Actively Recruiting

Phase Not Applicable
Age: 12Years - 17Years
All Genders
NCT06018285

Stepped Approach to Reducing Risk of Suicide in Primary Care

Led by Cynthia Fontanella ยท Updated on 2025-08-08

2572

Participants Needed

15

Research Sites

207 weeks

Total Duration

On this page

Sponsors

C

Cynthia Fontanella

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Suicide is the second leading cause of death among young people aged 12-17 years in the United States, yet many youth at risk for suicide are not identified or go untreated. Stepped care approaches have been shown to be effective at reducing suicide risk in clinical settings, including primary care. The goal of this hybrid I stepped wedge effectiveness-implementation study is to test the effectiveness of a population-based quality improvement (QI) intervention, entitled STARRS-PC (Stepped Approach to Reducing Risk of Suicide in Primary Care) compared to treatment as usual (TAU), in reducing the risk of suicidal behavior among youth in the pediatric primary care setting. STARRS-PC implements a clinical pathway for youth at elevated risk for suicide in pediatric primary care clinics. Clinical pathways are tools used by health professionals to guide evidence-informed practice. The STARRS-PC pathway consists of three evidence-based suicide clinical care processes: risk detection, assessment and triage, and, if needed, follow-up transitional care. STARRS-PC is guided by the Practical, Robust Implementation, and Sustainability Model (PRISM), which allows for the study of factors that influence effective implementation of the suicide prevention clinical pathway and is focused on scalability. The main questions the study aims to answer are: * Will STARRS-PC be more effective than TAU at reducing the rate of suicide attempt at 12 months post-baseline (primary outcome)? * Will STARRS-PC be more effective than TAU at reducing suicidal ideation and non-suicidal self-injury, and improving family satisfaction at 12 months post-baseline (secondary outcomes)? * What are the barriers and facilitators of effective implementation and sustainability of STARRS-PC?

CONDITIONS

Official Title

Stepped Approach to Reducing Risk of Suicide in Primary Care

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 12 to 17 years and their parent/guardian at time of consent
  • Identified as being at risk for suicide
  • Receive primary care services at one of 14 participating sites
  • Youth recruited regardless of current or past mental health history
  • Youth with comorbid physical illness or receiving medication for physical or psychiatric conditions may participate if other criteria met
  • Providers working with patients at participating primary care clinics
Not Eligible

You will not qualify if you...

  • 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
  • Providers unable to give consent
  • Providers unable to speak English adequately to understand study procedures

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 15 locations

1

AxessPointe Community Health Centers/Health Quarters

Akron, Ohio, United States, 44303

Actively Recruiting

2

Signature Health

Ashtabula, Ohio, United States, 44004

Actively Recruiting

3

Holzer Health System

Athens, Ohio, United States, 45701

Actively Recruiting

4

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Not Yet Recruiting

5

Dayton Children's Hospital - Hope Center

Dayton, Ohio, United States, 45404

Actively Recruiting

6

Dayton Children's Hospital - Main

Dayton, Ohio, United States, 45404

Actively Recruiting

7

Holzer Health System

Gallipolis, Ohio, United States, 45613

Actively Recruiting

8

Hilliard Pediatrics

Hilliard, Ohio, United States, 43026

Actively Recruiting

9

Holzer Health System

Jackson, Ohio, United States, 45640

Actively Recruiting

10

Maumee Pediatric Associates

Maumee, Ohio, United States, 43537

Actively Recruiting

11

Cornerstone Pediatrics

Miamisburg, Ohio, United States, 45342

Actively Recruiting

12

Signature Health

Painesville, Ohio, United States, 44077

Actively Recruiting

13

Village Square Primary Care Center

Perrysburg, Ohio, United States, 43551

Not Yet Recruiting

14

Franklin Avenue Primary Care Center

Toledo, Ohio, United States, 43620

Terminated

15

Signature Health

Willoughby, Ohio, United States, 44094

Actively Recruiting

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Research Team

C

Cynthia Fontanella, PhD

CONTACT

P

Priyanka Desirazu, MSE

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

2

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Stepped Approach to Reducing Risk of Suicide in Primary Care | DecenTrialz