Strategic Treatment Assessment With Youth (STAY): A Measurement-based Care Approach to Promote Treatment Retention Among Racial and Ethnic Minoritized Youth With Depression or Suicide Risk
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire-9 Item Version
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Teens and their parents will not know what condition their clinician is randomly assigned to, but clinicians will be aware as will the site.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •*Note: This study includes data collection from mental health clinicians, youth, and parents/caregivers. The age limits for each participant group vary and are specified below.
- •Inclusion Criteria for Aim 2 Adolescent client participants:
- •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
- •Inclusion Criteria for Aim 2 Parent/Guardian participants:
- •Legal guardian of one of the adolescent client participants included in the study (above)
- •English-speaking
- •Able to provide informed consent
- •Inclusion Criteria for Aim 2 Clinician participants:
- •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
- •Individuals who do not meet all inclusion criteria are, by definition, excluded. There are no other
排除标准
- 未提供
研究组 & 干预措施
Strategic Treatment Assessment for Youth (STAY)
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.
干预措施: Strategic Treatment Assessment for Youth (STAY) (Behavioral)
Measurement-Based Care (MBC) As Usual
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
干预措施: Measurement Based Care As Usual (Behavioral)
结局指标
主要结局
Patient Health Questionnaire-9 Item Version
时间窗: Baseline, 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.
Revised Child Anxiety and Depression Scale (RCADS-25)
时间窗: 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.
Treatment Retention (Treatment Completion/Continuation)
时间窗: 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.
Working Alliance Inventory - Short Revised
时间窗: Baseline, 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) Parent/Guardian-Rated Level 1 Cross-Cutting Symptom Measure-Child Age 6-17
时间窗: Baseline, 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.
Session Attendance (Behavioral Treatment Engagement)
时间窗: 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)
时间窗: 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.
Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: 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).
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
时间窗: Baseline, 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.
Treatment Evaluation Inventory - Short Form
时间窗: Baseline, 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.
次要结局
- Implementation Climate Scale (ICS)(Baseline, 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) Knowledge, Skills and Attitudes(Baseline (pre-training), Immediately Post-Training, 6 Months Post-Training)
- Cultural Humility Scale (CHS)(Baseline, 2-Month Follow-Up, 4-Month Follow-Up)
- Treatment Outcome Expectations Scale (TOES)(Baseline, 2-Month Follow-Up, 4-Month Follow-Up)
- Treatment Process Expectations Index (TPEI)(Baseline, 2-Month Follow-Up, 4-Month Follow-Up)
- Therapist Cultural Comfort Scale (TCCS)(Baseline, 2-Month Follow-Up, 4-Month Follow-Up)
- Strategic Treatment Assessment for Youth (STAY) Feasibility(Baseline (pre-training), Immediately Post-Training, 6 Months Post-Training)
- Intervention Usability Scale (IUS)(6 Months Post-Training)
- Strategic Treatment Assessment for Youth (STAY) Observational Coding System(6 Months Post-Training)
- Strategic Treatment Assessment for Youth (STAY) Acceptability(Baseline (pre-training), Immediately Post-Training, 6 Months Post-Training)
- Multicultural Counseling Knowledge and Awareness Scale(Baseline (pre-training), Immediately Post-Training, 6 Months Post-Training)
- Current Assessment Practice Evaluation (CAPE)(Baseline (pre-training), Immediately Post-Training, 6 Months Post-Training)
- Attitudes toward Standardized Assessment Scale - Monitoring and Feedback(Baseline (pre-training), Immediately Post-Training, 6 Months Post-Training)