Evaluating care pathways for pediatric anxiety disorders: Study protocol for a pilot randomized controlled trial of stepped care vs stratified care.

Introduction: Anxiety disorders are common and debilitating in children and adolescents. Cognitive behavioral therapy (CBT), delivered both in-person and by the internet (ICBT), is efficacious, but access for young individuals is limited and it remains unclear how to structure the care pathway to maximize benefit.
Methods: To inform a fully powered randomized controlled trial (RCT), a pilot RCT will be conducted where 50 youth with anxiety disorders are randomized to one out of two care pathways: stepped care or stratified care. Both pathways consist of up to two courses (A and B) of evidence-based treatment (12 weeks of either ICBT or in-person CBT). The two treatments share the same basic components (e.g., psychoeducation, exposure) but differ in their format of delivery, with in-person CBT enabling higher personalization and therapist-involvement, but to a higher cost. In stepped care, all participants are offered ICBT in course A and treatment non-responders are offered in-person CBT in course B. In stratified care, those with the highest risk of treatment non-response are offered in-person CBT in course A (~50%), while the other half are offered ICBT. As in stepped care, non-responders in stratified care are offered in-person CBT in course B. The primary endpoint is the outcome assessment after course B. The objectives of the pilot are to examine the feasibility, acceptability, and safety of the study procedures.
Time plan: Recruitment for the study will begin in August 2023 and the final participant is expected to reach the primary endpoint in August 2024.