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NCT06018285 · ClinicalTrials.gov registry record · NA
Stepped Approach to Reducing Risk of Suicide in Primary Care
A NA study of Suicidal Ideation and Suicide, Attempted, sponsored by Cynthia Fontanella.
- Recruiting
- Registry status
- NA
- Development phase
- 2,572
- Enrollment target
- 15
- Study locations
NCT06018285 is a NA study of Suicidal Ideation and Suicide, Attempted that is actively recruiting participants, run by Cynthia Fontanella. The registered enrollment target is 2,572 participants, above the 237-participant average among 84 other Suicidal Ideation trials with a reported enrollment target (985% higher). The trial reports 15 study locations across 1 state.
The verdict
NCT06018285, a NA study of Suicidal Ideation and Suicide, Attempted, is actively recruiting participants, sponsored by Cynthia Fontanella.
- RECRUITING
- Registry status
- NA
- Development phase
- 2,572 participants
- Enrollment target
- 15
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 2,572 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 237-participant average among 84 other Suicidal Ideation trials with a reported enrollment target (985% higher). The listed sponsor is Cynthia Fontanella, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT06018285 reports 15 study locations spanning 1 distinct geographic area - top geographies include Ohio.
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.
What interventions are being tested in trial NCT06018285?
The interventions under investigation include: Stepped Approach to Reducing Risk of Suicide in Primary Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT06018285?
This trial is sponsored by Cynthia Fontanella, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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