Strategic Treatment and Assessment for Youth (STAY)

NCT06515236 | Enrolling By Invitation DMC

• 3 other identifiers: 200003670424-063R34MH134915
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression in Adolescence; Suicide Prevention

Outcome Measures

Primary Outcomes (10)

• Patient Health Questionnaire-9 Item Version

  The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure for use with individuals over 12 years of age. Items are scored on a 3-point Likert scale (0="Not at all"; 3= "Nearly every day") with greater scores indicative of higher depression. The PHQ-9 has been well established as a brief depression severity measure and used in numerous studies examining the effectiveness of MBC for depression. Internal consistency of the PHQ-9 is high (α\>0.80) and criterion validity was established by conducting 580 structured interviews which showed that individuals who scored high (≥ 10) on the PHQ-9 were 7 to 13.6 times more likely to be diagnosed with depression. Moreover, among a sample of 442 adolescents enrolled in mental health treatment, a PHQ-9 score of ≥11 had a sensitivity of 89.5% and specificity of 77.5% for detecting youth with major depression.

  Baseline, 2-Month Follow-Up, 4-Month Follow-Up

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  The Columbia-Suicide Severity Rating Scale (C-SSRS) is a semi-structured interview that measures suicide ideation and behavior. It is predictive of lifetime history of non-suicidal self-injury among adolescents and suicide attempts at return visit to an emergency department. The C-SSRS is the leading national suicide assessment measure and has been used in numerous National Institute of Mental Health (NIMH) clinical trials. In three multisite studies with 673 adolescents and adults, internal consistency on the intensity subscale ranged from moderate (α=.73) to high (α=.95) and the C-SSRS demonstrated good convergent and divergent validity with other prominent suicidal ideation/behavior scales (100% specificity and 100% sensitivity in correctly identifying lifetime suicide attempts).

  Baseline, 2-Month Follow-Up, 4-Month Follow-Up

• Session Attendance (Behavioral Treatment Engagement)

  Behavioral engagement will be measured by participation in sessions, which is defined as the number of sessions attended divided by number of sessions scheduled over a 4-month period.

  4-Month Follow-Up

• Patient Activation Measure (Attitudinal Treatment Engagement)

  Attitudinal engagement will be measured using the reduced, 13-item version of the Patient Activation Measure (PAM). This measure has strong psychometric properties particularly in relation to the other limited measures of this construct; the theoretical range of items and mean scores is 0-100 but means among a sample of 1,515 individuals with a high school education or less range from 38-51, where higher scores reflect higher levels of activation.

  Baseline, 2-Month Follow-Up, 4-Month Follow-Up

• Treatment Retention (Treatment Completion/Continuation)

  Treatment retention will be assessed via records review for successful completion or continuation vs. whether they terminated inappropriately (e.g., early) at four months after treatment started. If the patient has terminated services by the 4-month mark, the investigators will code the discharge reason as "successful completion" (i.e., retained) or "premature termination" (i.e., not retained). If the patient is still in services at the 4-month mark, they will be considered "retained" unless they have missed all three of the most recently scheduled consecutive sessions. This is an established treatment retention measure.

  4-Month Follow-Up

• Treatment Evaluation Inventory - Short Form

  Treatment relevance and acceptability will be measured by the caregiver- and youth-reported Treatment Evaluation Inventory (TEI). The 15 items are rated on a 7-point Likert scale (1="strongly disagree"; 7="strongly agree") that load on a unitary factor. Item scores are summed to provide a general treatment acceptability index, with higher values indicating higher rated acceptability. The Treatment Evaluation Inventory-Short Form (TEI-SF) has shown variable internal consistency (α\>0.35 to 0.80) and is considered to be the first and most frequently used instrument of treatment acceptability. The study team will adapt wording in items 1 and 2 to refer to depression instead of problem behavior.

  Baseline, 2-Month Follow-Up, 4-Month Follow-Up

• Working Alliance Inventory - Short Revised

  Therapeutic alliance will be measured by youth and caregiver report on the Working Alliance Inventory - Short Revised (WAI-SR). This 12-item measure was developed using confirmatory factor analysis and item response theory on the original WAI and includes Goal, Task and Bond constructs. Items are rated on a 5-point Likert scale (1="Seldom"; 5="Always"), with higher scores indicating stronger alliance. Reliability is strong (α\>0.80), convergent validity is adequate r \>0.64), as is model fit.

  Baseline, 2-Month Follow-Up, 4-Month Follow-Up

• Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) Self-Rated Level 1 Cross-Cutting Symptom Measure Child Age 11-17

  This measure consists of 25 questions that assess 12 mental health domains that are important across psychiatric diagnoses. These domains include depression, anger, irritability, mania, anxiety, somatic symptoms, inattention, suicidal ideation/attempt, psychosis, sleep disturbance, repetitive thoughts and behaviors, and substance use. Each item asks the child, age 11-17, to rate how much or how often they have been bothered by each symptom during the past 2 weeks. 19 items are rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day). The suicidal ideation, suicide attempt, and substance abuse items are rated on a "Yes" or "No" scale. This measure was found to have good test-retest reliability in the DSM-5 Field Trials conducted in pediatric clinical samples across the United States.

  Baseline, 2-Month Follow-Up, 4-Month Follow-Up

• Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) Parent/Guardian-Rated Level 1 Cross-Cutting Symptom Measure-Child Age 6-17

  This measure consists of 25 questions that assess 12 mental health domains that are important across psychiatric diagnoses. These domains include depression, anger, irritability, mania, anxiety, somatic symptoms, inattention, suicidal ideation/attempt, psychosis, sleep disturbance, repetitive thoughts and behaviors, and substance use. Each item asks the parent/guardian to rate how much or how often their child has been bothered by each symptom during the past 2 weeks. 19 items are rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day). The suicidal ideation, suicide attempt, and substance abuse items are rated on a "Yes", "No" or "Don't know" scale. This measure was found to have good test-retest reliability in the DSM-5 Field Trials conducted in pediatric clinical samples across the United States.

  Baseline, 2-Month Follow-Up, 4-Month Follow-Up

• Revised Child Anxiety and Depression Scale (RCADS-25)

  This 25-item measure is a revised shortened version of the original Revised Child Anxiety and Depression Scale (RCADS). Each item is rated on a 4-point scale (0=never; 3=Always). There are two subscales: an Anxiety Total scale and a Depression Total scale, with higher sum scores representing greater severity of general anxiety and depressive symptoms. Both subscales have shown acceptable reliability within clinic-referred and school-based samples.

  Baseline, 2-Month Follow-Up, 4-Month Follow-Up

Secondary Outcomes (14)

• Strategic Treatment Assessment for Youth (STAY) Observational Coding System

  6 Months Post-Training

• Strategic Treatment Assessment for Youth (STAY) Feasibility

  Baseline (pre-training), Immediately Post-Training, 6 Months Post-Training

• Strategic Treatment Assessment for Youth (STAY) Appropriateness

  Baseline (pre-training), Immediately Post-Training, 6 Months Post-Training

• Strategic Treatment Assessment for Youth (STAY) Acceptability

  Baseline (pre-training), Immediately Post-Training, 6 Months Post-Training

• Strategic Treatment Assessment for Youth (STAY) Knowledge, Skills and Attitudes

  Baseline (pre-training), Immediately Post-Training, 6 Months Post-Training

Study Arms (2)

Strategic Treatment Assessment for Youth (STAY)

EXPERIMENTAL

Clinicians assigned to the STAY condition will receive training and ongoing consultation in the STAY protocol and implementation plan. STAY is a culturally-modified version of measurement-based care (MBC) for racial and ethnic minoritized adolescents. Clinicians in this condition will receive training materials and consultation on standard MBC practices using the PHQ-9-A for depression plus cultural competence training, the "Introduce" component to assess and address treatment expectations at the start of care, and individualized goal and alliance progress measures.

Behavioral: Strategic Treatment Assessment for Youth (STAY)

Measurement-Based Care (MBC) As Usual

ACTIVE COMPARATOR

Clinicians assigned to the active comparison condition will receive standard MBC training and ongoing consultation that is routinely used and evaluated by the research team with child and adolescent mental health clinicians. MBC As Usual training materials will be customized to focus on collection and use of the PHQ-A with adolescents and their caregivers using a feedback system. MBC As Usual clinicians will be offered the opportunity to be trained in STAY at the conclusion of data collection

Behavioral: Measurement Based Care As Usual

Interventions

Strategic Treatment Assessment for Youth (STAY) BEHAVIORAL

Culturally tailored measurement based care

Strategic Treatment Assessment for Youth (STAY)

Measurement Based Care As Usual BEHAVIORAL

Measurement based care as usual

Measurement-Based Care (MBC) As Usual

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 12 to 18
• Identify as a racial or ethnic minoritized (i.e., Black or African American; American Indian or Alaska Native; Asian American, Native Hawaiian or Other Pacific Islander; Hispanic or Latinx) youth
• Have at least moderate depression symptoms based on moderate range of a validated depression assessment collected at intake by the participating agency such as the Center for Epidemiological Studies Depression Scale for Children (CES-DC) or Hamilton Depression Index with or without Parent- or adolescent- reported or healthcare provider- documented thoughts and/or behaviors related to self-harm or suicide in the three (3) months prior to first contact with participating agency
• Assigned or triaged to work with one of the clinician participants included in the study (below)
• Made first contact (e.g., initial phone call, attended intake appointment) with a participating agency less than or equal to one (1) month prior to the recruitment date (but ideally within (1) week of intake appointment)
• English- or Spanish-speaking
• Legal parent or guardian available to provide informed consent
• Able to provide informed assent
• Legal guardian of one of the adolescent client participants included in the study (above)
• English-speaking
• Able to provide informed consent
• Provides community-based mental health treatment to youth
• Holds a professional license or certification in their state to provide mental health treatment OR are supervised by a clinician with professional license or certification in their state to provide mental health treatment
• Are a clinician identified for recruitment because they are part of a participating mental health clinic/site
• Age 18 or older

Sponsors & Collaborators

• Yale University: lead
• Teachers College, Columbia University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

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MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Elizabeth Connors, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Teens and their parents will not know what condition their clinician is randomly assigned to, but clinicians will be aware as will the site.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Strategic Treatment Assessment for Youth (STAY) is a theoretically-driven, culturally-tailored measurement-based care (MBC) approach for racial and ethnic minoritized youth with depressive symptoms and/or suicidal thoughts and behaviors.

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 23, 2024
• Study Start: March 25, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)