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

Award Number: R01MH131698
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/21/2023
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $932,559 )
2026	2026	SAN DIEGO STATE UNIVERSITY FOUNDATION	5250 CAMPANILE DR	SAN DIEGO	CA	92182	SAN DIEGO	USA	Mental Health Research Grants	000	4	5/8/2026	NON-COMPETING CONTINUATION	$932,559
														Subtotal = $932,559

Issue Date FY: 2025 ( Subtotal = $1,060,735 )
2025	2025	SAN DIEGO STATE UNIVERSITY FOUNDATION	5250 CAMPANILE DR	SAN DIEGO	CA	92182	SAN DIEGO	USA	Mental Health Research Grants	000	3	6/10/2025	NON-COMPETING CONTINUATION	$1,060,735
														Subtotal = $1,060,735

Issue Date FY: 2024 ( Subtotal = $1,045,231 )
2024	2024	SAN DIEGO STATE UNIVERSITY FOUNDATION	5250 CAMPANILE DR	SAN DIEGO	CA	92182	SAN DIEGO	USA	Mental Health Research Grants	000	2	5/15/2024	NON-COMPETING CONTINUATION	$1,045,231
														Subtotal = $1,045,231

Issue Date FY: 2023 ( Subtotal = $1,070,654 )
2023	2023	SAN DIEGO STATE UNIVERSITY FOUNDATION	5250 CAMPANILE DR MC1947	SAN DIEGO	CA	92182	SAN DIEGO	USA	Mental Health Research Grants	000	1	8/21/2023	NEW	$1,070,654
														Subtotal = $1,070,654

Grand Total All Awards = $4,109,179

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

Award Number: R01MH131698

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/21/2023

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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