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Recruiting Not applicable Interventional

Stepped Approach to Reducing Risk of Suicide in Primary Care

ClinicalTrials.gov ID: NCT06018285

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.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:50 PM EDT

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
Lead sponsor
Cynthia Fontanella
Other
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.

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