The SMART Study: A Clinical Effectiveness Trial of Pediatric Anxiety Treatment in a Diverse and Clinically Complex Sample
3 - (SYM 5) SMART Study for Pediatric Anxiety: Outcomes
Saturday, November 22, 2025
4:09 PM - 4:26 PM CST
Location: Bolden 5, Level 2
Keywords: Child, Anxiety, Treatment Recommended Readings: Peterson BS, West AE, Weisz JR, et al. A Sequential Multiple Assignment Randomized Trial (SMART)study of medication and CBT sequencing in the treatment of pediatric anxiety disorders. BMC Psychiatry. Jun 30 2021;21(1):323. doi:10.1186/s12888-021-03314-y, Walkup JT, Albano AM, Piacentini J, et al. Cognitive Behavioral Therapy, Sertraline, or a Combination in Childhood Anxiety. New England Journal of Medicine. Dec 25 2008;359(26):2753-2766. doi:Doi10.1056/Nejmoa0804633, Higa-McMillan CK, Francis SE, Rith-Najarian L, Chorpita BF. Evidence Base Update: 50 Years of Research on Treatment for Child and Adolescent Anxiety. Journal of Clinical Child & Adolescent Psychology. 2016/03/03 2016;45(2):91-113. doi:10.1080/15374416.2015.1046177, Wang Z, Whiteside S, Sim L, et al. Anxiety in Children. Comparative Effectiveness Review No. 192.(Prepared by the Mayo Clinic Evidence-based Practice Center under Contract No. 290-2015-00013-I .) AHRQ Publication No. 17-EHC023-EF. Rockville, MD: Agency for Healthcare Research and Quality; August 2017., Strawn JR, Geracioti L, Rajdev N, Clemenza K, Levine A. Pharmacotherapy for generalized anxiety disorder in adult and pediatric patients: an evidence-based treatment review. Expert opinion on pharmacotherapy. 2018;19(10):1057-1070. doi:10.1080/14656566.2018.1491966
Chief of Child & Adolescent Psychiatry University of Southern California, Children's Hospital Los Angeles Los Angeles, CA, United States
Abstract Body Objectives To present the findings of a Sequential Multiple Assignment Randomized Trial (SMART)that aimed to determine (1) whether, in community practice settings, beginning treatment forpediatric anxiety disorders with fluoxetine or Cognitive Behavioral Therapy (CBT) yields betteroutcomes; and (2) when more improvement is needed, whether optimizing the initial treatment ortransitioning to combination therapy is better.
Methods This 24-week SMART study employed two randomizations, one in each of two 12-weektreatment stages. In Stage 1, youth received either fluoxetine or CBT. In Stage 2, non-remitters wererandomized to either (1) optimization of Stage 1 treatment, or (2) combination therapy.Randomizations were stratified by age, sex, and symptom severity. Statistical analyses tested (1)whether fluoxetine or CBT as initial therapies yielded better 24-week outcomes; (2) whether non-remitters at week 12 had better outcomes if their initial treatment was optimized or if theytransitioned to combination therapy; (3) whether any of the possible treatment sequences yieldedbetter 24-week outcomes than the other sequences. Primary outcomes of anxiety symptoms andfunctioning were measured by youth report and secondary outcomes by parent report.
Results 316 youths, ages 8-17, who had at least moderately severe and functionally impairinganxiety disorder were randomized. The enrolled sample was highly diverse: 64% were Hispanic, 56%had Medicaid. Data collection is complete, and findings on primary and secondary anxiety symptomsand functional outcomes will be presented through 24 weeks.
Conclusions This investigation will contrast the clinical effectiveness of CBT, fluoxetine, theircombination, and variations in their sequencing delivered for diverse, anxious youth in communitysettings.
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