2 - (SYM 5) The Methods of a SMART Effectiveness Study of Medication and CBT Sequencing in Treating Pediatric Anxiety Disorder

This presentation will describe the methods of a randomized control trial that examined medication and cognitive behavioral therapy treatment sequencing in pediatric anxiety disorders. A goal of this presentation will be to describe the rationale for the design choices used in this clinical trial.  A methodologically stringent randomized controlled trial was designed with the goal to compare the effectiveness of pharmacotherapy to psychotherapy in the treatment of youths 8-17 years who were suffering from an anxiety disorder. The participants were recruited from 9 clinical site in the greater Los Angeles area who predominantly came from historically underserved minority populations.  A 24-week, 2-stage study was conducted under single-blind conditions. Each stage was 12 weeks in lengths. In stage 1, participants were randomized to receive either Coping Cat cognitive behavioral therapy (CBT) or fluoxetine. At the end of stage 1, participants who met remission criteria were continued on their initial treatment. Those who did not meet remission criteria at the age of stage 1 had their treatment optimized during stage 2. Some participants who did not achieve remission in phase 1 also were randomized to possibly have the alternative intervention added to their treatment regimen. The primary outcome measure was the self-reported 41-item Screen for Child Anxiety Related Disorders (SCARED). A feasible study was designed. Results from this randomized controlled trial will inform clinicians what sequence of treatments lead to optimal outcomes in this vulnerable patient population.