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

> **NIH NIH R01** · SAN DIEGO STATE UNIVERSITY · 2024 · $1,045,231

## Abstract

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 ...

## Key facts

- **NIH application ID:** 10911344
- **Project number:** 5R01MH131698-02
- **Recipient organization:** SAN DIEGO STATE UNIVERSITY
- **Principal Investigator:** FRANCES L LYNCH
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,045,231
- **Award type:** 5
- **Project period:** 2023-08-21 → 2028-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10911344

## Citation

> US National Institutes of Health, RePORTER application 10911344, Behavioral telehealth in low-resource primary care settings for anxiety and depression in youth: A randomized effectiveness-implementation study (5R01MH131698-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10911344. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*