# Signature Project

> **NIH NIH P50** · RESEARCH INST NATIONWIDE CHILDREN'S HOSP · 2022 · $756,296

## Abstract

Suicide is the second leading cause of death in those aged 10 to 19 years; it is a critical public health problem.
Suicidal ideation and nonfatal suicide attempts are even more prevalent and result in substantial morbidity and
increased risk of suicide. Pediatric primary care is an ideal service setting for intervention research designed to
rapidly reduce suicide and suicidal behaviors among US youth, as 80% of youth who die by suicide are seen
by their primary care clinicians (PCC) in the year prior to death while only 20% have contact with a mental
health professional. Despite the importance of identifying youth at risk for suicidal behavior, most PCCs do not
routinely screen for suicide.
 In recent years, new treatment and management strategies have been developed, tested and implemented
in some organizations, but they are not yet widely used. Existing clinical trials have tended to focus on testing
effectiveness of evidenced-based interventions (e.g., universal screening, safety planning) for high-risk
populations in emergency departments; less is known about the efficacy of these approaches in primary care
settings. Research is critically needed to test the effectiveness of evidence-informed practices to reduce
suicide risk for youth treated in primary care.
 To address this gap, we propose a stepped wedge hybrid effectiveness-implementation cluster-randomized
controlled trial to test effectiveness of a population-based quality improvement (QI) intervention, Stepped
Approach to Reducing Suicide in Primary Care (STARRS_PC) that implements a clinical pathway for youth
identified by screening as being at elevated risk for suicide. The pathway is designed to promote the use of
evidence-based suicide clinical care processes and includes three separate components: suicide risk
screening, risk assessment and triage, and care management. The application builds on a pilot study of real-
world implementation of suicide risk screening into a pediatric primary care setting, using an iterative Plan, Do,
Study, Act (PDSA) quality improvement approach that was well-accepted by patients, families, and PCCs. In
the proposed study, we will test the effectiveness of STARRS-PC relative to treatment as usual (TAU) on
primary (suicidal attempts and suicide deaths), secondary outcomes (suicidal ideation, non-suicidal self-injury,
and family satisfaction) at 3, 6, 12 months post-baseline; examine clinicians’ knowledge, self-efficacy, and buy-
in regarding suicide risk screening, assessment, and management as mechanisms of change; and
organizational factors (e.g., organizational readiness and practice integrations) as potential moderators of the
treatment effect on patient outcomes During this five-year project, we will recruit and assess 2274 youth aged
12 to 17 years from 12 primary care sites, including 910 youths during the TAU phase and 1364 youths during
the Screening + Intervention phase. Participating sites serve vulnerable low-income youth in urban and rura...

## Key facts

- **NIH application ID:** 10436046
- **Project number:** 1P50MH127476-01A1
- **Recipient organization:** RESEARCH INST NATIONWIDE CHILDREN'S HOSP
- **Principal Investigator:** Cynthia Ann Fontanella
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $756,296
- **Award type:** 1
- **Project period:** 2022-08-01 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10436046

## Citation

> US National Institutes of Health, RePORTER application 10436046, Signature Project (1P50MH127476-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10436046. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*
