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RECRUITING
NCT06018285
NA

Stepped Approach to Reducing Risk of Suicide in Primary Care

Sponsor: Cynthia Fontanella

View on ClinicalTrials.gov

Summary

Suicide is the second leading cause of death among young people aged 12-17 years in the United States, yet many youth at risk for suicide are not identified or go untreated. Stepped care approaches have been shown to be effective at reducing suicide risk in clinical settings, including primary care. The goal of this hybrid I stepped wedge effectiveness-implementation study is to test the effectiveness of a population-based quality improvement (QI) intervention, entitled STARRS-PC (Stepped Approach to Reducing Risk of Suicide in Primary Care) compared to treatment as usual (TAU), in reducing the risk of suicidal behavior among youth in the pediatric primary care setting. STARRS-PC implements a clinical pathway for youth at elevated risk for suicide in pediatric primary care clinics. Clinical pathways are tools used by health professionals to guide evidence-informed practice. The STARRS-PC pathway consists of three evidence-based suicide clinical care processes: risk detection, assessment and triage, and, if needed, follow-up transitional care. STARRS-PC is guided by the Practical, Robust Implementation, and Sustainability Model (PRISM), which allows for the study of factors that influence effective implementation of the suicide prevention clinical pathway and is focused on scalability. The main questions the study aims to answer are: * Will STARRS-PC be more effective than TAU at reducing the rate of suicide attempt at 12 months post-baseline (primary outcome)? * Will STARRS-PC be more effective than TAU at reducing suicidal ideation and non-suicidal self-injury, and improving family satisfaction at 12 months post-baseline (secondary outcomes)? * What are the barriers and facilitators of effective implementation and sustainability of STARRS-PC?

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

2572

Start Date

2023-08-08

Completion Date

2027-07-31

Last Updated

2025-08-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

Stepped Approach to Reducing Risk of Suicide in Primary Care

Intervention consists of implementation of clinical pathway for youth suicide risk

Locations (15)

AxessPointe Community Health Centers/Health Quarters

Akron, Ohio, United States

Signature Health

Ashtabula, Ohio, United States

Holzer Health System

Athens, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Dayton Children's Hospital - Hope Center

Dayton, Ohio, United States

Dayton Children's Hospital - Main

Dayton, Ohio, United States

Holzer Health System

Gallipolis, Ohio, United States

Hilliard Pediatrics

Hilliard, Ohio, United States

Holzer Health System

Jackson, Ohio, United States

Maumee Pediatric Associates

Maumee, Ohio, United States

Cornerstone Pediatrics

Miamisburg, Ohio, United States

Signature Health

Painesville, Ohio, United States

Village Square Primary Care Center

Perrysburg, Ohio, United States

Franklin Avenue Primary Care Center

Toledo, Ohio, United States

Signature Health

Willoughby, Ohio, United States