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Strategic Treatment and Assessment for Youth (STAY)

NCT06515236 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-05-21

No results posted yet for this study

Summary

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.

Conditions

  • Depression in Adolescence
  • Suicide Prevention

Interventions

BEHAVIORAL

Strategic Treatment Assessment for Youth (STAY)

Culturally tailored measurement based care

BEHAVIORAL

Measurement Based Care As Usual

Measurement based care as usual

Sponsors & Collaborators

  • Teachers College, Columbia University

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Elizabeth Connors, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2026-10-31
Completion
2026-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06515236 on ClinicalTrials.gov