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ViewAttendees 6

Symposia

Child / Adolescent - Anxiety

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

5 - (SYM 5) SMART Study for Pediatric Anxiety: Implications for Evidence-based Practice and Future Research

Saturday, November 22, 2025
4:43 PM - 5:00 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: To present clinical and scientific implications of a Sequential Multiple Assignment Randomized Trial (SMART) that aimed to determine (1) whether, in community practice settings, beginning treatment for pediatric anxiety disorders with fluoxetine or Cognitive Behavioral Therapy (CBT) yields better outcomes; and (2) when more improvement is needed, whether optimizing the initial treatment or transitioning to combination therapy is better.



Methods: As described in previous talks, this 24-week SMART study employed two randomizations, one in each of two 12-week treatment stages. In Stage 1, youth received either fluoxetine or CBT. In Stage 2, non-remitters were randomized to either (1) optimization of Stage 1 treatment, or (2) combination therapy. Primary outcomes of anxiety symptoms and functioning were measured by youth report and secondary outcomes by parent report. In order to index the clinical and scientific implications of the trial results, the SMART study will be benchmarked against the (a) samples, (b) settings, and (c) outcomes of the evidence-based literature consisting of pediatric anxiety randomized controlled trials (RCT) for psychosocial and pharmacological interventions.



Results: 316 youths, ages 8-17, who had at least moderately severe and functionally impairing anxiety disorder were randomized. Baseline measures suggest the SMART study sample was (a) markedly more socioculturally diverse, (b) likely more socioeconomically disadvantaged, (c)  as or more clinically severe in terms of anxiety symptoms, and (d) substantially more comorbid than the samples enrolled in comparable efficacy-focused pediatric anxiety randomized controlled trials (RCT). Outcomes will be similarly benchmarked against the effects seen in RCTs for CBT, SSRIs, and their combination.


Conclusions: Clinical implications of findings and implications for updating evidence-based treatment recommendations for the pediatric anxiety disorders will be discussed. Lessons learned on enrolling and retaining community youths and practitioners in effectiveness trials will be summarized.