Behavioral telehealth in low-resource primary care settings for anxiety and depression in youth: A randomized effectiveness-implementation study

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The proposed hybrid type 1 randomized effectiveness-implementation trial will probe the effects of brief behavioral therapy (STEP-UP) for youths with anxiety and/or depression recruited from low-resource primary care community health centers (CHCs) that serve a diverse population of vulnerable families. Anxiety and mood disorders in youth are prevalent and impairing, with high current and lifetime comorbidity in part due to shared etiologic factors. Untreated, these disorders lead to sustained functional impairment and convey increased risk for recurrent disorder and suicide. Only 1 in 5 anxious and 2 in 5 depressed youth report any lifetime mental health use, the lowest treatment rates for any youth mental health condition. In addition, there are notable disparities in care, with families experiencing high social determinants of health (SDOH) burden and minority youths significantly less likely to receive mental health services than similarly affected, but less disadvantaged, youths. Further, families who are served in safety-net settings such as CHCs often experience multiple, intersectional risks and barriers to evidence-based care. Therefore, effective treatment of anxiety and depression is a critical public health priority, especially for traditionally underserved youths. STEP-UP is a streamlined transdiagnostic behavioral intervention developed to efficiently treat anxiety and depression as a unified problem area by targeting avoidance behavior common to both disorder classes. The proposed study builds on a successful multi-site RCT of STEP-UP based in primary care with an insured population of youths. To increase dissemination potential to low-resource CHCs, we have adapted the program from a face-to-face format to a digital health framework and developed a Spanish-language translation. Pilot studies of this revised version of STEP-UP have shown feasibility and acceptability; however, data on clinical effectiveness are still needed in this new setting (CHC) and sample (high SDOH risk). Thus, we propose to conduct an innovative, 5-year hybrid effectiveness-implementation study (Type 1) rigorously testing the clinical effectiveness of the digital health version of STEP-UP, while simultaneously collecting data to plan future CHC implementation trials. Youths (age 8.0-16.5, N=220) will be identified and recruited through electronic health records (EHR) and clinician referral. Eligible youths will be randomized to (a) STEP-UP or (b) facilitated referral to TAU in the community (TAU+). Clinical effectiveness will be assessed by masked independent evaluators at STEP-UP post-treatment (Week 16) and at follow-up (Week 32). Implementation data will be pulled from: (a) surveys of CHC leaders, (b) surveys of and interviews with STEP-UP clinicians, and (c) EHR and CHC administrative data. Specific aims include testing the clinical effectiveness of STEP-UP and engagement of the intervention mechanism (Aim 1), probing cost effectiveness (Aim 2), testing SDOH predictors and moderators to evaluate robustness of effects (Aim 3), and identifying target mechanisms for future implementation trials using the Consolidated Framework for Implementation Research (Aim 4).