Stepped Approach to Reducing Risk of Suicide in Primary Care

Recruiting now · Not applicable

Conditions studied: Suicidal Ideation, Suicide, Attempted, Suicide Prevention

In brief

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 facts

Study ID

NCT06018285

Run by

Cynthia Fontanella

People needed

2572

Starts

2023-08-08

Expected to finish

2027-07-31

Last updated by the study team

2025-08-08

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Signature Health — Willoughby, Ohio, United States (enrolling)
• Signature Health — Ashtabula, Ohio, United States (enrolling)
• Holzer Health System — Athens, Ohio, United States (enrolling)
• Cornerstone Pediatrics — Miamisburg, Ohio, United States (enrolling)
• Signature Health — Painesville, Ohio, United States (enrolling)
• AxessPointe Community Health Centers/Health Quarters — Akron, Ohio, United States (enrolling)
• Dayton Children's Hospital - Hope Center — Dayton, Ohio, United States (enrolling)
• Dayton Children's Hospital - Main — Dayton, Ohio, United States (enrolling)
• Holzer Health System — Gallipolis, Ohio, United States (enrolling)
• Hilliard Pediatrics — Hilliard, Ohio, United States (enrolling)
• Holzer Health System — Jackson, Ohio, United States (enrolling)
• Maumee Pediatric Associates — Maumee, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Village Square Primary Care Center — Perrysburg, Ohio, United States
• Franklin Avenue Primary Care Center — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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