Strategic Treatment and Assessment for Youth (STAY)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06515236
Status
Enrolling By Invitation

Conditions

  • Depression in Adolescence
  • Suicide Prevention

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Strategic Treatment Assessment for Youth (STAY) — BEHAVIORAL
    Culturally tailored measurement based care
  • Measurement Based Care As Usual — BEHAVIORAL
    Measurement based care as usual

Study Details

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.

Key Dates

Start date
Mar 25, 2025
Status verified
May 2025
Primary completion
Oct 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06511-

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By research site
Yale University· New Haven, CT

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