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

Rodriguez F, Lynch FL, Gonzalez A, Rozenman M, Dickerson J, O'Keeffe-Rosetti M, Donald J, Hatch B et al.

Trials, 2026

220 participants

Abstract

Background: 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.

Method: 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…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 220 participants or records.

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