Strategic Treatment Assessment for Youth for Suicide Prevention

(STAY Trial)

Overseen By Elizabeth Connors, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Non-minoritized, Non-depressed, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mental health treatment approach called STAY (Strategic Treatment Assessment for Youth), designed specifically for racial and ethnic minority youth experiencing depression or thoughts of self-harm. The trial compares this new approach to usual care to determine which is more effective. Participants who may be a good fit have moderate depression symptoms and identify as a racial or ethnic minority, such as Black, Hispanic, or Asian American. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research tailored to their community's needs.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the STAY protocol is safe for REM youth?

Research shows that the Strategic Treatment Assessment for Youth (STAY) helps young people from racially and ethnically diverse backgrounds who face depression or suicidal thoughts. Although specific safety data from trials about STAY is not available, it builds on a method called measurement-based care (MBC), commonly used in mental health treatment.

Those who have used MBC generally find it safe and helpful, with improvements in managing depression and reducing suicidal thoughts. For instance, one study found that suicidal thoughts decreased by 54% by the time of discharge. This suggests that the STAY approach might also be safe and beneficial.

STAY enhances MBC by incorporating cultural elements to better serve diverse groups. While detailed safety data specifically for STAY is lacking, its foundation on a proven method like MBC provides some confidence in its safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Strategic Treatment Assessment for Youth (STAY) because it offers a culturally-tailored approach to suicide prevention for racial and ethnic minoritized adolescents. Unlike standard measurement-based care (MBC), which mainly focuses on symptom monitoring, STAY incorporates cultural competence training and personalized goal setting to better address the unique needs of these communities. This approach aims to enhance the therapeutic alliance and improve treatment outcomes by aligning care with the adolescents' cultural context and expectations.

What evidence suggests that this trial's treatments could be effective for depressive symptoms or suicidal thoughts and behaviors?

Research has shown that the Strategic Treatment Assessment for Youth (STAY) approach, a treatment in this trial, holds promise for assisting young people from racially and ethnically diverse backgrounds who face depression or suicidal thoughts. Studies have found that culturally tailored methods like STAY can make mental health treatments more relatable and effective for these groups. Early results suggest that STAY helps maintain these young people's engagement in mental health care, which is crucial for their ongoing support. By focusing on cultural needs and personalizing care, STAY aims to reduce the risk of depression and suicide in these communities. ^{1 3 6 7 8}

Who Is on the Research Team?

Elizabeth Connors, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

The STAY trial is for racially and ethnically minoritized youth aged 12-18 with moderate depression or suicidal thoughts/behaviors. Participants must have contacted a participating agency within the last month, speak English or Spanish, and have a guardian to consent. Clinicians, youth, and parents/caregivers are involved.

Inclusion Criteria

My legal guardian can give consent for me.

I am part of a group (clinician, youth, or caregiver) involved in a mental health study.

I am a part of a racial or ethnic minority group.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Protocol Refinement

Refinement of the STAY protocol and implementation plan using user-centered design methods

6 months

Pilot Testing

Pilot effectiveness-implementation Hybrid Type 2 trial of STAY vs MBC As Usual

20 months

Monthly 1-hour consultation calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Measurement Based Care As Usual
• Strategic Treatment Assessment for Youth (STAY)

Trial Overview STAY compares two approaches in treating depressed REM youths: the new Strategic Treatment Assessment for Youth (STAY) versus Measurement Based Care As Usual. The study aims to refine STAY's protocol and test its effectiveness in community mental health clinics.

How Is the Trial Designed?

Group I: Strategic Treatment Assessment for Youth (STAY) Experimental Treatment 1 Intervention

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.

Group II: Measurement-Based Care (MBC) As Usual Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Teachers College, Columbia University

Collaborator

Trials

27

Recruited

6,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39541064/

Strategic Treatment and Assessment for Youth (STAY) - PubMed Racial and ethnic minoritized (REM) youth are at greater risk for depression and suicide than their White peers. Despite this, REM youth are ...

2. reporter.nih.gov reporter.nih.gov/project-details/11011441

Strategic Treatment Assessment with Youth (STAY) This project offers an innovative, culturally-tailored approach to retain REM youth in mental health services, reduce disparities and improve patient outcomes.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06515236/strategic-treatment-and-assessment-for-youth-stay

Strategic Treatment and Assessment for Youth (STAY) *Note: This study includes data collection from mental health clinicians, youth, and parents/caregivers. The age limits for each participant group vary and ...

4. clinicaltrial.be clinicaltrial.be/en/details/458102?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Strategic Treatment and Assessment for Youth (STAY) - Cli... It is predictive of lifetime history of non-suicidal self-injury among adolescents and suicide attempts at return visit to an emergency ...

5. withpower.com withpower.com/trial/strategic-treatment-assessment-for-youth-for-suicide-prevention-9fa0e

Strategic Treatment Assessment for Youth for Suicide ... The STAY trial is for racially and ethnically minoritized youth aged 12-18 with moderate depression or suicidal thoughts/behaviors. Participants must have ...

6. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2834286

Safety Planning Interventions for Suicide Prevention in ... This systematic review and meta-analysis investigates the effectiveness of safety planning as a standalone intervention for suicide ...

7. childrenshospitals.org childrenshospitals.org/news/childrens-hospitals-today/2025/08/preventing-youth-suicide-with-evidence-based-care

Preventing Youth Suicide With Evidence-Based Care Suicidal thoughts decreased by 54% by the time of discharge. · There was a large reduction of depressive symptoms, with significant improvement ...

8. mentalhealth.bmj.com mentalhealth.bmj.com/content/28/1/e301575

Preventing suicide with Safe Alternatives for Teens and ... At the primary endpoint, two (14%) participants in SAFETY and four (27%) in supportive therapy had attempted suicide. Non-suicidal self-injury ...