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Stepped Approach to Reducing Risk of Suicide in Primary Care
NCT06018285 · View on ClinicalTrials.gov ↗
Study 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?
Conditions Studied
Interventions
- BEHAVIORAL Stepped Approach to Reducing Risk of Suicide in Primary Care
Study Locations (15)
Ohio
- AxessPointe Community Health Centers/Health Quarters — Akron
- Signature Health — Ashtabula
- Holzer Health System — Athens
- Nationwide Children's Hospital — Columbus
- Dayton Children's Hospital - Hope Center — Dayton
- Dayton Children's Hospital - Main — Dayton
- Holzer Health System — Gallipolis
- Hilliard Pediatrics — Hilliard
- Holzer Health System — Jackson
- Maumee Pediatric Associates — Maumee
- Cornerstone Pediatrics — Miamisburg
- Signature Health — Painesville
- Village Square Primary Care Center — Perrysburg
- Franklin Avenue Primary Care Center — Toledo
- Signature Health — Willoughby
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,572 participants |
| Start Date | 2023-08-08 |
| Est. Completion | 2027-07-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06018285
The ClinicalTrials.gov registry entry for NCT06018285 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,572 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cynthia Fontanella, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Suicidal Ideation appearing as the primary indexed condition, and to 1 intervention — of which Stepped Approach to Reducing Risk of Suicide in Primary Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06018285 reports 15 study locations spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06018285 about?
NCT06018285 is a clinical study titled "Stepped Approach to Reducing Risk of Suicide in Primary Care". 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....
What is the current status of trial NCT06018285?
This trial is currently recruiting. It is a NA study. The enrollment target is 2,572 participants. The study started on 2023-08-08. Estimated completion is 2027-07-31.
What conditions does trial NCT06018285 study?
This clinical trial studies the following conditions: Suicidal Ideation, Suicide, Attempted, Suicide Prevention. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06018285?
The interventions under investigation include: Stepped Approach to Reducing Risk of Suicide in Primary Care (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06018285?
This trial is sponsored by Cynthia Fontanella, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06018285 being conducted?
This trial has 15 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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