Stepped Approach to Reducing Risk of Suicide in Primary Care

NCT06018285 | Recruiting DMC

• 3 other identifiers: STUDY000025151P50MH1274767956
• Study Type: interventional
• Target: 2,572
• Locations: 1 country
• Sites: 15

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Columbia Suicide Severity Rating Scale (C-SSRS) [suicide attempt]

  Columbia Suicide Severity Rating Scale (C-SSRS) is a semi-structured interview that tracks suicidal ideation and behavior severity over time.

  Baseline, 3, 6, 12 Months

• Suicidal Ideation Questionnaire-JR [Suicidal ideation]

  Suicidal Ideation Questionnaire-JR is a 15-item modified version of the SIQ, a 30 item self-report measure of suicidal ideation severity in adolescents, that has been tested in a variety of cultural settings and has been used as an outcome measure in several pediatric treatment studies.

  Baseline, 3, 6, 12 Months

Secondary Outcomes (5)

• Non-Suicidal Self-Injury (NSSI) [NSSI]

  This measure will be administered to youth only at baseline as well as at 3-, 6-, and 12-months after baseline to track NSSI over time. This is a youth only assessment.

• Client Satisfaction Questionnaire-8 (CSQ-8) [Family satisfaction]

  Baseline ONLY, Parent and Child receive survey independently.

• AIM (Acceptability of Intervention Measure) [Family satisfaction]

  Baseline ONLY, Parent and Child receive survey independently.

• Service Assessment Child and Adolescent

  Baseline, 3, 6, & 12 Month Follow-ups. Parent ONLY receives this measure.

• Social Determinants of Health

  Baseline. Parent ONLY Assessment

Other Outcomes (2)

• The DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure

  Baseline, 3, 6, & 12 Month Follow-ups. Parent & youth receive this independently from each other.

• The RCADS-25 Assessment

  Baseline appointment ONLY. Parent & youth will complete independently from each other.

Study Arms (2)

Treatment As Usual

NO INTERVENTION

Treatment as Usual

STARRS-PC

EXPERIMENTAL

Intervention consists of implementation of clinical pathway for youth suicide risk

Behavioral: Stepped Approach to Reducing Risk of Suicide in Primary Care

Interventions

Stepped Approach to Reducing Risk of Suicide in Primary Care BEHAVIORAL

Intervention consists of implementation of clinical pathway for youth suicide risk

STARRS-PC

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Providers must work with patients at one of the participating PCCs.

You may not qualify if:

• 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
• Unable to give consent
• Unable to speak English adequately to understand study procedures.

Sponsors & Collaborators

• Cynthia Fontanella: lead
• National Institute of Mental Health (NIMH): collaborator
• Ohio State University: collaborator
• Holzer Athens: collaborator
• Signature Health Ashtabula: collaborator
• Signature Health Willoughby: collaborator
• Signature Health Painesville: collaborator
• AxessPointe - Arlington: collaborator
• Dayton Children's Pediatrics - Main Campus: collaborator
• Dayton Children's Pediatrics - Hope Center: collaborator
• Cornerstone Pediatrics: collaborator
• Village Square Primary Care Center: collaborator
• Maumee Pediatric Associates: collaborator
• Holzer Jackson: collaborator
• Holzer Gallipolis: collaborator
• AxessPointe - Health Quarters: collaborator

Study Sites (15)

AxessPointe Community Health Centers/Health Quarters

Akron, Ohio, 44303, United States

RECRUITING

Signature Health

Ashtabula, Ohio, 44004, United States

RECRUITING

Holzer Health System

Athens, Ohio, 45701, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

NOT YET RECRUITING

Dayton Children's Hospital - Hope Center

Dayton, Ohio, 45404, United States

RECRUITING

Dayton Children's Hospital - Main

Dayton, Ohio, 45404, United States

RECRUITING

Holzer Health System

Gallipolis, Ohio, 45613, United States

RECRUITING

Hilliard Pediatrics

Hilliard, Ohio, 43026, United States

RECRUITING

Holzer Health System

Jackson, Ohio, 45640, United States

RECRUITING

Maumee Pediatric Associates

Maumee, Ohio, 43537, United States

RECRUITING

Cornerstone Pediatrics

Miamisburg, Ohio, 45342, United States

RECRUITING

Signature Health

Painesville, Ohio, 44077, United States

RECRUITING

Village Square Primary Care Center

Perrysburg, Ohio, 43551, United States

NOT YET RECRUITING

Franklin Avenue Primary Care Center

Toledo, Ohio, 43620, United States

TERMINATED

Signature Health

Willoughby, Ohio, 44094, United States

RECRUITING

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MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted; Suicide Prevention; Suicide

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jeffrey Bridge, PhD

  Abigail Wexner Research Institute at NCH

  PRINCIPAL INVESTIGATOR

• Alex Kemper, MD, MPH, MS

  Abigail Wexner Research Institute at NCH

  PRINCIPAL INVESTIGATOR

• Cynthia Fontanella, PhD

  Abigail Wexner Research Institute at NCH

  STUDY DIRECTOR

• Jennifer Hughes, PhD, MPH

  Abigail Wexner Research Institue at NCH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Fontanella, PhD

CONTACT

(614) 938-0323; cynthia.fontanella@nationwidechildrens.org

Priyanka Desirazu, MSE

CONTACT

(614) 938-1113; STARRS@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Stepped Wedge Design

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 30, 2023
• Study Start: August 8, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: We will follow NIMH guidelines for dissemination of study data and related materials.
• Access Criteria: To be provided.

Locations

US (15)