A Randomized Clinical Trial of the Acceptability and Preliminary Effectiveness of an Online CBT Platform in Diverse Youth.

Background: The objective of this study was to evaluate the preliminary effectiveness of a self-administered digital mental health intervention, COPE2Thrive, in improving symptoms and functional impairment in youth in a diverse community setting. Methods: Outcome measures included self-reported Kiddie-Computerized Adaptive Testing (K-CAT) scores on seven diagnostic domains, and self-reported scores of six domains and the total score of the Weiss Functional Impairment Rating Scale (WFIRS)-Self Report. All youth were eligible to participate unless they were currently in another therapy. Primary analyses followed the stepped-wedge randomized design, comparing participants assigned to one of three randomized intervention sequences. Secondary analyses treated the study as an open-label intervention study and evaluated pre- to post-treatment change among participants who engaged in the intervention, using the last observation carried forward for non-completers. Results: We successfully recruited a majority non-White sample that was 31.5% Black, 31.5% Hispanic/Latino, and 19.6% Asian. Of the eligible participants, 30.5% enrolled in the study, 23.4% completed the intervention, and 12.5% participated in the follow-up. Racial and ethnic minority subjects were less likely to have received outside behavioral health therapies, both in the screening sample and among those who participated in the intervention. There was no statistically significant improvement in the total score or any of the domain scores on the K-CAT or the WFIRS-S, either in the RCT or in the open-label analysis. Conclusions: Given the low acceptability of the program and the absence of clinically significant improvement in this pilot study, the findings suggest that the intervention, as implemented, may have limited utility for addressing youth distress in diverse communities.