This multi-method, multi-phase pilot trial is designed to explore initial implementation
and effectiveness of a theoretically-driven, culturally-tailored, measurement-based care
(MBC) approach, Strategic Treatment Assessment for Youth (STAY), for racial and ethnic
minoritized (REM) youth with depressive symptoms or suicidal thoughts and behaviors
(STB). STAY offers an innovative, culturally-tailored approach to retain REM youth with
depressive symptoms with or without STB in mental health treatment. In this R34 study,
the investigators will first refine the STAY clinical protocol and implementation plan,
develop STAY instrumentation (STAY, Aim 1), and then pilot test the effectiveness of STAY
in three community-based mental health clinics (Aim 2). Aim 2 focuses on testing the
protocol through a pilot Hybrid Type 2 trial by comparing clinicians randomly assigned to
STAY (intervention condition) as compared to those assigned to the MBC As Usual (active
comparison condition). Results from this pilot trial will inform optimal study
procedures, measures, and site selection for a subsequent, fully-powered Hybrid Type 2
trial to examine STAY implementation, effectiveness, and scalability.
In Aim 1 of the research plan, the investigators will refine the STAY protocol and
intervention plan based on the study team's preliminary development of the STAY model,
protocol, and implementation plan. The STAY protocol includes a clinician manual
(including clinician guide for each STAY component, step-by-step instructions, sample
scripts, clinical vignettes) and assessment measures. The STAY implementation plan
includes the STAY training, goals and objectives, responsibilities, and timelines. The
investigators will employ user-centered design (UCD) methods guided by a Discover,
Design, Build, and Test (DDBT) Development process to revise the STAY protocol and
implementation plan to ensure STAY is aligned with the needs of deployment contexts and
end users. A sample size of N=12 users (i.e., clinicians and clinical administrators)
divided into three cohorts of four participants each will be used as per recommendations
for user-centered design (UCD) testing for complex interventions. Aligned with best
practices, sampling will balance both novice and more experienced users. Participants
will interact with the STAY protocol and implementation plan prototypes and engage in
usability tests, including cognitive walk-throughs and lab-based user testing.
Participants will also compete the 10-item Intervention Usability Scale. Iterative data
analysis and prototyping between each cohort will be used to rapidly refine the STAY
protocol and implementation plan to optimize usability. Then, the STAY Observational
Coding System (SOCS) will be developed to assess its feasibility and scalability for
future trials, as well as a 10-item STAY Knowledge, Skills and Attitudes (KSAT) Measure
to tap core knowledge domains and implementation mechanisms to be assessed in the Aim 2
trial. At the end of Aim 1, the study team will have refined a STAY protocol and
implementation plan. The investigators will also have an observational coding system to
assess STAY fidelity and a brief, pragmatic measure to assess knowledge, attitudes and
practices of clinicians trained in STAY.
In Aim 2 of the research plan, the investigators will conduct a pilot
effectiveness-implementation Hybrid Type 2 trial of STAY vs MBC As Usual. Using a
randomized design, 20 clinicians at three public mental health sites will be stratified
by site and randomly assigned to STAY (intervention condition) or to MBC As Usual (active
control condition). Clinicians randomized to STAY will receive the STAY protocol, and MBC
As Usual clinicians will receive standard MBC educational materials used in the study
team's other MBC studies. Clinicians in both conditions will attend a one-day training
and monthly, 1-hour, post-training consultation calls for 6 months. Clinicians in both
conditions will be asked to implement MBC with REM youth and their families who meet
eligibility criteria and facilitate study referrals. All clinicians will complete
measures at baseline (pre-training) and post-training and post-implementation (6-month
post-training follow-up). Half of the clinicians in each condition will be randomly
selected to participate in the SOCS. Youth/caregiver dyads will be recruited on a rolling
basis due to enrollment patterns at the clinical sites, which is why the investigators
are planning 20 months of data collection to achieve 4-month follow-up measures from all
youth. Youth and caregivers will complete measures at baseline (within 30 days of their
first contact with the site), 2-months (8 weeks) and 4-months (16 weeks) following the
baseline measure. Youth measures capture implementation outcomes (e.g., clinicians'
cultural humility and cultural comfort), engagement mechanisms (e.g., treatment relevance
and acceptability, therapeutic alliance), service outcomes (e.g., attitudinal
engagement), and youth symptom outcomes (e.g., depression symptoms, suicidal ideation and
behavior). Caregiver measures capture implementation outcomes (e.g., clinicians' cultural
comfort), engagement mechanisms (e.g., treatment relevance and acceptability, therapeutic
alliance), and service outcomes (e.g., attitudinal engagement). Youth and caregivers will
also be asked to consent to secondary data collection by the study team to obtain medical
records information for their attendance, discharge reason and fidelity of MBC. Clinician
measures capture implementation outcomes (e.g., feasibility, acceptability,
appropriateness).
The investigators will assess STAY implementation outcomes of fidelity, feasibility,
acceptability, and appropriateness (primary outcomes). Further, the investigators will
explore whether STAY, as compared to MBC As Usual, will result in (secondary outcomes):
(1) Greater therapeutic alliance and treatment relevance and acceptability (engagement
mechanisms); (2) Greater session attendance, attitudinal engagement and treatment
completion (service outcomes); and (3) Greater reduction in youth depressive symptoms,
suicidal ideation and behavior (treatment outcomes).
Appropriateness of Methods Follow up intervals are informed by typical treatment length
and retention measures in prior research. Sample size was determined based on the
resources and time frame constraints of 3 years; participating clinicians and families
will be recruited in year 1, quarter 4 to finish all data collection in year 2. Also,
individual clinician patterns in MBC administration and feedback can feasibly be examined
with this small sample size, as has been useful in other implementation pilot studies.
Knowledge gained from this pilot will be used to refine the research strategy for a fully
powered, subsequent R01 with optimal procedures. Piloting STAY with procedures that would
be exactly mirrored in a future, multi-site R01 provides numerous learning opportunities
about the feasibility and parameters of measures, study recruitment and data collection
procedures (e.g., collecting youth- and caregiver-reported data over the phone),
clinician engagement in consultation calls, record review procedures to track fidelity,
missing data patterns, and range and pattern of session attendance for both the STAY and
MBC As Usual groups. Also, site variation in this trial is expected to provide
information about how different sites handle STAY implementation, which the investigators
can further investigate as site-level variation in a fully-powered R01 trial. Outcomes of
this trial could inform potential additions to the R01 design, such as 1) enhancements to
STAY to more comprehensively address logistical barriers, 2) testing STAY among REM
adolescents with conditions other than depression, and/or 3) a fully-powered Type 2
Hybrid trial to detect clinician effects, moderators, and effectiveness outcomes.