NCT06018285 · Cynthia Fontanella
Stepped Approach to Reducing Risk of Suicide in Primary Care
(STARRS-PC)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (Youth and Parent):
- All patients between the ages of 12 - 17 years and their parent/guardian at time of consent who are identified as being at risk for suicide and receive primary care services at one of 14 participating sites are eligible for study inclusion.
- Youth will be recruited without regard to current or past histories of mental health problems.
- Youth with comorbid physical illness (e.g., asthma) and those receiving medication treatment for a comorbid physical or psychiatric condition will be eligible to participate provide they otherwise meet study entry criteria. Inclusion Criteria (Provider):
- Providers must work with patients at one of the participating PCCs.
Exclusion criteria
- (Youth and Parent): Subjects will be excluded for being:
- 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 Exclusion Criteria (Provider):
- Unable to give consent
- Unable to speak English adequately to understand study procedures.
Where
- Akron, Ohio
- Ashtabula, Ohio
- Athens, Ohio
- Columbus, Ohio
- Dayton, Ohio
- Gallipolis, Ohio
- Hilliard, Ohio
- Jackson, Ohio
- Maumee, Ohio
- Miamisburg, Ohio
- Painesville, Ohio
- Perrysburg, Ohio
And 2 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 8, 2025 · Source of record for eligibility and locations