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

Anxiety and mood disorders in youth are prevalent and impairing, with high current and lifetime comorbidity. Untreated, these disorders lead to sustained functional impairment and increased risk for recurrent disorder and suicide. In addition, there are notable disparities in care, with both families experiencing increased social risk and youth of color significantly less likely to receive mental health services. In previous research, a primary-care-based transdiagnostic brief behavioral therapy (BBT) was developed and found to be effective for a broad population of youths with anxiety and depression. To increase dissemination potential to settings that serve low-resource families (e.g., community health centers CHCs), the intervention, now called “STEP-UP,” has been expanded to support a digital health framework and delivery in Spanish. We describe the protocol for a hybrid type 1 randomized-effectiveness trial to test the effects of STEP-UP in a community sample of youths with anxiety and/or depression. Youths (age = 8–16, N = 220) will be randomized to (a) STEP-UP or (b) assisted referral to treatment as usual (TAU+). Clinical effectiveness will be assessed by masked independent evaluators at posttreatment (week 16) and at follow-up (week 32). Implementation data will be pulled from the following: (a) Surveys of health system leaders, (b) surveys of and interviews with STEP-UP clinicians, and (c) electronic health record (EHR) and health system 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 social determinants of health (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 (CFIR, Aim 4). Results of the randomized trial may help move effective treatments for youth anxiety and depression problems into widespread community practice. NCT06273982. Registered on February 15, 2024