Video-visit Behavior Therapy for Anxiety and Depression in Youth
Phase: NA
Conditions: Anxiety, Depression
Sponsor: San Diego State University

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TITLE: 
Video-visit behavior therapy for anxiety and depression in youth: A randomized effectiveness-
implementation study in low-resource primary care settings 
NCT NUMBER: NCT05417412 
REVISED DOCUMENT DATE: 03/01/24
PROJECT SUMMARY AND AIMS: 
This document summarizes the aims and analysis plan of an invited R56 project focused on adapting an 
efficacious brief behavioral therapy (STEP-UP) for youths with anxiety or depression to be delivered as a 
telehealth intervention by clinic staff in low-resource community health centers (CHCs). The R56 application 
was requested following the review of our R01 proposal, in which we proposed a randomized hybrid 1 
implementation-effectiveness study of STEP-UP compared to referral to community treatment-as-usual. The 
R01 application (1R01MH125159-01) was viewed very favorably by reviewers and matches key NIMH 
priorities. However, our original design relied on the use of research staff as STEP-UP interventionists. Per 
review and program officer suggestions, we have obtained support of our community partners for a 
re-design of the R01 RCT using native clinic staff as interventionists. In preparation for this more 
ambitious R01 project, we are received 2 years of R56 support to: 
Aim 1. Assess degree of fit and need for adaptation. We aim to systematically assess the degree of fit 
and needed adaptation of STEP-UP to be effective when delivered in CHC practice by CHC 
providers. Fit will be assessed at the clinic, provider, and patient level by leveraging secondary data 
available in the OCHIN network system, collecting original survey data, and seeking qualitative 
feedback from key stakeholders.    
Aim 2. Complete adaptations of content and procedures. Based on the results of Aim 1, we plan to 
adapt the STEP-UP intervention content, training, supervision, and implementation procedures to 
the CHC environment through iterative end-user feedback.  
Aim 3. Conduct feasibility test of intervention implementation. Finally, we aim to conduct a feasibility 
test of the intervention implementation process by conducting a case series of youth/parent 
participants (n=14) treated by two CHC providers.   
NO STATISTICAL ANALYSIS PLAN:
Please note that this pilot R56 project focuses on calculating descriptive statistics and achieving 
feasibility benchmarks. There is no plan to conduct low power inferential statistical tests. 
FEASIBILITY BENCHMARKS:  
Thus, for each aim, we briefly describe benchmarks for successful completion and discuss how reaching 
these benchmarks will prepare us for submission of a follow-up R01 application. 
Assess degree of fit and need for adaptation (Aim 1). In Aim 1, we systematically assess the fit between 
the STEP-UP intervention and the CHC setting and population. We will (a) leverage secondary data to assess 
features of OCHIN network CHCs that may influence implementation of the intervention, (b) conduct a brief 
survey with CHCs leaders to assess clinic readiness to implement STEP-UP, and (c) log communications 
(phone call, email) during clinic recruitment to identify barriers to implementation of STEP-UP and/or to 
participation in research related to STEP-UP. To assess fit to the population, we will meet with the OCHIN 
Patient Engagement Panel (PEP) prior to the R56 case series to review intervention dosing, content, and 
clarity and representativeness of materials; proposed outreach processes; and research activities. Our 
benchmarks for success at this stage include: 
(a) Detailed analyses of EHR data on characteristics of current TAU mental health services for youths with
target diagnoses, including use of telehealth. These data will allow us to understand the extent to which
the STEP-UP model imposes more demands on CHCs than usual care. In analyses from the Kaiser
system, the number of hours allocated for the STEP-UP intervention was comparable to usual care
behavioral health services; however, this may not be true of lower resource CHC settings.

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(b) Successful recruitment of CHC clinics and completion of leadership survey by at least one designated
representative per clinic. Surveys will focus on issues of staffing and workflow and will form the basis of
pilot clinical pathways that clinics may adopt when implementing STEP-UP.
(c) Analysis of reasons for refusal given by CHCs that chose not to participate in the R56 to identify
barriers to larger scale implementation of STEP-UP in the OCHIN network. We anticipate that smaller
clinics with less prior experience with integrated behavioral health will be more likely to refuse
participation (i.e., related to concerns about staffing and workflow).
(d) Identification of adaptation targets for the intervention from clinic (see b) and patient perspectives (e.g.,
the PEP panel). We will be particularly alert to concerns about the length or number of intervention
sessions.
Complete adaptations of content and procedures (Aim 2). In Aim 2, we move from an assessment of fit to 
active adaptation of content and procedures to improve fit. We will seek to complete the majority of these 
adaptations before commencing the feasibility case series (see Aim 3); however, some of our adaptation 
targets, such as supervision processes, are intended to be refined iteratively during the pilot. Our benchmarks 
for success at the adaptation stage include: 
(a) Adaptation of STEP-UP dosing, if indicated. We anticipate that clinics, providers, and patients may
support moving to 30-minute versus 45-minute sessions. We also will evaluate feedback on the
suggested total number of sessions, with the option of moving some content (e.g., relaxation) into an
online only instructional format or allowing the total number of plan practice sessions to flex (from 4 to 8
visits), based on youth response to intervention.  Given that the STEP-UP intervention has been
successfully tested in a prior effectiveness RCT and telehealth case series, we do not anticipate
content revisions at this stage of development.
(b) Core materials refined for clarity and representation of diverse families. Based on feedback, we will
craft final versions of the web site, downloadable handouts, and instructions for accessing the
intervention and moving through treatment.
(c) Creation of provider-facing content and support tools. Based on clinic leadership feedback and the
experience of interventionists in the case series, we will create new provider support materials to aid in
the delivery of the STEP-UP intervention. While STEP-UP has been previously delivered by Masters’-
level mental health providers (MSW, MFT) and nursing staff, the program has not yet been
implemented as part of the general workflow of a practice setting. To support the implementation of
STEP-UP, we will create sample, standardized charting notes for sessions (based on our current
adherence measures), after visit summaries, and workflow documents. In addition, we will include a
provider-facing page on the STEP-UP website with these resources and with archived material from the
STEP-UP provider training (e.g., videos of role play examples conducted during training).
(d) Adaptation of training and supervision. Based on clinic leadership input and initial interviews with the
case series interventionists, we will finalize our model of training and supervision, prior to moving
toward the second stage RCT. Our research staff-based model will be adapted to better fit the optimal
duration and intensity of training within the constraints of the interventionists’ settings, content and
preferred style and mode of training, and preferred and sustainable levels of ongoing supervision and
implementation supports.
Conduct feasibility test of intervention implementation (Aim 3).  During the R56, we also will complete a 
STEP-UP case series with 14 youth/parent dyads treated by CHC interventionists. Our benchmarks for 
success at the pilot testing stage include: 
(a) Recruit a lead clinic to pilot the intervention.
(b) Train at least two interventionists from the lead clinic in the STEP-UP intervention and have them
deliver the intervention with adequate adherence (90% of content delivered in adherence ratings).
(c) Identify and recruit eligible patients as a pilot test of our EHR and provider-referred recruitment
pathways. 
(d) Retain youths in the intervention. We aim to retain 80% of enrolled youths in a minimum of 8 STEP-UP
sessions (the minimum dose in the F2F RCT) and to have 80% youths and parents demonstrate at
least adequate engagement with services (e.g., above the midpoint of TASC, above average for
interventionists’ ratings of session engagement).

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(e) Deliver the intervention with high satisfaction. We will assess youth, interventionist, and clinic
leadership satisfaction with the STEP-UP case series. We aim for 80% of families reporting satisfaction
with the intervention and reporting no more than mild technical difficulties in accessing website content
and connecting with telehealth video visit sessions.
(e) Benchmark clinical and mechanism outcomes. Finally, we will benchmark pre-post change in anxiety
symptoms, depression symptoms, and behavioral avoidance (target mechanism) against the values
observed in our F2F RCT. STEP-UP outcomes on anxiety symptoms have been particularly robust and
stable; accordingly, we expect to observe at least a 7-point drop (approximately 1 standard deviation) in
SCARED scores in 80% of the sample of youths enrolled in the case series.
Foundation for the R01 phase. Successfully achieving the benchmarks associated with the aims of the R56 
will provide a solid foundation to move forward into an R01 RCT application. In the R01, we propose 
randomizing 200 youth/parent dyads to STEP-UP or community TAU. The R56 project will provide a critical 
opportunity for the OCHIN system and research team to pilot test and refine procedures for clinic-based 
implementation of the protocol. Of note, the R56 will also produce tangible products (e.g., revised intervention 
materials and dosing schedule, provider-facing tools and archived training resources, draft workflows) that will 
support scaling up the intervention not only for the R01 project but also for larger-scale dissemination and 
implementation projects in the future.