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Search / Trial NCT06018285

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

Suicide Starrs Pc Adolescent Risk Assessment Triage

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.

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

0 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