Kids Formats of Anxiety Care Effectiveness Study For Extending the Acceptability and Reach of Services (Kids FACE FEARS)
Phase: NA
Conditions: Child Anxiety, Anxiety Disorders, Anxiety, Anxiety Symptoms, Anxiety, Mild to Moderate, Pediatric Anxiety Disorders
Sponsor: Boston Medical Center

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CLINICAL STUDY PROTOCOL 
 
 
 
KIDS FACE FEARS PRAGMATIC TRIAL FOR 
CHILD ANXIETY 
NCT03707158 
H-37862 
PI- Donna Pincus, PhD 
dpincus@bu.edu 
 
 
Funder 
PCORI 
 
Protocol Version 
December 22, 2020 
 
Statistical Analysis Plan-  pages 76-79 
 
 
 
 
 

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Study Personnel 
Principal Investigator 
 
 
Donna B. Pincus, PhD 
Associate Professor 
Director, Child and Adolescent Fear and 
Anxiety Treatment Program 
Center for Anxiety and Related Disorders 
Boston University 
Email: dpincus@bu.edu  
 
 
 
 
 
 
 
 
 
Investigator 
 
Jonathan S. Comer, PhD 
Professor, Psychology and Psychiatry 
Director, Mental Health Interventions and 
Novel Therapeutics (MINT) Program 
Center for Children and Families 
Florida International University 
Email: jocomer@fiu.edu  
 
Christina Borba, PhD, MPH 
Associate Professor 
Boston University School of Medicine 
Director of Research 
Department of Psychiatry 
Director, Global and Local Center for Mental 
Health Disparities 
Boston Medical Center 
Email: Christina.borba@bmc.org 
 
Lisa Fortuna, MD, MPH 
Director, Child & Adolescent Psychiatry 
Services 
Boston University School of Medicine 
Department of Psychiatry 
Boston Medical Center 
 
Michelle Porche, EdD 
Clinical Associate Professor 
Boston University 
Wheelock College of Education and Human 
Development 
Email: michelle.porche@ucsf.edu  
 
 

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Regional Co-Investigators  
 
New England 
Sites: 
Massachusetts General Hospital 
Boston Medical Center  
South Boston Community Health Center 
 
 
 
 
Andrea Spencer, MD 
Assistant Professor, Department of Psychiatry 
Boston University School of Medicine 
Email: andrea.spencer@bmc.org 
Pacific Northwest 
Sites: 
Harborview Medical Center Seattle 
Seattle Children’s Hospital 
Swedish Medical Center Seattle 
Molly Adrian, PhD 
Assistant Professor, Department of Psychiatry 
and Behavioral Sciences 
University of Washington School of Medicine 
Attending Psychologist, Mood and Anxiety 
Disorders Program 
Seattle Children’s Hospital 
Email: adriam@uw.edu 
 
Kendra Read, PhD 
Assistant Professor, Division of Child and 
Adolescent Psychiatry 
Department of Psychiatry and Behavioral 
Sciences 
University of Washington School of Medicine 
Clinic Director, Division of Child and 
Adolescent Psychiatry  
Mood and Anxiety Disorders Program 
Seattle Children’s Hospital 
Email: adriam@uw.edu 
 
Mid-Atlantic 
Sites: 
John Hopkins: Bayview Medical Center 
Baltimore Medical Systems:  
Middlesex Clinic 
Rheanna Edith Platt, MD, MPH 
Assistant Professor, Psychiatry and Behavioral 
Sciences 
Johns Hopkins University School of Medicine 
Email: rplatt1@jhmi.edu  
 
Leslie Miller, MD 
Assistant Professor, Division of Child and 
Adolescent Psychiatry 
Johns Hopkins University School of Medicine 
 
 
Southeast 
Sites: 
Nicklaus Children’s Hospital 
Jonathan S. Comer, PhD 
Professor, Psychology and Psychiatry 
Director, Mental Health Interventions and 
Novel Therapeutics (MINT) Program 
Center for Children and Families 
Florida International University 
Email: jocomer@fiu.edu  
 

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Dana McMakin, PhD 
Associate Professor, Department of 
Psychology 
Center for Children and Families, Florida 
International University 
Department of Neurology 
Nicklaus Children’s Hospital 
Email: dmcmakin@fiu.edu  
 
Other Key Study Personnel: 
 
Haniya Syeda, MPH 
Program Manager, Kids FACE FEARS 
Boston Medical Center 
Email: Haniya.syeda@bmc.org  
 
Administration Personnel 
Members of the Training, Fidelity and 
Sustainability Team:  
 
Donna Pincus, PhD 
Associate Professor 
Director, Child and Adolescent Fear and 
Anxiety Treatment Program 
Center for Anxiety and Related Disorders 
Boston University 
Email: dpincus@bu.edu 
 
 
Jami Furr, PhD 
Clinical Assistant Professor 
Center for Children and Families 
Florida International University  
Email: jfurr@bu.edu  
 
 
 
 
 
 
 
 
 
 
 
 
 

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Synopsis 
Primary Objective 
• 
To compare the acute and longer-term effectiveness of Therapist-Led CBT 
(telehealth, office-based, or hybrid) versus Guided Online CBT (with minimal 
clinician involvement) for treating youth anxiety identified in pediatric healthcare. 
Secondary Objectives  
The secondary objectives are: 
• 
To determine whether key factors predict or moderate differential treatment 
engagement or response, in turn informing treatment personalization for various 
patient subgroups 
• 
To explore quantitative and qualitative data to understand perspectives, 
preferences, background factors, clinical and treatment engagement variables, and 
organizational factors that impede or facilitate implementation of, and patient 
engagement with, the comparators in pediatric health settings. 
Primary Outcome Variables 
• 
Youth anxiety symptoms - measured via the PROMIS Pediatric Short Form Item 
Bank v2.0-Anxiety.  
• 
Life interference - measured via the Child Anxiety Life Interference Scale; CALIS  
• 
Treatment Responder Status – measured via the Pediatric Anxiety Rating Scale; 
PARS 
• 
Family Perceived Effectiveness – measured via caregiver- and youth self-report 
• 
Treatment Satisfaction – measured via caregiver- and youth self-report 
Secondary and Exploratory Outcome Variables 
Treatment engagement and barriers, broader youth psychopathology (i.e., internalizing 
problems, externalizing problems, and attention problems), youth sleep difficulties, 
caregiver internalizing symptoms (i.e., depression symptoms, anxiety symptoms, and 
stress symptoms), and therapist perceptions of treatment response. Other secondary 
analyses will examine predictors and moderators of differential outcomes, including: 
demographic factors, clinical factors, caregiver and youth attitudes, and language of care 
(English versus Spanish), among other factors. 
Study Duration 
The study project has a duration of 5 years. 
Study Design 

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The study design entails a large-scale, streamlined, pragmatic Randomized Controlled 
Trial (RCT), in which eligible anxious youth presenting to pediatric health care settings will 
be randomly assigned to receive therapist-led (telehealth, office-based, or hybrid care) 
versus guided online CBT for youth anxiety and monitored for up to 1 year.  
Intervention 
Cognitive Behavior Therapy (CBT) is a well-supported standard of care for the treatment of 
anxiety in children and adolescents. This study is a pragmatic comparative effectiveness 
design comparing two modalities for administering CBT: Therapist-led CBT (telehealth, 
office-based, or hybrid care) vs. Guided Online CBT (with minimal therapist involvement).  
Study Population 
We will include youth ages 7-18 years of age presenting to pediatric health care sites, 
including community health centers serving primarily low-income and traditionally 
underserved populations, affiliated with four major academic medical centers, each 
distinguished by renowned programs in behavioral health integration: Boston Medical 
Center in Boston, MA; Nicklaus Children's Hospital in Miami, FL; John's Hopkins Hospital 
in Baltimore, MD, and Seattle Children's Hospital in Seattle, WA. 
Number of Participants 
We require 150 participants per treatment group, for a total of 300 participants. 
 
 
 

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Abbreviations 
Abbreviation  
Explanation 
ADHD 
Attention-deficit/hyperactivity disorder 
AHRQ 
Agency for Healthcare Research and 
Quality 
BMC 
Boston Medical Center 
BUMC 
Boston University Medical Campus 
CALIS 
Child Anxiety Life Interference Scale 
CBT 
Cognitive Behavioral Therapy 
CCF 
Center for Children and Families 
CRF 
Case Report Form 
DE 
Design Effect 
FIML 
Full information maximum likelihood 
FISMA 
Federal Information Security Management 
Act 
FIU 
Florida International University 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and 
Accountability Act 

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IRB 
Institutional Review Board 
KFF 
Kids Formats of Anxiety Care Effectiveness 
study For Extending the Acceptability and 
Reach of Services 
Kids FACE FEARS 
Kids Formats of Anxiety Care Effectiveness 
study For Extending the Acceptability and 
Reach of Services 
LAR 
Legally authorized representatives 
LR 
Likelihood ratio 
ML 
Maximum likelihood 
PCORI 
Patient Centered Outcomes Research 
Institute 
PRO 
Patient Reported Outcome 
RA 
Research Assistant 
RCT 
Randomized Controlled Trial  
RE-AIM 
Reach, Effectiveness, Adoption, 
Implementation, Maintenance 
REDCap 
Research Electronic Data Capture 
SD 
Standard Deviation 
SES 
Socioeconomic status 
SSRI 
Selective Serotonin Reuptake Inhibitor 
 

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Table of Contents 
1 - Introduction .................................................................................................................... 13 
1.1 Introductory Statement .............................................................................................. 13 
1.2 Project Synopsis ........................................................................................................ 13 
2 – Background and Rationale ............................................................................................ 14 
2.1 Pediatric Anxiety and its Sequelae Constitute a Very Serious Public Health Concern 14 
2.2 Cognitive-Behavioral Therapy is Well Supported in Treating Pediatric Anxiety .......... 14 
2.3 Treatment Gaps: Problems in the Availability, Accessibility, and Acceptability of CBT 
for Pediatric Anxiety ......................................................................................................... 15 
2.4 Service Barriers Disproportionately Affect Youth from Minoritized Communities ........ 15 
2.5 Technology-Based Strategies Have Shown Promise for Improving Access to Care .. 15 
2.6 Gaps Persist in Understanding How Various Pediatric Anxiety Treatment Formats 
Perform and Compare in Typical Care Settings ............................................................... 16 
3 - Rationale/Significance ................................................................................................... 18 
3.1 Problem Statement .................................................................................................... 18 
3.2 Purpose of Study/Potential Impact ............................................................................. 18 
3.3.1 Potential Benefits ............................................................................................ 19 
3.3.2 Potential Risks ................................................................................................ 19 
4 - Study Objectives and Aims ............................................................................................ 21 
4.1 Primary Objective ...................................................................................................... 21 
4.2 Secondary Objectives ................................................................................................ 22 
5 – Engagement and Partnerships with Patients, Other Stakeholders, and Scientific Advisors
 ........................................................................................................................................... 23 
6 - Study Design ................................................................................................................. 26 
6.1 General Design Overview .......................................................................................... 26 
6.1.1 Study Setting .................................................................................................. 26 
6.2 Outcomes .................................................................................................................. 26 
6.2.1 Primary Outcome Variables ............................................................................. 27 
6.2.2 Secondary and Exploratory Outcome Variables............................................... 27 
6.3 Study Population ....................................................................................................... 28 

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6.3.1 Number of Participants .................................................................................... 28 
6.3.2 Eligibility Criteria .............................................................................................. 28 
6.4 Therapist Participants ................................................................................................ 30 
7 - Methods ......................................................................................................................... 28 
7.1 Participation Flow ...................................................................................................... 31 
7.2 Description of Intervention/Comparators .................................................................... 31 
7.3 Implementation of Cool Kids CBT in Pediatric Health Settings ................................... 34 
7.4 Evaluating Therapist-Led Cool Kids (office-based or telehealth) vs. Self-Administered 
Web-Based CBT for Child Anxiety ................................................................................... 34 
7.5 Method of Assignment/Randomization ...................................................................... 35 
7.6 Measures ................................................................................................................... 36 
7.6.1 Primary clinical outcomes ............................................................................... 59 
7.6.2 Secondary clinical outcomes ........................................................................... 40 
7.6.3 Treatment variables ........................................................................................ 43 
7.6.4 Study covariates, predictors and other included measures ............................. 49 
7.7 Therapist Training and Ongoing Consultation ............................................................ 56 
7.7.1 Training Workshop .......................................................................................... 57 
7.7.2 Asynchronous online resources ...................................................................... 58 
7.7.3 Consultation and support ................................................................................ 58 
7.8 Safety, Reaction Management, and Clinical Deterioration ......................................... 59 
7.8.1 Safety Policy ................................................................................................... 59 
7.8.2 Removal of Participants .................................................................................. 61 
7.8.3 Data Safety Monitoring Plan: .......................................................................... 62 
7.8.4 Adverse Events Definition and Reporting: ....................................................... 63 
7.8.5 Adverse Event Reporting Plan: ....................................................................... 64 
7.9 Screening for Anxiety and Study Enrollment .............................................................. 65 
7.10 Enrollment ............................................................................................................... 67 
7.10.1 Eligibility Determination ................................................................................. 67 
7.10.2 Eligibility Screening Procedures .................................................................... 69 
7.10.3 Informed Consent Procedures ...................................................................... 69 

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7.11 Baseline Assessment Procedures ........................................................................... 70 
7.11.1 PARS Baseline Procedures .......................................................................... 71 
7.12 Clinical Intake Procedures ....................................................................................... 71 
7.13 Randomization Procedures...................................................................................... 71 
7.14 Assigned Diagnoses Form ....................................................................................... 71 
7.15 Study Visits, Therapeutic Contacts, and Assessments ............................................ 72 
7.15.1 Study Visits and Therapeutic Contacts .......................................................... 72 
7.15.1.1 Therapist Contacts During the Treatment phase for Guided Online CBT 
Participants .......................................................................................................... 72 
7.15.1.2 Therapists Contacts During the Treatment Phase for Therapist-led CBT 
Participants  ......................................................................................................... 73 
7.15.1.3 Therapist Session Logs .......................................................................... 73 
7.15.2 Midtreatment, Posttreatment, and Follow-Up Assessment Procedures .......... 74 
7.15.3 Posttreatment PARS ...................................................................................... 74 
7.15.4 Retention and Study Compensation .............................................................. 75 
7.16 Statistical Considerations ........................................................................................ 76 
7.16.1 Sample size determination ............................................................................ 76 
7.16.2 Handling of Missing Data .............................................................................. 77 
7.16.2.1 Prevention and monitoring ..................................................................... 77 
7.16.2.2 Statistical handling of missing data ........................................................ 77 
7.16.2.3 Reporting dropout and missing data ....................................................... 78 
7.16.2.4 Loss to follow-up and withdrawal from treatment .................................... 78 
7.16.3 Covariates .................................................................................................... 78 
7.16.4 Primary analyses: Comparative effectiveness analyses ................................ 78 
7.16.5 Heterogeneity of treatment effects ................................................................ 79 
7.16.6 Facilitators and barriers ................................................................................ 79 
7.16.7 Interim Analysis ............................................................................................ 79 
8 Ethical Considerations ..................................................................................................... 80 
8.1 Ethical Considerations ............................................................................................... 80 
8.2 Ethical Considerations and Institutional Review Board (IRB) Review ......................... 83 

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8.2.1 Potential Risks ................................................................................................ 83 
8.2.2 Adequacy and Protection Against Risk ........................................................... 84 
8.2.3 Potential Benefits of the Proposed Research to Human Subjects and Others . 84 
8.2.4 Importance of the Knowledge to Be Gained .................................................... 85 
8.3 Participants Confidentiality ........................................................................................ 85 
8.4 Data Quality Assurance ............................................................................................. 86 
8.5 Data Collection .......................................................................................................... 87 
8.5.1 Access to Data ................................................................................................ 87 
8.5.2 Data Storage/Security ..................................................................................... 88 
8.6 Study Records ........................................................................................................... 89 
8.6.1 Retention of Records ...................................................................................... 89 
9 Research Team and Project Coordination ........................................................................ 90 
References ......................................................................................................................... 96 
 
 
 

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1 - Introduction 
1.1 Introductory Statement 
This document is a protocol for a human research study, Kids FACE FEARS (Formats of 
Anxiety Care Effectiveness study For Extending the Acceptability and Reach of Services). The 
purpose of this protocol is to ensure that this study is to be conducted according to PCORI 
guidelines, applicable government regulations, and participating institutional research policies 
and procedures. Each site will adhere to their institution’s human subject research policy. This 
study protocol and statistical analysis plan details the trial’s rationale, stakeholder partnerships, 
treatment conditions, participant recruitment, assessment schedule/strategy, provider 
training/consultation, and analytic plan. 
 
1.2 Project Synopsis 
Pediatric anxiety constitutes a serious public health concern. Cognitive-behavioral therapy 
(CBT) is a “gold standard” treatment, preferred by families over pharmacological options, but 
barriers limit CBT accessibility. Modern CBT formats include varying levels of therapist 
involvement and differential technologies to overcome barriers, but little is known about their 
effectiveness in typical care settings. The Kids Formats of Anxiety Care Effectiveness study For 
Extending the Acceptability and Reach of Services (Kids FACE FEARS) trial addresses these 
gaps. The Kids FACE FEARS trial (N~300 youth; ages 7-18 years) is a multisite, pragmatic 
randomized trial comparing Therapist-Led CBT (telehealth, office-based, or hybrid) versus 
Guided Online CBT (self-administered/self-paced, with minimal therapist support) for treating 
anxiety identified in pediatric care. English- and Spanish-speaking families are enrolled from 
high-volume, urban pediatric healthcare sites affiliated with major medical centers in four 
metropolitan regions. Children with elevated anxiety (and their families) are randomized to 
receive one of the two treatment comparators. Families participate in major assessments 
conducted at baseline, midtreatment, posttreatment, and one-year follow-up. Data for the study 
are drawn from caregiver-reports, youth self-reports, ratings of independent evaluators who are 
masked to treatment condition assignment), therapist-reports, and administrative logs. 
Exclusion criteria are minimal relative to other large-scale youth anxiety treatment trials. 
Treatment is provided by natural providers at the participating clinical settings (i.e., clinicians not 
employed by the Kids FACE FEARS investigative team, and not working in anxiety specialty 
settings). 
Primary study aims focus on comparative effectiveness between the two treatment conditions 
on symptom severity, impairment, and patient-centered outcomes. Secondary aims focus on 
examining factors that predict heterogeneity of treatment response outcomes across youth (i.e., 
predictors and moderators), and exploring factors that impede or facilitate the treatment 
implementation and engagement. 

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2 – Background and Rationale 
2.1 Pediatric anxiety and its sequelae constitute a very serious public health concern. 
Anxiety disorders are the most common psychiatric problems affecting children and 
adolescents,1–4 with one-fifth of the population meeting criteria for an anxiety disorder by the 
time they reach adulthood.3 Pediatric anxiety is associated with considerable burdens including 
school absenteeism, academic underachievement, social difficulties, family dysfunction, somatic 
symptoms, and frequent medical visits.5–8 When left untreated, pediatric anxiety often persists 
into adulthood and can worsen with time, increasing risk for substance use, psychiatric 
comorbidity, educational under-attainment, more medical visits, poor quality of life, lost wages 
and job productivity, suicidal thoughts and behaviors, and substantial costs to society.9–15 
Pediatric anxiety rates have been rising across the past decade,16–20 against a backdrop of 
increased political division and social unrest, widening disparities and inequities, potentially 
harmful social media impacts, rising climate concern, and a global pandemic with far-reaching 
ripples and hardships. In the United States (U.S.), minoritized status confers particular risk for 
anxiety, especially for youth of color, language-minority youth, and children of foreign-born 
caregivers.21–25 At the same time, minoritized youth are often underrepresented in pediatric 
anxiety research. 
2.2 Cognitive-Behavioral Therapy is Well-Supported in Treating Pediatric Anxiety. 
Efficacious treatments for youth anxiety can decrease lifelong symptoms, functional burdens, 
costs, and the subsequent onset of comorbid problems (e.g., depression, substance use).26–30 
Cognitive-behavioral therapy (CBT) is a “gold standard” psychological treatment for mild-to-
moderate anxiety,31–34 and is preferred by families over pharmacological approaches.35 CBT 
is goal-directed, brief and time-limited, can be manualized and broadly disseminated, and is 
divided into two general phases: (1) skills building; and (2) exposure practice.  
Dozens of large randomized trials indicate the majority of anxious youth are markedly improved 
after CBT, significantly outperforming waitlist, bibliotherapy, active support, and placebo 
comparators.31–33,36 In the landmark, multisite Child/Adolescent Anxiety Multimodal Study 
(CAMS),34 for example, 60% of youth treated with CBT were classified as treatment responders 
by independent evaluators (IEs), compared to 55% of youth treated with sertraline and only 23% 
of youth treated with placebo. For those with severe anxiety, a combination approach of CBT 
plus sertraline (associated with an 80% responder rate) was required for response,37 although 
medication approaches introduce side effect concerns for families to consider. More recent work 
has also called into question whether added benefits observed from multimodal treatment reflect 
true medication augmentation effects or simply a placebo effect added to existing CBT gains.  
 

15 
 
2.3 Treatment Gaps: Problems in the Availability, Accessibility, and Acceptability of CBT 
for Pediatric Anxiety.  
Despite the demonstrated efficacy of CBT for youth anxiety, up to 80% of anxious 
children do not seek or receive help.3 Among individuals with anxiety disorders who do receive 
treatment, the median delay from disorder onset to time of initial treatment contact ranges from 
9-23 years.38 Such failures and delays in treatment utilization underscore major problems in the 
availability, accessibility, and acceptability of care. Several barriers interfere with the receipt of 
needed care for anxious youth. For many families, traditional office-based care presents 
transportation obstacles, time demands that compete with work needs, childcare coordination 
challenges, and prohibitive costs and co-payments 39. The relative unavailability of services in 
non-English languages causes linguistic disparities,40 and institutional mistrust and stigma 
associated with visiting a mental health clinic place traditional office-based care out of reach for 
many families.41,42 Moreover, for several years the COVID-19 pandemic and associated stay-at-
home guidelines shut down the majority of office-based services.  
2.4 Service barriers disproportionately affect youth from minoritized communities.  
Thus, it is not surprising that anxious youth from such communities are particularly underserved. 
For example, anxious youth of color and in families with resource insecurity are significantly less 
likely to receive anxiety services than non-Hispanic White youth43,44 and youth from resource-
secure households.44,45 Also, anxious youth in immigrant households and in non-English-
speaking households use mental health services less than anxious children of U.S.-born 
caregivers and English-speaking households.46  
2.5 Technology-Based Strategies Have Shown Promise for Improving Access to 
Care. 
Technology-based strategies for extending the delivery of CBT to anxious youth have been 
supported in the literature47–58 and show promise for meaningfully overcoming treatment 
barriers. Research documents rapidly rising rates of household Internet availability in the U.S., 
with 97% of people below the age of 65 years now reporting regular Internet use, and 85% of 
people below the age of 65 years having household Internet access.59 Racial/ethnic- and 
income-related disparities in Internet access persist, particularly when considering household 
and mobile Internet access, although 91% of Black people and 86% of people earning less than 
$30,000/year  nonetheless report regular Internet usage.59 Work remains for continuing to 
expand Internet access, but these latest Internet use data speak to the considerable potential 
Internet-delivered CBT formats hold for broadening the reach of supported care. Two leading 
Internet-delivered approaches for extending CBT availability are (1) telehealth and hybrid care, 
and (2) guided online care.  

16 
 
Telehealth and Hybrid Care. Telehealth formats and hybrid options (i.e., mix of telehealth and 
office-based care) leverage synchronous telecommunications (typically videoconferencing) for 
the remote provision of live and interactive therapist-led care. Telehealth has been increasingly 
studied47–50 as a means to overcome logistical challenges to traditional brick-and-mortar CBT for 
youth anxiety and stigma about attending a mental health facility. Research in controlled 
settings and specialty clinics finds that telehealth options for a range of child mental health 
challenges can produce gains comparable to traditional office-based CBT. 47–50,60–62 In some 
trials, telehealth has even outperformed traditional office-based care on key outcomes,61 likely 
due to the improved ecological validity afforded in telehealth by treating families in their natural 
spaces. Furthermore, relative to traditional office-based care, telehealth is associated with 
significantly reduced caregiver-perceived barriers to care 61 and significantly improved session 
attendance, particularly for racial and ethnic minoritized youth.63 After years of research, 
telehealth entered the clinical mainstream during the COVID-19 pandemic,64–66 during which 
time it temporarily became the dominant mode of outpatient mental health care. In post-
pandemic times, telehealth still plays a prominent (albeit understudied) role in youth mental 
health care. 
Guided Online Care. Guided online care (i.e., self-administered/self-paced, with minimal 
therapist support) offers a computerized CBT delivery format that reduces therapist demands 
relative to both office-based care and telehealth, while also affording greater family flexibility, 
agency, and control. As such, guided online care addresses many of the same logistical care 
barriers as telehealth, but can also address person-power issues in the mental health workforce, 
inconsistencies in care quality across practice settings, cost issues, and, for some families, 
issues of mistrust about working directly with a healthcare professional. Accordingly, self-
administered online CBT may in some cases be the preferred treatment mode. CBT lends itself 
well to standardization to reduce drift and digitization due to its highly structured nature, and 
digital delivery may be particularly well-suited to youth and younger families who avidly engage 
with media and technology. That said, attrition can be high in self-administered online care. 
Increasing studies find some level of minimal/low-intensity human support is often needed to 
accompany self-administered online CBT—i.e., guided online CBT—to sustain patient 
motivation, promote adherence, and prevent disengagement.67,68 Several very strong self-
paced, computerized CBT programs have been developed for the treatment of youth anxiety 
and controlled trials have shown many of these programs can produce sizeable treatment gains, 
particularly when administered with some level of guided support.51–58 
2.6 Gaps Persist in Understanding How Various Pediatric Anxiety Treatment 
Formats Perform and Compare in Typical Care Settings.  
Despite great promise in the use of technology-based strategies relying on varying levels of 
therapist involvement to expand the reach of CBT for pediatric anxiety, much remains to be 
learned about how such modernized CBT formats perform in typical care settings. Similarly, little 

17 
 
is known about what factors may facilitate versus challenge successful engagement with these 
modernized CBT formats in usual care settings, and whether specific subpopulations of anxious 
youth may differentially benefit from these options. With regard to telehealth and hybrid 
strategies for pediatric anxiety, most support has come from small-scaled trials conducted in 
tightly controlled contexts and anxiety specialty clinics with highly selected samples and 
research therapists. Such work cannot speak to telehealth effectiveness or hybrid treatment 
under typical care circumstances and is underpowered to examine predictors of differential 
telehealth response. With regard to guided online CBT for pediatric anxiety, research to date 
has been conducted with predominantly non-Hispanic White and English-speaking samples, 
and most of the trials have been implemented in anxiety-specialty clinics and/or research 
settings. Evaluating the effectiveness of guided online CBT in diverse populations under usual 
care conditions is critical for understanding the extent to which this format can truly expand the 
accessibility and acceptability of care and reach underserved populations. Further, clinical trials 
of guided online CBT have not included a therapist-led treatment comparison, rendering it hard 
to make informed comparisons across treatment formats and precluding an understanding of 
which CBT formats for pediatric anxiety work best for whom.  
 
 
 

18 
 
3 - Rationale/Significance 
3.1 Problem Statement 
Most children with anxiety do not receive treatment for many reasons, including lack of 
therapists, stigma, getting to appointments, and time-commitment. Online delivery of CBT can 
lead to meaningful improvements in child anxiety and could make CBT available for more 
families (Morgan et al., 2017). Providing these treatments in community pediatrics practices 
could help even more children, particularly lower income and minority families who may not 
seek care elsewhere. Despite increasing support and uptake of face-to-face and online formats 
of CBT, to date no study has directly compared face-to-face and online CBT delivery methods in 
pediatric settings with predominantly low income and minority families, nor has research 
evaluated whether these two formats may differentially work better for certain patients or 
scenarios.  
The project outlined in this protocol responds to PCORI’s (Patient Centered Outcomes 
Research Institute) Special Area of Emphasis on digital health interventions for treating anxiety 
in children and adolescents at risk of reduced access to care, including immigrant, racial/ethnic 
minority, and low-income patients. This protocol also addresses the AHRQ (Agency for 
Healthcare Research and Quality) future research needs for the integration of mental 
health/substance use treatment in primary care.  
3.2 Purpose of Study/Potential Impact 
This study addresses three critical yet unanswered questions related to improving the delivery 
of CBT and treatment outcomes for anxiety in pediatric health settings. Answering the following 
question offers the potential to meaningfully improve the quality of the evidence available to help 
children, families, and organizational stakeholders make informed decisions regarding clinical 
practice and implementation strategies for the treatment of childhood anxiety:  
(1)  What is the comparative effectiveness of implementing therapist-led (telehealth, office-
based, or hybrid) versus guided online formats of CBT to treat youth anxiety identified in 
pediatric health care settings?  
(2)  Which factors might moderate outcomes across treatment formats and sequences? 
Which patient subgroups might benefit most from each of the treatment formats?  
(3)  What are the barriers and facilitators to delivering this care in pediatric health care 
settings and for the diverse patient populations served?  

19 
 
Both the effectiveness and implementation questions are relevant to advancing strategies for 
addressing anxiety in pediatric health care and optimizing patients' and families' access to, 
options for, and quality of anxiety treatment. In recent years there has been a surge of interest 
in online treatment delivery formats that offer more accessible, flexible, and efficient care with 
the potential to reach a greater portion of the population in need. 
3.3.1 Potential Benefits 
Families enrolled in the study would benefit from: 
• 
Receiving evidence-based treatment for youth anxiety 
• 
Parents or guardians receiving education on anxiety and how they can help manage 
their child’s anxiety through an evidence-based program 
• 
Receiving support from a trained professional over the phone (if they are randomized to 
the guided online format) 
• 
Having access to a convenient evidence-based self-administered CBT program online (if 
randomized to the online format) that would not be offered outside of the study 
Therapists and program staff enrolled in the study would benefit from: 
• 
Assisting participating families with access to child behavioral health services  
• 
Learning a new framework for delivering CBT 
• 
Providing valuable information to primary care practices and integrated health networks 
about the potential benefits and barriers to implementing these interventions for children 
with anxiety  
• 
Providing evidence-based information to support patient and provider decision making 
and patient centered care 
3.3.2 Potential Risks 
Potential risks to patient participants are psychological and the need to protect confidentiality: 
• 
Because the research covers the topic of mental health and potential psychosocial 
stressors, participation may be emotionally distressing to individuals in the study. 
• 
Although we will strive to maximize cultural sensitivity in delivery of the proposed 
intervention, it is possible that, among guardians, their explanatory models of their child's 
condition will be incompatible with our proposed interventions and even the 
assessments, which may upset some participants. 

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• 
Although data will be stored in a secure and confidential manner, and we will code all 
stored data and store it separate from any direct participant identifiers, accidental 
breaches of confidentiality are technically possible.   
Potential risks for staff participants are the need to protect confidentiality: 
• 
Although data will be stored in a secure and confidential manner, and we will code all 
stored data and store it separate from any direct participant identifiers, accidental 
breaches of confidentiality are technically possible. 
• 
Because the research involves feedback about the study and the clinic's ability to 
implement mental health care, staff participants may be concerned or distressed about 
how this may impact their employment. Their responses will be kept confidential and will 
not be shared with their employer. 
The primary risk for study participants is breach of confidentiality. We have taken measures to 
ensure the safety and security of all data and participant information which is outlined in the 
data storage/ security section of this protocol. 
 
 

21 
 
4 - Study Objectives and Aims 
Building on the strong evidence supporting CBT for the treatment of mild-to-moderate pediatric 
anxiety, the present multisite trial was designed to examine the comparative effectiveness of 
modernized CBT delivery formats that have shown initial promise for expanding the reach of 
care. Specifically, the Kids FACE FEARS trial (Kids Formats of Anxiety Care Effectiveness 
Study For Extending the Acceptability and Reach of Services) is a type 1 hybrid effectiveness 
and implementation pragmatic study designed to compare Therapist-Led CBT (telehealth, 
office-based, or hybrid) versus Guided Online CBT (with minimal therapist support) in usual care 
settings for the treatment of pediatric anxiety.  
Table 1, below, presents the specific aims and objectives of the Kids FACE FEARS trial.  
Table 1. Specific Aims of the Kids FACE FEARS Trial 
Aim 
Domain 
Objective 
Aim I 
Comparative 
Effectiveness 
To compare the acute and longer-term effectiveness of 
Therapist-Led CBT (telehealth, office-based, or hybrid) versus 
Guided Online CBT (with minimal clinician involvement) for 
treating youth anxiety identified in pediatric healthcare.  
Aim II 
Heterogeneity of 
Treatment Effects 
To determine whether key factors predict or moderate 
differential treatment engagement or response, in turn 
informing treatment personalization for various patient 
subgroups.  
 
Aim III 
Implementation 
Facilitators and 
Barriers 
To explore quantitative and qualitative data to understand 
perspectives, preferences, background factors, clinical and 
treatment engagement variables, and organizational factors 
that impede or facilitate implementation of, and patient 
engagement with, the comparators in pediatric health settings. 
 
Note: Kids FACE FEARS=Kids Formats of Anxiety Care Effectiveness study For Extending the 
Acceptability and Reach of Services 
 
4.1 Primary Objective 
The objective of Aim 1 (Comparative Effectiveness) is to compare the acute and long-term 
effectiveness of Therapist-Led CBT (telehealth, office-based, or hybrid) vs Guided Online CBT 
(with minimal clinician support) for treating youth anxiety identified in pediatric healthcare. It is 
hypothesized that youth in both conditions would show significant curvilinear improvements over 
time characterized by relatively steep improvements during the beginning and middle of the 
treatment phase, followed by a slowing down of improvements toward the end of treatment and 
then relative stability across the follow-up time interval. Comparative effectiveness analyses will 

22 
 
compare differences in outcome slopes across the two conditions. Aim 1 focuses on the 
following primary treatment outcomes across the comparators: family-rated anxiety severity, 
family-rated anxiety-related life impairment, independently rated treatment responder and 
anxiety remission status, family perceived effectiveness, and family satisfaction with care. Data 
on a range of secondary outcomes are also collected.  
 
4.2 Secondary Objectives  
The objective of Aim 2 (Heterogeneity of Treatment Effects) is to determine whether key factors 
predict or moderate differential treatment engagement or response, in turn informing treatment 
personalization for various patient subgroups. To understand heterogeneity in treatment 
response across youth, moderating factors examined include: demographic factors, clinical 
factors, caregiver and youth attitudes, and language of care (English versus Spanish). 
Additional factors are also assessed to afford further tests of predictors and moderators of 
treatment response. 
 
Aim 3 (Implementation Facilitators and Barriers) is exploratory, with the objective to understand 
perspectives, preferences, background factors, clinical and treatment engagement variables, 
and organizational factors that facilitate or impede implementation of, and patient engagement 
with, the comparators in routine pediatric health settings.  
 
 

23 
 
5 – Engagement and Partnerships with Patients, 
Other Stakeholders, and Scientific Advisors 
Throughout all stages of the Kids FACE FEARS trial, investigators are engaged in 
collaborations with patient, parent, and community stakeholders who have experience 
(themselves or loved ones) with mental health challenges such as anxiety, as well as with 
treatment providers, clinical supervisors, and program administrators who are responsible for 
providing care to families. Investigators also engage with a Study Advisory Committee 
comprised of members dedicated to improving access to evidence-based treatment, and a Data 
Safety and Monitoring Board to further ensure patient safety and protection. These mutual 
partnerships with stakeholder groups meaningfully inform each aspect of the study design, 
implementation, and dissemination, as described below. 
Patient Family Advisory Council (PFAC). The Kids FACE FEARS Patient Family Advisory 
Council (PFAC) is made up of 22 members (16 parents and 7 adolescents) with lived 
experience (personal or family) with youth anxiety and its treatment. PFAC members were 
identified and recruited through patient advisory boards at participating clinical sites in all four 
study regions, extended patient networks of hospital systems, clinical networks of study team 
members, and through study team member connections with patients and families with anxiety 
in their communities. Throughout study design, implementation, and analysis, the PFAC will 
convene regularly in person and on group videoconferencing calls to ensure that patient/family 
perspectives are fully integrated into all aspects of the study and that research activities are 
aligned with patient/family needs. PFAC meetings will be held throughout the study. Separate 
meetings will be held in English and Spanish. For each set of meetings, separate one-hour 
sessions are held with an English-speaking Youth Council, an English-speaking Caregiver 
Council, and a Spanish-speaking Youth/Caregiver Council. Bilingual youth can chose whether 
to be in the English-speaking Youth Council or the Spanish-speaking Youth/Caregiver Council. 
Meetings will occur quarterly during the first three years of the study, bi-annually during the 
fourth year of the study, annually during the fifth year of the study, and twice during the data 
analysis/interpretation phase of the study.  Each PFAC meeting is structured as followed: 1) an 
overview of the meeting agenda, 2) a review of study progress and updates (including study 
changes based on PFAC feedback), 3) a presentation of current study tasks/goals 4) 
introduction of specific questions/prompts for discussion, 5) division into breakout groups to 
facilitate small group discussion and brainstorming, and 6) full-group discussion and closure. 
Prior to the COVID-19 pandemic, PFAC meetings were held in a hybrid format, with all regions 
convening together on Zoom, and in-person break-out groups convening within study regions 
prior to a final all-region discussion on Zoom. After the pandemic began, all PFAC meetings are 
held entirely on Zoom, with virtual breakout rooms used for small group discussions. To further 
facilitate virtual engagement, brainstorming, and interaction among group members, study staff 
will utilize collaborative digital tools (e.g., Zoom reaction features, screensharing, a collaborative 

24 
 
digital whiteboard via Google Jamboard). PFAC members will help with study planning and 
provide input throughout about participant recruitment and project implementation. PFAC co-
investigators will assist in creating research poster presentations for professional conferences 
and will be invited to collaborate on major scholarly papers for the project. PFAC members will 
also provide suggestions about ways to effectively disseminate findings to study participants 
and to the public.  
Treatment Providers and Clinical Supervisors. Natural providers in participating pediatric 
health settings (i.e., clinicians not employed by the Kids FACE FEARS investigative team, and 
not working in anxiety specialty settings) serve as the treatment providers in the Kids FACE 
FEARS trial. These providers also provide stakeholder input and collaboration, along with 
clinical supervisors and clinic staff at the participating settings. Their participation and feedback 
helps the investigative team refine training and implementation efforts and contribute to an 
improved understanding of barriers and facilitators to implementing the treatment comparators 
in usual care settings. Therapists and clinical supervisors from across the four participating 
pediatric health networks will be trained by the study team to deliver best-practices CBT for 
youth anxiety. Clinicians and supervisors at the participating sites will engage in full-day training 
and then receive bi-weekly, small group consultation through videoconferencing calls led by a 
pediatric anxiety treatment expert (see Procedures) throughout the study. Therapists and 
clinical supervisors will provide quantitative and qualitative feedback about the training and 
consultation model and overall effectiveness via questionnaires about their CBT knowledge pre- 
and post-training, through quantitative ratings and qualitative feedback, questionnaires about 
their comfort with technology and the organizational climate of their professional setting, and 
through therapist session forms and posttreatment logs. Clinicians and supervisors provided 
further information about successes and challenges in delivering the CBT comparators during 
bi-monthly consultation calls led by an expert in child anxiety treatment. These calls will be used 
to clarify therapy skills, promote sustained learning and prevent drift, support therapists, and 
gain feedback from clinicians about their experiences implementing the treatment.  
Study Advisory Committee (SAC). The Study Advisory Committee (SAC) consists of 14 
nationally known researchers and other clinical professionals (e.g., psychiatrists, psychologists, 
pediatricians, clinical social workers, child health service researchers, primary care physicians, 
medical directors) committed to clinical research to improve access to evidence-based 
treatments for underserved youth. The SAC includes a scientific steering committee with 
considerable collective expertise in pediatric mental health, digital mental health, working with 
minoritized youth, leading large multisite randomized clinical trials, and overseeing prior PCORI-
funded projects. The SAC will meet roughly twice annually with the investigators via 
videoconferencing across the planning, recruitment, implementation, and analysis phases of the 
study. These meetings will afford a structured opportunity to provide external advisory support 

25 
 
and input on project design and implementation, as well as navigation of various challenges as 
they arise, including those introduced by the COVID-19 pandemic.  
Data Safety and Monitoring Board (DSMB). Data Safety and Monitoring Board (DSMB) 
members will have considerable collective experience in the conduct of clinical and 
developmental research with youth, the conduct of clinical trials, and working with diverse 
families. They will be involved to externally assess the protection of data and participant 
confidentiality, and help ensure the trial is conducted according to high scientific and ethical 
standards. The DSMB is responsible for safeguarding the interests of study participants, 
assessing the safety and efficacy of study procedures, and monitoring the overall conduct of the 
study. The DSMB will meet via videoconferencing about twice yearly to provide independent 
oversight of data management and integrity and participant safety.  DSMB members will include 
a clinical child psychologist with experience conducting federally funded clinical trials and 
experience serving on university Institutional Review Boards (IRB) and DSMBs, and a 
child/developmental psychologist with extensive experience conducting applied research with 
diverse families.  
 

26 
 
6 - Study Design 
6.1 General Design Overview 
The KFF trial is a multisite, pragmatic, randomized clinical trial (RCT) comparing the 
effectiveness of Therapist-Led CBT (telehealth, office-based, or hybrid) versus Guided Online 
CBT (with minimal therapist support) for the treatment of elevated youth anxiety identified in 
pediatric health care settings. Families are enrolled from high-volume, urban pediatric health 
care sites affiliated with major medical centers in four U.S. cities: Baltimore, MD, Boston, MA, 
Miami, FL, and Seattle, WA. Universal screening of English- and Spanish-speaking youth 
receiving primary or secondary pediatric health care in these hospital networks will identify 
potentially eligible youth with elevated anxiety who, if interested, are referred to behavioral 
health teams in their hospital system for potential study participation. Elevated youth anxiety is 
required for eligibility; to maximize generalizability a formal anxiety disorder diagnosis is not 
required. Eligible and interested families are randomly assigned to one of the two treatment 
comparators and given up to 20 weeks to complete their allocated treatment. All services and 
assessments are provided in English and in Spanish, as needed. Major assessments are 
conducted at baseline, midtreatment, posttreatment, and roughly one-year follow-up.  
To maximize generalizability, exclusion criteria are minimal compared to previous large-scale 
RCTs of youth anxiety treatment.34 To observe treatment comparators under natural 
circumstances in general pediatric health care settings, study treatment is incorporated into the 
natural flow of care at each participating site (e.g., clinical care is not funded by the study grant, 
research therapists are not being used, anxiety specialty clinics are not involved in clinical care). 
Natural therapists at the participating clinical settings will complete training led by youth anxiety 
treatment experts, and then participate in biweekly consultation calls.  
Institutional review boards (IRBs) at each participating site approved and oversaw the human 
subjects research aspects of the study, with Boston Medical Center’s IRB serving as the primary 
ethics review board for the trial. The trial is pre-registered (ClinicalTrials.gov ID: NCT03707158). 
6.1.1 Study Setting 
This multisite comparative effectiveness trial is being conducted at high-volume, urban pediatric 
health care sites affiliated with four major medical centers (Johns Hopkins Hospital in Baltimore 
MD, Boston Medical Center in Boston MA, Nicklaus Children’s Hospital in Miami FL, Seattle 
Children’s Hospital in Seattle WA). These sites were selected as clinical performance partners 
due to their roles in serving large numbers of diverse pediatric patients and providing a high 
volume of services in English and in Spanish, their collective representativeness of under-
resourced pediatric health settings that serve diverse populations from a range of 
socioeconomic backgrounds, and for the advantages offered in studying the treatment 
comparators in the context of academic hospital-community health center partnerships. For 

27 
 
example, Boston Medical Center is the largest safety net hospital in New England with a large 
affiliated network of community health centers. Nicklaus Children’s Hospital is home to the 
largest pediatric teaching program in the Southeastern United States and the majority of its 
patient population is Hispanic/Latine, reflecting the demographics of the South FL community.  
6.2 Outcomes 
6.2.1 Primary Outcome Variables. The primary clinical outcomes assessed in the Kids FACE 
FEARS trial are focused on anxiety symptoms, anxiety-related impairment, treatment responder 
status, anxiety remission status, and patient-centered outcomes focused on perceived 
effectiveness and treatment satisfaction. Specifically, these include: 
• 
Youth anxiety symptoms - measured via the PROMIS Pediatric Short Form Item Bank 
v2.0-Anxiety. The PROMIS pediatric self-report will be completed by children ages 8-18 
and parent proxy reports will be complete by guardians for all children. Only parent proxy 
reports will be collected for children under the age of 8. 
• 
Life interference - measured via the Child Anxiety Life Interference Scale; CALIS  
• 
Treatment Responder Status – measured via the Pediatric Anxiety Rating Scale; PARS 
• 
Family Perceived Effectiveness – measured via caregiver- and youth self-report 
• 
Treatment Satisfaction – measured via caregiver- and youth self-report 
6.2.2 Secondary and Exploratory Outcome Variables. Secondary clinical outcomes 
assessed in the Kids FACE FEARS trial focus on treatment engagement and barriers, broader 
youth psychopathology (i.e., internalizing problems, externalizing problems, and attention 
problems), youth sleep difficulties, caregiver internalizing symptoms (i.e., depression symptoms, 
anxiety symptoms, and stress symptoms), and therapist perceptions of treatment response. 
Specifically, these include: 
• 
Treatment engagement and barriers – measured via administrative logs, therapist 
reports, and family reports of: Attendance, Homework engagement,  Treatment 
completion, Child participatory engagement, Caregiver participatory engagement, 
Comprehension difficulties, Difficulties making time for treatment, Treatment discomfort, 
Technology treatment challenges, and Therapeutic alliance. 
• 
Youth internalizing problems - measured via the Pediatric Symptom Checklist; PSC-17 
• 
Youth externalizing problems - measured via the Pediatric Symptom Checklist; PSC-17 
• 
Youth attention problems - measured via the Pediatric Symptom Checklist; PSC-17 
• 
Youth sleep problems - measured via a sleep item generated for this study 
• 
Caregiver depression symptoms – measured via the Depression, Anxiety, Stress Scale; 
DASS-21 

28 
 
• 
Caregiver anxiety symptoms – measured via the Depression, Anxiety, Stress Scale; 
DASS-21 
• 
Caregiver stress symptoms – measured via the Depression, Anxiety, Stress Scale; 
DASS-21 
• 
Therapist-perceived effectiveness – measured via items generated for this study 
Other secondary outcomes incorporate a series of a moderator analyses to elucidate 
heterogeneity of treatment effects across formats among important subgroups of patients. On 
this front, we will examine: Patient characteristics, Family characteristics, Provider 
characteristics, and Organizational and system characteristics  
6.3 Study Population 
6.3.1 Number of Participants. Power analysis (accounting for an expected attrition and 
missing data) indicated we require 150 participants per group, for a total of 300 participants in 
the study.  
6.3.2 Eligibility Criteria. The study eligibility and inclusion, and exclusion criteria for families 
include: 
Inclusion/ Eligibility 
• 
Elevated child/adolescent anxiety - Operationalized as T-Score on the PROMIS 
Pediatric Short Form-Anxiety Scale v2.0 > 55 (Child eligible if either the Pediatric Self-
Report or the Parent Proxy Report score was > 55) 
• 
Child aged 7-18 years (inclusive) at time of screening 
• 
Child and caregiver(s) are fluent in English or Spanish 
• 
If taking medication for emotional problems, child must be on a stable dose 
(Operationalized as no adjustments to prescription for > 8 weeks)  
Exclusion Criteria 
• 
Severity requiring higher level of care, as defined by any of the following: 
o Suicidal thoughts or behaviors (STB) with active plan or STB(s) that required a 
higher level of care within the past 6 months (e.g., inpatient, partial hospitalization) 
o Anxiety-related absences > 50% of school days over the past month (If summer, 
attendance during last month of previous school year considered) 
o Substance use that required emergency services or inpatient/partial hospitalization 
within past 3 months 

29 
 
o Clinician determined child requires higher level of care than outpatient services 
• 
History of diagnosed autism spectrum disorder or intellectual disability with severe 
challenges and needs for support (e.g., complete absence of verbal communication 
unrelated to anxiety) 
• 
Currently engaged in CBT or planning to continue different therapy for anxiety during 
study treatment phase  
• 
Child is a ward of the state 
The decision to include families fluent in either English or Spanish was made to (a) improve the 
generalizability of trial findings, relative to existing research on the treatment of youth anxiety; 
(b) recruit a sample that would be more representative of the general U.S. population and the 
diverse range of anxious youth seen in clinical practice; and (c) provide treatment-related 
findings that would also be informative to the estimated 33.3% of mental health treatment 
facilities that provide services in Spanish.81 Currently, it is estimated that over 41 million people 
in the U.S. speak Spanish, and with migration patterns, this number is rising. Many single-site 
trials evaluating treatment for youth anxiety have offered intervention in English and in 
Spanish,50,82–85 but large multisite trials conducted to date on youth anxiety treatment have 
restricted eligibility to just English-speaking families. Accordingly, the Kids FACE FEARS trial 
offers a rare large-scale examination of treatment for pediatric anxiety that is more broadly 
generalizable to the >90% of U.S. households that speak either English or Spanish.  
Several factors informed the decision to not consider formal DSM or ICD diagnoses as part of 
study inclusion or exclusion. Eligibility criteria were intentionally relaxed relative to previous 
large-scale trialse.g.,34 to better approximate the full range of anxious youth in need of care. 
Inclusion criteria for this trial requires youth to have elevated anxiety levels, but does not require 
formal anxiety disorder diagnoses, given the high number of anxious individuals in need of care 
who miss diagnostic thresholds by DSM or ICD technicalities,86,87 especially in medical 
populations.88–90 Further, comorbid diagnoses do not preclude eligibility in the Kids FACE 
FEARS trial (as long as they do not acutely require a higher level of care such as inpatient or 
partial hospitalization), given research showing such requirements can exclude up to half of 
children seeking care from research trials.91 By relaxing eligibility criteria in these ways, the Kids 
FACE FEARS trial can be thought to generalize broadly to the common range of anxious youth 
and their families who typically present for care, rather than to just “pure” diagnostic groups of 
youth with anxiety disorders who are represented in narrower efficacy trials. The decision to not 
consider DSM or ICD diagnoses as part of study eligibility is consistent with concerns about the 
poor reliability and differentiation of pediatric anxiety disorder diagnoses,92–95 and associated 
trends in clinical science priorities moving away from formal diagnoses.96,97 Moreover, there is 
evidence that clinicians rarely use structured diagnostic interviews outside of research 
contexts,98 rendering findings based on structured diagnostic interviews poorly aligned for 
informing clinical practice. Finally, not including structured research-based diagnostic interviews 

30 
 
in the trial’s assessment protocol addresses the need to minimize participant burdens and 
assessment demands in a pragmatic effectiveness trial. Reducing the assessment time that is 
focused on diagnostic nuances also affords opportunity to instead assess several important 
factors that have previously been neglected in large-scale clinical trials for the treatment of child 
anxiety (e.g., adverse childhood events, experiences of discrimination, mental health stigma; 
see Measures, below). 
6.4 Therapist Participants 
 
Existing therapists from across the four participating pediatric health networks will participate. 
Therapists will be natural providers in the pediatric health settings participating in the trial (i.e., 
clinical staff not employed by the research trial and not working in anxiety specialty settings). 
We estimate around 50-60 therapists will participate in the study. They will consent to be in the 
study as participants before their on-site training for the Cool Kids Program. The study eligibility 
and inclusion criteria for therapists and program staff include: 
Inclusion/ Eligibility 
• 
Currently employed as therapist or staff at participating pediatric health care sites  
• 
Agreed to participate in study and collect data on their patient for study purposes 
Exclusion  
• 
Has not completed the Cool Kids program training 
 
 

31 
 
7 - Methods 
7.1 Participation Flow 
Figure 1 presents the study timeline for participating families. Following initial screening and 
consent, families complete baseline assessment (Week 0) and eligible participants are then 
randomized to one of the two treatment comparators. Participants are granted up to 20 weeks to 
complete their allocated treatment program. The decision to allow a 20-week treatment window 
was informed by PFAC and stakeholder input urging that an appropriate and realistic timeframe 
for treatment would be one that allows for periodic missed sessions, holiday breaks, health-
related cancellations, and attendance-interfering life events. All randomized families are invited 
to complete a midtreatment assessment once they complete half of their allocated treatment. 
Families who do not complete half of their allocated treatment by the end of the second month 
of their treatment phase are invited to complete a midtreatment assessment at Week 8. All 
randomized families are invited to complete a posttreatment assessment once they fully 
complete their allocated treatment program. Families who do not complete their allocated 
treatment program by the end of the fifth month of their treatment phase are invited to complete 
a posttreatment assessment at Week 20. All randomized families are invited to complete a 
follow-up assessment at Week 52.  
Figure 1. 
 
Note: Week numbers reflect target number of weeks since baseline that participants in the Kids FACE 
FEARS Trial will complete assessments at each timepoint. 
 
7.2 Description of Interventions/Comparators 
We are testing two delivery strategies of CBT for youth anxiety disorders. CBT is the “gold 
standard” for the treatment of anxiety and is currently used as the standard of care by therapists 
at all our participating sites. This research does not change the current standard of care used by 
our sites – it expands the mode used to deliver standard of care by providing therapists training 
on the evidence-based Cool Kids framework (i.e. a standardized version of CBT).  

32 
 
 
Specifically, the Kids FACE FEARS trial tested two CBT delivery strategies for pediatric anxiety: 
(1) Therapist-Led CBT (telehealth, office-based, or hybrid), and (2) Guided Online CBT (with 
minimal therapist support). 
Comparator 1: Therapist-Led CBT for Youth Anxiety (telehealth, office-based, or hybrid). 
An extensive body of controlled studies supports Therapist-Led CBT for anxious youth and their 
families, with therapist-led CBT conventionally considered a “gold standard” psychological 
treatment for anxious youth.31–34 Therapist-Led CBT has traditionally entailed office-based care 
in which a therapist directly trains youth (and often caregivers) in anxiety management skills 
then guides children in planning and participating in graded exposure tasks in which they 
approach increasingly feared situations. In the landmark Child/Adolescent Anxiety Multimodal 
Study (CAMS) trial, roughly 60% of youth treated with therapist-led CBT classified as “treatment 
responders” by masked IEs.34 In more recent years, telehealth formats of Therapist-Led CBT for 
youth anxiety have received considerable and comparable research support.47–50 
Although a number of established and highly overlapping Therapist-Led CBTs for youth anxiety 
exist, the well-supported Cool Kids CBT suite for youth anxiety99,100 was selected for several 
important reasons. First, Cool Kids includes all the “gold standard” CBT components for treating 
youth anxiety and has an extensive research base.101–103 Second, Cool Kids is a time-limited 
and relatively brief suite of treatment programs delivered across roughly 3 months, which 
accommodated the PFAC and stakeholder advisor suggestion for relatively short-term 
treatment. Third, the Cool Kids suite of treatment programs comprehensively includes 
developmentally tailored versions for the full age range of youth included in the study (7-18 
years). Fourth, the Cool Kids treatment suite has a documented history of successful 
implementation when rolled out on large-scale levels.103,104 Fifth, a parallel self-administered 
online version of Cool Kids teaches youth the same anxiety management skills as the therapist-
led version, and in a roughly comparable number of sessions/modules, thus allowing for well-
matched and time-equitable comparisons. And finally, the Cool Kids therapist-led and online 
treatment programs are all available in English and in Spanish.  
The standard Therapist-Led Cool Kids Therapy for Anxiety (ages 7-12)99 is a structured, 
evidence-based, 10-session program for treating youth anxiety in middle childhood and entails 
ten 50-minute weekly sessions with children and families. Therapists teach youth and 
caregivers core CBT components including anxiety psychoeducation, cognitive/coping skills for 
thinking more realistically and adaptively, problem-solving skills, and graded exposures to 
anxiety provoking situations. Caregivers and youth are taught skills for managing anxiety and for 
reducing avoidant behaviors. Caregivers are included in all sessions (adjusted developmentally) 
and are taught parenting skills plus personal anxiety management. The program is supported by 

33 
 
a structured therapist manual and with developmentally tailored child and parent workbooks. 
Cool Kids is available in many languages, including English and Spanish, and has been 
adapted slightly for different age groups. The Therapist-Led Chilled Therapy for Anxiety (ages 
13-18 years) is an adolescent version of Cool Kids and includes a workbook geared specifically 
for adolescents; in this version teens take a more central role in managing their anxiety, and 
caregivers do not participate in all of the sessions. This version also includes ten sessions. 
Comparator 2: Guided Online CBT for Youth Anxiety (With Minimal Therapist Support). 
To expand the accessibility and reach of CBT for anxious youth, a suite of self-paced, online, 
multimedia, CBT-based programs for youth anxiety was developed to run parallel to the 
therapist-led Cool Kids program. This online suite of programs covers identical content in a 
largely self-administered format. Similar to Therapist-Led Cool Kids, the Cool Kids Online suite 
of programs is comprised of separate developmentally tailored online programs, two of which 
were used in the present trial, depending on the age of the child: (1) “Cool Kids Online” for ages 
7-12 years, and (2) “Chilled Out” for youth ages 13-18. 54,105,106 These programs consist of 8 
modules that are to be completed on a roughly weekly basis allowing for well-matched and time-
equitable comparisons to the Therapist-Led CBT comparator. The online programs have 
already been used in numerous countries and are available in multiple languages, including 
Spanish. The programs include the same core CBT components as the Therapist-Led Cool Kids 
programs, feature interactive, engaging formats, and include video and audio clip examples of 
how to implement skills. In Cool Kids Online, caregivers take on the role of their child’s coach, 
helping them put their skills into practice, and learn helpful ways of responding to their child’s 
anxiety. In the Chilled Out adolescent online version, the teen takes primary responsibility for 
program completion, and there are features designed to specifically increase teen 
engagement—e.g., there are real teens featured in the videos, teens demonstrate skills for 
managing anxiety, and there is a “playlist” menu where teens can choose to re-visit content and 
cover skills at their own pace. The programs were originally developed in Australia. For both 
Cool Kids Online and Chilled Out, “Americanized” versions of the programs were used that 
include videos with diverse representation (e.g., American children, families, and experts; 
broader representation of individuals of color; removed Australian accents or vernacular).  
To foster supportive accountability and engagement,67,68 families in this condition receive brief 
phone check-in calls (i.e., < 15 minutes) from a therapist every other week. To ensure these 
brief calls do not drift into treatment sessions, therapists work from a conversation guideline to 
standardize calls (with space for flexibility as appropriate). Therapists should begin each check-
in call with an explanation of the purpose of the call—i.e., to see how their use of the online 
modules is going, to find out whether the child/teen/caregiver has any questions, to support the 
family with the program, and to make a plan for continued practice. Therapists then check in 
briefly about each of the following components: (a) engagement with online program and activity 
completion (“Were you able to log into the online program? If not, what got in the way?”); (b) 

34 
 
identification of current difficulties/barriers, including technical or motivational challenges (“Did 
anything get in the way of completing activities or practice? Did you experience any difficulties 
as a parent with respect to your child/teen’s anxiety management?”); (c) brainstorming possible 
solutions to identified barriers (“Let’s see if we can problem-solve together and come up with 
some solutions to help you complete materials this week”); (d) review of anxiety and caregiver 
progress (“Has your/your child’s level of anxiety changed since beginning the program?); (e) 
technical questions about content (“Do you have any specific questions about the material that 
you learned in the modules you completed?”); (f) assignment/plan for next two weeks, providing 
encouragement and praise for even small successes; and (g) confirmation of the next call.   
Of note, the comparators included across the two treatment delivery strategies cover identical 
therapeutic content, although the therapist-led CBT program entails slightly more sessions than 
there are modules in the self-administered CBT program in order to afford opportunities for 
alliance building. At the same time, participants in the self-administered online CBT program are 
able to revisit various modules multiple times. It is believed that the additional number of 
sessions in the therapist-led CBT program is roughly offset by the opportunity for those in the 
self-administered CBT program to revisit modules multiple times. In addition to the two 
comparators offering identical therapeutic content, participants across the two delivery 
strategies will be given the identical amount of time (i.e., up to 20 weeks) within which to 
complete their course of treatment, further ensuring equipoise across comparators. 
7.3 Implementation of Cool Kids CBT in Pediatric Health Settings 
In order to analyze component 1 of the study, therapists, program staff, and research assistants 
will be asked to complete assessments about organizational factors that serve as barriers or 
facilitators to implementing the comparators in the real-world context of pediatric primary care 
and pediatric health settings. Study personnel will have a team meeting with site staff to 
introduce them to the study and their roles as researchers and participants in the study. 
Therapists and program staff will be sent consent forms along with their pre-training 
assessments prior to their on-site Cool Kids CBT training. By completing the pre-training 
assessments, therapists are indicating that they have read the consent form, that all of their 
questions have been answered, and that they voluntarily agree to participate the study. 
Research staff will track which staff were sent consent forms and completed pre-training 
assessments, and will follow up individually with clinic staff as needed to ensure enrollment into 
the study before the site training day. 
7.4 Evaluating Therapist-Led Cool Kids (office-based or telehealth) vs. Self-
Administered Web-based CBT for Child Anxiety 
Once therapists at sites are trained in delivering therapist-led Cool Kids CBT, all patients 
screened positive for elevated anxiety can be offered Cool Kids CBT as standard treatment at 

35 
 
the discretion of their therapist. Those who screen positive for elevated anxiety and choose to 
enroll in the study will be randomized to receive either the therapist-led Cool Kids (telehealth, 
office-based, or hybrid) CBT, or the guided online Cool Kids CBT. Participants in the study will 
be asked to complete assessments throughout their treatment and post-treatment for the 
purposes of this study. Short-term and longer-term outcomes will be analyzed in both arms to 
compare both forms of delivering CBT. 
7.5 Method of Assignment/Randomization 
Participants will be randomized by family. If the participant will be completing the program and 
enrolling in the study without parental involvement, they will be randomized individually. Each 
patient/family will receive a unique study ID at the time of referral to the study that is not 
connected to identifiable data. Before randomization, the referred patient/family will complete 
the following enrollment procedures: (1) each referred patient will complete a clinical intake at 
their referral site with a therapist, (2) each referred patient/ family with complete an assessment 
to determine eligibility for the study, (3) each referred patient/family will give study staff consent 
to participate in the study, (4) the participants will complete baseline assessment, and (5) the 
participants will complete the PARS assessment  
Once a participant/family gives consent to enroll in the study, they will be provided with a unique 
ID number and this ID number will be connected to their identifiable data (access to identifiable 
data will be limited). The clinical intake can happen before or after consent is received, but the 
baseline assessment and PARS assessment must be completed after the patient gives consent 
to enroll in the study. Once all four steps of enrollment (consent, clinical intake, baseline 
assessment, and PARS) are completed, the participant/family will be randomized. 
Anticipated participants were divided into 16 strata based on the 16 combinations of 4 regions 
(Boston, Miami, Baltimore, Seattle), 2 languages (English, Spanish), and 2 age groups (7-12, 
13-18). For each strata, a randomized list of conditions (therapist-led treatment versus guided 
online treatment) was generated at Sealed Envelope using random blocks of size 4. Random 
blocks help maintain equally sized treatment groups while also reducing bias in random 
assignment by making it more difficult for researchers to (deliberately or not) predict the next 
condition. Random assignment lists have been archived with the Data Management team and 
with Dr. Coxe. 
Randomization assignments are made centrally at the FIU data coordination site. Once a 
participating family’s baseline assessments are completed (see Measures), the randomization 
assignment software is programmed to send an automated push notification revealing their 
assigned condition simultaneously to the FIU data management team (for data recording 
purposes) and to the research coordinators and clinical team at the participant’s site (to orient 
the family to their assigned treatment condition). 

36 
 
Each site will create their own workflow for recruitment procedures and submit this to the lead 
site. Sites will also report their standard of care procedures for delivering the therapist-led 
program – whether it will be office-based, via telehealth, or a hybrid.  
Because of the nature of the intervention, we will not be able to mask study participants, 
therapists, and RAs from treatment assignment. However, research staff who will be 
administering the PARS assessment will be masked to study condition. 
7.6 Measures 
All measures and interviews are to be available and administered in English or Spanish, 
depending on participant preference. Consistent with a recommended multi-informant 
assessment strategy, 112,113 measurement of outcomes includes caregiver-report questionnaires, 
youth-report questionnaires, therapist-report questionnaires, ratings of independent evaluators 
masked to each family’s treatment condition, and administrative logs. To maximize 
generalizability and rigor while minimizing patient and clinic burdens, priority has been placed 
on supported measures that are brief and available free-of-cost in the public domain. Moreover, 
consistent with growing recognition that supported clinical interventions are intended to impact a 
range of domains of functioning (rather than a single narrow domain),114,115 a set of outcomes 
were included to consider multiple aspects of treatment response, including symptom severity, 
impairment, and more patient-centered factors like perceived effectiveness, treatment 
satisfaction, and treatment engagement.  
Although attempts should be made to collect data from both caregivers and youth across 
assessment points for all families, to minimize participant burdens and maximize engagement, 
only caregiver-reports are required to randomize children ages 7-12 years, and only youth self-
reports are required to randomize adolescents ages 13-18 years. Furthermore, 7-year-old 
participants are not to be administered self-report questionnaires, due to concerns about the 
reliability and validity of self-reports of anxiety in children this age voiced by the trial’s patient 
and family advisory council and scientific advisory panel, and corroborated by scientific 
literature. 116–118 Such youth should be administered self-report forms at later assessment points 
if they turn 8 during the trial. In addition, although youth self-reports of primary and secondary 
clinical outcomes are to be administered to all youth > 8 years, a subset of youth self-report 
variables will only be administered to youth > 13 years given: (a) recommendations from the 
trial’s patient and family advisory council and the scientific advisory panel to minimize the 
assessment burdens outside of clinical outcomes for participating children < 12 years, and (b) 
concerns from these advisory groups about younger children’s abilities to accurately self-report 
on some of these variables (e.g., their own treatment histories, family treatment barriers; details 
below).  

37 
 
Measures included in the Kids FACE FEARS trial can be sorted into four groups: (i) Primary 
Clinical Outcomes. (ii) Secondary Clinical Outcomes; (iii) Treatment Variables; and (iv) Study 
Covariates, Predictors and Other Included Measures.  
7.6.1 Primary clinical outcomes. Primary clinical outcomes assessed in the Kids FACE 
FEARS trial focused on anxiety symptoms, anxiety-related impairment, treatment responder 
status, anxiety remission status, and patient-centered outcomes focused on perceived 
effectiveness and treatment satisfaction. Table 3 presents a summary of the primary clinical 
outcomes assessed, which are described in detail below.  

38 
 
Table 3. Primary Clinical Outcomes in the Kids FACE FEARS Trial 
Domain 
Measure 
Informant(s) 
Assessment Point 
Baseline 
Midtreatment 
Posttreatment 
1-Year Follow-
Up 
Youth Anxiety Symptoms 
PROMIS Pediatric Short Form-Anxiety (8a 
v2.0) 
C, Y 
X 
X 
X 
X 
Anxiety-Related Impairment 
Child Anxiety Life Interference Scale (CALIS) 
C, Y 
X 
X 
X 
X 
Treatment Responder Status 
 
 
 
 
 
 
PARS Treatment Responder 
Pediatric Anxiety Rating Scale (PARS) 
IE 
X 
 
X 
 
Primary Patient-Centered Outcomes 
 
 
 
 
 
 
Family-Perceived Effectiveness 
Perceived Effectiveness Scale 
C 
 
 
X 
X 
Family-Perceived Treatment 
Response 
Clinical Global Impression Scale-
Improvement (CGI) 
C, Y 
 
X 
X 
X 
Treatment Satisfaction 
Satisfaction Scale 
CS, Y 
 
X 
X 
 
Note: Kids FACE FEARS= Kids Formats of Anxiety Care Effectiveness study For Extending the Acceptability and Reach of Services; C = 
Caregiver Report of Child; CS = Caregiver Self-Report; Y = Youth Self-Report (administered to youth > 8 years); IE = Independent Evaluator 
Report (masked to treatment condition) 
 

39 
 
Anxiety symptoms. The PROMIS Pediatric Short Form-Anxiety Scale (8a v2.0) is being used to 
assess youth anxiety severity across time. Caregiver-reports will be collected via the parent-
proxy form, and youth self-reports will be collected via the pediatric form for youth ages > 8 
years. Across psychometric studies, the measure has exhibited strong reliability, structure, and 
validity in the measurement of youth anxiety severity.72–75 The PROMIS Pediatric Short Form-
Anxiety Scale is also free, brief (8 items), and publicly accessible, which minimizes patient and 
clinic burdens and positions the measure for use in under-resourced settings and other typical 
care settings.72 Raw total scores are converted to T-scores normed for age and sex.  
Anxiety-related impairment. The Child Anxiety Life Interference Scale (CALIS)119 is a measure 
of life interference and impairment associated with youth anxiety problems. Items are each rated 
on a five-point Likert-style scale (0= not at all, 4 = a great deal), and are summed to generate a 
total interference score. Parent and youth > 8 years will complete separate CALIS forms to offer 
distinct accounts of caregiver-reported and youth self-reported anxiety-related life impairment. 
The parent form consists of 16 items (scoring range: 0-64) and the youth form consists of 9 
items (scoring range: 0-36) The CALIS parent and youth forms have exhibited strong 
psychometric properties in previous research.119,120 
Treatment responder status. The Pediatric Anxiety Rating Scale (PARS)79 will be used to 
independently evaluate clinical significance across the treatment conditions and to benchmark 
study findings against previously conducted RCTs on youth anxiety.34 The PARS is a well-
supported, clinician-rated instrument for assessing the frequency and severity of anxiety 
symptoms associated with common anxiety disorders in children between the ages of 6 and 17 
years.79,121 It consists of a 50-item symptom checklist followed by seven global items each rated 
on a six-point (0-5) scale. Six of the global items are summed to generate a PARS Total Score 
(range: 0-30). PARS Total Score reductions of 35% or more from baseline to posttreatment are 
interpreted as reflecting “PARS Treatment Response.”121 For the present study, Independent 
Evaluators (IEs) masked to treatment condition conducted PARS interviews at baseline and at 
posttreatment with caregivers and youths together and then generated scores based on the 
pooled information. 
Primary patient-centered outcomes. To assess Caregiver-Perceived Effectiveness, caregivers 
will be asked on a 7-point scale at midtreatment and again at posttreatment “How effective do 
you think the program [has been/was] in treating your child's anxiety?” [0=very ineffective; 
3=somewhat effective; 6=very effective]. In addition, caregivers and youth  > 8 years will 
complete a patient-adapted version of the Clinical Global Impression-Improvement Scale (CGI-
I)122 to characterize their judgement of treatment-related improvement, relative to the child’s 
baseline presentation. Consistent with the standard version of the CGI-I, scores of 1 (“very 
much improved”) or 2 (“much improved”) will be interpreted as reflecting “Caregiver-Perceived 
Treatment Response” (for caregiver-report) or “Youth-Perceived Treatment Response” (for 

40 
 
youth self-report). The caregiver- and youth-report versions of the CGI-I will be administered at 
midtreatment, posttreatment, and follow-up. 
To assess Treatment Satisfaction, caregivers and youth > 8 years will be administered a 
Satisfaction Scale that has them rate three items along 0-3 rating scales at midtreatment and 
again at posttreatment: “Overall, how satisfied [have you been/were you] with the services that 
[your family/you] received?” [0=quite dissatisfied; 3=very satisfied]; “Would you recommend this 
program to a friend if they [had a child with/had] anxiety?” [0=no, definitely not; 3=yes, 
definitely]; and “How pleased [have you been/were you] with how this program has helped [your 
child/you] with anxiety” [0=quite displeased; 3=very pleased]. These three items will be 
averaged for each informant to generate Caregiver Total Satisfaction Scores and Youth Total 
Satisfaction Scores. For dichotomous interpretation, mean scores >2 will be interpreted as 
“Satisfied” and mean scores <2 will be interpreted as “Dissatisfied.”  
7.6.2 Secondary clinical outcomes. Secondary clinical outcomes assessed in the Kids 
FACE FEARS trial focus on broader youth psychopathology (i.e., internalizing problems, 
externalizing problems, and attention problems), youth sleep difficulties, caregiver internalizing 
symptoms (i.e., depression symptoms, anxiety symptoms, and stress symptoms), and therapist 
perceptions of treatment response. Table 4 presents a summary of the Secondary Clinical 
Outcomes assessed, which are described in detail below.  

41 
 
 
 
Table 4. Secondary Clinical Outcomes in the Kids FACE FEARS Trial 
Domain 
Measure 
Informant(s) 
Assessment Point 
Baseline 
After Each 
Session 
Midtreatment 
Posttreatment 
1-Year Follow-Up 
Broader Youth Psychopathology 
 
 
 
 
 
 
 
Internalizing problems 
Pediatric Symptom Checklist (PSC-17) 
C, Y 
X 
 
X 
X 
X 
Externalizing problems 
Pediatric Symptom Checklist (PSC-17) 
C, Y 
X 
 
X 
X 
X 
Attention problems 
Pediatric Symptom Checklist (PSC-17) 
C, Y 
X 
 
X 
X 
X 
Youth Sleep Difficulties 
Sleep Item 
C, Y 
X 
 
X 
X 
X 
Caregiver Internalizing Symptoms 
 
 
 
 
 
 
 
Depression symptoms 
Depression, Anxiety, Stress Scale 
(DASS-21) 
CS 
X 
 
X 
X 
X 
Anxiety symptoms 
Depression, Anxiety, Stress Scale 
(DASS-21) 
CS 
X 
 
X 
X 
X 
Stress symptoms 
Depression, Anxiety, Stress Scale 
(DASS-21) 
CS 
X 
 
X 
X 
X 
Therapist Perceptions of Treatment 
Response 
 
 
 
 
 
 
 
Therapist-Perceived Effectiveness 
Perceived Effectiveness Scale 
T 
 
 
 
X 
 

42 
 
Therapist-Perceived Improvement 
Clinical Global Impression Scale-
Improvement  
T 
 
X 
 
X 
 
Note: Kids FACE FEARS= Kids Formats of Anxiety Care Effectiveness study For Extending the Acceptability and Reach of Services; C = 
Caregiver Report of Child; CS = Caregiver Self-Report; Y = Youth Self-Report (administered to youth > 8 years); T = Therapist Report 

43 
 
 
Broader youth psychopathology. The Pediatric Symptom Checklist (PSC-17)76 is a brief 
questionnaire developed to identify child and adolescent emotional and behavioral challenges in 
pediatric and primary care settings. The measure has exhibited strong validity and reliability in 
psychometric analyses across diverse samples of youth.123–125 PSC-17 subscales separately 
assess internalizing problems, externalizing problems, and attention problems. For the present 
study, caregivers and youth > 8 years will complete separate PSC reports, and all three 
subscales will be included. 
Youth sleep difficulties. Caregivers will be asked to rate on a 5-point scale the frequency with 
which the following statement applies to their child: “In the past 7 days, my child has been 
having sleep-related difficulties (for example, difficulty falling asleep or sleeping through the 
night)” [0=never; 2=sometimes; 4=always]. Youth > 8 years will be similarly asked to rate on a 
5-point scale the frequency with which the following statement applies to them: “In the past 7 
days, I have been having sleep-related difficulties (for example, difficulty falling asleep or 
sleeping through the night)” [0=never; 2=sometimes; 4=always]. 
Caregiver internalizing symptoms. The Depression, Anxiety, and Stress Scales (DASS-21)126,127 
is an adult self-report of negative emotional states that has demonstrated strong psychometric 
properties.127,128 Respondents rate their experiences across 21 items using a 4-point 
severity/frequency scale ranging from 0 (never) to 3 (always). DASS-21 subscales separately 
assess symptoms of depression, anxiety, and stress. All three subscales were used in the 
present study. 
Therapist perceptions of treatment response. To assess Therapist-Perceived Effectiveness, 
therapists will be asked on a 7-point scale at posttreatment: “How effective do you think the 
program was for treating this child?” [0=very ineffective; 3=somewhat effective; 6=very 
effective]. In addition, after each treatment session (for Therapist-Led CBT cases) or check-in 
call session (for Guided Online CBT cases), therapists will complete the CGI-I122,129 to 
characterize their session-by-session judgement of the extent of treatment-related improvement, 
relative to the child’s baseline presentation. Therapists will again complete a CGI-I at 
posttreatment. 
7.6.3 Treatment variables. Treatment variables assessed in the Kids FACE FEARS trial 
focus on treatment preferences and expectancies, the scope and content of each session and 
check-in call, treatment fit and flexibility, treatment engagement and barriers, and therapeutic 
alliance. Table 5 presents a summary of the treatment variables assessed, which are described 
in detail below.  

44 
 
Table 5. Treatment Variables in the Kids FACE FEARS Trial 
Domain 
Measure 
Informant(s) 
Assessment Point 
Baseline 
After First 
Session
After Each 
Session
Midtreatment 
Posttreatment 
Treatment Preferences and Expectancies 
 
 
 
 
 
 
 
Treatment Preference 
Treatment Preferences & Expectancies Survey 
CS, Y 
X 
 
 
 
 
Anticipated Treatment Comfort 
Treatment Preferences & Expectancies Survey 
CS, Y 
X 
 
 
 
 
Anticipated Treatment Comprehension 
Difficulties 
Treatment Preferences & Expectancies Survey 
CS, Y 
X 
 
 
 
 
Anticipated Treatment Scheduling Difficulties 
Treatment Preferences & Expectancies Survey 
CS, Y 
X 
 
 
 
 
Therapist-Anticipated Treatment Effectiveness  
Early Treatment Expectations Form 
T 
 
X 
 
 
 
Therapist-Anticipated Participatory 
Engagement 
Early Treatment Expectations Form 
T 
 
X 
 
 
 
Therapist-Anticipated Therapeutic Alliance 
Early Treatment Expectations Form 
T 
 
X 
 
 
 
Therapist Case-Specific Self-Efficacy 
Early Treatment Expectations Form 
T 
 
X 
 
 
 
Scope and content of treatment sessions/check-in 
calls 
Session Summary Form 
T 
 
 
X 
 
 
Treatment Fit and Flexibility 
Session Summary Form 
T 
 
 
X 
 
 
Treatment Engagement and Barriers 
 
 
 
 
 
 
 
Attendance 
Administrative Data 
A 
 
 
X 
 
 
Homework engagement 
Session Summary Form 
T 
 
 
X 
 
 

45 
 
Treatment completion 
Administrative Data 
T 
 
 
 
 
X 
Child participatory engagement 
Session Summary Form 
T 
 
 
X 
 
 
Caregiver participatory engagement 
Session Summary Form 
T 
 
 
X 
 
 
Comprehension difficulties 
Treatment Barriers Survey 
CS, Y 
 
 
 
X 
X 
Difficulties making time for treatment 
Treatment Barriers Survey 
CS, Y 
 
 
 
X 
X 
Treatment discomfort 
Treatment Barriers Survey 
CS, Y 
 
 
 
X 
X 
Technology treatment challenges (family 
report) 
Technological Experiences And Reactions Scale 
CS, Y 
 
 
 
X 
X 
Technology treatment challenges (therapist 
report) 
Technological Experiences And Reactions Scale 
T 
 
 
X 
 
 
Therapeutic alliance (family report) 
Perceptions of Therapeutic Alliance Scale 
C/CS, 
Y 
 
 
 
X 
X 
Therapeutic alliance (therapist report) 
Perceptions of Therapeutic Alliance Scale 
T 
 
 
 
 
X 
Note: Kids FACE FEARS= Kids Formats of Anxiety Care Effectiveness study For Extending the Acceptability and Reach of Services; C = 
Caregiver Report of Child; CS = Caregiver Self-Report; Y = Youth Self-Report (administered to youth > 13 years); T = Therapist Report; A = 
Administrative Data

46 
 
Treatment preferences and expectancies. Prior to randomization, caregivers and youth > 13 
years will each complete a Treatment Preferences and Expectancies Survey designed for the 
present study. Respondents will indicate whether they would prefer to receive Therapist-Led 
CBT (coded: 0) or Guided Online CBT (coded: 2), or whether they have no preference between 
the two conditions (coded: 1) [Treatment Preference]. Respondents will also rate each of the 
two treatments on Anticipated Treatment Comfort, Anticipated Treatment Comprehension 
Difficulties, and Anticipated Treatment Scheduling Difficulties on 0-6 scales.  
Data will also be collected on therapist’s early treatment expectations for each family. 
Specifically, after the first clinical encounter with an assigned family (i.e., first session for 
Therapist-Led CBT families; first check-in call for Guided Online CBT families), therapists will 
complete an Early Treatment Expectations Form developed for the present study. This form has 
therapists indicate their level of agreement with the following item on a scale from 0 (very 
ineffective) to 6 (very effective): “Thinking about the treatment course ahead, how effective do 
you think the child’s assigned treatment condition will be in treating this child’s anxiety?” 
(anticipated treatment effectiveness). To measure therapist’s Anticipated Effectiveness of the 
Non-Assigned Treatment, therapists will also use the same scale to indicate their level of 
agreement with the following statement: “If instead of [Therapist-Led CBT/Guided Online CBT], 
this family had been assigned to Guided Online CBT/Therapist-Led CBT], how effective do you 
think that treatment would be in treating this child’s anxiety?” (Anticipated Effectiveness of Non-
Assigned Treatment). 
The Early Treatment Expectations Form will also assess therapists’ early expectations about 
treatment engagement for each family. Specifically, after their first clinical encounter with an 
assigned family, therapists will be asked to respond to the following items, along a scale from 0 
(to a small extent) to 4 (to a very great extent): “Thinking about the treatment course ahead, to 
what extent do you expect this child will actively participate in their assigned course of 
treatment?” (Anticipated Child Participatory Engagement); and “Thinking about the treatment 
course ahead, to what extent do you expect this child’s caregiver(s) will actively participate in 
their assigned course of treatment?” (Anticipated Caregiver Participatory Engagement). 
Furthermore, the Early Treatment Expectations Form also assesses therapists’ early 
expectations about treatment alliance for each family. Specifically, after their first clinical 
encounter with an assigned family, therapists will be asked to respond to the following items, 
along a scale from 0 (never) to 6 (always): “Across treatment, I think this child and I will work 
well together” (Anticipated Therapist-Child Collaboration); and “Across treatment, I think this 
child’s caregiver(s) and I will work well together” (Anticipated Therapist-Caregiver 
Collaboration). Therapists will also use the same scale to rate the extent to which they predict 
they will enjoy working with the child (Anticipated Therapist-Child Bond); the extent to which 
they predict the child will enjoy working with them (Anticipated Child-Therapist Bond); the extent 

47 
 
to which they predict they will enjoy working with the child’s caregiver(s) (Anticipated Therapist-
Caregiver Bond); and the extent to which they predict the child’s caregiver(s) will enjoy working 
with them (Anticipated Caregiver Therapist Bond). 
Finally, the Early Treatment Expectations Form will be used to assess Therapist Case-Specific 
Self-Efficacy with regard to implementing the assigned treatment. Specifically, after their first 
encounter with a family, depending on the family’s treatment assignment, the therapist will be 
asked to rate how well they predict they will be able to conduct [Therapist-Led CBT/Guided 
Online CBT], along a 0 (very limited) to 4 (very high) scale. 
Scope and content of treatment sessions and check-in calls. After each treatment session (for 
Therapist-Led CBT cases) or check-in call session (for Guided Online CBT cases), therapists 
will complete a Session Summary Form that was developed for the present study. On this form, 
therapists will indicate who participated in the session (e.g., youth, caregiver, other), the 
language in which the session was held (English, Spanish, or both), whether the session began 
on time (and if not, how late it began), the length of the session, and the format of the session 
(e.g., in-office, phone, videoconference). Therapists in each condition will also check off all of 
the content and topics that were covered in the session they just held, from a list of options: 
psychoeducation; detective/realistic thinking; fear hierarchies; future exposure practice; in- 
session exposure practice; rewards and reinforcement; parenting issues related to youth 
anxiety; additional coping skills (e.g., problem-solving, social skills, assertiveness, relaxation 
techniques); non-CBT strategies (e.g., interpreting the meaning of symptoms, interpreting the 
meaning of child’s play or artwork); discussion of issues not directly related to anxiety (e.g., 
major family transitions, conflicts other than co-occurring non-anxiety problems); review of 
previous homework; assignment of new homework; and/or addressing barriers to 
treatment/homework. For Therapist-Led CBT cases, therapists will also indicate the session 
number(s) in the protocol that were covered in that session. 
Treatment fit and flexibility. As part of the Session Summary Form completed by the therapist 
after each treatment session (for Therapist-Led CBT cases) or check-in call session (for Guided 
Online CBT cases), therapists will indicate their level of agreement with the following statement 
on a scale from 0 (not at all) to 6 (extensively): “To what extent was the content covered this 
[session/check-in call] a fit to this child’s clinical presentation and individual needs?” To assess 
needs for treatment flexibility, therapists will also indicate after each session their level of 
agreement with the following statement on a scale from 0 (not at all) to 6 (extensively): “How 
much did you need to tailor or adapt the content or structure of this session because of the 
child’s clinical presentation and individual needs?” Moreover, as part of the Session Summary 
Form, therapists will select the reason(s) they may have covered content outside of the 
treatment protocol in the session they just held from a list of options (if relevant): (a) had to 
address a clinical emergency that made them concerned about immediate safety, (b) needed to 

48 
 
address a topic of the week that did not directly relate to the focus of the treatment protocol 
(e.g., family conflict, school trouble), (c) had to address a co-occurring/co-presenting issue other 
than child anxiety (e.g., ADHD, medical problem), (d) needed to engage in an alliance-building 
activity, (e) needed to address treatment resistance, (f) other (describe). 
Treatment engagement and barriers. Therapists will complete weekly logs reporting whether 
study families on their caseloads attended their scheduled sessions or support calls and 
whether they completed the homework assigned in their previous session or support call. These 
data will be used to characterize Treatment Attendance and Homework Engagement. Treatment 
Completion is defined for Therapist-Led CBT as attending 10 treatment sessions, and for 
Guided Online CBT Care as attending 4 support calls. For Guided Online CBT families, 
administrative backend data will also be collected from the central server to further assess 
user/usage analytics.   
To assess session-by-session participatory engagement, as part of the Session Summary Form 
completed by the therapist after each treatment session (for Therapist-Led CBT cases) or 
check-in call session (for Guided Online CBT cases), therapists will indicate their level of 
agreement with the following statement on a scale from 0 (not at all) to 6 (extensively): “To what 
extent did you feel that this child was engaged in today’s [session/check-in call]. For example, 
did the child appear motivated and committed to improving, and was the child actively 
participating in the [session/call]” (Child Participatory Engagement). When appropriate, a 
parallel item will be asked of therapists regarding the caregiver’s engagement in that session 
(Caregiver Participatory Engagement). At posttreatment, therapists will respond to modified 
versions of these items to report on participatory engagement across the entire course of 
treatment. 
To assess Comprehension Difficulties, caregivers and youth > 13 years across both conditions 
will be asked at midtreatment and again at posttreatment “How hard has the intervention been 
for [your family/you] to understand?” [0=never hard; 3=sometimes hard; 6=very hard]. To 
assess Difficulties Making Time for Treatment caregivers and youth > 13 years will be asked at 
midtreatment and again at posttreatment “How hard has it been for [your family/you] to [make 
your schedule work for treatment sessions/find time to work on and complete the computer-
based treatment modules online]?” [0=never a problem; 3=sometimes a problem; 6=often a 
problem].  To assess Treatment Discomfort, caregivers and youth > 13 years will be asked at 
midtreatment and again at posttreatment “How comfortable [has your family/have you] felt when 
[attending treatment sessions/completing the computer-based treatment modules online]?” 
[0=very comfortable; 3=sometimes comfortable; 6=very uncomfortable].   
The Technological Experiences And Reactions Scale (TEARS)130 will be administered to 
specifically assess Technology-Based Treatment Challenges. The TEARS is a brief 

49 
 
questionnaire that measures disruptions and patient frustrations with telehealth sessions and 
digital mental health. Psychometric research has demonstrated the reliability and validity of the 
measure. At midtreatment and again at posttreatment, Therapist-Led CBT participants (most of 
which completed sessions via telehealth) and Guided Online CBT participants will use the 
TEARS to rate the extent to which technology issues and time spent addressing technology-
related issues took away from the quality of the intervention, frustrated them, and/or interfered 
with treatment understanding. For families in either condition, therapists will also complete the 
therapist-report TEARS at the conclusion of each session/check-in call and again at 
posttreatment. In addition to the TEARS, therapists and families will report basic information on 
how families were logging in and engaging with the treatment, and the devices they were using. 
Therapeutic alliance. A caregiver Perceptions of Therapeutic Alliance Scale will aske caregivers 
at midtreatment and again at posttreatment to respond to the following items, along a scale from 
0 (never) to 6 (always): “I think the therapist and I [work/worked] well together to help with my 
child’s anxiety” (Caregiver-Therapist Collaboration); “I feel like I [like/liked] the therapist” 
(Caregiver-Therapist Bond); “I feel like the therapist [likes/liked] me” (Therapist-Caregiver 
Bond); “I feel like my child [likes/liked] the therapist” (Child-Therapist Bond); and “I feel like the 
therapist [likes/liked] my child” (Therapist-Child Bond).  
A youth Perceptions of Therapeutic Alliance Scale will ask youth > 13 years at midtreatment 
and again at posttreatment to respond to the following items, along a scale from 0 (never) to 6 
(always): “I think the therapist and I [work/worked] well together to help with my anxiety” (Child-
Therapist Collaboration); “I feel like I [like/liked] the therapist” (Child-Therapist bond); and “I feel 
like the therapist [likes/liked] me” (Therapist-Child Bond). 
A Therapist Perceptions of Therapeutic Alliance Scale will ask therapists at posttreatment to 
respond to the following items, along a scale from 0 (never) to 6 (always): “Looking back on 
treatment, I think this child and I worked well together to help with their anxiety” (Child-Therapist 
Collaboration); “Looking back on treatment, I feel like I liked this child” (Therapist-Child Bond); 
and “Looking back on treatment, I feel like I liked the child’s caregivers” (Therapist-Caregiver 
Bond). 
7.6.4 Study covariates, predictors and other included measures. A number of study 
covariates, predictors, and other included measures will be assessed in the Kids FACE FEARS 
trial. These measures focus on demographic information, youth health and education, adverse 
childhood experiences, experiences with discrimination, mental health stigma, caregiver beliefs 
about youth anxiety and overprotection, technological literacy, openness to technology-based 
supports, therapist attitudes and knowledge about youth anxiety and treatment, therapist self-
efficacy, and organizational climate of the treatment setting. Table 6 presents a summary of 

50 
 
these Study Covariates, Predictors, and Other Included Measures (which are described in 
detail, below). 

51 
 
Table 6. Covariates, Predictors, and Other Variables Assessed in the Kids FACE FEARS Trial 
 
Domain 
Measure 
Informant(s) 
Assessment Point 
Baseline 
Midtreatment 
Posttreatment 
1-Year Follow-Up 
Demographic information 
Demographics and Background Form 
C/CS, Ya 
X 
 
 
 
Youth health and Education 
Demographics and Background Form 
C, Ya 
X 
 
 
 
Adverse Childhood Experiences 
CYW ACE-Q; Expanded ACE-Q 
C, Yb 
X 
X 
X 
X 
Experiences with Discrimination 
Everyday Discrimination Scale (EDS)-Short 
Version 
CS, Ya 
X 
 
 
 
Mental Health Stigma 
Parental Attitudes Toward Psychological Services 
Inventory—Stigmatization Scale 
CS 
X 
 
 
 
Beliefs about Youth Anxiety & 
Overprotection 
Parental Attitudes, Beliefs, and Understanding of 
Anxiety (PABUA)—Overprotection Scale 
CS 
X 
X 
X 
X 
Technological Literacy 
Technological Ease and Computer Habits 
Inventory (TECHI) 
CS, Yb, T 
X 
 
 
 
Openness to Technology-Based Supports 
Beliefs and Attitudes about Technology as a Child 
Health Resource (BATCH-R) 
CS 
X 
 
X 
 
Therapist Attitudes and Knowledge 
 
 
 
 
 
 
About evidence-based treatments 
Evidence-Based Practice Attitudes Scale (EBPAS) 
T 
Xc,d 
 
 
 
About exposure therapy 
Therapist Beliefs about Exposure Therapy Scale 
(TBES) 
T 
Xc,d 
 
 
 

52 
 
About child anxiety and CBT 
Knowledge Test 
T 
Xc,d 
 
 
 
Therapist Self-Efficacy  
 
 
 
 
 
 
CBT/Anxiety Self-Efficacy 
Therapist Self-Efficacy Scale-CBT for Youth 
Anxiety 
T 
Xc,d 
 
 
 
Common Factors Self-Efficacy 
Therapist Self-Efficacy Scale-CBT for Youth 
Anxiety 
T 
Xc 
 
 
 
Patient Responsivity Self-Efficacy 
Therapist Self-Efficacy Scale-CBT for Youth 
Anxiety 
T 
Xc 
 
 
 
Organizational Climate of Treatment 
Setting 
 
 
 
 
 
 
Adequacy of Resources 
TCU Organizational Readiness for Change Scale 
T 
Xc 
 
 
 
Organizational Climate 
TCU Organizational Readiness for Change Scale 
T 
Xc 
 
 
 
Note: Kids FACE FEARS= Kids Formats of Anxiety Care Effectiveness study For Extending the Acceptability and Reach of Services; C = 
Caregiver Report of Child; CS = Caregiver Self-Report; Y = Youth Self-Report 
a  Administered to youth > 11 years 
b  Administered to youth > 13 years 
c  Measure administered to therapists prior their onboarding and training 
d  Measure administered again to therapists after their training 
 
 

 
 
 
Demographic information. Caregivers and youth > 11 years will provide data on caregiver 
and youth age, gender, race, ethnicity, nativity (U.S.- or foreign-born), family and household 
living structure, languages spoken, and language(s) preference, among a number of other 
demographic pieces of information. Caregivers will also provide information on their child’s 
grade level, as well as their own highest level of education and literacy comfort. Families will 
be classified as experiencing baseline resource insecurity if the caregiver indicates at 
baseline that the family experienced any of the following circumstances over the prior 12 
months: (a) unhoused or living in a shelter; (b) unable to pay the rent or mortgage on time; 
(c) the food they purchased did not last and they did not have money to get more; (d) there 
was concern their food would run out before they got money to buy more; and/or (e) the gas 
or electric company threatened to shut off or refuse gas or electricity to their residence for 
not paying bills. 
Youth health and education. Caregivers will provide information on the child’s 
developmental history, medical history, previously diagnosed mental health problems, 
mental health treatment history, academic performance and attendance, and school 
accommodations. 
Adverse childhood experiences. The Center for Youth Wellness (CYW) Adverse Childhood 
Experiences Questionnaire (CYW ACE-Q)131 will be used to assess stressful life 
experiences that can impact child adjustment and development. From a list of 19 specific 
adversities, caregivers and youth > 13 years will each report on the total number of 
challenging circumstances that participating children and adolescents have endured or 
encountered. This list includes 10 items from the original conceptualization of adverse 
childhood experiences (e.g., physical, emotion, and sexual abuse; physical and emotional 
neglect; household dysfunction; living with family members who misuse substances; living 
with family members with mental illness), as well as a broadened set of 9 additional 
experiences that can similarly cause prolonged stress that were not included in the original 
ACES conceptualization (e.g., death of a caregiver, exposure to neighborhood violence; 
immigration- or deportation-related separation from caregiver; identity-based discrimination; 
abuse or threats from a romantic partner). Two more additional items were also added to 
assess whether the child had directly experienced a natural disaster (e.g., earthquake, 
tornado, wildfire, hurricane) or a manmade disaster (e.g., terrorist attack, mass shooting, 
plane crash, industrial fire/explosion, bridge collapse). Respondents will review the list of 
items, tally the number of these experiences that the child has endured, and report that total 
number. Accordingly, the quantity of experienced ACES will be assessed, but information 
will not be collected for the research record that clarifies which specific ACES were 
experienced by the child. Per guidelines for the CYW ACE-Q, scores between 1 and 3 
indicate “moderate exposure” to ACES and scores > 4 are considered “high” and indicate 
“considerable exposure” to ACES. 

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Experiences with discrimination. The Everyday Discrimination Scale-Short Version (EDS)132 
will be used to measure the frequency with which youth and caregivers are subjected to 
routine experiences of unfair treatment. The EDS Short Version is a briefer 5-item 
adaptation of the original 9-item EDS133 that has been found to show strong reliability and 
reliability. Respondents indicate how often they experience situations such as being treated 
with less respect than other people, having people act afraid of them, having people act as if 
they are not smart, and being threatened or harassed. The frequency of each item is rated 
on a scale ranging from 0 (never) to 5 (almost everyday). For responses > 2, follow-up 
questions ask respondents to indicate what they think is the main reason for these 
experiences (e.g., their ancestry, gender, race, age, religion, weight, sexual orientation, 
education or income level). The scale has been used extensively in the mental health field.  
Higher scores represent more incidences of everyday discrimination as compared to lower 
scores. 
Mental health stigma. The Parental Attitudes Toward Psychological Services Inventory 
(PATPSI)134 Stigmatization scale will be administered to assess the extent to which 
caregivers are concerned about how others negatively perceive people who have emotional 
or behavioral health challenges or who seek psychological services. Using a scale ranging 
from 0 (strongly disagree) to 5 (strongly agree), respondents will rate their level of 
agreement with eight items (e.g., “I would not want others to know if my child had a 
psychological or behavioral problem”; “Having been mentally ill carries with it feelings of 
shame”). The measure has exhibited strong psychometric properties, including a sound 
factor structure and great reliability and validity.134 
Caregiver beliefs about youth anxiety and overprotection. The Parental Attitudes, Beliefs, 
and Understanding of Anxiety (PABUA) – Overprotection Scale135 is a supported self-report 
measure that evaluates caregiver attitudes and beliefs about their child’s anxiety, and the 
extent to which they believe they must protect their child from anxiety and distress. Items 
assess caregiver beliefs about appropriate levels of autonomy-granting, whether caregivers 
believe they should let their anxious child avoid anxiety-provoking situations, and issues of 
general enmeshment in the caregiver-child relationship. Psychometric research has found 
the measure and scale to exhibit strong convergent validity, divergent validity, and internal 
consistency.135   
Technological literacy. Caregiver and youth technological literacy at baseline will be 
assessed via the Technological Ease and Computer Habits Inventory (TECHI)136 which 
consists of 17 items assessing the extent/frequency of technological usage in everyday life, 
as well as competency and patience with technology. Items are rated on 0-5 scales, and the 
TECHI Total Score ranges from 0-85 (with higher scores indicating greater technological 
usage, competency, and patience). The TECHI has demonstrated strong psychometric 

Study: Kids FACE FEARS  
 
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properties for measuring technological literacy in the context of technology-based mental 
health treatment.136 
To assess therapist technological literacy going into the project, therapists will also complete 
the TECHI prior to full onboarding and training for the trial. 
Openness to technology-based supports. The Beliefs and Attitudes about Technology as a 
Child Health Resource (BATCH-R)137 is a brief supported self-report that assesses caregiver 
attitudes (e.g., comfort, trust) toward technology’s role in mental health supports and 
services, parenting information and resources, and professional guidance. The Openness to 
Technology-Based Mental Health Supports and Treatment scale has caregivers rate from 0 
(strongly disagree) to 5 (strongly agree) their level of agreement with eight items (e.g., 
“Online computer-based mental health programs can be helpful for treating childhood 
anxiety”; “I am open to seeking out information online about my child’s health and 
development”; “I trust the information I receive online about parenting”). The measure has 
exhibited strong psychometric properties, including a sound factor structure and great 
reliability and validity.137 
Therapist attitudes toward evidence-based treatments. The Evidence-Based Practice 
Attitudes Scale (EBPAS)138 assesses mental health provider attitudes toward evidence-
based practices and adopting new interventions. Fifteen EBPAS items assess the extent to 
which the therapist: (a) would adopt a new practice if it made sense and was used by 
trusted colleagues (Appeal subscale); (b) would adopt a new practice if it was required by 
their agency (Requirements subscale), (c) is open to trying new treatments (Openness 
subscale), and (d) believes research-based interventions are not clinically useful 
(Divergence subscale). Respondents rate their agreement with items on a scale from 0 (not 
at all) to 4 (to a great extent), resulting in four subscale scores and an EBPAS Total Score 
reflecting overall positive disposition toward adopting evidence-based treatments and 
protocols. Therapists will complete the EBPAS prior to completing their training, and again 
after completing training. 
Therapist openness to exposure therapy. The Therapist Beliefs about Exposure Therapy 
Scale (TBES)139 is a therapist self-report questionnaire that measures negative attitudes 
they may hold about exposure therapy (e.g., “Compared to other psychotherapies, exposure 
therapy leads to higher dropout rates”). Respondents rate their agreement with each of 21 
beliefs about exposure therapy along a 5-point scale (0=disagree strongly; 4=agree 
strongly). Items are summed, resulting in a TBES Total Score (range: 0-84), with higher 
scores reflecting more negative views of exposure therapy. Therapists will complete the 
TBES prior to completing their training and again after completing training. 

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Therapist knowledge about child anxiety and CBT. An 8-item Knowledge Test was created 
to assess therapists’ familiarity with basic research findings about child anxiety (e.g., fear is 
a natural emotion; physical sensations of anxiety cannot harm a child; differences between 
fear and anxiety) and its evidence-based treatment (e.g., the three-component model of 
CBT; the value of exposures). Therapists will complete this knowledge test prior to 
completing their training and again after completing training.  
Therapist self-efficacy. Therapists will complete the Therapist Self-Efficacy Scale-CBT for 
Anxiety in Youth (TSES-CAY),140 a 16-item survey that measures the extent to which 
therapists perceive they are capable of competently conducting CBT for youth anxiety. Items 
from a therapist self-efficacy scale for the treatment of adult depression141 were adapted to 
assess therapist perceptions of their abilities treating anxiety in children and adolescents. 
TSES-CAY factor analysis has identified a three-factor structure: (a) CBT/Anxiety-Specific 
Self-Efficacy (which measures perceived ability to conceptualize client problems using the 
CBT model, maintain the structure of CBT, teach CBT skills, putting anxious patients in 
anxiety-provoking situations, and instruct patients to practice skills outside of session); (b) 
Common Factors Self-Efficacy (which measures perceived ability to build therapeutic 
alliance, empathize with children/families, etc); and (c) Patient Responsivity Self-Efficacy 
(which measures perceived ability to adapt to patient/family needs, work collaboratively with 
patients/families, and address treatment barriers as they arise). Therapists will complete all 
three scales of the TSES-CAY prior to completing their training. After completing their 
training, therapists will again complete the TSES-CAY CBT/Anxiety-Specific Self-Efficacy 
scale.  
Organizational climate of treatment setting. The Texas Christian Association Organizational 
Readiness for Change scale (TCU ORC)142 will be used to assess organizational attributes 
and motivational factors of the clinical settings participating in the trial that can impact the 
overall success of treatment implementation. Prior to training and onboarding for the trial, 
therapists, supervisors, administrative directors, and staff across the clinics participating in 
the trial will complete the TCU ORC subscales that assess Adequacy of Resources 
(including Offices, Staffing, Training, Equipment, Internet, and Supervision) and 
Organizational Climate (including Mission, Cohesion, Autonomy, Communication, Stress, 
and Change). The TCU ORC has exhibited strong psychometric properties, and observed 
ORC subscale scores can be compared for interpretation against 25th percentile scores, 50th 
percentile scores, and 75th percentile scores reported from national data.143   
7.7 Therapist Training and Ongoing Consultation 
Existing therapists and clinical supervisors from across the four participating pediatric health 
networks will be trained by the study team to deliver CBT for youth anxiety. Consistent with 
best practices for promoting quality implementation of evidence-based treatment,107–110 a 

Study: Kids FACE FEARS  
 
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multi-component strategy is to be used that involves training workshops for therapists and 
supervisors, followed by asynchronous online resources and ongoing small group 
consultation of therapists and supervisors. The same therapists are to participate in care 
across both treatment comparators. 
7.7.1 Training workshop. Prior to treating patients on the Kids FACE FEARS trial, 
therapists and supervisors will participate in one full-day (8 hour) training or two half-day (4-
hour) trainings. These trainings will be led by members of the Training, Fidelity and 
Sustainability Core (e.g., Dr. Donna Pincus, Dr. Alyssa Farley, Dr. Jami Furr, Dr. Kelsey 
Hudson, Dr. Rachel Merson, and Annie Dantowitz, LICSW). Those attending these trainings 
should be natural providers and supervisors in the pediatric health settings participating in 
the trial (i.e., clinical staff not employed by the research trial and not working in anxiety 
specialty settings). Trainings can be provided in-person or on Zoom. All clinicians and 
supervisors will be provided with a full set of Cool Kids treatment workbooks prior to the start 
of the training. Trainings will incorporate didactic components and active teaching 
approaches (e.g., live role-plays, demonstrations of core skills, small break-out groups, 
interactive video presentations, opportunities for therapists to actively practice using specific 
CBT skills to treat child anxiety).  
Trainings are to start with an introduction to the trial, followed by: (a) overviews of the core 
principles of CBT for youth anxiety, (b) detailed, step-by-step instructions in how to deliver 
the core skills in the Cool Kids and Chilled therapy protocols (e.g., psychoeducation, 
cognitive restructuring, exposure, and parenting anxious behaviors), and (c) additional 
coping skills such as problem solving, social skills building, and progressive muscle 
relaxation. Therapists and supervisors are taught about the adaptive and unhelpful aspects 
of anxiety, factors that maintain youth anxiety, and evidence-based strategies for offsetting 
these factors. Trainings will also emphasize the importance of caregiver involvement in 
treatment (as appropriate, and when feasible), between-session practice, and treatment 
fidelity within flexibility.69,111 Moreover, therapists and supervisors will be provided guidance 
on addressing common treatment barriers, such as lack of between-session practice or poor 
treatment attendance, and how to problem-solve and support families through various 
challenges that can emerge during treatment. 
These trainings will also include a demonstration of the guided online programs (including 
illustrative video clips and how to log in and access the online materials) and will incorporate 
direct instruction on how to conduct check-in calls for the guided online treatment condition. 
Therapists and supervisors will be provided with a check-in call conversation 
guidelines/scripts to follow (see description of Comparator 2, above), and will be taught how 
to navigate common questions. 

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After each training, therapists and supervisors will complete post-training knowledge 
quizzes. Any therapist who scores <80% on the post-training knowledge quiz will receive 
individualized follow-up training and support, and will then be retested with an alternate form 
of the knowledge quiz, and will be required to meet the 80% training criterion prior to treating 
patients in the study.  
7.7.2 Asynchronous online resources. After each training, therapists and supervisors will 
be provided resources to support their delivery of the treatment comparators, including 
session outlines, training recordings and booster supports as needed. In response to 
requests from therapists and supervisors, a website with helpful resources has been 
developed to further support therapists as they implement treatment. This website includes 
treatment demonstration videos, treatment module summaries, and therapist training slides. 
A guided refresher course was created and is included on the website that includes audio 
and video training demonstration videos and interactive training activities.  
7.7.3 Consultation and support. Providers (therapists and supervisors) at the study 
performance sites will participate in regularly held group consultation videoconferencing 
calls led by experts in the treatment of pediatric anxiety. These consultation calls will be held 
in addition to any routine supervision that may be naturally afforded to providers in their local 
hospital or clinical network.   
All participants who attend a training workshop will be assigned to a recurring consultation 
call group. Therapist consultation calls will be held biweekly (i.e., twice monthly). These calls 
are designed to support therapists on the project, to prevent therapist drift, and to afford 
education and scaffolding to providers. Approximately 4-6 therapists are to be assigned to 
each call group. The remote format enables consultation call groups to contain a mix of 
therapists from across study sites and regions. Calls will each be one hour, and will be used 
to clarify and role-play therapy skills, to answer any questions about the two treatment 
formats, and to support therapists as they implemente the treatments. Site supervisors will 
also participate in a separate, once-monthly supervisor group consultation call, also led by 
an expert in pediatric anxiety treatment. 
Each consultation call will be structured to formally review a specific rotating skill or topic, 
including: psychoeducation, fear hierarchies and exposures, cognitive strategies, cultural 
considerations, parenting factors, check-in calls, homework compliance, general coping 
skills, treatment flexibility, COVID-related anxiety, school anxiety, developmental 
considerations, and technology-related issues. Each call will also include a “Therapist 
Spotlight,” in which a rotating therapist will have an opportunity to receive more 
individualized attention and in-depth consultation about one of their patients. These 
Therapist Spotlights give call leaders the opportunity to clarify and correct any potential 

Study: Kids FACE FEARS  
 
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problems with treatment delivery, and to provide individualized follow-up training and 
support to therapists as needed. Therapist spotlights also provide opportunities for 
therapists to provide peer input to one another and to learn from one another’s experience 
and perspectives.  
7.8 Safety, Reaction Management, and Clinical Deterioration 
All study participants will be working with trained therapists who can assist participants if 
they were to become upset. If a participant becomes upset during the process of being 
interviewed and/or while completing assessment measures with an RA (Research 
Assistant), the RA will ask if the participant/ family would like to check-in with their doctor or 
one of the clinicians with behavioral health training at the site. Participants will also be 
provided with the phone numbers of their site research staff who they can contact if they 
become upset while completing the assessments online. The research staff will connect 
them with an available clinician in these situations. The study facility will be appropriate to 
children, as these facilities will be pediatric healthcare sites. We will make sure that all 
psycho-educational materials, treatment plans are written in a straightforward manner, at the 
appropriate literacy level. We will use translators/language line as needed to further ensure 
guardians fully understand study procedures and communicate concerns about their child's 
care.  
As all site staff and the investigators are mandated reporters, families will be informed that 
any disclosure of abuse, risk to a child or elder will need to be reported to the appropriate 
state protection agency. Endorsement of suicidality, risk to self or others will require 
emergency evaluation for safety and disposition by the clinical staff and RAs will have a 
contact at each site for reporting such disclosures and to activate the clinical protocol for 
these types of events. RAs will also contact the study PIs and report the event to the lead 
site and for inclusion in reports to the DSMB. 
7.8.1 Safety policy 
The study intervention does not pose an additional risk to pregnant women and so pregnant 
women (guardians or youth participants) can be enrolled in the study. 
Therapist concern for patient mental health severity and/or safety: 
If the child’s therapist has concerns over the safety of the child or their current severity of 
illness, the therapist will report their concerns to the site clinical supervisor and a decision 
regarding the needed level of care (e.g., inpatient, acute care) will be made based on a 

Study: Kids FACE FEARS  
 
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clinical determination.  The team will then report this to the study PIs to discuss if the child 
should be removed from the study. 
Research assistant concern for patient mental health severity and/or safety:  
If the PROMIS Short Form for Anxiety shows an increase of 5 points on the T-score metric 
at an assessment point (or the equivalent of 0.5 standard deviation which is a clinically 
meaningful difference) (Norman, Sloan, & Wyrwich, 2003), the local RA will notify the 
participant’s therapist. Their therapist will discuss with the clinical supervisor and site PI if 
the participant should be removed from the study and referred to a different model of care or 
level of treatment.  
If the DASS-21 completed by guardians shows severe or extremely severe in any dimension 
of the assessment (depression, anxiety, stress) or if the guardian marks a score of 2 or 3 on 
item 21 (“I feel that life is meaningless”) at an assessment point, the RA will notify the 
family’s therapist (Lovibond & Lovibond, 1995). Their therapist will discuss the appropriate 
course of action with the site supervisor for clinical determination to ensure the safety and 
well-being of the child and guardian. The clinical team will again discuss with the PI if family 
should be removed from the study. 
Examples of situations where family/ child may need to be removed from the study include: 
emergence of a psychotic disorder, need for prolonged residential placement, youth 
detention, suicidal behavior, parental/ guardian psychiatric hospitalization. Clinical decision 
making will be the first principle for addressing family treatment needs for any worsening 
mental health severity, safety and functioning.  
REDCap will automatically send an email to the local RA at each site whenever a score is 
flagged on either measures.  
Telehealth and Zoom Videoconferencing 
In order to protect patients during pandemics, such as COVID-19, patients and participants 
will have to option to complete study visits via Zoom Video Communications software. This 
will be provided as an option for study visits/ procedures including consent procedures, 
PARS baseline assessments, and technical orientation. Zoom Video Communications is a 
remote conferencing services company that provides remote conferencing services, that 
combines video conferencing, screen sharing services, online meetings, chat, and mobile 
collaboration, with both audio and video communication options. Participants can use zoom 
via their phone, computer, or tablet/Ipad. Study visits will not be recorded. 

Study: Kids FACE FEARS  
 
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If the participant’s preference is for videoconference, the RA will send the participant a link 
to a Zoom meeting, along with a link to the Zoom Privacy Policy. The RA will also send 
instructions on how to use Zoom, including guidance on best practices for sharing as little 
personal information with Zoom as possible. These best practices will be: (1) suggesting 
that the participant only enter their first name instead of their full name, and (2) if they don’t 
want to give their email, that they should feel free to use 
name@noemail.com<mailto:name@noemail.com> as their email address. The link to join 
the Zoom meeting with only be accessible by the RA conducting the visit and the patient or 
participant. The RA will complete the video conference in a private room, and the meeting 
will not be recorded. If a participant is not comfortable with using the Zoom software, they 
will always have the option to call-in to the meeting via phone, or meet in-person. 
7.8.2 Removal of Participants. All instances of study dropout will be documented using a 
Premature Termination form on REDCap including the reason for dropout, who decided that 
the participant would drop out (i.e., parent or guardian, therapist, study staff, adolescent 
patient), and whether the dropout resulted from burden of intervention, study assessment, or 
both. Withdrawn participants will be encouraged to continue to participate in study 
assessments throughout the 1-year follow-up period in order to optimize the intention-to-
treat assessment design. Participants may withdraw voluntarily at any time for any reason. 
There are two types of participant withdrawal: “treatment withdrawal” and “study withdrawal.”   
1. Treatment withdrawal is when a participant drops out of treatment (either because 
they are no longer interested or because a clinician or study investigator feels that 
treatment is no longer appropriate), but still provides the research team with 
posttreatment data by completing assessments at post treatment and Week 52.   
2. Study withdrawal is when a participant (or a provider on behalf of the participant) 
explicitly communicates that they are no longer interested in being a part of the study 
at all – including future assessments and compensation. Cases of “treatment 
withdrawal” are not automatically considered to be “study withdrawal” unless the 
participant specifically states that they never want to be contacted again by the 
study, or if a clinician or study investigator deems that any future contact would be 
inappropriate.   
Participants may be removed if: 
• 
If the participant’s provider or therapists feels the study is negatively impacting the 
participant’s health or wellbeing resulting in increasing severity of illness that is 
clinical assessed as such by the therapist/ provider team. Such cases will be 

Study: Kids FACE FEARS  
 
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assessed clinically, and an appropriate treatment plan will be determined and then 
discussed with the PI for determination of whether patient should be removed from 
study.  
• 
If there is an increase in the participant’s anxiety levels based on the PROMIS 
Pediatric Short Form for Anxiety and or other worsening of mental health status that 
leads to change in the treatment plan/ level of care determination by clinical team. 
• 
If the participant becomes suicidal and presents with clinically determined safety risk 
to self or others. 
If staff or therapists participating in the study leave the participating clinical site, they will be 
asked to complete 1 follow up assessment before leaving. Once they leave employment at 
the site, they will be removed from the study.  
7.8.3 Data Safety Monitoring Plan. The study PIs, Donna Pincus and Jonathan Comer, will 
be responsible for monitoring the study and will do so in the following way:  
(1) They will continuously assess protection of data and participant confidentiality. If any 
breach in the protection of participant data is identified or breach of confidentiality, it 
will be reported as an adverse event to the lead site and be assessed to determine if 
the event relates to the study and requires any protocol changes or study-wide 
action to ensure the protection of patient data.  
(2) They will meet with site PIs on a monthly basis to review study progress and elicit 
any concerns. They will be charged with minimizing any risk involved with 
participation, monitoring the risks and benefits during implementation of the project 
on a timely basis, and ensuring that the research is conducted according to high 
scientific and ethical standards.  
The principal investigators will also report the findings to the PCORI program staff. PCORI 
will be informed of any actions taken by the IRB as a result of their continuing review. 
In addition, a Data Safety and Monitoring Board (DSMB) will meet twice annually to 
provide independent oversight of data management and integrity, and participant safety. 
Data Safety and Monitoring Board Co-Chairs: Martha Tompson, PhD is Associate 
Professor of Psychology at Boston University and Director of the Family Development and 
Treatment Program; she is a renowned expert in the family-based treatment of pediatric 
mood and anxiety problems, and has extensive experience leading randomized clinical 
trials. Shannon Pruden, PhD is Professor of Psychology at Florida International University 
and a leading expert on child development and individual differences. The Co-Chairs will 

Study: Kids FACE FEARS  
 
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meet twice annually to independently review and evaluate study data for participant safety, 
study conduct, progress, and efficacy, and make recommendations for modifications if 
needed. 
7.8.4 Adverse Events Definition and Reporting. Potential Adverse events are defined as 
potential physical, emotional, legal or financial risk. We do not foresee any physical, legal, or 
financial risk for any of the study participants. 
The following definitions will be used in the assessment of safety: 
Adverse Event (AE) is any abnormal or harmful behaviors, increasing severity of symptoms 
that are identified by the therapist, suicidal behaviors or attempts, breach in the protection of 
participant data or breach of confidentiality whether or not considered related to the 
participants’ participation in the research.  
Serious Adverse Event (SAE) is any adverse event that  
(1) results in death; 
(2) is life-threatening; 
(3) results in inpatient hospitalization or prolongation of existing hospitalization; 
(4) results in a persistent or significant disability/incapacity; 
(5) based upon appropriate medical judgment, may jeopardize the participant’s health 
and well-being and requires hospitalization, other mental health or medical 
stabilization, child protection services or other higher level of care. 
Life-threatening means that the event places the participant at immediate risk of death from 
the event as it occurred.  
Unanticipated Problem is defined as an event, experience or outcome that meets all three 
of the following criteria:  
• is unexpected; AND 
• is related or possibly related to participation in the research; AND 
• suggests that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized.  
Possibly related means there is a reasonable possibility that the incident, experience, or 
outcome may have been caused by the procedures involved in the research. 

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Unexpected means the nature, severity, or frequency of the event is not consistent with 
either: 
• 
the known or foreseeable risk of adverse events associated with the procedures 
involved in the research that are described in (a) the protocol–related documents, 
such as the IRB-approved research protocol, any applicable investigator brochure, 
and the current IRB-approved informed consent document, and (b) other relevant 
sources of information, such as product labeling and package inserts; or 
• 
the expected natural progression of any underlying disease, disorder, or condition of 
the participant(s) experiencing the adverse event and the participant’s predisposing 
risk factor profile for the adverse event. 
7.8.5 Adverse Event Reporting Plan 
 
Reporting Adverse Events to IRB: 
If adverse events arise; 
1. Study staff will inform their site PI and document the adverse event using an adverse 
event form and adverse event log (provided by lead site).  
2. The site PI will determine if the adverse event meets the definition of a serious 
adverse event or an unanticipated problem, or only meets the criteria of an adverse 
event.  
3. The site PI will report the event to their institution's IRB per their institution’s 
guidelines for reporting.  
At BMC, adverse events that are not unanticipated problems will be reported at the time of 
continuing review by the IRB. No other adverse events/serious adverse events are 
anticipated — any that arise and meet the definition of an unanticipated problem will be 
reported to the IRB within two business days of learning of the event if it is life-threatening. 
Other unanticipated problems will be reported within 7 days. 
 
Reporting Adverse Event to Lead Site (BMC): 
All adverse events must be reported to the lead site using an adverse event form. 
For all adverse events, 

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1. The adverse event form and log should be emailed to the study PIs (Drs. Comer and 
Pincus) and the lead site manager at least 2 days prior to the biweekly study PIs 
meeting (which will include all site PIs). 
2. Site PIs must disclose adverse events at the biweekly meeting for the purposes of 
informing all site PIs and discussing any potential trends that need to be addressed 
across the study. 
3. The lead site will review all adverse events on a monthly basis to identify if any 
adverse event needs to be re-defined as a serious adverse event or unanticipated 
problem based on study-wide data and assess if any actions need to be taken as a 
result. 
If the event meets the definition of a serious adverse event, an adverse event form should 
be emailed to the study PIs (Drs. Comer and Pincus) and the lead site manager within 2 
business days. 
If the event meets the definition of an unanticipated problem, an adverse event form 
should be emailed to the study PIs (Drs. Comer and Pincus) and the lead site manager 
within 24 hours. 
7.9 Screening for Anxiety and Study Enrollment 
All participating primary and secondary pediatric care clinics use either the 8-item PROMIS 
Anxiety Short Form v272–75, the Pediatric Symptom Checklist (PSC-17),76 Generalized 
Anxiety Disorder (GAD-7),77 and/or the Patient Health Questionnaire (PHQ-9)78 to initially 
screen for elevated anxiety in their patients. These screenings are part of standard practice 
at the participating sites. Sites will not be required to receive consent to screen because the 
screen is part of standard of care at either the primary care or behavioral health level. For 
clinics only using the PHQ-9 (which provides a depression score) for initial screening of 
potential internalizing problems, elevations are to be followed-up with administration of a 
validated anxiety assessment. These screenings are part of their standard practice so every 
child is screened for anxiety related symptoms at every visit. Youth in participating primary 
and secondary pediatric care settings who show elevated anxiety scores are referred to 
integrated or co-located behavioral health teams in their hospital for information about the 
Kids FACE FEARS trial. Families at the participating primary and secondary pediatric care 
clinics who voice concerns about youth anxiety (regardless of screener scores) are also to 
be referred to integrated or co-located behavioral health teams in their hospital for 
information about the trial and potential eligibility evaluation. All sites have the option to refer 
patients to the study directly.  HIPAA waivers have been secured to access (but not store) 
screening data for the purposes of identifying and contacting potential study participants. 
Such referral and permission are documented through each pediatric health setting’s 
internal mechanism(s) for referring families to ancillary services and case management. The 

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overall goal is to align referral and consent as closely as possible with existing workflows to 
reduce staff/family burden and to support sustainability. Primary and secondary pediatric 
care providers and staff should be educated about the study to increase project awareness 
and facilitate referrals. Sites are not required to receive consent to screen because 
screening is part of standard care. When a family is referred to the study, a Kids FACE 
FEARS staff member contacts them to inform them about the study, answer any questions, 
review eligibility (see Eligibility), and enroll them if interested and eligible. Once the patient is 
referred to a behavioral clinician, the clinician will use the 8-item PROMIS Anxiety Short 
Form v2 as a secondary screening measure as part of standard practice. 
Research staff at some sites will also routinely review behavioral health and psychiatric 
clinic referral queues in the electronic medical record (a list of patients referred to behavioral 
health/psychiatry by providers at primary care and affiliated pediatric practices) to check for 
referrals to anxiety treatment. The research staff at sites will follow up with the patient’s 
referring providers, or clinical staff responsible for reviewing and triaging referrals, to provide 
more information about the study and request permission to follow up directly with patients 
about the study. Once permission is received, staff should follow the same screening 
procedures outlined under the “direct referral” pathway in the MOP.  
Different sites may have varying referral mechanisms. However, all sites will obtain 
permission from the guardian or 18-year-old, or their clinical provider, prior to contacting 
study staff about the eligible child. 
A positive PROMIS 8a Anxiety v2 Short Form screen is defined as a T-score above 55 
which is: 
A raw score of 17 or above on the pediatric parent proxy  
Or 
A raw score of 19 or above on the pediatric self-report 
A positive screen using the PSC-17 is defined as: 
An internalizing score of 5 or above  
Or 
Responding to item 15 (“worries a lot”) with “sometimes” or “often” 
Participant recruitment will be very closely monitored on a monthly basis. If the enrollment 
and randomization rate across the study falls short for any consecutive two-month period 
(i.e., <90% of the targeted goal for each two-month period) investigators will evaluate the 
underperformance, and may shift allocation of funds as necessary to sites that are meeting 

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recruitment numbers to ensure milestones are met. 
7.10 Enrollment 
 
7.10.1. Eligibility Determination 
Below are the steps completed for each participant before they are deemed eligible for the 
study: 
1. The participant is identified as potentially eligible (step 1 of eligibility) by clinician or 
through standard of care screening (refer to Section “Screening for Anxiety and 
Study Enrollment”). 
2. The participant is invited to participate in the study by their pediatric clinician and 
referred to the study. 
3. The local RA reaches out to the participant to initiate consent and enrollment 
procedures. 
4. The local RA completes the eligibility assessment screening form on REDCap to 
determine if they meet inclusion criteria and do not meet any exclusion criteria (step 
2 of eligibility). 
5. The participant completes their baseline assessment and has their final eligibility 
screening (step 3 of eligibility). 
6. The participant is deemed eligible. 
There are 3 steps for screening in this study to confirm eligibility: 
 
Eligibility 1 – Standard of Care 
 
Screening in pediatric health site for potentially eligible patients: 
The screening procedure for the first step of eligibility is a standard of care procedure 
already being implemented at all participating sites. All sites participating in the study will 
either screen in waiting rooms using the (1) PROMIS or (2) other standardized behavioral 
health screening to refer to the study, or (3) refer directly to the study based on clinical 
judgment. For all 3 avenues of referral, the patient will have an initial screening using the 
PROMIS scale before referral to the study. These patients will be identified as potentially 
eligible and invited to the study by their pediatric clinician.  
 
Eligibility 2 – Eligibility Screening Form 
Screening after referral to the study: 

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This screening form will be completed by RAs with patients after they have been referred to 
the study to determine if they meet the study’s inclusion criteria and do not meet any 
exclusion criteria. If it is identified that the patient requires a higher level of care, the safety 
protocol will be initiated and a clinician will follow-up to decide if this treatment is appropriate 
for this child and if they can be enrolled in the study. 
 
Eligibility 3 – Research Assessment 
Screening to determine final eligibility of study participants: 
Final determination of eligibility will be based on the participant’s PROMIS score 
from their baseline assessment. After a participant gives consent to participate in the 
study and completes the eligibility assessment, they will complete baseline 
assessment which includes the PROMIS measure. If either the parent-proxy or self-
report score at baseline is positive, they will be deemed eligible for the study.  
 
A positive PROMIS 8a Anxiety v2 Short Form screen is defined as a T-score above 
55 which is: 
 
A raw score of 17 or above on the pediatric parent proxy  
 
Or 
 
A raw score of 19 or above on the pediatric self-report 
Randomization Determination 
Once a patient is referred to the study, the following procedures will be initiated to enroll the 
participant, confirm eligibility, and randomize the participant. In order to be randomized to 
the study, the RA must confirm that the following procedures have been completed with the 
participant: 
a. Eligibility Screening Procedures 
b. Informed Consent Procedures 
c. Baseline Assessment Procedures 
d. PARS Baseline Procedures 
e. Clinical Intake Procedures 
Once these procedures are complete, randomization procedures are automatically initiated. 

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Each site will provide a workflow for their recruitment procedures that includes eligibility 
assessment and informed consent procedures, baseline assessment, PARS assessment, 
and clinical intake. This workflow will be shared with the lead site and any changes will be 
reported within a week of implementing the updated workflow. 
7.10.2 Eligibility Screening Procedures. Once a referral is sent to the on-site research 
team for eligible families who are interested in participating and have a positive PROMIS 
score (eligibility 1), the research staff will complete an eligibility screening to determine if 
they meet inclusion criteria. The research staff member will first read the brief screening 
consent script and get permission to screen the patient. Once they have received 
permission to screen, they will complete the screening form on REDCap. This data will be 
collected on REDCap with no identifying patient information but the research staff at the 
clinic will hold the screen ID for eligible and interested patients to link the screening form to 
the patient. Sites will request a HIPAA waiver to access screening data to identify and 
contact potential study participants. If the participant meets inclusion criteria and does not 
meet any exclusion criteria, the research staff member will continue to informed consent 
procedures.  
7.10.3 Informed Consent Procedures. Consent can be done in person, on the phone, or 
via videoconference using Zoom software. Research staff will meet in-person with the family 
to complete informed consent while in the clinic when both research staff and family are able 
to do so, or families will be consented by phone or videoconference using Zoom later (i.e., 
because family could not stay in clinic to provide informed consent or research staff were 
not present on site).  
Research staff will attain assent for patients under the age of 18. Sites will follow their local 
IRBs policy for attaining assent for minors. Sites will also follow their institution’s policy for 
re-consenting child participants in the study who turn 18 while in the study.  
For patients who choose to designate a coach who is not their parent, the coach will be 
consented over the phone. On site clinical staff will not be involved in the research consent 
process as that is the responsibility of the PIs with the help of designated research staff.  
If consent procedures are done in-person, site staff will also request a HIPAA agreement 
during the time of consent to access patient’s diagnostic history coded in their medical 
record at clinical assessment. If consent procedures are done over the phone, the site 
coordinators will request a HIPAA agreement over the phone and collect the participant’s 
signature via REDCap. If the site’s IRB requires a signed paper HIPAA agreement, site 
coordinators will work with clinic staff to find a time to meet with the participant in person to 
request a HIPAA agreement, or 

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All sites will have site-specific consent forms approved by their local IRB. These forms will 
be uploaded to REDCap to capture consent electronically. If local IRBs require paper 
consent forms, sites will be able to document that consent was attained on REDCap so the 
lead site can track enrollment centrally.  
BMC will request an alteration of consent for children turning 18 years old while enrolled in 
the study. BMC RAs will call children who turn 18 and read them a short script describing 
what the study and what they have given assent for previously. 
The procedures for attaining consent are outlined in the Manual of Procedures in the 
Informed Consent section. These procedures include consent for guardians and adult 
patients, assent for minors, and consent for coaches. 
7.11 Baseline Assessment Procedures 
As part of enrollment procedures, the participant must complete the baseline assessment. 
Baseline assessment will be completed by the participant with an RA in person or over the 
phone after consenting to be in the study. If participants are unable to complete the 
assessment at that time, they will be emailed a REDCap link to complete the assessment at 
another time.  
Research staff will call the participant at least every week for a month after the participant 
has given consent to remind them to complete the assessment, or to complete their baseline 
assessment with them over the phone. If the patient does not receive the call, research staff 
will leave a message using the message script.  Research staff should stop follow-up calls 
after 1 month if the participant still has not completed baseline assessment.  
For a child under the age of 13, it is necessary to have the completed parent baseline 
assessment for randomization. For a child ages 13 or over, it is necessary to have the 
completed child baseline assessment for randomization. The local RA should aim to 
facilitate the completion of both parent and child baseline assessments. In each family, if 
one subject has completed baseline but the other has not (i.e. the parent completed 
baseline but the child did not), continue to follow up with the family for 2 weeks to have the 
other complete baseline assessment. After 2 weeks, even if the other subject has not 
completed their baseline assessment, proceed with randomization of the family only if the 
necessary assessment has been completed (parent baseline for children <13 and child 
baseline for children ≥13). 
If the participant completes the assessment and their PROMIS score in the baseline 
assessment is negative, they are no longer be eligible for the study. The RA will notify the 

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participant of their ineligibility, and a clinician will follow-up with them to discuss other 
treatments. 
7.11.1 PARS Baseline Procedures. As part of baseline assessment and enrollment 
procedures, the participant must complete the PARS assessment with a trained clinical 
therapist, post-doc associate, graduate student, or a research staff member. This 
assessment must be completed after the participant has given consent to participate in the 
study. Sites may designate a clinician or research staff member to administer PARS at the 
site, or choose to have a central trained assessor at BU or FIU complete PARS with the 
participant. The PARS assessment can be administered in-person at the site, over the 
phone, or via videoconference using Zoom.  
7.12 Clinical Intake Procedures 
As part of the enrollment procedures, the participant must complete a clinical intake with a 
clinical therapist to determine the patient’s clinical condition and if outpatient CBT is an 
appropriate level of care for the patient. Participants will complete the designated program 
based on their age (Cool Kids for 7-12 year olds, and Chilled for 13-18 year olds).  
7.13 Randomization Procedures 
Once a participant has completed all 5 procedures necessary to be randomized, the local 
RA will complete a randomization form in REDCap to document and confirm that all 
procedures have been completed. Once all procedures have been documented, the form 
can be submitted, and the random assignment will be released. Randomization assignments 
are made centrally at the FIU data coordination site. Families are randomly assigned to one 
of the two treatment conditions by randomization software programmed to stratify 
assignments by Site (Baltimore, Boston, Miami, or Seattle), Language of Treatment (English 
or Spanish), and Age (7-12 years or 13-18 years). An automated push notification is sent 
that reveals the family’s assigned condition simultaneously to the FIU data management 
team (for data recording purposes) and to the research coordinators and clinical team at the 
participant’s site (to orient the family to their assigned treatment condition). The local RA will 
report the result to their clinical team and to the participant. 
7.14 Assigned Diagnoses Form 
In order to complete an Assigned Diagnoses Form, the clinic site must have a signed HIPAA 
authorization agreement from the participant. The participant can refuse to give HIPAA 
authorization and still continue to be in the study.  

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The local RA will review the HIPAA authorization agreement with participants once they 
have given consent to enroll in the study. If the participant agrees, a link to the REDCap 
HIPAA authorization form will be emailed to them for their signature. If the site IRB does not 
allow collection of their signature via REDCap, the local RA will work with the clinic team to 
identify a day to review a HIPAA authorization agreement form with the participant in 
person. If the participant agrees, the form needs to be signed by the participant and stored 
in a secure filing cabinet. Once an RA confirms on REDCap that a HIPAA authorization 
agreement has been signed by the participant, the assigned diagnoses form will be 
available in the participant’s REDCap record to be completed by the therapist or RA.  
A local RA will access diagnostic information via the participant’s medical record to complete 
the assigned diagnoses form on REDCap or the participant’s therapist will complete the 
form as part of their session 1 log. If the form has been completed by an RA on REDCap, 
the therapist will go into their session form for the first visits, click submit at the bottom and 
will move onto the Assigned Diagnoses Form. They will see that the form has already been 
completed and can just click submit. If the form had not been completed by an RA, the 
therapist will click on the link to complete their log for the first visit and will be redirected to 
the Assigned Diagnoses form where they can fill out the form. 
7.15 Study Visits, Therapeutic Contacts, and Assessments 
7.15.1 Study Visits and Therapeutic Contacts. Participants will have different points of 
contact with therapists and different modes of follow-up according to which study arm they 
are assigned to. The scheduling and coordination effort for therapy delivery and check-ins 
for the self-paced online version will be conducted at individual sites.  
7.15.1.1 Therapist Contacts During the Treatment Phase for Guided Online CBT 
Participants. Before the beginning of treatment in the guided online CBT arm, the following 
points of engagement must occur: 
1. The therapist providing supportive accountability for the case must reach out to the 
patient over the phone or online to introduce themselves to boost patient 
engagement. 
2. A technical orientation on the self-paced online program must take place with the 
participant. The technical orientation will be conducted using tools provided by the 
lead site. This orientation will go over how to navigate the program and who to 
contact with technical issues. This orientation can be conducted in-person, over the 
phone or via videoconference using Zoom software. The participant will always be 

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given the option to either attend the orientation in-person, on the phone, or via 
videoconferencing.  
3. Participating families in this condition are given up to 20 weeks (i.e., the treatment 
phase) to complete their treatment program.  
4. The therapist will work with the participant (and/or their family) to schedule check-in 
calls every 2 weeks. Throughout the duration of the program, these check-in calls 
will be held with the family or caregiver for children ages 7-12, and will be held with 
the child for children ages 13-18.  
5. The participating family is guided to complete one self-administered module of the 
program each week. Families are encouraged to revisit and review completed 
modules as frequently as they wish. 
6. The therapist will call the guardian and/or child every 2 weeks to check-in and 
provide supportive accountability. For each scheduled check-in/supportive 
accountability call, therapists should make at least 3 attempts to contact the family. 
7. Therapists are to complete will complete a brief session log on REDCap after every 
check-in/supportive accountability call. 
7.15.1.2 Therapist Contacts During the Treatment Phase for Therapist-led CBT 
Participants 
1. Participating families in this condition are given up to 20 weeks (i.e., the treatment 
phase) to complete their treatment program.  
2. Each therapy session should be scheduled for 50-60 minutes. Therapists are 
advised to schedule families for roughly one therapy session per week.  
3. Therapists can schedule multiple sessions a given week to help “catch up” if 
cancellations, missed appointments, holidays, or schedule breaks places them 
behind schedule. 
4. Therapists are to complete will complete a brief session log on REDCap after after 
every treatment session. 
*All clinics will work with their team to establish a workflow that is conducive to the 
procedures established above. This workflow will be shared with the lead site and any 
changes will be reported within a week of implementing the updated workflow. 
7.15.1.3 Therapist Session Logs 
Therapists will be required to complete a session log on REDCap after every session with 
study participants. The session log will include a checklist to record the skills/content 
covered in that session.  At the point of randomization, FIU will generate a link that is 
specific to the participant and send this link to the site RA. The RA will send the link to the 

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participant’s therapist with the name of the participant. The therapist is responsible for 
keeping this link and accessing it to fill out the log after every session. 
7.15.2 Midtreatment, Posttreatment, and Follow-up Assessment Procedures 
Florida International University (FIU) will be responsible for emailing a link to participants to 
complete the midtreatment, posttreatment, and follow-up assessments. Specifically, all 
randomized families are invited to complete a midtreatment assessment (consisting of 
caregiver- and youth self-report questionnaires) once they complete half of their allocated 
treatment. Families who do not complete half of their allocated treatment by the end of the 
second month of their treatment phase are invited to complete a midtreatment assessment 
at Week 8. All randomized families are then invited to complete a posttreatment assessment 
(consisting of caregiver- and youth self-report questionnaires) once they fully complete their 
allocated treatment program. Families who do not complete their allocated treatment 
program by the end of the fifth month of their treatment phase are invited to complete a 
posttreatment assessment at Week 20. All randomized families are then invited to complete 
a follow-up assessment at Week 52 (consisting of caregiver- and youth self-report 
questionnaires). Families will be emailed 2-4 weeks ahead of their follow-up assessment 
target date (i.e., 2-4 weeks before week 52).  
BMC and FIU RAs will assist all sites in conducting follow-up calls to participants in order to 
increase assessment completion rates. A reminder email will be sent to the participating 
family by FIU to complete their assessment every 4 days for at least 2 weeks (or until the 
assessment is complete). FIU RAs will run weekly reports off REDCap to see which 
participants have not completed their assessments and inform local RAs of which of their 
participants have outstanding data. If a participant has not completed their assessment after 
2 weeks, the RA from the participant’s site will call the participant in an attempt to complete 
the assessment over the phone. For posttreatment assessments, RAs should stop reminder 
contacts to participants when the participant 8 weeks after the assessment is initially 
emailed to them. At this point, the posttreatment assessment point is considered missing. 
For follow-up assessments, RAs should stop reminder contacts to participants 8 weeks after 
the assessment is initially emailed to them. 
7.15.3 Posttreatment PARS 
PARS assessments will be completed at posttreatment for each family by central assessors 
at FIU, BU, or BMC who are masked to treatment assignment.  
 

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7.15.4 Retention and Study Compensation  
Based on similar studies conducted in usual care settings that do not provide free study 
treatment, we expect roughly 30-50% attrition by the final follow-up timepoint, and roughly 
10% of data points to be missing with each collected timepoint. REDCap surveys will be 
configured to minimize missing values (e.g., requiring participants to complete each item, or 
explicitly indicate “refuse to answer” before proceeding to the next item; providing real time 
alerts to the data management team when items or entire forms are missing). Data will 
additionally be checked on a weekly basis by a research supervisor, and patterns of 
missingness will be identified and corrected in real time throughout the study. To further 
reduce instances of missing data, we have kept the number of study forms to a minimum in 
order to minimize the burden to participants, and participants will be provided compensation 
for their time completing study forms. Finally, participants will be compensated for the 
burdens of completing study assessments (see below).  
Given the aim to evaluate treatment engagement and performance under typical 
circumstances, families are not compensated for participating in treatment. To ensure 
generalizability and observe the treatment comparators under natural conditions, treatment 
is not funded by the study nor offered for free. Rather, treatment is to be paid for via the 
natural channels of payment in the participating health centers (e.g., insurance and co-
payments). In contrast, families are compensated for participation in study assessments that 
are not part of the treatment comparators under study. Specifically, families will receive the 
following compensations for completing various study assessment components: 
a. $50 for baseline assessment (staggered payments: $25 following baseline 
questionnaires and $25 following baseline PARS completion) 
b. $25 for midtreatment assessment 
c. $50 for posttreatment assessment 
i. $30 additional compensation for completing posttreatment PARS 
assessment 
d. $100 for completing follow-up assessment 
 
*Coaches (who are not guardians) will not receive compensation for the 
assessments they complete. Compensation will only be provided to the youth and 
guardian informants. One ClinCard that will be loaded with the above payments will 
be given to each family for each child enrolled in the study.  
Automatic email reminders and weekly emails and phone calls from Kids FACE FEARS staff 
members should be used to increase participation in study assessments. Families who do 
not complete the baseline assessment are not randomized. Families who do not complete 

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their assigned treatment are still invited to complete all subsequent evaluations (i.e., 
midtreatment, posttreatment, and follow-up evaluations). 
FIU will run weekly reports to see which participants have completed their assessment and 
send this report to BMC. The lead site RA will load the appropriate compensation amount 
onto the participant’s ClinCard as each of the assessment points is complete. 
7.16 Statistical Considerations 
Study results will be reported according to CONSORT guidelines.  
7.16.1 Sample size determination. Power analysis to determine the appropriate sample 
size for the trial had to take into account data clustering and repeated measurements. Study 
data were clustered in multiple ways, resulting in non-independent observations and inflated 
type I error. First, there were multiple observations per child due to the repeated measures 
design with four major assessment points. Second, there was additional clustering due to 
multiple children from each site. The intraclass correlation (ICC) is a quantitative estimate of 
clustering and allows for adjustment for non-independence. Study investigators estimated 
an ICC of .5, meaning it was anticipated that 50% of the variation in the observations would 
be due to differences between individuals and between sites (the remaining 50% of the 
variation was assumed to be due to individuals varying in their responses over time). The 
design effect (DE) reflects the extent to which standard errors are deflated if clustering is 
ignored. The DE is equal to 1 + (m – 1) × ICC, where m is the number of repeated 
measures. Accordingly, with 4 time points and an assumed ICC of .5, the design effect was 
calculated to be 2.5. Any sample size estimate must be multiplied by 2.5 in order to obtain a 
sample size appropriate for the observed clustering while maintaining nominal alpha and 
power levels.  
The required study sample size was calculated via conventional methods for repeated 
measures / mixed models analysis. Required sample size is a function of the alpha (type I 
error rate) and beta (1 – power) values. Required size per group is: 𝑛=  2 ∗(𝑍1−𝛼+ 𝑍1−𝛽)2. 
Before adjusting for the DE, these computations found n=60 was required in each group for 
an alpha=.05 (assuming family-wise error rates=.05 across the study to account for multiple 
comparisons) and power=.8 (corresponding to beta=.2). After adjusting for the DE of 2.5, 
this power analysis indicated n=150 was required per group (60 × 2.5), for a total of N = 
300.  
The needed sample size of N = 300 (outlined above) was based on the primary comparative 
effectiveness tests of this study (Aim I). That said, a sensitivity analysis was also conducted 
to evaluate the magnitude of effects that could be detected in moderation analyses 

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examining heterogeneity of treatment effects (Aim II). These analyses were conducted with 
G*power using the repeated measures analysis of variance (ANOVA) test. Repeated 
measures ANOVA is similar to a mixed model in some respects, but simpler and uniformly 
less powerful80 using the repeated measures ANOVA, therefore, offers a conservative 
estimate of the effects able to be detected with each mixed model. With N = 300, alpha = 
.05, power = .8, two treatment conditions, four measurements, and a correlation between 
repeated measures of .5, the trial was powered to detect moderation effects as small as 
Cohen’s d = 0.068. This is 7% of a SD difference and a very small effect. 
7.16.2 Handling of Missing Data 
7.16.2.1 Prevention and monitoring. All study data will be collected via electronic capture 
and communication directly with the study team. Based on similar studies conducted by our 
group and in related research in similar settings, we expect roughly 10% of data points to be 
missing. REDCap surveys will be configured to minimize missing values (e.g., requiring 
participants to complete each item, or explicitly indicate "refuse to answer" before 
proceeding to the next item; providing real time alerts to the data management team when 
items or entire forms are missing). Data will additionally be checked on a weekly basis by a 
research supervisor, and patterns of missingness will be identified and corrected in real time 
throughout the study. To further reduce instances of missing data, we have kept the number 
of study forms to a minimum in order to minimize the burden to participants, and participants 
will be provided compensation for their time completing study forms. Finally, participants will 
be compensated for the burdens of completing study assessments at a rate of $50 for 
baseline assessments (including PARS) and, $25 for midtreatment assessments, $50 for 
posttreatment assessments (including PARS), $100 for week 52 assessments and $30 for 
completion of PARS at posttreatment (note: compensation will not be provided for 
completion of measures that will be included as part of routine care). Coaches will not 
receive compensation for the assessments they complete. 
7.16.2.2 Statistical handling of missing data. All analyses will consist of intention-to-treat 
models drawing on all available data. To account for missing data, we will employ multiple 
imputation. Recommended procedures for single and multilevel multiple imputation will be 
conducted using BLIMP software, using fully conditional specification multiple imputation 
(FCS-MI). For each model, 50 datasets with imputed values will be created using other 
model covariates as predictors of missingness. Model convergence will be assessed across 
8 Markov Chain Monte Carlo (MCM) processes and verified for potential scale reduction 
(PSR) factor<1.05. Main analyses will be conducted on the imputed dataset and the results 
will be pulled for final estimates (using R 4.4.1 mitml for imputation pooling per Rubin’s 
rules, and lme4 for multilevel models, or lm and glm for linear and logistic regression 
models). 

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7.16.2.3 Reporting dropout and missing data. All instances of study dropout will be 
documented, including the reason for dropout, who decided that the participant would drop 
out (i.e., parent or guardian, therapist, study staff, adolescent patient), and whether the 
dropout resulted from burden of intervention, study assessment, or both. Withdrawn 
participants will be encouraged to continue to participate in study assessments throughout 
the follow-up period in order to optimize intention-to-treat models. A CONSORT diagraph 
will account for all participants across the study.   
7.16.2.4 Loss to Follow-up and Withdrawal from Treatment. This study will be using an 
intent-to-treat analysis so once a participant is randomized, they will always be included in 
analysis. If participants do not complete their entire treatment program (or withdraw from 
treatment) or take longer than 20 weeks, all post and follow-up assessments will still be sent 
to them at the indicated time points and local RAs will still perform follow-up procedures to 
assist with data collection.  
7.16.3 Covariates 
Covariates for each model will include site, language of care, youth age, youth gender, 
youth race, youth ethnicity, and family resource insecurity (see Measures) 
7.16.4 Primary analyses: Comparative effectiveness analyses. For primary analyses on 
continuous outcomes that were measured across the 4 major timepoints (e.g., caregiver- 
and youth-reports on the PROMIS Anxiety Scale, CALIS), mixed models of change144 will be 
run separately for each outcome. Mixed models are preferred for longitudinal designs 
because they allow for individual estimates of change and have robust power in the 
presence of missing data and attrition.145,146 Covariates for each model will include site, 
language of care, youth age, youth gender, youth race, youth ethnicity, and family resource 
insecurity (see Measures), and any other baseline variables found to significantly differ 
across participants in the two conditions. The random effects of intercept (reflecting 
individual variation in mean outcome level) will be assessed. The fixed effects of Treatment 
Condition, Time, and the Treatment × Time interaction will be analyzed in the prediction of 
change. We will examine non-linear models of change (i.e., log transformations of Time), 
which afford examination of symptom trajectories across time that are not gradual and 
incremental (e.g., steep improvements during initial weeks of treatment, followed by a 
slowing down of improvements toward the end of treatment, and then relative stability 
across the follow-up time interval). To aid interpretation of the meaningfulness of between-
group differences, Cohen’s d’s will be computed for each continuous outcome on model 
means at post and follow-up. 

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For primary analyses on the dichotomous categorical outcomes PARS Treatment 
Responder Status at posttreatment, baseline PARS scores will be examined for each 
participant to determine their individual thresholds for classification as Treatment 
Responders (i.e., 35% PARS score reduction). These thresholds will be used to classify 
each participant’s statuses as posttreatment. Logistic regression models will examine 
Treatment Condition (along with the study covariates) as a predictor of Treatment 
Responder Status and Remission Status at post. For primary analyses on continuous 
outcomes of Treatment Satisfaction at post, linear regression models will examine 
Treatment Condition (with the study covariates) as a predictor of caregiver- and youth-
reported posttreatment satisfaction. 
7.16.5 Heterogeneity of treatment effects. For Aim II analyses (heterogeneity of treatment 
effects) predictor and moderator terms will be added to the models predicting youth anxiety 
severity that were outlined above. For study covariates being considered as 
predictors/moderators (e.g., language of care, youth age, youth gender, youth race, youth 
ethnicity, and family resource security), this will entail only adding interaction terms, as the 
main effects of these variables will already be in the models. For the additional variables 
considered as treatment moderators that are not already included as model covariates (e.g., 
caregiver nativity) this will entail adding main effects and interaction terms to the models. 
For each model examining heterogeneity of treatment effects, the relevant terms of interest 
will be the 2-way interaction of Variable × Time (reflecting whether the variable uniformly 
predicted change across the two treatments) and the 3-way interaction of Variable × 
Treatment Condition × Time (reflecting whether the variable moderated treatment effects; 
i.e., whether the variable predicted differential response across the treatments). As with the 
Aim I comparative effectiveness analyses, log transformations of Time will be entered to 
consider non-linear models of change. Significant interactions will be followed up with post-
hoc probing on subgroups to clarify the nature and direction of interaction, and results will be 
plotted for visual depiction.  
7.16.6 Facilitators and barriers. Descriptive statistics will be run for models exploring 
facilitators and barriers to care and implementation (Aim III). These models will include the 
same covariates as outlined for Aim I and Aim II analyses. Treatment Condition will be 
added as a predictor in models comparing whether facilitators and barriers differ between 
the two treatment comparators. 
7.16.7 Interim Analysis. Interim descriptive data will be summarized each year for the 
investigative team. Our team will conduct analyses as required for the reporting of findings 
in peer-reviewed manuscripts and at conferences, and will assist with editing and writing 
manuscripts.  
 

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8 – Ethical Considerations 
8.1 Ethical Considerations 
Recruitment and retention strategies: This study is designed as a pragmatic trial. To 
maximize external validity, CBT for child anxiety will be integrated into routine clinic 
workflows and all children ages 7-18 years, with exception of those meeting minimal 
exclusion criteria described below, will be eligible.  
Retention strategies for CBT trial, data collection and follow-up assessments: Families will 
provide primary and additional contact information and will be provided with reminders for 
appointments and assessments. Modest patient incentives ($25-50) over the course of 
study participation at each data point will be provided for completing assessments. 
Exclusion Criteria: The intervention is suitable for patients ages 7-18 with elevated anxiety 
under consideration for outpatient psychological treatment. In this pragmatic trial, study 
entry criteria is very inclusive, so most anxious children with other problems are not 
excluded. However, children will not be able to participate if they are acutely at risk, if they 
require a higher level of care, or if they have developmental delays or intellectual 
impairments with very severe challenges (e.g., complete absence of verbal communication 
unrelated to anxiety). 
Involvement of vulnerable populations: The study will recruit children between 7-18 years 
and a parent or legal guardian. It will not involve prisoners or institutionalized individuals. 
The study could involve four populations considered to be vulnerable: pregnant women, 
children, and non-English speakers. As detailed elsewhere, we will obtain informed consent, 
child assent where applicable based on the child’s age, protect confidentiality, prevent 
undue influence and coercion, and protect against risks of the study.  
• 
Pregnant women:  Although the study will not specifically target pregnant women, 
given that the study enrolls young children and their families, it is possible that a 
participant could be pregnant. Such women will not be excluded. Women of 
childbearing potential will be entitled the same protections as listed above. We 
foresee no extra risk for a woman of childbearing potential relative to other 
participants.  
• 
Children: This research targets youth with elevated anxiety. Parents between the 
ages of 16-21 who are the legal guardians of the child referred for assessment, will 
not be excluded based on age; thus it is possible that we will enroll parents who are 
under 21. Young parents often face additional barriers accessing health services for 

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their children. For this reason and because according to state law in the study 
jurisdictions, we plan to enroll parents in this age group. We have enrolled such 
parents in previous studies, which were reviewed and approved by the IRBs at each 
of our institutions and without any adverse events.  Therefore, we are confident that 
protocols for the proposed research will be ethical, lawful and will be approved by the 
participating institutions' IRB.  
• 
Non-English speakers: We include non-English speakers (Spanish speakers) in 
order to address the need for research and an evidence base for effective treatments 
in this population. All materials, modules, and general resources presented to 
participants will be available in Spanish. We will have Spanish speaking RAs 
conducting screening and assessments who will also be available to answer any 
questions participants have. Additionally, many of our therapists are Spanish 
speakers. We are confident that our study will have enough resources and staff 
available to Spanish speakers to ensure the ethical conduct of research. 
• 
Children and Parents Involved with DCF: Children who are wards of the state will be 
excluded. Children who are involved with DCF will still require us to obtain informed 
consent from the legal guardian and permission from DCF prior to study enrollment. 
A caregiver confirmed to be safe by DCF must be available to voluntarily participate 
along with the youth as already outlined in the protocol for all youth/ family 
participants. We will not include study participants who are mandated to treatment. 
We will follow all applicable laws for including children and parents who are involved 
with DCF. 
Research Sites: The settings for the proposed project are Academic Medical Centers and 
Community Health Centers.  We will collect data from all of these sources via de-identified, 
coded data in REDCap. 
Material to be collected. The study will not make any use of biological specimens. 
Investigators will gather data from the following sources: (1) Patient and family reported 
measures; (2) Semi-structured interviews; (3) Provider fidelity measures; (4) therapist 
engagement logs; (5) administrative data and patient records. 
Access to individually identifiable private information. All research staff will complete CITI 
Human Subjects Training and Child Protection Training. Only study staff completing training 
in HIPAA regulations and human subjects protections will have access to study data. For all 
sources of data, with the exception of the interviews, all identifying information will be 
removed and names replaced by ID codes. Furthermore, identifying information will not be 
shared with others outside this study. Names and contact information for each participant 
will be stored in REDCap separate from project data. Project data will only be linked to the 
patient's record ID. For the interviews, only names, phone numbers, and site information will 
be available to the qualitative team to contact participants and conduct interviews. 

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Transcripts from interviews will be identified by ID codes and identifying personal 
information will be masked. Cross-reference listing of this contact information for the subset 
of interviewees will be kept in password-protected encrypted files on secure servers. 
Data collection, management, and protection. Research Electronic Data Capture (REDCap) 
located at Boston Medical Center will securely collect research data from across all four 
study regions, and Boston Medical Center will be responsible for overseeing the integrity 
and security of the data. REDCap is a scalable, web-based electronic data capture system 
that allows the investigative team to build online surveys and databases and input remote 
data over a secure web connection (a SSL certificate is required). REDCap features 
authentication, auto-logout setting, data logging (audit trails for tracking data manipulation 
and export procedures), user privileges (each user only has access to granted projects; 
privileges are granular on the project level, e.g., being able to export, enter, add or modify 
database metadata, to build/run reports, to modify user privileges, to view logs, etc). 
REDCap can be used to collect data for 21 CFR Part 11, FISMA, and HIPAA-compliant 
environments, and is specifically geared to support online or offline data capture for 
research and operations. The Data Services Group of the FIU Center for Children and 
Families (CCF) will have continuous 24/7 access to the data as well as project 
administration rights in order to fully execute their duties of data management, monitoring, 
and analysis. 
Planning, configuration and end-user support for REDCap will be provided by BU and the 
Data Services Group of the CCF. To help protect and secure the data stored in REDCap’s 
database, the software application employs several methods to protect against malicious 
users who may attempt to identify and exploit any security vulnerabilities in the system. 
Access to the REDCap data entry website will be based on permissions granted by 
username and password which will be managed by the Boston University Clinical and 
Translational Sciences Institute for the Medical Campus Office of Information Technology.  
Only authorized study members will be able to enter or view data.  The login information 
(username) of the person submitting the information, the date and time submitted, and other 
navigational information will be automatically obtained and stored in the database.  
Information posted on forms will be electronically encrypted using secure socket layering 
(SSL) encryption technology so that only the intended recipient can decode the data.  Data 
will reside on a secure, password protected server at Boston Medical Center (BMC) to which 
only designated individuals have access, thus providing a secure environment for all project 
data.  The database will be automatically backed up on a nightly basis.  Files stored on BMC 
servers will be protected by electronic ‘firewalls’ that restrict access to designated users.  
Restrictions and permissions to update the database will be controlled through the REDCap 
web application. 

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Non-BMC sites will be able to access the REDCap system after submitting an end user 
agreement. A Boston University REDCap account will be created for them and the BMC 
team will be responsible for giving users a customized level of project access. In particular, 
the Data Services Group of the FIU Center for Children and Families (CCF) will have 
accounts created for them and will have continuous 24/7 access to the data as well as 
project administration rights in order to fully execute their duties of data management, 
monitoring, and analysis. 
8.2 Ethical considerations and Institutional Review Board (IRB) Review 
This study is to be conducted according to applicable US federal regulations and institutional 
policies (which are based in federal regulations, guidance, and Good Clinical Practice 
guidelines). This protocol and any amendments will be submitted to the Boston Medical 
Center and Boston University Medical Campus IRB, for formal approval of the study 
conduct. The decision of the IRB concerning the conduct of the study will be made in writing 
to the investigator. A copy of the initial IRB approval letter will be provided to the sponsor. 
All participants for this study will be provided a consent form describing this study and 
providing sufficient information for subjects to make an informed decision about their 
participation in this study. The consent form will be submitted with the protocol for review 
and approval by the IRB. The consent of a subject, using the IRB-approved consent form, 
must be obtained before that subject is submitted to any study procedure. Consent will be 
documented as required by the IRB.   
This protocol was made in accordance with Boston University/ Boston Medical Center IRB 
policies and will be reviewed by the institution’s IRB. The study's clinical sites in Boston will 
be overseen by Boston Medical Center's IRB. Regional sites will submit separate IRB 
applications using the study protocol and site specific forms to their respective institutional 
IRBs for approval according to their institutional policies. Oversight of clinical sites outside of 
Boston will be conducted by their respective IRBs. IRB oversight is by the respective IRBs 
with overall oversight from the study PIs as well as regional co-PIs.  
8.2.1 Potential Risks. We do not foresee any physical, legal, or financial risk for any of 
the study participants in Aims I, II, or III.  
Potential risks are psychological and the need to protect confidentiality  
● Because the research covers the topic of mental health and potential psychosocial 
stressors participation may be emotionally distressing to individuals in the study. 
● Although we will strive to maximize cultural sensitivity in delivery of the proposed 
intervention, it is possible that, among parents, their explanatory models of their 

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child’s condition will be incompatible with our proposed interventions and even 
assessments, which may upset some participants. 
● A potential risk to participants is potential loss of confidentiality. Although data will be 
stored in a secure and confidential manner, and we will de-identified all stored data, 
accidental breaches of confidentiality are technically possible. 
 
8.2.2 Adequacy of Protection Against Risk 
Recruitment and Informed Consent. We will obtain parental permission and child assent 
for all enrolled families. Youth 18 years of age will provide their own informed consent. A 
written description of the study and other informational materials (in English, Spanish, and at 
appropriate literacy level) will be made available to all families to assist them in the informed 
consent process. For eligible families who are interested in participating, research staff will 
complete eligibility assessment and consent procedures. This could be done at the time of a 
positive screen in the clinic, later on the phone, or later in person depending on the 
preference and availability of the parent/patient. To mitigate risks, subjects will be given 
multiple opportunities to decline participation. They will be advised of their right to refuse 
participation in all or any part of the research. Families who decline to participate will still be 
offered usual clinical services at the participating clinical setting. All participants will be 
assigned a numerical code and only project personnel will have access to a file linking 
names/contact information and ID codes. Research data will not include identifying 
information and will be encrypted and electronically stored on a password-protected study 
server. 
To provide additional protections, we will assure that the investigative team has the 
appropriate expertise to deal with children and parents. Study facilities will be appropriate to 
children, as these facilities will be either families’ homes or pediatric healthcare sites. We 
will make sure that all psycho-educational materials, treatment plans are written in a 
straightforward manner, at the appropriate literacy level. We will use translators/language 
line as needed to further ensure parents fully understand study procedures and 
communicate concerns about their child’s care. As all site staff and the investigators are 
mandated reporters, families will be informed that any disclosure of abuse, risk to a child or 
elder will need to be reported to the appropriate state protection agency. Endorsement of 
suicidality, risk to self or others will require emergency evaluation for safety and disposition 
by the clinical staff and RAs will have a contact at each site for reporting such disclosures 
and in order to activate the clinical protocol for these types of events.  
8.2.3  Potential Benefits of the Proposed Research to Human Subjects and Others. 
The potential long-term benefits of participating in this study outweigh the risks.  All eligible 

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children who demonstrate anxiety symptoms during screening will receive evidence-based 
services that match or exceed those currently provided at the participating sites.  
8.2.4 Importance of the Knowledge to Be Gained. This pragmatic comparative 
effectiveness trial will generate high-quality experimental data that can directly inform best 
practices in the CBT treatment of pediatric anxiety. The plan to test two models of CBT 
delivery (therapist-led vs. guided online care) in pediatric healthcare settings in which low-
income, ethnically diverse children receive routine health care services will provide valuable 
information to pediatric care practices and integrated health networks about the potential 
benefits and barriers to implementing this type of intervention for children with anxiety. The 
results can provide rigorous evidence-based information to support patient and provider 
decision-making and patient-centered care. 
8.3 Participants Confidentiality 
All research staff will complete CITI Human Subjects Research Training and HIPAA 
Training. Only study staff completing training in HIPAA regulations and human subject’s 
protections will have access to study data. Boston University Medical Campus’ Research 
Electronic Data Capture (REDCap) system will securely collect and manage research data 
from across all four study regions. For all sources of data, all identifying information will be 
linked to ID codes. Boston Medical Center and the participant’s site will have access to the 
participant’s name and contact information. Identifying information shared across sites will 
be limited to sites that need some information for their role in the study. Sites will hold the 
master code for their participants and only coded data will be shared with other sites.  
FIU will have limited access to identifiable patient information. They will only have access to 
patient participant names, emails, and phone numbers which will be linked to a record ID in 
a file that will be stored separately from any clinical data. Assessments will be sent to 
participants via email by the FIU research team. The FIU research team will have access to 
only record ID numbers, phone numbers, and emails in order to; (1) create login usernames 
for participants randomized to the web-based treatment which will be linked to their study ID 
number; (2) send assessments to participants via email and; (3) conduct follow-up calls for 
assessment completion across sites. PARS administrators at FIU will have access to 
participant’s names and contact information in order to contact participants to complete 
PARS over the phone. FIU will have continuous access to the data and will be able to run 
weekly reports to see when participants have completed mid-treatment sessions/modules 
and post-treatment sessions/modules. In order to provide all sites with data collection 
support, the regional site PI, Jonathan Comer, and his project manager will have access to 
all data including identifiable data. 

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BMC will be responsible for; (1) setting up participant’s ClinCards and loading compensation 
amounts onto the card and; (2) managing and providing assistance to sites and; (3) 
conducting follow-up calls for assessment completion across sites. BMC will run weekly 
reports to identify participants who have completed assessments to provide compensation 
to participants. In order to set up ClinCards, BMC will need access to the patient’s 
participant number and contact information including name, address, date of birth. In order 
to provide technical assistance to participants and sites, the BMC team will also need 
access to participant emails, phone numbers, and login information. All other participant 
data shared with BMC will be coded. 
The Cool Kids Online IT Support team will only have access to participants’ name, email 
addresses, and Cool Kids login information. This team will consist of study assistants led by 
PI - Dr. Jonathan Comer – who will reply to emails from participants regarding technical 
concerns with the Cool Kids Online program. Participants will be able to send emails to an 
encrypted BU email account regarding their technical issue. The support team will have 
access to this account and will be able to directly reply to participants.  
Our consulting team at Macquarie University will be providing technical support to the Cool 
Kids IT Online Support team with the Cool Kids online system. The Macquarie team’s 
involvement with the study will be strictly for technical support and troubleshooting any 
glitches in the Cool Kids Online system where the Cool Kids IT Support team needs support. 
The team will only have access to participant’s email addresses and login information.  
Access to data involving therapist/staff participants will be very limited. To maintain 
confidentiality, all identifying information will be linked to ID codes. Only BMC will hold the 
master code for these participants and only coded data will be shared with other sites, 
including their own site. FIU will only have access to therapist/staff participant emails which 
will be linked to a record ID in a file that will be stored separately from any clinical data. 
Assessments (except baseline assessment) will be sent to participants via email by the FIU 
research team. FIU will have continuous access to the data and will be able to run weekly 
reports to see when participants have to complete assessments.  
8.4 Data Quality Assurance 
BMC will be responsible for overseeing the security and integrity of the data. At the outset of 
the study, personnel who will be using the systems for direct data capture will attend in-
person or remote training (depending on geographical proximity). Study team members 
outside of the South Florida area will attend web-based training. The goal of the training is to 
ensure uniformity of procedures among personnel, to achieve the ultimate aim of ensuring 
high quality protocol implementation and data collection. Subsequent training for new staff 
and booster sessions for existing staff will be conducted via webinar. The FIU CCF data 

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team will also provide quality control procedures for data collection and data entry. The 
quality control measures that we shall implement include detailed and unambiguous 
specifications for completion of each of the data collection forms. The FIU CCF data team 
will also oversee and monitor randomization assignments and sequences.  
The CCF data team will provide regular status updates regarding data collection. They will 
also provide regular statistical summaries to the investigative team that include reports on 
enrollment as well as the current status of each study participant. 
8.5 Data Collection 
All PROs will be collected over the phone or electronically (i.e., no separate office-visits will 
be required for the collection of study data).  
Consent, eligibility assessment, and baseline assessment will be completed on a tablet 
(through the electronic, HIPAA compliant REDCap). However, different clinics may choose 
to slightly alter the process in order for it to fit their current workflows (i.e. conducting paper 
and pencil screening). In all clinics, paper screening forms will be available for 
patients/guardians upon request if they prefer and the data entered into REDCap by study 
staff. All data will be entered by study staff into the REDCap database and the paper forms 
will be securely stored in a locked cabinet.  
The team at Macquarie University will collect non-clinical data related to participant use of 
the online program from the back end of the online Cool Kids program. This data includes 
participant’s login information, login times, content accessed at each login, module 
completion time, and their IP address. The study team will also have access to back end 
data from the online Cool Kids program that will be used for analysis including usage of 
program, clicks, and participant answers to questions. 
Due to the pragmatic nature of the trial, we have designed the data collection protocol to be 
concurrent and as integrated as possible with clinical encounters and participant 
progression through the Cool Kids therapist-led and self-administered online versions.  
8.5.1 Access to Data 
Only study staff completing training in HIPAA regulations and human subject’s protections 
will have access to study data. After data collection is complete, the FIU CCF data team will 
work to create a data sharing file that comprises the following components and 
accompanying annotation: the protocol, REDCap user's manual, annotated copies of all 
forms used in the study, the schedule of assessments, the data dictionary providing data 

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attributes and descriptive statistics for each variable, the study database tables representing 
the captured and cleaned data, the analytic data tables and the programming statements 
responsible for any data recoding or subsetting, data summaries of each data table 
including descriptive statistics for validation of value integrity, and written description of the 
study conduct and noteworthy details anticipated to potentially affect data interpretation. 
8.5.2 Data Storage/Security 
BUMC’s Research Electronic Data Capture (REDCap) system will securely collect and 
manage research data from across all four study regions. REDCap is a scalable, web-based 
electronic data capture system that allows the investigative team to build online surveys and 
databases and input remote data over a secure web connection (a SSL certificate is 
required). REDCap features authentication, auto-logout setting, data logging (audit trails for 
tracking data manipulation and export procedures), user privileges (each user only has 
access to granted projects; privileges are granular on the project level, e.g., being able to 
export, enter, add or modify database metadata, to build/run reports, to modify user 
privileges, to view logs, etc.). REDCap can be used to collect data for 21 CFR Part 11, 
FISMA (Federal Information Security Management Act), and HIPAA (Health Insurance 
Portability and Accountability Act)-compliant environments, and is specifically geared to 
support online or offline data capture for research and operations. 
To help protect and secure the data stored in REDCap’s database, the software application 
employs several methods to protect against malicious users who may attempt to identify and 
exploit any security vulnerabilities in the system. Access to the REDCap data entry website 
will be based on permissions granted by username and password which will be managed by 
the Boston University Clinical and Translational Sciences Institute for the Medical Campus 
Office of Information Technology.  Only authorized study members will be able to enter or 
view data.  The login information (username) of the person submitting the information, the 
date and time submitted, and other navigational information will be automatically obtained 
and stored in the database.  Information posted on forms will be electronically encrypted 
using secure socket layering (SSL) encryption technology so that only the intended recipient 
can decode the data.  Data will reside on a secure, password protected server at Boston 
University Medical Center (BUMC) to which only designated individuals have access, thus 
providing a secure environment for all project data.  The database will be automatically 
backed up on a nightly basis. Files stored on BUMC servers will be protected by electronic 
‘firewalls’ that restrict access to designated users.  Restrictions and permissions to update 
the database will be controlled through the REDCap web application. 
Non-BUMC sites will be able to access the REDCap system after submitting an end user 
agreement. A Boston University REDCap account will be created for them and the BMC 

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team will be responsible for giving users a customized level of project access. Planning, 
configuration and end-user support for REDCap (https://redcap.bumc.bu.edu/) will be 
provided by the Data Services Group of the CCF. The Data Services Group of the FIU 
Center for Children and Families (CCF) will have accounts created for them and will have 
continuous access to the data as well as project administration rights in order to fully 
execute their duties of data management, monitoring, and analysis. All data will be stored at 
BUMC.  
All paper records will be stored in locked storage spaces (cabinets or drawers) at the 
participant's clinic site. Only study staff will have access to the key to get into these storage 
spaces. Participant forms will be stored in a single folder that is labeled with their respective 
study ID number. 
8.6 Study Records 
Study records will include consent forms and patient data. We will gather data from the 
following sources: (1) Patient and family reported clinical measures; (2) Provider fidelity 
measures; (3) therapist engagement logs.  
8.6.1 Retention of Records. Per Boston Medical Center policy, all study records will be 
retained for seven years after completion of the study. The full data package will be 
deposited in a PCORI-designated data repository for 7 years. The Full Data Package 
includes the Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical 
analysis plan (including all amendments and all documentation for additional work 
processes), and analytic code from a PCORI-funded research project. The package will be 
made available to third-party requests when PCORI makes the Final Research Report 
available on the PCORI website. 
 
 
 

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9 – Research Team and Project Coordination 
The KIDS FACE FEARS project brings together an interdisciplinary team of researchers, 
and patient and stakeholder partners from across the country. The research team includes 
clinical psychologists, pediatricians and health services researchers with leading expertise in 
child behavioral health, technology and child anxiety disorders. Our team also includes 
patient and family partners as co-investigators. Members of the research team have prior 
experience working together successfully, and will have resources available (financial and 
institutional support) to ensure the projects’ success. The proposed project will be 
conducted in Research and Community Environments (Boston University; Boston Medical 
Center; Florida International University; Seattle Children’s Hospital; John’s Hopkins 
University) are all institutions with extensive experience and well-resourced research 
environments to support a proposal of this scope and affiliated community primary care 
partners serving diverse populations, urban and rural, with experience in community-
academic partnerships. 
The Kids FACE FEARS project is overseen by the KFF Executive Committee (made up of 
Dual PIs Jonathan Comer, Ph.D. and Donna Pincus, Ph.D.), in consultation with the 
Scientific Steering Committee, the Patient and Family Advisory Council (PFAC), and the 
Study Advisory Committee. The Executive Committee coordinates with the Lead 
Investigators (made up of the primary Kids FACE FEARS investigators from each 
participating region and clinic, plus key investigators with specific content expertise in 
biostatistics and/or technology-based care) to implement all aspects of the study. One-to-
two lead investigators serve as Regional Lead(s) for each of the four Kids FACE FEARS 
study regions. These Regional Leads coordinate and oversee all study activities in their 
respective regions. Four “scientific cores” were designed for the Kids FACE FEARS project, 
as well: the Research and Methodology Core is responsible for the study design and 
overall research conduct; the Clinical Training & Fidelity Core is responsible for all staff 
training and intervention delivery fidelity; the Methodology and Statistics Core is 
responsible for overseeing statistical planning and oversight, randomization and allocation 
concealment, data collection and integrity, and statistical analysis; and the Technology 
Core, assists with the technology aspects of the project and in particular the Web-based 
Cool Kids program.  
 
 

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Figure 2, below, provides and organizational overview of study: 
  
 
Principal Investigators:  Donna Pincus, Ph.D. and Jonathan S. Comer, Ph.D. (Dual-PIs) 
make up the Executive Committee and will direct the research team; they have an existing 
productive working relationship and will work synergistically to achieve project aims. Donna 
Pincus, PhD is a licensed clinical psychologist, an internationally known child anxiety expert, 
and the Director of the Child Anxiety Treatment Program at Boston University, Dr. Pincus’ 
research focuses on the development of evidence-based treatments for youth with anxiety 
disorders. Dr. Comer is a Professor of Psychology and Psychiatry at Florida International 
University, where he is Director of the Mental Health Interventions and Novel Therapeutics 
(MINT) Program—an interdisciplinary clinical-research center devoted to leveraging 
technology to expand the reach and scope of children’s mental health care. He is a leading 
expert in the treatment of pediatric anxiety, telehealth and digital mental health, and clinical 
trial methodology. Together, Dr. Comer and Dr. Pincus lead the Kids FACE FEARS 
Executive Committee. 
The Executive Committee will resolve any issues related to planning, design, 
implementation, and financing. They are responsible for managing the overall project 
operations and project cores. They will work closely with the Study Cores, communicating 

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about methodology and aims and providing data about the project implementation. In 
addition, they will assist with the interpretation of outcomes and evaluation, and 
dissemination. The PIs will also regularly monitor risks to project goals and patient safety, 
and regularly report and problem solve with the Scientific Steering Committee. Both PIs will 
work closely with all clinical sites, consultants, subcontractors, and all project cores to 
monitor the progress of the project in regards to implementation, fidelity, and recruitment. 
Dr. Comer will have primary responsibility for overseeing the methodology, design, study 
implementation, and statistical aspects of the clinical trial. Dr. Pincus will have primary 
responsibility for the dissemination, training, treatment fidelity, and sustainability 
components of the Kids FACE FEARS project, and will serve the main point of contact with 
PCORI. 
Earlier in the study’s development and implementation, Lisa Fortuna, M.D., MPH (a leading 
child psychiatrist, health services, and disparities research) served as a Principal 
Investigator on this project as well, overseeing the coordination and launch of the project. 
Dr. Fortuna was the original chair of the study’s Executive Committee, until she stepped 
down from the project when she left the project’s prime institution (BMC) to accepted a 
department chair position at another institution. 
Methodology Lead. Jonathan Comer, Ph.D. is a Professor of Psychology and Psychiatry at 
Florida International University, where he is Director of the Mental Health Interventions and 
Novel Therapeutics (MINT) Program—an interdisciplinary clinical-research center devoted 
to leveraging technology to expand the reach and scope of children’s mental health care.  
Qualitative Lead. Christina P.C. Borba, PhD, MPH is Director of Research for the 
Department of Psychiatry at Boston Medical Center. Dr. Borba has extensive experience in 
mixed methods research, teaching and training, and development and management of 
randomized clinical trials. Dr. Borba’s current research focuses on mental health problems 
and cultural psychiatry in low-resourced settings in the US and abroad. She has expertise in 
mixed methods research and has participated in dissemination efforts for PCORI and NIMH 
studies.  
Earlier in the study’s development and implementation, Michelle Porche, Ed.D. (a 
developmental psychologist with extensive experience working with community partners in 
behavioral health services research, and in conducting mental health disparities research) 
served as the qualitative lead for the study. Dr. Porche was a member of the original 
Executive Committee for this study and served as the lead in launching the “Americanized” 
version of the guided online CBT program used in the study. Dr. Porche stepped down from 
the project when she left Boston University to accept a faculty position at another institution.  

Study: Kids FACE FEARS  
 
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Biostatistics. Stefany Coxe, Ph.D. is an expert in quantitative methods for the social 
sciences and prevention science, having overseen data analysis for a number of large 
clinical trials, and serves as the lead biostatistician for the trial. Anthony Dick, Ph.D. serves 
in additional biostatistical capacities. 
Regional Leads.  We purposefully selected research sites with diverse patient populations in 
four different regions of the US to enhance generalizability of findings. 
 
Regional Lead 
Experience 
New England 
Regional Lead: Andrea Spencer, 
MD 
Associate Director of Behavioral Health Integration 
in Pediatrics at BMC; behavioral health 
integration/clinical trial methods  
Pacific North West 
Regional Lead: Molly Adrian, Ph.D. 
Pediatric mood and anxiety disorders; randomized 
clinical trials; technology-based treatment delivery; 
behavioral health integration in pediatric health 
settings 
Mid-Atlantic 
Regional Lead:  Rheanna Platt, MD, 
MPH and Leslie Miller, MD 
Dr. Platt has experience implementing interventions 
among Spanish-speaking populations and Dr. Miller 
has experience with randomized trial of 
psychotherapy implementation at Bayview 
community psychiatry and delivery of 
psychotherapy at several college counseling 
centers. 
Southeast 
Regional Lead: Jonathan S. Comer, 
PhD; Dana McMakin, PhD 
International expert on pediatric anxiety treatment, 
clinical trials, use of technology, design and 
methodology, pragmatic trials (Comer). Mental 
health interventions for adolescent mood and 
anxiety disorders; translational research to inform 
intervention science (McMakin). 
 
The research team will report to the Study Advisory Committee (SAC), made up of a 
multidisciplinary team of stakeholders. Members of each of the advisory groups have been 
engaged in all aspects of planning this proposal and will continue to play a key role in 
project implementation, analysis, interpretation/dissemination of findings. Scientific Steering 
Committee (SSC) Chairs. Margarita Alegría, PhD is the Chief of the Disparities Research 
Unit at Massachusetts General Hospital, and a Professor in the Department of Psychiatry at 
Harvard Medical School. She has published extensively on improving health care service 
delivery for diverse populations, and ways to bring the community’s perspective into the 
design of health services. She is currently PI of four National Institutes of Health (NIH)-
funded research studies as well as a PCORI project. Ron Rapee, Ph.D., internationally 
known child anxiety expert developer of the Cool Kids Suite of online and face-to-face CBT 
protocols is Distinguished Professor and ARC Laureate of Psychology at Macquarie 
University in Sydney, Australia. His recent work has focused on public dissemination and 
access to empirically validated programs and so his participation in the scientific advisory 

Study: Kids FACE FEARS  
 
94 
 
board meetings will be helpful in advising the large scale study of Cool Kids. Study Advisory 
Committee (SAC) Co-Chairs. Tumaini Rucker Coker, MD, MBA is Director of Research for 
the Center for Diversity and Health Equity at Seattle’s Children’s Hospital. She has 
extensive experience with programs that build the capacity of hospitals and community to 
respond to the mental health needs of children. Rebecca Brigham, LICSW is supervisor of 
the Pediatric Integrated Behavioral Health (IBH) social work team at Boston Medical Center 
where she provides programmatic support, clinical supervision, and training in evidence-
based practices. In year 3 of the study, the SSC and SAC meetings will be combined for 
continued engagement in all aspects of project implementation as a multidisciplinary team.     
Other Key Personnel and Consultants: Lauren McLellan, Ph.D., co-developer of the Cool 
Kids Suite of online CBT protocols, is Director of Online Programs in the Centre for 
Emotional Health at Macquarie University, and an expert in the development and evaluation 
of technology-based strategies for improving the reach of youth anxiety treatment. Drs. 
Rapee and McLellan have extensive experience collaborating and conducting large clinical 
trials using both Cool Kids comparators. Their research has included the wide dissemination 
and implementation of Cool Kids nationally in Australia and Norway. 
Data Safety and Monitoring Board Co-Chairs. Martha Tompson, PhD is Associate 
Professor of Psychology at Boston University and Director of the Family Development and 
Treatment Program; she is a renowned expert in the family-based treatment of pediatric 
mood and anxiety problems, and has extensive experience leading randomized clinical 
trials. Shannon Pruden, PhD is Professor of Psychology at Florida International University 
and a leading expert on child development and individual differences.  
 
Kids FACE FEARS Advisory Groups 
Scientific Steering 
Committee (SSC) 
MEETS TWICE 
ANNUALLY (2 hour 
meetings) 
Address methodological 
issues, recruitment and 
retention, analysis, and advise 
on dissemination of results. 
Chair: Margarita Alegría, PhD; 
Michael Silverstein, MD, MPH; 
Barry Zuckerman, MD. Ron 
Rapee, PhD; Lauren McLellan, 
PhD; Ricardo Munoz, PhD 
Study Advisory 
Committee (SAC) 
MEETS QUARTERLY (2 
hour meetings) 
Ensure stakeholder 
perspectives inform study 
conduct. The SAB holds 
primary responsibility for all 
decisions regarding 
publications, communications, 
and dissemination of results. 
Chairs: Rebecca Brigham, 
LICSW and Tumanini Rucker 
Coker, MD, MBA 
David Henderson, MD; Megan 
Bair-Merritt, MD, MSCE; Robert 
Vinci, MD; Alexander Fiks, MD, 
MSCE; Iman Sharif, MD; 
Jonathan Woodson, MD; Eileen 
Costello, MD; Jonathan Welch, 
MD, and Gwen Wurm, M.D. 
Patient and Family 
Advisory Council (PFAC) 
Ensure research activities are 
aligned with patients’ needs 
Patient and Parent Co-
Investigators: Melissa Ripley, 

Study: Kids FACE FEARS  
 
95 
 
MEETS QUARTERLY (2 
hour meetings) 
and that patients’ perspectives 
are fully integrated in all 
aspects of the study. 
Karen Pierre-Louis, Gary 
McCreary, and Tomas Munarriz 
Parent Advisory Councils from 
all four regions  
Data Safety Monitoring 
Board (DSMB) 
MEETS TWICE 
ANNUALLY (1 hour 
meetings)  
Independently review and 
evaluate study data for 
participant safety, study 
conduct, progress, and 
efficacy, and make 
recommendations for 
modifications if needed  
Chairs: Martha Tompson, PhD 
and Shannon Pruden, Ph.D. 
 
 
 
 

Study: Kids FACE FEARS  
 
96 
 
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