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Symposia

Child / Adolescent - Anxiety

The SMART Study: A Clinical Effectiveness Trial of Pediatric Anxiety Treatment in a Diverse and Clinically Complex Sample

1 - (SYM 5) SMART Study for Pediatric Anxiety: Study Conceptualization and Design

Saturday, November 22, 2025
3:35 PM - 3:52 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
Abstract Body



Objectives: Describe the conceptualization and design of the Sequential Multiple Assignment Randomized Trial (SMART) study for pediatric anxiety. This study was designed to inform CBT and medication treatment sequencing and predictors of treatment response in when anxiety treatment is delivered to diverse youth in community practice settings.

Methods The SMART study is a single-blind randomized trial of 24 weeks duration with two levels of randomization, one in each of two 12-week stages. In Stage 1, children were randomized to fluoxetine or exposure-based cognitive-behavioral therapy (CBT). In Stage 2, non-remitters during the first 12 weeks of treatment will be randomized to either (1) optimization of their Stage 1 treatment, or (2) optimization of Stage 1 treatment and addition of the other intervention(remitters will continue maintenance-level therapy with the single-modality treatment received in Stage 1).



Results: An intent-to-treat analysis will compare youth randomized to fluoxetine first versus those randomized to CBT first. Then, among Stage 1 youth (non-remitters), we will compare those randomized to optimization of their Stage 1 monotherapy versus those randomized to combination treatment. The interaction of these main effects will assess whether one of the 4treatment sequences (CBT to CBT; CBT to med; med to med; med to CBT) in youth with pediatric anxiety is significantly better or worse than predicted from main effects alone.



Conclusions: Findings from this study will identify treatment sequences that optimize outcomes in ethnically diverse and underserved pediatric patients who have anxiety disorders and receive treatment in community practice settings.