Strategic Treatment and Assessment for Youth (STAY)

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT06515236

Acronym / sponsor ID

STAY / 2000036704

Conditions

Depression in Adolescence, Suicide Prevention

Study type

Interventional

Recruitment status

Enrolling by invitation

Enrolment

140 participants (estimated)

Lead sponsor

Yale UniversityUniversity, hospital or other

Collaborators

Teachers College, Columbia University, National Institute of Mental Health (NIMH)

Study start

25 Mar 2025 (actual)

Primary completion

30 Nov 2026 (estimated)

Study completion

30 Nov 2026 (estimated)

First posted

23 Jul 2024 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Single blind (participant)

Number of arms

2

Model description

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.

Who may qualify

Ages

12 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Patient Health Questionnaire-9 Item Version

   Time frame: 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.

2. Columbia-Suicide Severity Rating Scale (C-SSRS)

   Time frame: 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).

3. Session Attendance (Behavioral Treatment Engagement)

   Time frame: 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.

4. Patient Activation Measure (Attitudinal Treatment Engagement)

   Time frame: 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.

5. Treatment Retention (Treatment Completion/Continuation)

   Time frame: 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.

6. Treatment Evaluation Inventory - Short Form

   Time frame: 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.

7. Working Alliance Inventory - Short Revised

   Time frame: 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.

8. 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

   Time frame: 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.

9. 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

   Time frame: 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.

10. Revised Child Anxiety and Depression Scale (RCADS-25)

    Time frame: 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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
• Background: PubMed 20823946Ingoldsby EM. Review of Interventions to Improve Family Engagement and Retention in Parent and Child Mental Health Programs. J Child Fam Stud. 2010 Oct 1;19(5):629-645. doi: 10.1007/s10826-009-9350-2.
• Background: PubMed 32253634Lyon AR, Dopp AR, Brewer SK, Kientz JA, Munson SA. Designing the Future of Children's Mental Health Services. Adm Policy Ment Health. 2020 Sep;47(5):735-751. doi: 10.1007/s10488-020-01038-x.
• Background: PubMed 29456295Lyon AR, Koerner K. User-Centered Design for Psychosocial Intervention Development and Implementation. Clin Psychol (New York). 2016 Jun;23(2):180-200. doi: 10.1111/cpsp.12154. Epub 2016 Jun 17.
• Background: PubMed 31599736Lyon AR, Munson SA, Renn BN, Atkins DC, Pullmann MD, Friedman E, Arean PA. Use of Human-Centered Design to Improve Implementation of Evidence-Based Psychotherapies in Low-Resource Communities: Protocol for Studies Applying a Framework to Assess Usability . JMIR Res Protoc. 2019 Oct 9;8(10):e14990. doi: 10.2196/14990.
• Background: PubMed 23618996Turner AM, Reeder B, Ramey J. Scenarios, personas and user stories: user-centered evidence-based design representations of communicable disease investigations. J Biomed Inform. 2013 Aug;46(4):575-84. doi: 10.1016/j.jbi.2013.04.006. Epub 2013 Apr 22.
• Background: PubMed 27524832Yeager DS, Romero C, Paunesku D, Hulleman CS, Schneider B, Hinojosa C, Lee HY, O'Brien J, Flint K, Roberts A, Trott J, Greene D, Walton GM, Dweck CS. Using Design Thinking to Improve Psychological Interventions: The Case of the Growth Mindset During the Transition to High School. J Educ Psychol. 2016 Apr;108(3):374-391. doi: 10.1037/edu0000098.
• Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Background: PubMed 29921564Bauer AM, Baldwin SA, Anguera JA, Arean PA, Atkins DC. Comparing Approaches to Mobile Depression Assessment for Measurement-Based Care: Prospective Study. J Med Internet Res. 2018 Jun 19;20(6):e10001. doi: 10.2196/10001.
• Background: PubMed 32015714Fortney JC, Unutzer J, Wrenn G, Pyne JM, Smith GR, Schoenbaum M, Harbin HT. A Tipping Point for Measurement-Based Care. Focus (Am Psychiatr Publ). 2018 Jul;16(3):341-350. doi: 10.1176/appi.focus.16303. Epub 2018 Jul 16.
• Background: PubMed 26315978Guo T, Xiang YT, Xiao L, Hu CQ, Chiu HF, Ungvari GS, Correll CU, Lai KY, Feng L, Geng Y, Feng Y, Wang G. Measurement-Based Care Versus Standard Care for Major Depression: A Randomized Controlled Trial With Blind Raters. Am J Psychiatry. 2015 Oct;172(10):1004-13. doi: 10.1176/appi.ajp.2015.14050652. Epub 2015 Aug 28.
• Background: PubMed 29954612Glazer K, Rootes-Murdy K, Van Wert M, Mondimore F, Zandi P. The utility of PHQ-9 and CGI-S in measurement-based care for predicting suicidal ideation and behaviors. J Affect Disord. 2020 Apr 1;266:766-771. doi: 10.1016/j.jad.2018.05.054. Epub 2018 Jun 15.
• Background: PubMed 20808102Richardson TM, He H, Podgorski C, Tu X, Conwell Y. Screening depression aging services clients. Am J Geriatr Psychiatry. 2010 Dec;18(12):1116-23. doi: 10.1097/JGP.0b013e3181dd1c26.
• Individual participant dataSharing planned: No. However, the study team's data and other materials will be structured and described according to best practices and the National Data Archive (NDA) five required data elements (e.g., the Global Unique Identifier, GUID) which will ensure that data are consistent with the NDA data harmonization approach. Data will also be stored in common and open formats, such as clinicaltrials.gov as a national dissemination and resource sharing platform. Information needed to make use of these data [e.g. the meaning of variable names, codes, information about missing data, other metadata etc] will be recorded in data dictionaries/codebooks that will be made accessible by the research team and will subsequently be shared alongside final datasets. Information about the study team's research process, including the details of their analysis pipeline will be maintained. This information will be accessible to all members of the research team and will be shared alongside study data.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

1 site in 1 country: see every site and its status.