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Stepped Approach to Reducing Risk of Suicide in Primary Care (STARRS-PC)

This study, called STARRS-PC, is looking for ways to reduce the risk of suicide in young people aged 12-17. Suicide is a serious concern for this age group, and many at-risk youth are not identified or treated. This study will test a new approach called "Stepped Approach to Reducing Risk of Suicide in Primary Care" (BEHAVIORAL) in pediatric primary care clinics. This approach involves putting a clinical plan in place for young people who are at a higher risk for suicide. Researchers will compare this new approach to the usual care to see if it helps reduce suicidal thoughts (suicidal ideation) and suicide attempts. The study aims to enroll 2,572 young people and their parents/guardians.

Study design
This is an interventional study that plans to enroll 2,572 participants. It compares a new approach to reducing suicide risk with standard care.
What's involved
If you join, you and your parent/guardian will complete initial assessments and follow-up assessments at 3, 6, and 12 months. Medical records will also be reviewed.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after their initial assessment.

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NCT06018285

Stepped Approach to Reducing Risk of Suicide in Primary Care

Recruiting
NAAges 12–17InterventionalPrevention
Cynthia Fontanella
~2,572 participants
Updated 2025-08-08 on ClinicalTrials.gov
What's tested:Stepped Approach to Reducing Risk of Suicide in Primary Care

At a glance

Recruiting sites
12 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Columbia Suicide Severity Rating Scale (C-SSRS) [suicide attempt]
Measured over Baseline, 3, 6, 12 Months
+1 more outcome measured

Conditions

Suicidal Ideation
Suicide, Attempted
Suicide Prevention

Explore related trials

Suicidal IdeationSuicide Attempt

Where it's being run

15 sites across 1 states
Ohio15

Study leadership

  • 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

Who to contact

Cynthia Fontanella, PhD
[email protected]
(614) 938-0323
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Providers must work with patients at one of the participating PCCs.

Exclusion

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
Unable to give consent
Unable to speak English adequately to understand study procedures.

What this trial measures

  • Columbia Suicide Severity Rating Scale (C-SSRS) [suicide attempt]Baseline, 3, 6, 12 Months

    Columbia Suicide Severity Rating Scale (C-SSRS) is a semi-structured interview that tracks suicidal ideation and behavior severity over time.

  • Suicidal Ideation Questionnaire-JR [Suicidal ideation]Baseline, 3, 6, 12 Months

    Suicidal Ideation Questionnaire-JR is a 15-item modified version of the SIQ, a 30 item self-report measure of suicidal ideation severity in adolescents, that has been tested in a variety of cultural settings and has been used as an outcome measure in several pediatric treatment studies.