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Stepped Approach to Reducing Risk of Suicide in Primary Care

Who can join

Ages 12 to 17 · All sexes

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.

About the study

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?

What is being tested

• Stepped Approach to Reducing Risk of Suicide in Primary Care (behavioral)

Sponsor: Cynthia Fontanella · Participants: 2,572 · Started: Aug 8, 2023

Contact the study team

• Cynthia Fontanella, PhD · Phone: (614) 938-0323
• Priyanka Desirazu, MSE · Phone: (614) 938-1113

Official record on ClinicalTrials.gov — NCT06018285

Locations in the U.S.

Conditions

• Suicide

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.