How Many Anxious Kids in Community Mental Health Would Be Eligible for an RCT? And Does It Matter? Insights from a...

Background: Decades of randomized controlled trials (RCTs) support cognitive behavioral therapy (CBT) for pediatric anxiety, but exclusion criteria may limit generalizability to routine settings. We examined common exclusion criteria in recent CBT RCTs for pediatric anxiety, trends in these criteria over time, and whether meeting RCT exclusion criteria affects outcomes in a naturalistic sample. Methods: We reviewed 81 RCTs from the past 25 years assessing CBT for pediatric anxiety or related disorders to identify common exclusion criteria. We examined how often youth seeking exposure-based treatment for anxiety or OCD at an urban community health center met these exclusion criteria and whether this impacted treatment response, using three-year retrospective chart review data (n = 94). Results: Common exclusion criteria in identified RCTs included psychotropic medication use (66.7%), autism spectrum disorder (63.0%), and other psychiatric comorbidities. Suicidal ideation increased as an exclusion criterion over time (p < 0.05, Cramér's V = 0.23). Based on these criteria, 53% of participants in our naturalistic sample would have been excluded from one or more RCTs. Excluded patients did not differ in baseline characteristics. Excluded youth required nearly twice as many treatment sessions and had more than double the rate of case management utilization (all ps < 0.01). Conclusions: Youth who would have been excluded from at least one RCT had poorer prognoses. Findings support continued emphasis on pragmatic trials to advance understanding of how to augment treatments to better meet the diverse needs of youth.