How Many Anxious Kids in Community Mental Health Would Be Eligible for an RCT? And Does It Matter? Insights from a Naturalistic Sample and a Non-Systematic Review

TL;DR

Most children with anxiety in community mental health settings would be excluded from clinical trials, and they often need more treatment sessions and support.

Contribution

The study reveals that exclusion criteria in RCTs may limit generalizability and highlights the need for more flexible treatment approaches for complex cases.

Findings

53% of youth in a community sample would have been excluded from at least one RCT based on common criteria.

Excluded youth required nearly twice as many treatment sessions and were more likely to use case management services.

Exclusion status may serve as a prognostic indicator for treatment needs in real-world settings.

Abstract

What are the main findings?
Among youth seeking specialty anxiety treatment in a community mental health setting, the majority would have been ineligible for at least one published randomized controlled trial of cognitive behavioral therapy for pediatric anxiety and related disorders.Ineligible youth required nearly twice as many treatment sessions and were more than twice as likely to receive case management services.

Among youth seeking specialty anxiety treatment in a community mental health setting, the majority would have been ineligible for at least one published randomized controlled trial of cognitive behavioral therapy for pediatric anxiety and related disorders.

Ineligible youth required nearly twice as many treatment sessions and were more than twice as likely to receive case management services.

What is the implication of the main finding?
These results do not imply cognitive behavioral therapy is less effective for clinically complex youth. Rather, they suggest that youth commonly excluded from efficacy trials may require more flexible or prolonged care than is typically represented in tightly controlled RCT protocols.Trial exclusion status may potentially serve as a prognostic indicator in community settings, helping clinicians set realistic expectations for families and signal when treatment adaptation or added supports are warranted.

These results do not imply cognitive behavioral therapy is less effective for clinically complex youth. Rather, they suggest that youth commonly excluded from efficacy trials may require more flexible or prolonged care than is typically represented in tightly controlled RCT protocols.

Trial exclusion status may potentially serve as a prognostic indicator in community settings, helping clinicians set realistic expectations for families and signal when treatment adaptation or added supports are warranted.

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.

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