Stepped Approach to Reducing Risk of Suicide in Primary Care
Public ClinicalTrials.gov record NCT06018285. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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?
Study identification
- NCT ID
- NCT06018285
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 2,572 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 12 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 7, 2023
- Primary completion
- Jul 30, 2027
- Completion
- Jul 30, 2027
- Last update posted
- Aug 7, 2025
2023 – 2027
United States locations
- U.S. sites
- 15
- U.S. states
- 1
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AxessPointe Community Health Centers/Health Quarters | Akron | Ohio | 44303 | Recruiting |
| Signature Health | Ashtabula | Ohio | 44004 | Recruiting |
| Holzer Health System | Athens | Ohio | 45701 | Recruiting |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | Not yet recruiting |
| Dayton Children's Hospital - Hope Center | Dayton | Ohio | 45404 | Recruiting |
| Dayton Children's Hospital - Main | Dayton | Ohio | 45404 | Recruiting |
| Holzer Health System | Gallipolis | Ohio | 45613 | Recruiting |
| Hilliard Pediatrics | Hilliard | Ohio | 43026 | Recruiting |
| Holzer Health System | Jackson | Ohio | 45640 | Recruiting |
| Maumee Pediatric Associates | Maumee | Ohio | 43537 | Recruiting |
| Cornerstone Pediatrics | Miamisburg | Ohio | 45342 | Recruiting |
| Signature Health | Painesville | Ohio | 44077 | Recruiting |
| Village Square Primary Care Center | Perrysburg | Ohio | 43551 | Not yet recruiting |
| Franklin Avenue Primary Care Center | Toledo | Ohio | 43620 | Terminated |
| Signature Health | Willoughby | Ohio | 44094 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06018285, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 7, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06018285 live on ClinicalTrials.gov.