Recruiting

Suicide Risk Reduction

Sponsor:

Cynthia Fontanella

Code:

NCT06018285

Conditions

Suicidal Ideation

Suicide, Attempted

Suicide Prevention

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Stepped Approach to Reducing Risk of Suicide in Primary Care

Study Details

Brief summary:

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

Suicidal Ideation

Suicide, Attempted

Suicide Prevention

Study ID

NCT06018285

Start date

Aug 8, 2023

Status verified date

May, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2572 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Treatment As Usual

Treatment as Usual

experimental: STARRS-PC

Intervention consists of implementation of clinical pathway for youth suicide risk

Interventions

Stepped Approach to Reducing Risk of Suicide in Primary Care

Intervention consists of implementation of clinical pathway for youth suicide risk

Primary outcome measure

  • Columbia Suicide Severity Rating Scale (C-SSRS) [suicide attempt] [ Time Frame: Baseline, 3, 6, 12 Months ]
  • Suicidal Ideation Questionnaire-JR [Suicidal ideation] [ Time Frame: Baseline, 3, 6, 12 Months ]

Central Contacts and Locations

Locations

AxessPointe Community Health Centers/Health Quarters

Recruiting

Akron, Ohio, United States, 44303

Contacts

Terah Omaits, LPN

tomaits@axesspointe.org

Signature Health

Recruiting

Ashtabula, Ohio, United States, 44004

Contacts

Holzer Health System

Recruiting

Athens, Ohio, United States, 45701

Contacts

Dayton Children's Hospital - Hope Center

Recruiting

Dayton, Ohio, United States, 45404

Contacts

Shipla Sangvai, MD, MPH

sangvai@childrensdayton.org

Dayton Children's Hospital - Main

Recruiting

Dayton, Ohio, United States, 45404

Contacts

Shipla Sangvai, MD,MPH

sangvai@childrensdayton.org

Holzer Health System

Recruiting

Gallipolis, Ohio, United States, 45613

Contacts

Hilliard Pediatrics

Recruiting

Hilliard, Ohio, United States, 43026

Contacts

Holzer Health System

Recruiting

Jackson, Ohio, United States, 45640

Contacts

Maumee Pediatric Associates

Recruiting

Maumee, Ohio, United States, 43537

Contacts

Cornerstone Pediatrics

Recruiting

Miamisburg, Ohio, United States, 45342

Signature Health

Recruiting

Painesville, Ohio, United States, 44077

Contacts

Signature Health

Recruiting

Willoughby, Ohio, United States, 44094

Contacts

More Information

Sponsor

Cynthia Fontanella

Last update posted

Aug 8, 2025

Last verified

May, 2025

Keywords

  • Suicide
  • STARRS-PC
  • Adolescent
  • Risk Assessment
  • Triage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cynthia Fontanella on 2025-08-08.