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

140 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Elizabeth Connors, PhD

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+