Stepped Care Versus Stratified Care for Youth with Anxiety Disorders: a Pilot Randomized Controlled Trial.

Anxiety disorders are common in children and adolescents, but access to evidence-based treatment is limited. Most clinical guidelines recommend stratified care, where less complex patients are offered low intensity interventions and complex patients more intensive options. Stepped care, where all patients initially receive low-intensity treatment, has gained traction due to its potential cost-effectiveness. Research on care models for youth with anxiety disorders is very limited. In this pre-registered (NCT06016907) pilot randomized controlled trial (RCT), we examined the feasibility, acceptability, and safety of a trial comparing stepped and stratified care for youth with anxiety disorders. In stepped care, all began with internet-delivered CBT. In stratified care, complex cases (based on a baseline risk score incorporating symptom severity, co-existing disorders, functional impairment, and family conflict) started with in-person CBT. Non-responders in both groups were offered in-person CBT. Over six months, 51 youth with anxiety disorders were enrolled (mean age = 14.18 years, range = 9.25-17.50; 71% girls), with 80% meeting criteria for more than one mental disorder. Treatment adherence (≥ 50% completion) was 78-84% across interventions. Masked outcome assessments were attended by 96% of participants. No serious adverse effects were reported. At the primary endpoint, 40% of participants in stepped care and 75% in stratified care were classified as treatment responders. However, the trial was not powered to detect efficacy differences, and no between-group comparisons were conducted. Results indicate that a definitive trial comparing stepped and stratified care for youth anxiety disorders is feasible.