The Kids FACE FEARS Pragmatic Randomized Trial of Therapist-Led vs Guided Internet Cognitive Behavioral Therapy for Pediatric Anxiety: Rationale and Methods

<h2>ABSTRACT</h2><h3>Objective</h3> 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, nor in pediatric care. The Kids Formats of Anxiety Care Effectiveness Study For Extending the Acceptability and Reach of Services (Kids FACE FEARS) trial addresses these gaps. <h3>Method</h3> The Kids FACE FEARS trial was a multisite, pragmatic randomized trial comparing Therapist-Led CBT (telehealth, office-based, or hybrid) versus Guided Internet-based CBT (self-administered/self-paced, with minimal therapist support) for treating youth anxiety (7-18 years) identified in pediatric care. English- and Spanish-speaking families were enrolled from high-volume, urban pediatric healthcare sites affiliated with major medical centers in four metropolitan regions. This paper describes the study's rationale, treatment conditions, participant recruitment, assessment schedule/strategy, and provider training/consultation. <h3>Discussion</h3> Recent innovations have expanded CBT delivery options for pediatric anxiety. This is the first multisite randomized trial directly comparing CBT formats that draw on differential levels of therapist involvement and modes of technology. Sampling and study design features poise the Kids FACE FEARS trial to be one of the largest and most diverse/representative controlled trials of CBT for pediatric anxiety. In the context of evolving CBT delivery options, trial findings can inform patient-centered decision-making and help tailor treatment selections for underserved youth with anxiety.