with one lost to 
follow-up (96% follow-up retention rate). Average duration of 
treatment for completers was 64 days with an 86% patient daily 
diary completion rate and 82% for parents. Families also provided feedback at discharge interviews: "My son 
gained confidence, and I was taught how to support him" (mom), "I can break activities down- it doesn't have 
Table 1. GET Living Outcomes  
Outcome 
Admit 
Discharge 
3-mos 
2 
Adolescent (n=26) 
 
 
 
 
Pain-related Fear (0-96) 
52.2 
36.3 
30.7 
0.36** 
Disability (0-60) 
24.8 
15.8 
11.3 
0.51** 
Pain (0-10) 
5.9 
4.5 
3.7 
0.26* 
Parent (n=23)a 
  
  
  
  
Pain-related Fear (0-52) 
37.9 
24.5 
21.4 
0.71** 
Protect (0-4) 
1.5 
1.0 
0.8 
0.62** 
2.7
4.2
4.5
3.9
5.8
1.8
2.2
2.3
2.2
3.1
1.4
1.6
1.7
1.7
2.3
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
10.0
ADL
Functional
-Physical
School
Social
Sports
Worry Level
Baseline
Discharge
3-Month
η2=0.26
η2=0.41
η2=0.35
η2=0.28
η2=0.51
Figure 2. PHODA-YE Outcomes (n=26) 
Note. aOne young adult participated without a 
parent. Two parents did not complete follow up 
self-reports; **p<0.001; *p=0.001 

 
 
11 
to be all or nothing" (patient). Developmentally sensitive modifications. “The word “worry” was used too 
often.” (mom and dad). Patients also struggled distinguishing between numerical ratings of worry and pain. 
In response, we developed a rating scale for exposure activities based on W: Willingness, I: Importance, L: 
Likelihood of Success, and D: Degree of Difficulty (WILD scale). “Diaries became repetitive” (patient). In 
response, we created multiple versions of the diaries with items in varying order. Families requested ‘coping 
tools’. In response, we devised exposure action plans (EAP) to increase task persistence (e.g., movement 
break, music during task).  
3. STUDY DESIGN 
This study employs a two-group randomized, controlled design to test GET Living, for adolescents with chronic 
musculoskeletal pain and elevated pain-related fear (Figure 3). Primary outcome is pain-related fear 
avoidance (adolescent, parent). Secondary outcome is disability. Additional outcomes are parent responses to 
pain and pain acceptance. Exploratory: adolescent biomechanics and physical activity. 
 
Figure 3. Study Design. a) Eligibility Screening: musculoskeletal pain patients (ages 8-18; pain > 3 months) at Stanford Children’s Health 
(SCH); b) Baseline Visit (BAS): Consent/Assent, Baseline Assessment: SR, motion analysis; Baseline Daily Diary: DD and actigraphy; c) 
Randomization: randomization to treatment group; d) GET Living and TPM begin: DD and actigraphy ongoing; e) Discharge Assessment: SR, 
motion analysis; f) 3-month Follow-Up: SR, 7-day DD, g) 6-month Follow-Up: SR, 7-day DD. Note. DD=daily diary; SR=self-report; W=week. 
 
Recruitment. An ideal recruitment site, Stanford houses a tertiary care pediatric pain management treating 
approximately 300 unique patients in the clinic each year. We will recruit adolescent patients and a primary 
parent (N = 74) from the outpatient pediatric pain management clinic (PPMC) at Stanford Children's Health 
(SCH). We will also recruit patients from Kaiser Permanente Bay Area satellite clinics, contingent upon referrals 
from pain rehabilitation clinicians. For inclusion, the patients: 1) are 8-18 years old; 2) have musculoskeletal 
or neuropathic pain (e.g., localized [back, limb], diffuse)47 not due to an acute trauma (active sprain or 
fracture); 3) have pain-related fear (FOPQ ≥ 35), 4) functional limitations (FDI ≥ 13), and 5) be English language 
proficient. Patient exclusion criteria are: 1) significant cognitive impairment (e.g., brain injury) and 2) 
significant medical or psychiatric problem that would interfere with treatment (e.g., seizures, psychosis, 
suicidality). Identification of Eligibility: Patients and their parents who meet eligibility criteria will be informed 
of the study by their pain clinicians at clinic appointments and provided a study brochure. Additionally, a study 
flyer will be posted on our bulletin board of all active clinical studies in the patient waiting room. Screening: 
For each patient referred to the trial, eligibility for enrollment will be determined by the GET Living research 
team via chart review, along with the Clinician Referral Checklist (MOOP Supplemental Materials I) and a 
screening phone call. Study Entry and Randomization: Individuals passing the first two stages will enter the 
study by attending the Baseline Assessment visit (BAS). Once enrolled, adolescents will be randomized to 
either GET Living or TPM and stratified on fear (moderate/high; FOPQ-C: low [0-34] moderate [35-49] high 
[50-96]) and disability (moderate/severe; mild [0-12] moderate [13-29] severe [30-60]48), to minimize the 
possibility of imbalance between the two treatment arms. To allow the use of small blocks while minimizing 
the probability of a blinded staff member predicting the next assignment, we will use blocks of size two and 
four and randomly choose block sizes. The study biostatistician (Derek Boothroyd, PhD) will create separate 
randomization lists for each of the four strata prior to the start of patient recruitment with each list long 
enough to include the total planned study size. A series of block sizes (either two or four, with probability 
weights two thirds and one third respectively) will be randomly created and within each block half will be 
randomly assigned to GET Living and the other half to TPM. Copies of the randomization lists will be kept by 
the biostatistician and Research Coordinator and not shared with other members of the team. The 

 
 
12 
biostatistician will also create a randomization scheme to determine the number of days for the pre-treatment 
baseline period for each individual participant (2 weeks on average). 
 
Study Procedures. At the BAS visit participants will complete informed assent/consent, complete baseline 
questionnaires, begin daily diaries, and begin wearing an Actigraph. Child participants will undergo 
biomechanical assessment (Michael Orendurff, Director of the Motion and Sports Performance Laboratory at 
SCH) during this visit. Notification of treatment arm allocation will occur at the end of the pre-treatment 
baseline period, and treatment will begin according to randomized group allocation: GET Living or TPM. 
Discharge testing occurs at the end of GET Living or TPM and includes participant questionnaires, child 
biomechanical assessment, and an exit interview. Daily diary and actigraphy ends at discharge. At 3 and 6 
months follow-up, participants complete daily diaries for 7-days and self-report questionnaires.  
 
Treatment Conditions. Participants will be randomized into: GET Living or Typical Pain Management (TPM). 
During the study, participants will be instructed to not seek new treatments for pain. GET Living. An outpatient 
team consisting of a pain psychologist and physical therapist (PT) provide GET Living, both trained in this 
modality of treatment by Laura Simons, PhD with ongoing consultation from Johan Vlaeyen, PhD (lead 
innovator of GET in adults) and exposed to treatment session videos from participants in the pilot. GET Living 
is focused and individually tailored. The primary aim of GET Living is returning to valued activities of daily life 
and restoring daily functioning, including return to school. The treatment manual, entitled GET Living: Graded 
Exposure Treatment for children and adolescents with chronic pain was adapted from the adult treatment 
manual49 (see Section 5.1 detailed description). The protocol consists of 12 50-minute sessions delivered twice 
a week for up to 12 weeks. Sessions 1-5 (education, formulation, goals) are conducted with the psychologist, 
PT, adolescent, and parent. Graded exposure begins in session 6. The psychologist and PT co-lead a portion of 
the exposure sessions. During the remaining exposure sessions, the PT leads the exposures while the pain 
psychologist meets individually with the parent. The final two sessions focus on relapse prevention and future 
goal setting. Typical Pain Management. After randomization, participants allocated to the TPM group will 
initiate treatment, as indicated by the TPM treatment manual. To ensure dose equivalency, we increased this 
to 6-Psychology/6-PT with 3 parent-only sessions. In pain management psychology50 child and parent sessions 
focus on biopsychosocial model education, goal setting, pain coping skills training, and cognitive restructuring. 
PT sessions are based on Guide to Physical Therapy Practice 3.051consisting of 1) therapeutic exercise, 2) 
balance and proprioception, 3) strength training, and 4) use of modalities (e.g., heat/cold pack). 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 
Inclusion Criteria 
Child participants must meet all the following inclusion criteria to participate in this study:  
• 
8-18 years old; Male or Female 
• 
Musculoskeletal or neuropathic pain  (e.g., localized [back, limb], diffuse)45 not due to acute trauma 
(e.g., active sprain or fracture).   
• 
Moderate to High pain-related fear (≥ 35 on the Fear of Pain Questionnaire, FOPQ), or clinician-
indicated referral if scores below 35.   
• 
Moderate to High functional disability (≥ 13 on Functional Disability Inventory, FDI), or clinician-
indicated referral if scores below 13.   
• 
Be English Language Proficient  

 
 
13 
4.2 
Exclusion Criteria 
Child participants meeting any of the following exclusion criteria at baseline will be excluded from study 
participation:  
• 
Significant cognitive impairment (e.g., brain injury) 
• 
Significant medical or psychiatric problems that would interfere with study (e.g. seizures, psychosis, 
suicidality)  
4.3 
Study Enrollment Procedures  
Patients who meet eligibility criteria will be informed of the study by their pain clinicians at clinic appointments 
and provided a study brochure. Additionally, a study flyer will be posted on our bulletin board of all active 
clinical studies in the patient waiting room. For each patient referred to the trial, preliminary eligibility for 
enrollment will be determined by the clinical team at the PPMC or Kaiser via chart review and a brief 
conversation with the patient family. If interested in participating, a member of the research team will conduct 
a brief screening phone call to confirm general eligibility requirements. At this point, the research team will 
conduct a secondary screening assessment to determine if the patient’s scores on the FOPQ and FDI meet 
cut-offs for the clinical trial. If eligible, patients and parent will be asked to come into the clinic for an initial 
baseline study visit (BAS) where consent and assent will be obtained. During this visit, following consent, 
participants will complete baseline assessments, including a baseline biomechanical assessment and self-
report questionnaires. Child participants will also be set up with an Actigraph (activity monitoring device), and 
all participants (child & parent) will be introduced to the Daily Diaries. Following BAS, participants will undergo 
a pre-treatment data collection period (2 weeks on average). During this time, participants will be asked to 
complete Daily Diaries and child participants will wear the Actigraph. Following the pre-treatment baseline 
period, participants will be randomized into one of two treatment conditions: GET Living or Typical Pain 
Management (TPM).  
 
5. STUDY INTERVENTIONS  
5.1 
Interventions, Administration, and Duration  
GET Living: Participants randomized into the GET Living intervention group, will participate in 12 sessions, 1-
hour each, delivered twice a week over for up to 6 weeks.    
Phase I-III. The goals of Phase I-III are to educate the participants about the fear avoidance model of pain 
(individual and interpersonal), present the treatment rationale and formulation, create values-based 
treatment goals to enhance motivation, and create a pain-related fear hierarchy from the PHODA-YE results 
to design specific exposures. The pain psychology therapist (PSY) and PT are both present for these sessions 
to ensure that the treatment message is consistent from both providers to the family. Most of these activities 
are conducted jointly with the adolescent and parent present, although this varies with the developmental 
level of the adolescent. For example, while younger adolescents require parental input when developing fear 
hierarchies, most older adolescents do not want or need parent involvement to complete this task. In addition, 
depending on parent awareness of their own distress and behavior that may be impacting their adolescent’s 
functioning, the interpersonal fear avoidance model formulation may initially be presented separately. The 
decision on whom to include for the different treatment exercises in these initial sessions will be jointly 
negotiated by the therapists, patient, and parents.  
 
Phase IV. Graded Exposure consists of engaging in activities perceived as potentially ‘harmful’ or ‘worrisome’ 
in a controlled and continuous manner in order to elicit anxiety and to foster habituation and the subsequent 

 
 
14 
reduction of the fearful response (extinction). Exposures can be either in-vivo or imaginal, depending on the 
ability to execute the activity in session. Exposures are presented in a graded fashion according to a fear 
hierarchy. Milder feared activities are presented first to allow patients to more easily practice the treatment 
techniques and to maximize the chance of successful habituation and initial treatment success. Each activity 
or movement is first modeled by the therapist, conveying to the patient that it is a safe thing to do. After 
completing exposure activities and having anxiety diminish within the safety of the clinician-supervised 
treatment session, patients are asked to complete exposure activities outside of session until distress 
diminishes across settings. Parent presence during exposures is at the discretion of the therapist team and 
patient comfort level. An adolescent may not want a parent present for any exposure sessions.  
 
Behavioral Experiments, or methods used to empirically test the validity of a belief, are conducted during 
exposure sessions. In essence when an adolescent performs an activity that challenges the validity of their 
catastrophic assumption or belief, they are empirically testing the belief. Progress can be monitored by asking 
patients to predict the occurrence of harm before the experiment and repeating the same question after 
exposure to that activity, “How would you rate the probability (0-100%) that you will be unable to move after 
doing this activity?” When the rating has decreased substantially, the therapist can move on. You can also ask 
the patient to predict their performance level, “How far do you think you will be able to go? One foot? 10 
feet? 50 feet?” Often patients will under estimate their ability and this can serve as salient feedback on their 
performance.   
 
WILD Scale: Clinical experience from the pilot study indicated that patients with chronic pain tend to have 
difficulty differentiating their numeric rating of pain from a numeric rating of distress/worry about anticipated 
pain. This renders the SUDs rating scale (Subjective Units of Distress) typically used in exposure-based 
interventions somewhat difficult to use in a meaningful way (as a measurement of distress) in this population. 
Therefore, in order to assess distress as required (as well as extend our assessment of each particular activity 
on the ladder), we generated a rating scale to assess four relevant aspects of each task. These are:  
• 
Willingness: patient’s willingness to complete the task 
• 
Importance: important of the activity to the patient 
• 
Likelihood of Success: patient’s assessment of their likelihood of successfully completing the activity 
• 
Difficulty: patient’s assessment of the activity’s level of difficulty 
 
Exposure Action Plan (EAP): Once again, clinical experience from the pilot study indicated that participants 
were coming to the program with limited, if any, exposure to pain coping skills, or active pain management 
strategies. The Exposure Action Plan is intended to provide the patient with a basic foundation in active pain 
management strategies, so that should pain increase (as is very possible) during an activity, the patient is able 
to persist with that activity. This plan is not intended as an all-encompassing pain coping psychoeducation 
module; rather, it is intended to offer the patient a number of basic pain management strategies so that they 
may feel more empowered and in control while completing challenging tasks. Such strategies included in the 
EAP are breathing, stretches, movement breaks, helpful thoughts, “getting into it,” and facilitators. (Note: 
Facilitators should not be confused with distractions. The patient needs to attend to the activity at least in 
part to observe that the feared outcome either did not happen or was manageable. Facilitators are activities 
that can coincide with the exposure activity to facilitate its completion – e.g., listening to music while working 
out).  
 
Home-based exposures (HBEs): are “homework” activities implemented at home or in the community, which 
typically entail the repetition, continuation, or extension of exposure activities already completed in session. 
However, on occasion, HBEs can also be used to address activities that cannot be completed in session (e.g., 
riding public transportation, prolonged activities) and to address values-based goals as appropriate.   
 
HBE Worksheets describing the specific instructions for the exposure activities, the pre-activity WILD scale, 
and the EAP are completed in session and sent home with patient to be brought back in the following session.  
 

 
 
15 
The Parent Component is integrally linked to individual treatment and is primarily delivered by the PSY. In 
addition to parent participation in Phases I-III, observation of selected graded exposure activities and 
providing support in the execution of home-based exposures, there is a unique parent-only intervention that 
consists of education and behavior change. Education is designed to discuss the etiology and treatment of 
pain-related fear to normalize the problem and promote increased treatment compliance. The interpersonal 
fear avoidance model will be revisited. Parent behavior change will focus on alternative responses to distress 
and avoidance behavior that both the adolescent and parent experience. The change in how parents respond 
to distress and avoidance behaviors in themselves and their adolescent is an essential treatment component 
aimed at fostering adolescent independence and treatment success.   
 
Phase V. Relapse prevention, long-term goal setting, and termination is designed to foster the maintenance 
and generalization of earlier treatment gains through problem solving. 
 
Discharge will consist of a second biomechanical motion analysis, an exit interview, and self-report 
questionnaires.  
 
Follow-ups will occur 3 and 6-months post-discharge assessment. During the follow-up periods, patients will 
be asked to complete 7-days of daily diaries and complete self-report questionnaires.  
 
 
Table 2. GET Living Intervention Sessions 
Session 
Topic 
Adolescent Content 
 
Parent Content 
 
1 
Rapport Building, 
Education, & the 
Pain Dilemma 
Build rapport; obtain patient history; discuss referral 
impressions and treatment expectations (e.g., increase 
in functioning vs. pain reduction); using Pain 
Dilemma, discuss possible life directions toward pain 
reduction vs. valued activities; discuss negative impact 
of the Cycle of Avoidance; introduce GET Living 
paradigm: graded exposure as means to return to 
valued activities 
Joint session: same content 
 
 
 
2 
Pain-Worry Cycle 
& Individualized 
Formulation 
Build rapport; increase program engagement through 
motivational interviewing strategies; discuss the Fear 
Avoidance Model (FAM) and Interpersonal FAM 
(IFAM) to identify unproductive patterns of activity 
avoidance; resume discussion of GET Living 
paradigm, introducing pain willingness (attitude) and 
activity engagement (action) as tenets 
Joint session: same content; present 
parent with Interpersonal FAM to be 
discussed in future session. 
3 
Setting Values-
based Treatment 
Goals 
Review FAM and GET Living homework; discuss 
values and contrast with goals; assist in identification 
of adolescent’s values across various life domains; 
discuss appropriate goal-setting; assist adolescent in 
completing values-based goals.  
Joint session: same content; assist in 
identification of parents’ own values 
across various life domains; assist 
parent in completing values-based 
goals that support adolescent’s 
values-based goals  
4 
Establishing a Fear 
Hierarchy 
Review values-based goals to ensure appropriateness; 
discuss rationale for exposures using metaphors and 
exposure graphs; review PHODA results to identify 
themes and select activities for upcoming exposure 
sessions; plot most-valued activities from each life 
domain upon hierarchy, from least to most worrisome. 
Joint session: same content; 
encourage parent to share any valued 
activities that are not listed on 
PHODA for inclusion as needed.  
5 
Introduction of 
WILD scale & 
Exposure Action 
Plan 
Review completed hierarchy and rationale for 
exposures, as needed; discuss use of WILD scale; 
conduct mini-exposure with least worrisome activity; 
modify activities and offer support as needed; plan 
Home Based-Exposures (HBEs) 
Joint Session: Same Content Parent 
observes adolescent exposure 
session, participating as appropriate. 
Psychology offers further explanation 
and rationale, as well as support to 
parent.  

 
 
16 
6 
Graded Exposure 
with Behavioral 
Experiments-1 
Review HBEs; continuing progressing exposures as 
appropriate; modify activities and offer support as 
needed; plan Home Based-Exposures (HBEs) 
Parent meets separately with 
psychologist; review IFAM to 
discuss and normalize cognitive and 
emotional responses to adolescent in 
pain; review values-based goals; 
discuss strategies for increasing 
distress tolerance, promoting activity 
engagement and independence, and 
conveying confidence in adolescent 
7 
Graded Exposure 
with Behavioral 
Experiments-2 
Review HBEs; continuing progressing exposures as 
appropriate; modify activities and offer support as 
needed; plan Home Based-Exposures (HBEs) 
Parent observes adolescent exposure 
session, participating as appropriate. 
Psychology offers further explanation 
and rationale, as well as support to 
parent. Psychology provides 
feedback to parent about any 
naturally occurring responses to 
adolescent during exposure.  
8 
Graded Exposure 
with Behavioral 
Experiments-3 
Review HBEs; continuing progressing exposures as 
appropriate; modify activities and offer support as 
needed; plan Home Based-Exposures (HBEs) 
Parent meets separately with 
psychologist; discuss strategies for 
increasing distress tolerance, 
promoting activity engagement and 
independence, and conveying 
confidence in adolescent 
9 
Graded Exposure 
with Behavioral 
Experiments-4 
Review HBEs; continuing progressing exposures as 
appropriate; modify activities and offer support as 
needed; plan Home Based-Exposures (HBEs) 
Parent observes adolescent exposure 
session, participating as appropriate. 
Psychology offers further explanation 
and rationale, as well as support to 
parent. Psychology provides 
feedback to parent about any 
naturally occurring responses to 
adolescent during exposure.  
10 
Graded Exposure 
with Behavioral 
Experiments-5 
Review HBEs; continuing progressing exposures as 
appropriate; modify activities and offer support as 
needed; plan Home Based-Exposures (HBEs)  
Parent meets separately with 
psychologist; discuss strategies for 
increasing distress tolerance, 
promoting activity engagement and 
independence, and conveying 
confidence in adolescent 
11 
Graded Exposure 
with Behavioral 
Experiments-6 
Review HBEs; continuing progressing exposures as 
appropriate; modify activities and offer support as 
needed; plan Home Based-Exposures (HBEs)  
 
*Exposure sessions may occur for 3 – 9 sessions 
depending on patient needs. 
Parent observes adolescent exposure 
session, participating as appropriate. 
Psychology offers further explanation 
and rationale, as well as support to 
parent. Psychology provides 
feedback to parent about any 
naturally occurring responses to 
adolescent during exposure.  
12 
Relapse 
Prevention, 
Termination & 
Future Goals 
Review HBEs; review general progress and 
accomplishments; discuss importance of relapse 
prevention and planning for future; target potential 
obstacles with Hot Seat cognitive-restructuring and 
problem-solving activity 
 
Review accomplishments; assist adolescent in 
developing long-term goals; identify “lessons learned” 
throughout treatment; present graduation certificate.  
Joint session: same content. 
 
Typical Pain Management (TPM) is a treatment intervention that is representative of current standards of care in 
a multidisciplinary pain clinic setting. We calculated historical PPMC treatment data for patients who met 
enrollment criteria (Mean sessions: Psychology=5 and PT=4). To ensure dose equivalency, we increased this to 6-
Psychology/6-PT with 3 parent-only sessions. The CBT has been adapted from published manual for CBT treatment 

 
 
17 
of pediatric chronic pain and depressive symptoms 52 and the PT sessions are based on Guide to Physical Therapy 
Practice 3.051. 
 
Overview. The protocol consists of approximately 12 sessions, 1-hour each, delivered twice a week, on 
average for 6 weeks. Patient and parent will complete daily diaries and patients will wear the Actigraph 
throughout the duration of treatment. Sessions will alternate between psychological CBT sessions and 
Physical Therapy sessions, as outlined in Table 2 below. 3 Parent-only CBT sessions with the pain psychologist 
will be included to address parental coping skills. 
 
Cognitive Behavioral Therapy (CBT). CBT will consist of 6 patient sessions and 3 parent-only sessions with a 
licensed pain psychologist focused on biopsychosocial model education, goal setting, coping skills training, 
and cognitive restructuring. The final CBT sessions with the psychologist will focus on relapse prevention, 
long term goals, reviewing of accomplishments during treatment. 
 
Physical Therapy (PT). PT will consist of 6 sessions with a licensed physical therapist based on Guide to 
Physical Therapy Practice 3.051 consisting of 1) therapeutic exercise, 2) balance and proprioception, 3) 
strength training, 4) use of modalities (e.g., heat/cold pack). 
 
Discharge will consist of a second biomechanical motion analysis (Michael Orendurff, PhD; Motion and Sports 
Performance Laboratory at SCH), and exit interview, and self-report questionnaires completed by patient and 
parent.  
 
Follow-up will occur 3 and 6-months post-discharge assessment. During the follow-up period, patients and 
parents will be asked to complete 7-days of daily diaries and complete self-report questionnaires.  
 
 
Table 3. Typical Pain Management Sessions 
Session 
Topic 
Adolescent Content 
Parent Content 
1 
Rapport Building, 
History 
Build rapport; obtain patient history. Discuss goals 
for treatment.  
Joint Session: Same content 
2 
PT Session 1 
Adolescent in Physical Therapy 
N/A 
3 
Biopsychosocial 
Model Education 
Biopsychosocial model of pain; gate control theory 
of pain; stress-pain connection 
Joint Session: Same content 
4 
PT Session 2 
Adolescent in Physical Therapy 
N/A 
5 
Setting Treatment 
Goals 
Discuss SMART goals; assist adolescent in 
completing goals. 
N/A 
6 
PT Session 3  
 
 
Treatment Goals 
(Parent only) 
Adolescent in Physical Therapy 
Parent meets separately with 
psychologist; Discuss SMART goals 
with the parent that focus on 
enhancing adolescent coping; assist 
parent in completing goals. 
7 
Coping Skills 
training 
Learn and rehearse relaxation techniques (e.g., 
breathing, progressive muscle relaxation, 
imagery) 
 
N/A 

 
 
18 
8 
PT Session 4  
 
 
 
Coping Skills 
Training 1  
(Parent only) 
Adolescent in Physical Therapy 
Parent a review of evidence 
supporting relaxation techniques 
(e.g., breathing, progressive muscle 
relaxation, imagery) that are being 
taught to the patient and how to 
encourage the patient to use these 
skills at home.  
9 
Cognitive 
Restructuring 
Introduction to fundamental cognitive-behavioral 
strategies including active coping, distraction, and 
cognitive restructuring  
 
N/A 
10 
PT Session 5  
 
 
Coping Skills 
Training 2  
(Parent Only) 
Adolescent in Physical Therapy 
Parent introduction to fundamental 
cognitive-behavioral strategies taught 
in the adolescent session including 
active coping, distraction, and 
cognitive restructuring 
11 
Relapse Prevention, 
Termination & 
Future Goals 
Review accomplishments; assist adolescent in 
developing long-term goals; identify “lessons 
learned” throughout treatment; present graduation 
certificate. 
Joint Session: Same content 
12 
PT Session 6 
Adolescent in Physical Therapy 
N/A 
l 
5.1.2 
Compensation  
  All patients will be closely monitored by the PI, Laura Simons, as well as the treatment and research team. 
Patients are compensated for their time and contribution to this study, with increased compensation for the 
3-and-6-month post-discharge follow-up. The following is the compensation timeline for all patients in the 
study:  
• 
Timepoint 1: $30.00 Amazon.com gift code at the start of treatment after baseline completion of 
questionnaires and daily diaries; 
• 
Timepoint 2: $30.00 Amazon.com gift code after completion of treatment, daily diaries, and end of 
treatment questionnaires; 
• 
Timepoint 3: $50.00 Amazon.com gift code at the 3 month post-discharge follow-up for completion 
of questionnaires and 7-day daily diary 
• 
Timepoint 4: $50.00 Amazon.com gift code at the 6 month post-discharge follow-up for completion 
of questionnaires and 7-day daily diary 
5.2 
Handling of Study Interventions  
The GET Living Intervention will be delivered jointly with a Pain Psychology Therapist (PSY) and Physical 
Therapist (PT). Sessions will involve both patient and parent.   
The Typical Pain Management intervention will be delivered with a Pain Psychology Therapist (PSY) and 
Physical Therapist (PT) separately. Sessions will involve the patient and 3 parent-only sessions held by the 
therapist.   
5.3 
Concomitant Interventions  
N/A 

 
 
19 
5.3.1 
Allowed Interventions 
We ask all patients enrolled in the study to not partake in outside interventions such as other Physical Therapy 
or psychology sessions that may interfere with active treatment related to the study.  
5.3.2 
Required Interventions 
Adherence to treatment group and intervention will be necessary throughout the study.  
5.3.3 
Prohibited Interventions 
N/A  
5.4 
Adherence Assessment  
In a pilot study for the GET Living intervention conducted at Boston Children’s Hospital by Laura Simons, a 
total of 78 patients were referred for the GET Living treatment study with a 45% enrollment rate. A total of 
37 patients (Mean age=13.7; 77% female) consented for treatment. Of the 34 patients who began treatment 
(3 dropped out during baseline), 26 completed treatment (18% attrition rate). One patient was lost to follow-
up (96% follow-up retention rate). To account for the observed attrition rate in the pilot study, we aim to 
recruit 74 patients for this exploratory clinical trial.  
Patients will be closely monitored by the PI, Laura Simons, as well as the treatment and research team. 
Patients are compensated for their time and contribution to this study, with increased compensation for the 
3 and 6-month follow-ups. Follow-up will occur at 3 and 6-months for both treatment groups. They will be 
asked to complete 7-days of daily diaries and self-report assessments. 

 
 
20 
6. STUDY PROCEDURES  
6.1 
Schedule of Evaluations 
Table 4.  
Assessment 
Recruitment   
Baseline Assessment 
Pre-Treatment  
Period 
 
Treatment  
Sessions 
 
Discharge 
Assessment 
3 mo Follow-
up 
 (Online) 
6 mo Follow-
up 
(Online) 
Screening   
X 
 
 
 
 
 
Medical Chart Review (i.e., 
diagnosis, current medications, 
current treatments, etc.) 
X 
 
 
X 
X 
X 
Enrollment: Informed Consent 
& Assent Forms 
 
X 
 
 
 
 
Demographics  
 
X 
 
 
 
 
Randomization 
 
 
X 
 
 
 
Self-Report Questionnaire 
Measures 
 
X 
 
X 
X 
X 
Biomechanical Motion Analysis 
 
X 
 
X 
 
 
Child Daily Diary 
 
X 
X 
X 
 
X 
X 
Parent Daily Diary 
 
X 
X 
X 
 
X 
X 
Actigraphy 
 
X 
X 
X 
 
 
 
Exit Interview  
 
 
 
X 
 
 
Adverse Events  
 
X 
X 
X 
X 
X 
X 

 
 
21 
6.2 
Description of Evaluations  
The Schedule of Evaluations will include Recruitment (i.e., screening, demographics, preliminary 
medical chart review), a Baseline Visit (i.e., informed consent/assent, enrollment in study, baseline 
assessment (i.e., completion of self-report questionnaires, biomechanical motion analysis, report 
of adverse events), Pre-treatment Baseline Period (i.e. Daily Diaries, Actigraphy), Treatment 
randomization allocation, Treatment Sessions (i.e., Daily Diaries, Actigraphy, reports of any 
adverse events during treatment), Discharge Assessment (i.e., self-report questionnaires, 
biomechanical motion analysis, exit interviews, reports of any adverse events), and 3 and 6-month 
follow-up (i.e., medical chart review, self-report questionnaires, Daily Diaries, and reports of any 
adverse events post-treatment).   
6.2.1 
Screening Evaluation 
Screening 
Clinicians will complete the “Clinician Referral: Eligibility Checklist” (Supplemental Materials I – CRF 
Templates) to indicate if a patient may be eligible for the GET Living study. Once potential 
participants are identified for participation at SCH, a brief screening phone call will be made by a 
study staff member to confirm general eligibility requirements (see Supplemental Material II for 
Phone Screening Form). At this point, the research team will conduct a secondary screening 
assessment to determine if the patient’s scores on the FOPQ and FDI meet cut-offs for the clinical 
trial.  
 
Screen Failures 
Participants will be considered a screen failure if they do not meet all of the inclusion criteria listed 
in section 4.1 or if they meet any of the exclusion criteria listed in section 4.2.  
Consenting Procedure 
Before obtaining formal written assent/consent from patients and their parents, clinical providers 
at the PPMC and Kaiser will obtain verbal consent to be approached by members of the research 
team. 
Study staff, which will include a research coordinator (RC) or postdoctoral fellow trained by Dr. Laura 
Simons, will conduct the consent and assent procedure. Eligible participants will be educated about 
study procedures or any changes in those procedures. Signed consent/assent forms will be kept in 
a locked filing cabinet in Dr. Simons’ office.  
6.2.2 
Enrollment, Baseline, and Randomization 
Enrollment 
Study consenting/assenting and enrollment will take place at the initial study visit. All procedures 
will be completed by a research coordinator (RC) and/or postdoctoral fellows.   
 
Consenting Procedure for Enrollment 
This study will follow the Informed Consent Process for Research according to the Stanford 
University Research Compliance Office. Each participant’s consenting process will be recorded by 
the study RC in the “Screening and Enrollment Log” (MOOP Supplemental Materials I) within an 
online REDCap CRF. The signed consent/assent documents will be stored in a locked cabinet in the 
PI, Dr. Laura Simons’, office.  
 
The informed consent process will take place in a private office, and participants will have the 
opportunity to choose their seating, read the consent form, and ask any questions they may have 

 
 
22 
at the beginning of the data collection session. Signed consent/assent forms will be stored in a 
locked file. Participants will be reminded that their involvement in this study is completely 
voluntary, and that they can withdraw it any time without any negative repercussions whatsoever 
(e.g., with regard to clinical care or healthcare access). They will also be explicitly told that they 
may leave any question blank for questionnaires or unanswered for the clinical interview if they do 
not feel comfortable answering.  See Supplement Material for the consent and assent form. 
 
Non-English Speaking Participants – Individuals who do not speak or understand English will not be 
recruited to the study. While we recognize the limitations of this approach, practical 
considerations necessitate the inclusion of only those who are able to speak or understand English.  
 
Enrollment date will be recorded in the “Screening and Enrollment Log” ECRF, which will also 
include documentation of inclusion/exclusion criteria.  
 
Baseline Assessment (BAS): 
During the initial study visit, a baseline biomechanical assessment will be conducted and self-reports 
questionnaires will be completed by the child and parent.  
• 
Child & Parent Baseline Self-Report Measures:  
See Supplemental Materials III for baseline self-report measures 
• 
Patient Biomechanical Assessment – Motion analysis will be assessed by Dr. Michael 
Orendurff, PhD, of the Motion and sports Performance Laboratory of Stanford Children’s 
Health. Gait (stride length and velocity) 37, drop jump landing37, and dynamic postural 
control41 tasks will be performed by the patient. 
Pre-Treatment Baseline Period 
During the Pre-Treatment Baseline period, patients will complete the following:  
• 
Child and parent will complete daily diaries collected via REDCap to monitor daily fear of 
pain, avoidance, acceptance, catastrophizing and pain ratings.  
• 
Actigraphy data will be collected to track daily physical activity and sleep.  
The pre-treatment baseline period will last an average of 2-weeks.  
See Supplemental Materials III for child and parent daily diaries 
 
Randomization 
After a 2-week (on average) pre-treatment daily diary, adolescents will be randomized to either GET 
Living or TPM and stratified on fear (moderate/high) and disability (moderate/high). A block 
randomization strategy (Table 5) will be used with randomly generated blocks of 2 and 4 to assure 
near equal distributions across arms as well as to minimize the probability of predicting the next 
assignment. A randomization spreadsheet with four strata will be created by the study 
biostatistician, Dr. Derek Boothroyd. 
 

 
 
23 
Table 5. Fear and Disability Stratification  
*Fear based on the FOPQ-C; Disability based on FDI – high fear = 50-96; moderate fear = 35-49; high disability = 30-60; moderate disability = 
13-29 
6.2.3 
Blinding 
Blinding of treatment arms will not be possible for patients, their parents, and the healthcare 
professional providing administering active treatment. Dr. Michael Orendurff, who will be assessing 
the biomechanical motion analysis during Baseline and Discharge visits for patients will be blinded 
to the treatment arm allocation of each patient. 
6.2.4 
Treatment Measures 
The following measures will be collected during Treatment:  
• 
Child Daily Diary 
• 
Parent Daily Diary  
• 
Actigraphy Monitoring  
See Supplemental Materials III for child and parent daily diaries 
6.2.5 Discharge Session  
At the Discharge Session for GET Living or TPM, child and parent will complete self-report 
measures, along with an exit interview.  
• 
Child & Parent Self-Report Questionnaires Measures:  
See Supplemental Materials III for discharge self-report measures 
• 
Patient Biomechanical Assessment – Motion analysis will be assessed by Dr. Michael 
Orendurff, PhD, of the Motion and sports Performance Laboratory of Stanford Children’s 
Health. Gait (stride length and velocity) 37, drop jump landing37, and dynamic postural 
control41 tasks will be performed by the patient. 
• 
Exit Interview: patient and parent will be asked questions about their treatment experience.  
See Supplemental Materials III for exit interview materials 
6.2.6 
Follow-Up Assessments 
A set of self-report measures will be completed by all participants (child & parent) after 3 and 
6-months post-discharge. 
See Supplemental Materials III for follow-up assessment measures 
  
 7. SAFETY ASSESSMENTS  
As the study is being conducted within a healthcare facility all normal monitoring of safety will be in 
place. There are few additional safety risks introduced as part of the involvement in the study 
procedures. If any risk arises as part of being interviewed, completing measures, or participating in 
the treatment, there are clinical psychologists and medical personnel immediately available to 
High Fear 
+
High Disability
High Fear
+ 
Moderate Disability
High Disability
+
Moderate Fear
Moderate Disability
+
Moderate Fear

 
 
24 
assess the situation and provide assistance.   
7.1 
Specification of Safety Parameters 
N/A 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
N/A  
7.3 
Adverse Events and Serious Adverse Events  
For the purposes of this study, the following AE definitions are used:  
 
Adverse Event (AE): Any unfavorable or unintended sign (including an abnormal laboratory finding), 
symptom or disease temporally associated treatment interventions, regardless of whether it is 
considered related to the treatment. AEs are categorized according to the following scale:  
 
Severity Ratings 
Adverse Events (AEs) will be rated on the following three-point scale, to the determine the severity 
of  
• 
Mild: An experience that is transient and requires no special treatment or intervention. 
The experience does not generally interfere with usual daily activities. 
• 
Moderate: An experience that is alleviated with simple therapeutic treatments. This 
experience impacts usual daily activities. Includes laboratory tests alterations indicating 
injury, but without long-term risk.  
• 
Severe: An experience that requires therapeutic intervention unrelated to clinical trial 
treatment intervention. The experience interrupts usual daily activities. If hospitalization 
is required for treatment, this will be classified as an SAE.  
 
Relatedness Ratings 
Adverse Events (AEs) will be rated on the following three-point scale, to the degree to which the 
event appears to be related to the study intervention: 
• 
0, Unrelated 
• 
1, Possibly Related 
• 
2, Definitely Related 
 
Expectedness Ratings 
Adverse Events (AEs) will be assessed as to wither they were expected to occur or unexpected, 
meaning not anticipated based on current knowledge found in the protocol or based on the treating 
clinician’s experience: 
 
• 
Unexpected: the nature or severity of the event is not consistent with information about 
the condition under study or intervention in the protocol, consent form, or clinician’s 
experience 
• 
Expected: the event is known to be associated with the intervention or condition under 
study.   
 
Unanticipated Problem (UP): an unanticipated problem involving risk to human participants or 
others, is one that (1) was unforeseen at the time of its occurrence, (2) is related or possibly related 
to participation in the research, and (3) indicates that participants or others are at an increased risk 
of harm. 
 

 
 
25 
 
 
Serious Adverse Events (SAE): Any AE that result in any of the following outcomes:  
• 
Death 
• 
Suicide/Homicide Attempt 
• 
Life-Threating event  
• 
Event requiring inpatient hospitalization 
• 
Persistent or significant escalation of disability/incapacity  
 
There is no evidence that participation in this treatment trial will increase risk of a serious adverse 
event (SAE). 
7.4 
Reporting Procedures 
AEs will be identified at any time during participation in this treatment study. Reports of AEs to the 
Get Living Study team will be assessed and noted. The study team will be informed to notify the PI 
of any AEs identified during treatment or throughout the duration of enrollment in the study. 
Parents of patients will also be asked to notify the study team if an AE has occurred. During follow-
up contact, the study staff will ask patient and parent if any AEs have occurred since the end of 
treatment. The known potential risks will be described in informed consent documents and 
protocol. 
 
All AEs and SAEs will be monitored on a continual basis and documented, by participant, in the 
respective eCRFS (MOOP Appendices B-C) on REDCap. All AEs and SAEs will also be collated across 
participants into a Master Sheet for presentation to the Safety Monitoring Committee (SMC) at 
quarterly meetings.  In addition, all SAEs and UPs are reported according to the Stanford Medical 
IRB reporting guidelines (within 10 working days of occurrence). Follow-up remediation will occur 
within five days of the IRB’s response or decision. All AEs will be reviewed quarterly by the PI and 
SMC. 
 
SAEs and specific treatment intervention-associated AEs will be reported to the PI, Dr. Laura Simons, 
and responsible study staff within 24 hours. All SAEs and UPs will be reported to the NIAMS within 
48 hours of the investigator becoming aware of the event. There are no SAEs anticipated for this 
research study. 
 
7.5 
Follow-up for Adverse Events 
All AE’s will be reported to the IRB of record within five days. Follow-up remediation will occur within 
five days of the IRB’s response or decision. 
7.6 
Safety Monitoring  
Oversight of this clinical trial is provided by the Principal Investigator (PI), Dr. Simons. The Study 
Monitoring Committee (SMC) will involve the following individuals:  
• 
Lonnie Zeltzer, MD (Medical Expertise) – Mattel Children’s at UCLA 
• 
Soumitri Sil, PhD (Clinical Psychology Expertise) – Children’s Healthcare of Atlanta 
• 
Tarcisio De Campos, PT (Physical Therapy Expertise) – Macquarie University 
As this is a single-site clinical trial involving low risk, the individuals listed above, along with the PI, 
Dr. Simons, and the Stanford University Institutional Review Board (IRB) will be responsible for the 
duties involved with this DSMP.   

 
 
26 
8. INTERVENTION DISCONTINUATION  
Patients and their parents have the right to withdraw consent/assent or discontinue participation at 
any time without penalty or any impact on the child’s care. Because this is an exploratory clinical 
trial, we will not discontinue participation based on missed attendance to treatment sessions. There 
will be no temporary discontinuations from treatment or study participation. The PI may withdraw 
a patient/parent dyad from the study for one or more of the following reasons:  
• 
Failure to follow instructions of the PI or study staff. 
• 
The PI decides that continued participation would be harmful (e.g., patient reports 
increased emotional or physical distress from exposure therapy) 
Patients and parents will be asked permission to use data collected form the study if they are asked 
to discontinue or decide to withdraw from the study.  
9. STATISTICAL CONSIDERATIONS  
9.1 
General Design Issues  
 
 
Aim 1a: To evaluate pain-related fear outcomes between GET Living and TPM. Hypotheses: Compared 
to TPM, the GET Living group will (1) have significantly less pain-related fear avoidance (adolescent, 
parent) at discharge, with continued gains at 3 and 6-month follow-up; Exploratory: (2) have fewer 
number of days to achieve pain-related fear improvement, assessed via daily diaries. 
 
Aim 1b: To evaluate disability and parent responses to pain outcomes between GET Living and TPM. 
Hypotheses: Compared to TPM, adolescents receiving GET Living will have (1) significantly less 
functional disability and protective parent responses at discharge, with continued gains at 3 and 6-
month follow-up; Exploratory: (2) fewer number of days to achieve decreased functional disability and 
protective parent responses, assessed via daily diaries; (3) significantly better adolescent joint kinetics 
at discharge, assessed via motion analysis; and (4) demonstrate significantly greater increases in daily 
physical activity levels at discharge via actigraphy. We will also examine treatment response correlates: 
age, pain, gender, diagnosis, and readiness to change. 
 
Aim 1 Analysis Plan. GET Living vs. TPM. Linear mixed effects models will be used to compare GET 
Living to TPM. The outcome of interest for H1a will be FOPQ-C and PFOPQ total scores. For H1b, 
outcomes are FDI and ARCS-Protect scores. Exploratory endpoints. Daily Diary (DD): We will use a 
randomization test (https://tamalkd.shinyapps.io/scda/)53 to assess the difference between 
baseline (BAS) to discharge (END) and BAS to 3 and 6-month follow-up (FU)21,54. We will also 
examine at what point during treatment significant improvements occur using delayed effect lags 
(one effect equals 1 day) until p-value 0.05 is reached. Actigraphy: Actilife software will be used to 
extract data and calculate mean and peak daily activity. Published data reduction methods will be 
used43. We will model physical activity (mean, peak) at two time points using mixed 2 (time) x 2 
(group) ANOVAs. Rate of change in physical activity from BAS to END will also be examined using 
DD method. Biomechanical assessment: Full body joint kinematic (motion) and kinetic (force) data 
will be collected with a 20-camera Vicon system (Centennial, CO, USA) with 5 integrated force 
plates (Bertec; AMTI).  Markers will be placed on each participant according to the 3D Plug In Gait 
model (Vicon) with data recorded and processed in Nexus 2.6.1. Participants will walk, complete 
the Star excursion balance test and drop jump task37,41. Biomechanical variables (stride length; 
peak hip and knee extensor moments; peak ankle plantarflexor moment; Star excursion balance 
score) will be extracted using Event Analyser (Vicon) for error free data reduction.  We will model 
biomechanical variables using mixed 2 (time) x 2 (group) ANOVAs. We will also examine treatment 
response correlates: age, pain, gender, diagnosis, and readiness to change. 

 
 
27 
 
Aim 2: To characterize feasibility of GET Living to inform implementation of a large multi-site RCT. 
Hypotheses: GET Living participants will have (1) high treatment satisfaction ratings (mean score ³ 40 
of 60; reflective of satisfied or very satisfied); Secondary: (2) ³ 80% sessions completed on-schedule, ≤ 
20% attrition rate, ³ 80% adolescent and parent daily diary adherence; Exploratory: (3) fewer health 
care costs at 3 and 6-month follow-up compared to TPM. 
 
Aim 2 Analysis Plan. Satisfaction. We will examine mean satisfaction scores. Adherence/Retention. 
We will examine mean parent and adolescent adherence to daily diary completion, percent of 
patients who dropout prior to treatment completion, and percent of sessions completed on-
schedule. Health care costs. We will examine mean costs across arms at 3 and 6-month follow-up. 
 
9.2 
Sample Size and Randomization 
We chose the largest feasible study size to obtain as precise estimates as possible of improvement 
in adolescent disability while ensuring adequate power for the treatment difference in the 
improvement in adolescent pain-related fear. This gave us a starting total sample size of 74 (37 in 
each arm). Based on pilot data, we expect roughly 19% attrition during treatment to a total of 60 
and further attrition to 58 at end of follow-up. 
Power calculations were first performed using the simplified approach of paired t-tests for the 
change from baseline to 3 and 6-months on those with 3 and 6-months data. For this approach, we 
used means and standard deviations of observed changes in pilot data. We then simulated data from 
our analytic model using the standard deviations at each time point and standard deviations of 
change to calculate correlation and hence the random effect and error variances. The mixed models 
simulation allowed us to use more data and yielded slightly higher power estimates. 
Primary Outcome: In our primary power calculation, we assumed that the improvement in 
adolescent pain-related fear at 3 and 6-months would be 22.4 in GET Living and 5 in TPM, a 
difference of 17.4, with a standard deviation for change of 21. Under this scenario we will have 
power of 87% with 58 (29 in each arm) at end of study. Under more conservative assumptions, we 
still have power of 80% with only 52 at the end of study and a treatment difference of 16.6. With a 
smaller standard deviation of 18.9, we will have power of 80% with 50 at end of study and a 
treatment difference of 15.4. 
Other Outcomes: For parent pain-related fear, our estimated treatment difference at 3 and 6-
months is 13 with an estimated standard deviation for change of 8.5. This would give us power close 
to 100% for 58 at end of study and we would still have 90% power with a treatment difference of 
only 8 and only 50 left at end of study. 
For adolescent disability, our estimated treatment effect at 3 and 6-months is 7 with a standard 
deviation for change of 11.2, yielding power based on the t-test of 65% assuming 58 at end of study. 
We also created 5000 simulated datasets using a mixed effects model with standard deviations of 
11.2 for change and 12.6 at each time point and estimated power by the fraction of simulated 
datasets in which the treatment difference at 3 and 6-months was significant at level 0.05. This 
provided a slightly higher power estimate of 67% and an estimated power of 79% if the treatment 
difference is 8 (1 point larger than expected). 
 
Treatment Assignment Procedures 
 
After a 2-week pre-treatment baseline period, patients will be randomized to either GET Living or 
TPM and stratified on fear and disability scores (see Table 6 for scoring criteria). A block 

 
 
28 
randomization strategy will be used with randomly generated blocks of 2 and 4 to assure near equal 
distributions across arms and minimize the probability of predicting the next assignment. A 
randomization spreadsheet with four strata will be created by the study biostatistician, Dr. Derek 
Boothroyd (please see Table 5 in section 6.2.2 for fear and disability stratification). 
 
Patients will be randomized by an un-blinded research coordinator or postdoctoral fellow. Those 
who are randomized to the TPM group can opt to participate in GET Living after their study 
assessments are complete (6.5 months after baseline). They will no longer be considered a 
participant of this study at that time.  
9.3  
Definition of Populations 
We do not plan to differentiate ITT and per protocol populations for the analyses.  
9.4 
Interim Analyses and Stopping Rules 
When we reach 50% of our planned sample of treatment completers, we will conduct an interim 
analysis. The intent of this interim analysis is to implement stopping rules for either overwhelming 
efficacy or futility. 
  
In order to maintain power at full planned enrollment (in the case that the interim analysis does 
not stop the study) without adding subjects while also accounting for the additional look at the 
data, we will use O’Brien-Fleming significance levels (0.0054 for the interim analysis and 0.0492 for 
the final analysis). For futility, we propose a conditional power approach where we will stop for 
futility if the conditional power is below 10%. Adding a futility rule for stopping does not require 
further reduction of significance levels since it decreases the chance of a type I error. 
9.5 
Outcomes  
Please refer to Section 9.1. Analysis and outcomes will be reviewed by PI, Co-Is, and consultants as 
needed.  
9.5.1 
Primary Outcome   
The primary outcome is pain-related fear (adolescent and parent). This will be measured through 
the Fear of Pain Questionnaire (FOPQ-C, FOPQ-P) measure collected at Baseline, treatment study 
Discharge, and 3 and 6-month post-discharge follow-up time points. The Photographs of Daily 
Activities (PHODA-YE) will also be used to measure pain-related fear outcomes at Baseline and 
treatment study Discharge.  
9.5.2 
Secondary Outcomes   
The secondary outcome is disability. This will be measured with the Functional Disability Inventory 
(FDI) measure at Baseline, treatment study Discharge, and 3 and 6-month post-discharge follow-up 
time points. 
 
9.5.3 Additional Outcomes 
Additional outcomes of interest include parent responses to pain and school functioning. These will 
be collected at Baseline, treatment study Discharge and 3 and 6-month post-discharge follow-up 
time points with the following measures: Adult responses to Child’s Symptoms (ARCS), Helping for 
Health Inventory (HHI), Parent Psychological Flexibility Questionnaire (PPFQ), Chronic Pain 
Questionnaire (PPAQ), and Pediatric Quality of Life – School Functioning Subscale (PedsQL). 
 

 
 
29 
9.5.4 Exploratory Outcomes 
Physical Activity (Actigraphy), Daily Diary (Child and Parent), and Biomechanics (motion analysis) are 
exploratory outcomes. Actigraphy will be measured during 2-week pre-treatment baseline 
throughout active treatment. The Daily Diary will be administered for an average of 14 days during 
the initial baseline period through treatment, and again for 7 days at the 3 and 6-month follow-up 
time points. Motion analysis will be conducted at Baseline and Discharge sessions.  
 
9.5.5 Feasibility Measures 
Feasibility will be measured in terms of treatment satisfaction, acceptability, adherence, fidelity, and 
healthcare use/cost. Treatment satisfaction will be evaluated by mean satisfaction of the Pain 
Service Satisfaction Test (PSST)60 scores completed by child participants in both intervention groups. 
Treatment Acceptability will be measured by the Treatment Expectancy and Creditability measure 
(TEC-C, TEC-P)61, along with exit interviews collected at the discharge session. Adherence and 
Retention will be examined through mean parent and patient adherence to daily diary completion, 
percent of patient who drop out prior to treatment completion, and percent of sessions completed 
on schedule. A trained research assistant will listen to audio/video recordings of treatment sessions 
and complete treatment fidelity checklists for content and process, for both parents and child 
sessions (See Supplemental Materials I for checklists). Healthcare use/cost will be measured at the 
Baseline and 3 and 6-month follow-up time points with the Healthcare Cost Diary62. 
 
Table 6. Assessment Measures 
 
 
Outcomes & Correlates 
Questionnaires  & Tests 
DD 
Full version 
Aim 1 
Primary Outcome 
Pain-related Fear 
Avoidance 
Fear of Pain Questionnaire (FOPQ-C; PFOPQ)  FOPQ-C: low [0-34] moderate [35-49] 
high [50-96]; Photographs of Daily Activities for Youth English (PHODA-YE) 
x 
BAS, END, FU3, FU6 
Secondary Outcome 
Functional Disability 
Functional Disability Inventory (FDI) mild [0-12] moderate [13-29] severe [30-60] 
x 
BAS, END, FU3, FU6 
Additional Outcomes 
Protective Behaviors 
Adult Responses to Child’s Symptoms (ARCS), Helping for Health Inventory (HHI) 
x 
BAS, END, FU3, FU6 
Parent Flexibility 
Parent Psychological Flexibility Questionnaire (PPFQ-10) 
x 
BAS, END, FU3, FU6 
Pain Acceptance 
Chronic pain acceptance questionnaire (CPAQ-A; PPAQ) 
x 
BAS, END, FU3, FU6 
School Functioning 
Pediatric Quality of Life – School Functioning Subscale (PedsQL) 
 
BAS, END, FU3, FU6 
Exploratory Outcomes 
Biomechanics 
Gait (stride length, velocity),  vertical drop landing,  dynamic postural control 
 
BAS, END 
Physical Activity 
Daily mean and peak activity via Actigraphy 
x  

 
 
30 
Correlates 
Pain Severity 
Numerical Rating Scale (NRS) 
x 
BAS, END, FU3, FU6 
Pain Catastrophizing 
Pain Catastrophizing Scale (PCS-C, PCS-P) 
 
BAS, END, FU3, FU6 
Medical History 
Pain Questionnaire: Time since onset, previous treatments (Pain-C, Pain-P) 
 
BAS 
Demographics 
Age, sex, socioeconomic status (Caregiver History) 
 
BAS 
Readiness to change 
Pain Stages of Change Questionnaire (PSOCQ-A; PSOCQ-P) 
 
BAS, END, FU3, FU6 
Depression 
Children’s Depression Inventory-2 (CDI-2) 
 
BAS, END, FU3, FU6 
Anxiety 
Multidimensional Anxiety Scale for Children (MASC) 
 
BAS, END, FU3, FU6 
Feasibility Measures 
Treatment Acceptability 
Treatment satisfaction (PPST); mean score 40 of 60; satisfied to very satisfied 
 
END, FU3, FU6 
Treatment Acceptability 
Treatment Expectancy & Credibility (TEC-C; TEC-P);  
 
S1 
Treatment Acceptability 
% drop-out; Exit Interview (patient/parent feedback) 
 
END 
Treatment Adherence 
% adherence to daily diary, at-home tasks, sessions completed on-schedule 
 
END 
Treatment Fidelity 
Process (e.g., reflective listening), Content (session outline adherence) 
 
** 
Healthcare Use/Cost 
Cost diary 
 
BAS, WK,FU3, FU6 
 
**To be assessed by ongoing coding of audio/video recordings of treatment sessions 
 
BAS=Baseline, DD=Item Generation for Daily Diary; WK= Weekly during treatment, END=End of treatment, FU3=3-month follow-up, FU6=6 month 
follow-up, S=Session. 
 
 
9.6 
Data Analyses  
 
Our statistician, Derek Boothroyd, PhD, will conduct analyses. Linear mixed effects models will be 
used for Aim 1. We chose the largest feasible study size to obtain as precise estimates as possible 
of treatment difference in our primary outcome, adolescent pain-related fear. With a starting 
sample of 74 (37/37), we expect 58 at follow-up (18% discharge attrition, 5% at 3 and 6-month 
follow-up). Using GET Living pilot data (see Table 2), we used a mixed model simulation using the 
standard deviations at each time point and standard deviations of change to calculate correlation 
and hence the random effect and error variances. In our primary power calculation, we assumed 
that the improvement in adolescent pain-related fear at 3 and 6-months would be 22.4 in GET Living 
and 5 in TPM19, a difference of 17.4, with a standard deviation for change of 21. Under this scenario 
we will have 87% power with 58 (29 in each arm) at study end. Under more conservative 
assumptions, we still have power of 80% with only 52 at the end of study and a treatment difference 

 
 
31 
of 16.6. With a smaller standard deviation of 18.9, we will have power of 80% with 50 at end of 
study and a treatment difference of 15.4. 
10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 
Data Collection Forms  
REDCap (Research Electronic Data Capture), the free, secure, HIPAA compliant web-based 
application, will be used to collect, store, and manage data. Vanderbilt University, with collaboration 
from a consortium of academic and non-profit institutional partners, has developed this software 
toolset and workflow methodology for electronic collection and management of research and 
clinical study data. Data will be maintained in private, non-shared, protected folders stored on 
central computers at Stanford University School of Medicine.  The hospital system provides nightly 
backup of files stored on its server. Only approved research staff will have access to these files.  
Identifying information will not be entered or stored on the computer with the behavioral data; 
thus, all relevant data other than separated consent forms will be de-identified. Documentations of 
clinical treatment sessions from the Screening and Treatment Delivery team will be collected weekly 
and stored in a study file for the participant by the study coordinator.  
10.2 
Data Management  
All questionnaire data collected for the study will be exported into SPSS, SAS or R via REDCap. 
Databases for all data collected for the purposes of this research study will be stored in a password 
protected SPSS file which only research staff will have access. Datasets related to this clinical trial 
will only be accessed by Dr. Simons (PI) and research team as needed. The database will be stored 
on a password protected, secured and encrypted server maintained by Dr. Simons and Stanford 
University IT.  
 
The Photographs of Daily Activity (PHODA) is a data collection platform that will be maintained by 
the study coordinator and administered to all patients at baseline and discharge sessions. 
Biomechanical data and analysis will be collected and maintained by the Motion and Sports 
Performance Laboratory (MSPL) at SCH and verified by the communications with the study 
coordinator on a weekly basis.  
 
Actigraphy data will be collected using ActiLife software and maintained by the study coordinator.  
 
Scheduling and enrollment data will be stored in an excel spreadsheet within a PHI-safe folder on 
Stanford Medicine Box – a secure, HIPAA compliant cloud-based data storage platform. 
 
Treatment session audio/video recordings will be collected digitally and saved on the secure, 
private drive on the server and only personnel associated with the study will have access to the 
files. After completion of the study, all audio and video recordings will be destroyed. 
10.3 
Quality Assurance  
10.3.1 Training 
All staff will complete the human participants protection training required by Stanford University. 
The University uses the “CITI” training program (Collaborative Institutional Training Initiative; 
https://www.citiprogram.org/). All staff must pass required tests on each module. A refresher 
course must be passed every 24 months. 
 
Per NIH requirements, all staff will be trained in Good Clinical Practice (GCP), consistent with 

 
 
32 
principles of the International Conference on Harmonisation (ICH) E6 (R2). The research coordinator 
will be responsible for maintaining documentation of all CITI and GCP training certifications. 
 
An outpatient team consisting of a pain psychology therapist (PSY) and physical therapist (PT) 
provide GET Living treatment, both trained in this modality of treatment by Laura Simons, PhD with 
ongoing consultation from Johan Vlaeyen, PhD (lead innovator of GET in adults) and Rikard Wicksell 
(lead innovator in CBT and ACT in adolescent chronic pain). Training for GET Living will involve 
outpatient team being exposed to treatment session videos from pilot patients (n=16). 
 
10.3.2 Quality Control Committee  
The PI and research coordinator will be hold primary responsibility for study data quality control. To 
address quality control methods, chart data will utilize standardized collection forms.  For data entry 
of study information, a portion of files will be re-entered by a separate person, to check for 
consistency.  If consistency is low, the entire data set will be re-entered.  
10.3.3 Metrics 
All self-report outcome measures have demonstrated psychometric soundness, including reliability 
and validity. 
10.3.4 Protocol Deviations 
Each protocol deviation (PD) will be captured and documented, by participant, in the Protocol 
Deviation Tracking Log eCRF (MOOP Appendix E). All PDs will be collated and reviewed by the 
research coordinator and study PI. 
A major protocol deviation or violation includes any procedure that differs from the IRB-approved 
protocol that was intended to eliminate an immediate hazard to the participant, was harmful, or is 
possible serious or continue non-compliance by a study staff member.   
Major protocol deviations will be communicated to the PI immediately. All events will be 
communicated to the NIAMS (through KAI) within 48 hours of the PI becoming aware of the event.  
Protocol deviations/violations that occur but do not affect participant safety will be submitted as 
part of the quarterly reports distributed to the SMC and subsequently shared with the NIAMS. 
10.3.5 Monitoring 
The study will be monitored by the research coordinator regularly throughout the collection of data. 
Oversight of this clinical trial is provided by the Principal Investigator (PI), Dr. Simons and a Study 
Monitoring Committee (see section 7.6).  
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 
Institutional Review Board (IRB) Review  
This protocol and the informed consent document (MOOP Supplemental Materials II) and any 
subsequent modifications will be reviewed and approved by the Stanford IRB responsible for 
oversight of the study.  
11.2 
Informed Consent Forms 
A signed consent form will be obtained from each parent participant, and a signed assent form for 
each child participant. For participants who cannot consent for themselves, such as those with a 
legal guardian (e.g., person with power of attorney), this individual must sign the consent form. The 

 
 
33 
consent form will describe the purpose of the study, the procedures to be followed, and the risks 
and benefits of participation. A copy will be given to each participant or legal guardian and this fact 
will be documented in the participant’s record.  
11.3 
Participant Confidentiality  
Any data, specimens, forms, reports, video recordings, and other records that leave the site will be 
identified only by a participant identification number (PID) to maintain confidentiality. All records 
will be kept in a locked file cabinet. All computer entry and networking programs will be done using 
PIDs only. Information will not be released without written permission of the participant, except as 
necessary for monitoring by IRB, the FDA, the NIAMS, and the OHRP. 
11.4 
Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIAMS, the OHRP, the FDA, or other 
government agencies as part of their duties to ensure that research participants are protected.  
12. COMMITTEES 
Steering committee – Study PI, Co-Investigators, and Research Coordinator for this study will meet 
monthly to discuss study progress relative to milestones, coordinate efforts, and review any protocol 
deviations or other issues requiring adjustment.  
Safety Monitoring Committee – The Study PI and Study Monitoring Committee (Section 7.6) will 
meet quarterly to review study accrual, status of enrollment, adherence to data regarding study visit 
and intervention, and adverse events.  
13. PUBLICATION OF RESEARCH FINDINGS  
As an NIH-funded Clinical Trial this study will be registered at, and will submit summary results 
information to, ClinicalTrials.gov for public posting. Publication of the results of this trial will be 
governed by the policies and procedures developed by the Steering Committee.  
 
 
 

 
 
34 
14. REFERENCES  
 
1. 
Burns JW, Glenn B, Bruehl S, Harden RN, Lofland K. Cognitive factors influence outcome 
following multidisciplinary chronic pain treatment: a replication and extension of a cross-lagged panel 
analysis. Behaviour research and therapy 2003;41:1163-82. 
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