Clinical trial Recruiting at 12 sites Interventional Ages 12 to 17

A program to reduce suicide risk in primary care for adolescents

Official title: Stepped Approach to Reducing Risk of Suicide in Primary Care

Run by Nationwide Children's Hospital · NCT06018285 · Data updated 2026-11-12

This study is testing a new program to see if it can help reduce the risk of suicide in teenagers aged 12-17 who visit their primary care doctors.

Quick facts

Study typeInterventional
Ages12 Years to 17 Years
SexAll
Enrollment2572 (estimated)
SponsorNationwide Children's Hospital
Academic / other
Locations15 sites (Akron, Ohio and 14 other locations)
StatusRecruiting
StartedAugust 8, 2023
Main results expectedJuly 31, 2027
Study endsJuly 31, 2027
Registry record updatedAugust 8, 2025
Trial IDNCT06018285 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adolescents aged 12-17 who are identified as being at risk for suicide and receive primary care services.

Probably not a fit

Patients who are medically or cognitively unable to participate in study procedures or do not have access to a telephone may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of the STARRS-PC intervention, a stepped approach designed to reduce suicide risk among adolescents aged 12-17 in pediatric primary care settings. It involves recruiting 2,572 participants, including both youth and their parents, who will undergo initial assessments and follow-up evaluations over a year. The intervention includes evidence-based clinical pathways for risk detection and management, compared to standard treatment practices. The study will be conducted across 14 primary care clinics, with data collected at multiple time points to assess the intervention's impact.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the incidence of suicidal behavior among adolescents in primary care settings.

How similar studies have gone: Previous studies have shown that stepped care approaches can effectively reduce suicide risk, indicating potential success for this intervention.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • AxessPointe Community Health Centers/Health Quarters
    Akron, Ohio, United States
    Recruiting
  • Signature Health
    Ashtabula, Ohio, United States
    Recruiting
  • Holzer Health System
    Athens, Ohio, United States
    Recruiting
  • Dayton Children's Hospital - Hope Center
    Dayton, Ohio, United States
    Recruiting
  • Dayton Children's Hospital - Main
    Dayton, Ohio, United States
    Recruiting
  • Holzer Health System
    Gallipolis, Ohio, United States
    Recruiting
Show 9 more locations
  • Hilliard Pediatrics
    Hilliard, Ohio, United States
    Recruiting
  • Holzer Health System
    Jackson, Ohio, United States
    Recruiting
  • Maumee Pediatric Associates
    Maumee, Ohio, United States
    Recruiting
  • Cornerstone Pediatrics
    Miamisburg, Ohio, United States
    Recruiting
  • Signature Health
    Painesville, Ohio, United States
    Recruiting
  • Signature Health
    Willoughby, Ohio, United States
    Recruiting
  • Nationwide Children's Hospital
    Columbus, Ohio, United States
    Not yet recruiting
  • Village Square Primary Care Center
    Perrysburg, Ohio, United States
    Not yet recruiting
  • Franklin Avenue Primary Care Center
    Toledo, Ohio, United States
    Terminated

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.