Stepped Approach to Reducing Risk of Suicide in Primary Care (STARRS-PC)

August 25, 2023 updated by: Cynthia Fontanella

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This five-year multi-site study consists of the following essential elements: (1) recruitment of 2,324 adolescents ages 12-17 years inclusive at baseline, and their parent/guardian; (2) initial assessment of youth and parent/guardian participants using direct interviews and standardized questionnaires; and (3) follow-up assessments of all participants at 3-months, 6-months, and 1-year post-baseline. To achieve the study objectives, the project will be conducted in 16 pediatric primary care practices.

The study consists of three phases of data collection: TAU, intervention, and sustainability. One thousand thirty-three suicidal youth will be enrolled during the TAU phase, and 1,291 suicidal youth will be enrolled during the intervention phase (total number of youth participants = 2,324). Youth and parent participants enrolled in the study will complete multiple questionnaires at four time points (baseline, 3-months, 6-months, and 12-months). Medical record reviews of youth participant files will occur throughout the study and be reviewed by research staff. The intervention phase is followed by a 6-month sustainability phase during which the participating practices will work on maintaining or further improving upon the anticipated gains made during the intervention phase.

Phase 1: TAU

TAU immediately precedes the intervention phase and ranges in length from 6 to 26 months. During TAU, participants will be treated according to usual and customary care, thus establishing each site's baseline rate of suicide risk screening and detection. Usual care at each participating practice involves screening for depression and suicide risk with the PHQ-9. This baseline rate will serve as the control for subsequent study phases.

Phase 2: Intervention

The intervention phase will range from 11 to 30 months. During this phase, each site will implement the clinical pathway, which includes universal screening for suicide risk using the Ask Suicide-Screening Questions (ASQ), a four-item questionnaire. Those who screen positive will then be evaluated using the Brief Suicide Safety Assessment (BSSA). The BSSA allows the clinician to assess the level of suicide risk to then choose how to proceed with clinical next steps. Clinicians will triage care based on three categories of risk: low-risk, further evaluation needed, and imminent-risk. The risk assessment will determine the type of care the individual then receives (e.g., mental health referrals, mental health evaluation and safety plan, tele-psychiatry crisis intervention consultation, send to ED).

We will also conduct in-depth qualitative interviews with a purposive sample of providers (e.g., physicians, nurses, social workers) at each of the participating sites. Purposive sampling is a way to identify and recruit participants that are especially experienced with or knowledgeable about a phenomenon of interest. Provider participants will complete a series of questionnaires at three separate times: 1) prior to clinical pathway training, 2) after training, and 3) 6 months after training. Provider participants will also be trained on the quality improvement process for implementing the intervention strategy. Some provider participants will be asked to complete up to four qualitative interviews that will focus on the implementation process, barriers and facilitators to successful implementation of the clinical pathway, and lessons learned.

Phase 3: Sustainability

The intervention phase is followed by a 6-month sustainability phase during which the site will work on maintaining or further improving upon the anticipated gains made during the intervention phase. No participants will be recruited during the sustainability phase and this phase will not be used to evaluate intervention effectiveness.

The specific aims include:

Aim 1: To implement, study, and improve through a Plan-Do-Study-Act (PDSA) cycle, the STARRS-PC intervention that includes suicide risk detection, assessment and triage, and care management based on risk profile. PDSA is a systematic way to test a change that is implemented by breaking down the implementation process into specific steps, and then evaluating the outcome, improving on it, and testing again.

Aim 2: Test the effectiveness of STARRS-PC compared to TAU on the primary patient outcome, suicide attempts, secondary patient outcomes (suicidal ideation, non-suicidal self-injury (NSSI), and family satisfaction) at 12 months post-baseline, as well as mediators and moderators, through a stepped wedge design.

  • Hypotheses: STARRS-PC will significantly reduce the rate of: 1) suicide attempts (nonfatal and fatal) and 2) suicidal ideation, NSSI, and improve family satisfaction during the 12-month post-baseline follow-up period compared with TAU.
  • Exploratory Aim 2a: To examine whether increases in provider knowledge, self-efficacy, and buy-in regarding suicide risk screening, assessment, and management will mediate the intervention effect on patient outcomes.
  • Exploratory Aim 2b: To examine whether organization readiness and practice integration will moderate effects of intervention on patient outcomes.

Aim 3: To identify barriers to and facilitators of implementation and sustainability of an intervention designed to improve suicide risk detection and risk management using qualitative interviews and surveys with clinical stakeholders at each study site.

Study Type

Interventional

Enrollment (Estimated)

4648

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44333
        • Not yet recruiting
        • AxessPointe Community Health Centers/Arlington
        • Contact:
      • Ashtabula, Ohio, United States, 44004
        • Not yet recruiting
        • Signature Health
        • Contact:
      • Athens, Ohio, United States, 45701
        • Not yet recruiting
        • Holzer Health System
        • Contact:
      • Columbus, Ohio, United States, 43205
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Eastglen Pediatrics
        • Contact:
      • Dayton, Ohio, United States, 45404
      • Dayton, Ohio, United States, 45404
      • Gallipolis, Ohio, United States, 45613
        • Not yet recruiting
        • Holzer Health System
        • Contact:
      • Hilliard, Ohio, United States, 43026
      • Holland, Ohio, United States, 43528
      • Jackson, Ohio, United States, 45640
        • Not yet recruiting
        • Holzer Health System
        • Contact:
      • Kettering, Ohio, United States, 45429
        • Not yet recruiting
        • Kettering Pediatric and Family Care
        • Contact:
      • Miamisburg, Ohio, United States, 45342
        • Not yet recruiting
        • Cornerstone Pediatrics
      • Painesville, Ohio, United States, 44077
        • Not yet recruiting
        • Signature Health
        • Contact:
      • Perrysburg, Ohio, United States, 43551
      • Toledo, Ohio, United States, 43620
      • Willoughby, Ohio, United States, 44094
        • Not yet recruiting
        • Signature Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 16 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment As Usual
Treatment as Usual
Experimental: STARRS-PC
Intervention consists of implementation of clinical pathway for youth suicide risk
Behavioral: Stepped Approach to Reducing Risk of Suicide in Primary Care
Intervention consists of implementation of clinical pathway for youth suicide risk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Columbia Suicide Severity Rating Scale (C-SSRS) [suicide attempt]
Time Frame: Baseline, 3, 6, 12 Months
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
Pierce Suicide Intent Scale (SIS) [suicide attempt]
Time Frame: Based on most recent attempt from CSSRS at baseline, 3, 6 and 12 months
Pierce Suicide Intent Scale (SIS) is a questionnaire that assesses behavior and circumstances surrounding the suicide attempt, including plans, preparation, communicative elements, and concept of lethality of the chosen method.
Based on most recent attempt from CSSRS at baseline, 3, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-Suicidal Self-Injury (NSSI) [NSSI]
Time Frame: 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.
The Non-Suicidal Self-Injury (NSSI) Assessment measures recent and lifetime 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.
Suicidal Ideation Questionnaire-JR [Suicidal ideation]
Time Frame: Baseline, 3, 6, 12 Months
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
Client Satisfaction Questionnaire-8 (CSQ-8) [Family satisfaction]
Time Frame: Baseline ONLY, Parent and Child receive survey independently.
Client Satisfaction Questionnaire-8 (CSQ-8) is an 8-item self-report measure with items scored on a 1-4 scale (1=the lowest satisfaction, 4=the highest satisfaction). The CSQ assesses parent and youth perceptions of treatment acceptability and helpfulness.
Baseline ONLY, Parent and Child receive survey independently.
AIM (Acceptability of Intervention Measure) [Family satisfaction]
Time Frame: Baseline ONLY, Parent and Child receive survey independently.
AIM (Acceptability of Intervention Measure) is a 4-item measure used to determine the extent the parent and child finds the intervention pathway acceptable.
Baseline ONLY, Parent and Child receive survey independently.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cynthia Fontanella

Collaborators

National Institute of Mental Health (NIMH)
Ohio State University
Holzer Gallipolis
Holzer Jackson
Holzer Athens
Eastglen Pediatrics
Signature Health Ashtabula
Signature Health Willoughby
Signature Health Painesville
AxessPointe - Arlington
Dayton Children's - Main Campus
Dayton Children's - Northwest Campus
Cornerstone Pediatrics
Kettering Pediatric and Family Care
Franklin Avenue Primary Care Center
Village Square Primary Care Center
Spring Valley Primary Care Center

Investigators

  • Principal Investigator: Jeffrey Bridge, PhD, Abigail Wexner Research Institute at NCH
  • Principal Investigator: Alex Kemper, MD, MPH, MS, Abigail Wexner Research Institute at NCH
  • Study Director: Cynthia Fontanella, PhD, Abigail Wexner Research Institute at NCH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

August 25, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002515
  • 7956 (NIMH)
  • 1P50MH127476 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available through the National Institute of Mental Health (NIMH) Data Archive (NDA) system.

IPD Sharing Time Frame

We will follow NIMH guidelines for dissemination of study data and related materials.

IPD Sharing Access Criteria

To be provided.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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