Video-visit behavior therapy for anxiety and depression in youth: A randomized effectiveness-implementation study in low-resource primary care settings.

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The proposed mixed-methods study will (a) test the effectiveness of brief behavioral therapy (STEP-UP) for youths with anxiety and/or depression recruited from primary care community health centers (CHCs), (b) evaluate a population-based method of implementation of STEP-UP, and (c) explore patient, provider, and clinic reactions to identify target mechanisms for successful and sustainable implementation. Anxiety and mood disorders in youth are prevalent and impairing, with a 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 suicidal behavior. 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. Further, there are notable disparities in care, with minority youths significantly less likely to receive services than non- Hispanic white (NHW) youths, despite experiencing similar or higher rates of disorder. Therefore, effective treatment of anxiety and depression is a critical public health priority, especially for traditionally underserved minority youths. STEP-UP is a streamlined behavioral intervention developed to efficiently treat anxiety and depression as a unified problem area by targeting avoidance behavior common to both disorders. The proposed study builds on a multi-site randomized trial demonstrating the effectiveness of STEP-UP, with especially strong effects for Hispanic youths. This application responds to RFA-MH-20-400 and focuses on implementing and testing this promising evidence-based practice in the OCHIN network of CHCs and federally qualified health centers which serves a diverse population of vulnerable families. STEP-UP has been adapted to a digital health framework with video visits to increase dissemination potential, scalability, and cost-effectiveness. We propose to conduct an innovative hybrid effectiveness-implementation study (type 1) testing digitally delivered STEP-UP compared to facilitated referral to traditional outpatient mental health services (treatment-as-usual, TAU). Youths (age 8-17, N = 250) will be identified and recruited at the population level through electronic health records (EHR) and direct clinician referral of new cases. Eligible youths will be randomized to (a) STEP-UP or (b) facilitated referral to TAU. Clinical outcomes will be assessed at Weeks 16 and 32 and process measures collected over the course of care. Qualitative interviews will occur with 20 youth-parent dyads, 35 CHC providers and staff, and 20 administrators sampled from enrolled clinics. Aims include testing the clinical effectiveness of STEP-UP and engagement of the intervention mechanism in the vulnerable CHC population of families (Aim 1), evaluating the impact of STEP-UP on equity in mental health outcomes for minority youths (Aim 2), estimating the implementation cost and incremental cost effectiveness of STEP-UP (Aim 3), and identifying target mechanisms for sustainable implementation of STEP- UP in CHCs using the Consolidated Framework for Implementation Research (Aim 4).