Stepped Approach to Reducing Risk of Suicide in Primary Care
Launched by CYNTHIA FONTANELLA · Aug 25, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called the STARRS-PC study, aims to find better ways to help young people who may be at risk of suicide. Suicide is a serious issue, especially among teens aged 12 to 17, and many at-risk youths are not getting the help they need. The study will compare a new care approach, which includes specific steps for identifying and supporting these young people, against the usual care they receive. This new method includes important processes like checking for suicide risk, assessing needs, and providing follow-up care if necessary.
To participate in this study, young people aged 12 to 17 and their parents or guardians must be identified as at risk for suicide and receiving care at one of the participating clinics. Importantly, the study is open to youths regardless of their past mental health history. Participants can expect to be part of a structured care pathway that aims to reduce the risk of suicide and improve overall family satisfaction over the course of a year. The study not only looks at how effective this new approach is but also explores what works well and what challenges exist in implementing it.
Gender
ALL
Eligibility criteria
- 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.
About Cynthia Fontanella
Cynthia Fontanella is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With extensive experience in managing and overseeing clinical trials, she emphasizes rigorous adherence to regulatory standards and ethical practices. Cynthia’s collaborative approach fosters partnerships with healthcare professionals, researchers, and institutions, facilitating the development of innovative therapies across various therapeutic areas. Her leadership ensures that each trial is conducted with precision, integrity, and a focus on generating valuable data to inform future clinical practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Columbus, Ohio, United States
Akron, Ohio, United States
Ashtabula, Ohio, United States
Athens, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Gallipolis, Ohio, United States
Hilliard, Ohio, United States
Holland, Ohio, United States
Jackson, Ohio, United States
Kettering, Ohio, United States
Miamisburg, Ohio, United States
Painesville, Ohio, United States
Perrysburg, Ohio, United States
Toledo, Ohio, United States
Willoughby, Ohio, United States
Akron, Ohio, United States
Dayton, Ohio, United States
Maumee, Ohio, United States
Patients applied
Trial Officials
Jeffrey Bridge, PhD
Principal Investigator
Abigail Wexner Research Institute at NCH
Alex Kemper, MD, MPH, MS
Principal Investigator
Abigail Wexner Research Institute at NCH
Cynthia Fontanella, PhD
Study Director
Abigail Wexner Research Institute at NCH
Jennifer Hughes, PhD, MPH
Principal Investigator
Abigail Wexner Research Institue at NCH
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported