Kids FACE FEARS Comparative Effectiveness Research

Anxiety disorders are among the most common and impairing psychiatric disorders to affect
children and adolescents. Cognitive Behavioral Therapy (CBT) is an effective psychological
treatment for youth anxiety, with roughly 60-80% of youth showing considerable clinical
response and global improvements in functioning. Regrettably, despite the existence of
well-supported treatments, most youth with anxiety disorders do not receive any form of
treatment, especially in resource poor settings. The pediatric health care setting offers an
optimal public health venue for youth anxiety management, yet there is a critical lack of
behavioral health specialty care providers who are trained in providing mental health
treatment, and a lack of information on the optimal methods of treating anxiety in pediatric
settings. Two evidence-based strategies for delivering CBT for youth with mild to moderate
anxiety in pediatric settings are (1) face-to-face CBT delivered by therapists within
pediatric health care and (2) online delivery of CBT skills to youth and families.
Importantly, however, there are no data on the relative effectiveness of these two treatment
formats in real-world settings, and no information on which patient subgroups benefit most
from which formats in patients in real-world practice.

The study design entails a large-scale, streamlined, pragmatic, Non-Inferiority Randomized
Controlled Trial (RCT), in which eligible anxious youth presenting to pediatric primary care
settings will be randomly assigned to face-to-face versus online Cool Kids suite of CBT
intervention for youth anxiety and monitored for up to two years post-intervention. Outcomes
for each participant will be monitored across five assessment points, corresponding to
baseline, mid-treatment, post-treatment, 1 year post-baseline, and 2 years post-baseline.
Long-term outcomes associated with face-to-face versus online CBT will be evaluated over a 2
-year period post-intervention. We will use the well-established Cool Kids suite of
face-to-face and online anxiety CBT protocols within pediatric primary care networks serving
primarily racial-ethnic minority children in both urban and rural settings across four
regions of the US: the Northeast, the Mid-Atlantic, the Southeast, and the Pacific Northwest.
Therapists embedded within pediatric primary care settings and mental health clinics
co-located with primary care will provide all services. All participants will be identified
and referred for enrollment from pediatric health settings.

This study addresses three critical yet unanswered questions related to improving the
delivery of treatment and outcomes for anxiety in pediatric primary care. 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 relative effectiveness of implementing face-to-face versus online formats of
CBT to treat youth anxiety in pediatric health settings?

2. How do factors such as clinical severity, treatment preference, socioeconomic status,
computer literacy, distance to clinic, organizational readiness, or medical home status
moderate outcomes across treatment formats? Which patient subgroups might benefit most
from which formats and sequences of treatment?

3. What are the barriers and facilitators to delivering this care in pediatric health
settings and for the diverse patient populations served?

Inclusion Criteria

- Children age 3-18 years at the time of screening

- Child has elevated anxiety as indicated by a T-score above 55 (greater than 0.5 SD
(Standard Deviation) above the mean) on the PROMIS Item Bank v2.0 — Anxiety — Short
Form 8a (child self-report or parent proxy report) in English or Spanish at the time
of screening

- For children ages 3-12, participating parent or legal guardian is fluent in English or
Spanish

- For children ages 7 and up, child is fluent in English or Spanish

- Child's parent or legal guardian is age 16 or older

- If child taking SSRI/Pharmacotherapy for anxiety, must be on stable dose for greater
than or equal to 8 weeks from the time of screening (self-reported, must be reported
by parent if under the age of 18)

- Hired therapists or program staff at primary care sites or co-located sites
participating in the study

Exclusion Criteria

- Severe anxiety, as indicated by suicidality and/or poor functioning defined as
anxiety-related inability to attend school 2 or more days per week for past 3 weeks,
or requiring higher level of care as determined by a clinician

- History of diagnosed severe autism spectrum disorder or intellectual disability
(self-reported, must be reported by parent if under the age of 18 or by primary care
physician)

- Currently undergoing cognitive behavioral therapy or planning to continue a different
psychotherapy for anxiety during the time of the study (self-reported, must be
reported by parent if under the age of 18)

- Treatment participants not fluent in English or Spanish

- If over the age of 12, child has had a problem with drugs and/or alcohol within the
past 6 months or at the time of screening (self-reported, must be reported by parent
if under the age of 18)

- Cognitively impaired youth will not be included based on clinical judgment at the time
of screening (Primary care staff will be consulted at time of referral)