A program to reduce suicide risk in primary care for adolescents
Stepped Approach to Reducing Risk of Suicide in Primary Care
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2572 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 15 sites (Akron, Ohio and 14 other locations) |
| Trial ID | NCT06018285 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown that stepped care approaches can effectively reduce suicide risk, indicating potential success for this intervention.
Eligibility criteria
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 this trial is running
Akron, Ohio and 14 other locations
- 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)
- Nationwide Children's Hospital — Columbus, Ohio, United States (Not_yet_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)
- 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)
- Village Square Primary Care Center — Perrysburg, Ohio, United States (Not_yet_recruiting)
- Franklin Avenue Primary Care Center — Toledo, Ohio, United States (Terminated)
- Signature Health — Willoughby, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Bridge, PhD — Abigail Wexner Research Institute at NCH
- Study coordinator: Cynthia Fontanella, PhD
- Email: cynthia.fontanella@nationwidechildrens.org
- Phone: (614) 938-0323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.