NCT06515236

Strategic Treatment and Assessment for Youth (STAY)

Enrolling by Invitation
NAAges 12+InterventionalTreatment
Yale University
~140 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Strategic Treatment Assessment for Youth (STAY)Measurement Based Care As Usual

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient Health Questionnaire-9 Item Version
Measured over Baseline, 2-Month Follow-Up, 4-Month Follow-Up
+9 more outcomes measured
Depression in Adolescence
Suicide Prevention
1 sites across 1 states
Connecticut1
  • Elizabeth Connors, PhD · PRINCIPAL_INVESTIGATOR · Yale University

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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
English- or Spanish-speaking
Able to provide informed consent
  • Patient Health Questionnaire-9 Item VersionBaseline, 2-Month Follow-Up, 4-Month Follow-Up

    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.

  • Columbia-Suicide Severity Rating Scale (C-SSRS)Baseline, 2-Month Follow-Up, 4-Month Follow-Up

    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).

  • Session Attendance (Behavioral Treatment Engagement)4-Month Follow-Up

    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.

  • Patient Activation Measure (Attitudinal Treatment Engagement)Baseline, 2-Month Follow-Up, 4-Month Follow-Up

    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.

  • Treatment Retention (Treatment Completion/Continuation)4-Month Follow-Up

    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.

  • Treatment Evaluation Inventory - Short FormBaseline, 2-Month Follow-Up, 4-Month Follow-Up

    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.

  • Working Alliance Inventory - Short RevisedBaseline, 2-Month Follow-Up, 4-Month Follow-Up

    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.

  • Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) Self-Rated Level 1 Cross-Cutting Symptom Measure Child Age 11-17Baseline, 2-Month Follow-Up, 4-Month Follow-Up

    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.

  • 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 6-17Baseline, 2-Month Follow-Up, 4-Month Follow-Up

    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.

  • Revised Child Anxiety and Depression Scale (RCADS-25)Baseline, 2-Month Follow-Up, 4-Month Follow-Up

    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.