Actively Recruiting
Stepped Approach to Reducing Risk of Suicide in Primary Care
Led by Cynthia Fontanella ยท Updated on 2025-08-08
2572
Participants Needed
15
Research Sites
207 weeks
Total Duration
On this page
Sponsors
C
Cynthia Fontanella
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Stepped Approach to Reducing Risk of Suicide in Primary Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 to 17 years and their parent/guardian at time of consent
- Identified as being at risk for suicide
- Receive primary care services at one of 14 participating sites
- Youth recruited regardless of current or past mental health history
- Youth with comorbid physical illness or receiving medication for physical or psychiatric conditions may participate if other criteria met
- Providers working with patients at participating primary care clinics
You will not qualify if you...
- Medically or cognitively unable to participate in study procedures
- Without permanent residence or access to a telephone
- Unable to speak English adequately to understand study procedures
- Providers unable to give consent
- Providers unable to speak English adequately to understand study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
AxessPointe Community Health Centers/Health Quarters
Akron, Ohio, United States, 44303
Actively Recruiting
2
Signature Health
Ashtabula, Ohio, United States, 44004
Actively Recruiting
3
Holzer Health System
Athens, Ohio, United States, 45701
Actively Recruiting
4
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Not Yet Recruiting
5
Dayton Children's Hospital - Hope Center
Dayton, Ohio, United States, 45404
Actively Recruiting
6
Dayton Children's Hospital - Main
Dayton, Ohio, United States, 45404
Actively Recruiting
7
Holzer Health System
Gallipolis, Ohio, United States, 45613
Actively Recruiting
8
Hilliard Pediatrics
Hilliard, Ohio, United States, 43026
Actively Recruiting
9
Holzer Health System
Jackson, Ohio, United States, 45640
Actively Recruiting
10
Maumee Pediatric Associates
Maumee, Ohio, United States, 43537
Actively Recruiting
11
Cornerstone Pediatrics
Miamisburg, Ohio, United States, 45342
Actively Recruiting
12
Signature Health
Painesville, Ohio, United States, 44077
Actively Recruiting
13
Village Square Primary Care Center
Perrysburg, Ohio, United States, 43551
Not Yet Recruiting
14
Franklin Avenue Primary Care Center
Toledo, Ohio, United States, 43620
Terminated
15
Signature Health
Willoughby, Ohio, United States, 44094
Actively Recruiting
Research Team
C
Cynthia Fontanella, PhD
CONTACT
P
Priyanka Desirazu, MSE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here