Suicidal IdeationSTARRS-PCNCT06018285
Stepped Approach to Reducing Risk of Suicide in Primary Care
A study testing Stepped Approach to Reducing Risk of Suicide in Primary Care in people with Suicidal Ideation and Suicide, Attempted, run by Cynthia Fontanella at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Suicidal Ideation, Suicide, Attempted, Suicide Prevention
- What is being tested?
- Stepped Approach to Reducing Risk of Suicide in Primary Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,572 participants
- Where
- 15 sitesUnited States
- Study dates
- 8 Aug 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Providers must work with patients at one of the participating PCCs.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 14 recruiting
- Recruiting
AxessPointe Community Health Centers/Health Quarters
Akron, Ohio, 44303
Terah Omaits, LPN, tomaits@axesspointe.org
- Recruiting
Signature Health
Ashtabula, Ohio, 44004
Libbie Stansifer, MD, (440) 992-8552, lstansifer@shinc.org
- Recruiting
Holzer Health System
Athens, Ohio, 45701
Jonathan Mathis, MD, (740) 589-3100, jmathis@Holzer.org
- Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Cynthia Fontanella, PhD, (614) 938-0323, cynthia.fontanella@nationwidechildrens.org
Priyanka Desirazu, MSE, (614) 938-1113, STARRS@nationwidechildrens.org
- Recruiting
Dayton Children's Hospital - Hope Center
Dayton, Ohio, 45404
Shipla Sangvai, MD, MPH, sangvai@childrensdayton.org
- Recruiting
Dayton Children's Hospital - Main
Dayton, Ohio, 45404
Shipla Sangvai, MD,MPH, sangvai@childrensdayton.org
- Recruiting
Holzer Health System
Gallipolis, Ohio, 45613
Jonathan Mathis, MD, (740) 446-5937, jmathis@Holzer.org
- Recruiting
Hilliard Pediatrics
Hilliard, Ohio, 43026
Cathy Homick, (614) 777-1800, chomick@hilliardpeds.com
- Recruiting
Holzer Health System
Jackson, Ohio, 45640
Jonathan Mathis, MD, (740) 395-8801, jmathis@Holzer.org
- Recruiting
Maumee Pediatric Associates
Maumee, Ohio, 43537
Amy Hardy, amy.hardy@nationwidechildrens.org
Iris Castillo, MD, 4193891444, iris.castillo2@nationwidechildrens.org
- Recruiting
Cornerstone Pediatrics
Miamisburg, Ohio, 45342
- Recruiting
Signature Health
Painesville, Ohio, 44077
Libbie Stansifer, MD, (440) 853-1501, lstansifer@shinc.org
- Not yet recruiting
Village Square Primary Care Center
Perrysburg, Ohio, 43551
Amy Hardy, amy.hardy@nationwidechildrens.org
- Terminated
Franklin Avenue Primary Care Center
Toledo, Ohio, 43620
- Recruiting
Signature Health
Willoughby, Ohio, 44094
Libbie Stansifer, MD, (440) 953-9999, lstansifer@shinc.org
About this 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.
Read more
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?
Read the detailed description
This five-year multi-site study consists of the following essential elements: (1) recruitment of 2,572 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 14 pediatric primary care practices.
The study consists of three phases of data collection: TAU, intervention, and sustainability. Eight hundred forty-nine suicidal youth will be enrolled during the TAU phase, and 1,723 suicidal youth will be enrolled during the intervention phase (total number of youth participants = 2,572). 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.
- Conditions
- Suicidal Ideation, Suicide, Attempted, Suicide Prevention
- Being tested
- Stepped Approach to Reducing Risk of Suicide in Primary Care
- Keywords
- Suicide, STARRS-PC, Adolescent, Risk Assessment, Triage
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted, Suicide Prevention, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped Approach to Reducing Risk of Suicide in Primary CareBehavioural
Intervention consists of implementation of clinical pathway for youth suicide risk
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | No intervention | Treatment as Usual |
| STARRS-PC | Experimental | Intervention consists of implementation of clinical pathway for youth suicide risk Receives: Behavioral: Stepped Approach to Reducing Risk of Suicide in Primary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 3, 6, 12 Months
Secondary outcomes (5)
Non-Suicidal Self-Injury (NSSI) [NSSI]
The Non-Suicidal Self-Injury (NSSI) Assessment measures recent and lifetime NSSI.
Measured: 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]
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.
Measured: Baseline ONLY, Parent and Child receive survey independently.
AIM (Acceptability of Intervention Measure) [Family satisfaction]
AIM (Acceptability of Intervention Measure) is a 4-item measure used to determine the extent the parent and child finds the intervention pathway acceptable.
Measured: Baseline ONLY, Parent and Child receive survey independently.
Service Assessment Child and Adolescent
A structured interview that assesses types of mental health services adolescents use, treatments they receive within each service setting, reasons for service use, and quality of services within a specified period. Test-retest reliability of the SACA is excellent. Parents only will complete the SACA, as it is expected they will best know the types of services youth are receiving.
Measured: Baseline, 3, 6, & 12 Month Follow-ups. Parent ONLY receives this measure.
Social Determinants of Health
An 8-item self-report measure assessing the nonmedical factors that influence health outcomes. These determinants shape the conditions of daily life for the parent and child. Only the parent/guardian will complete this measure.
Measured: Baseline. Parent ONLY Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start8 Aug 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (81)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped Wedge Design
- Masking
- None (open label)
- Enrolment
- 2,572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cynthia Fontanella
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Ohio State University, Holzer Athens, Signature Health Ashtabula, Signature Health Willoughby, Signature Health Painesville, AxessPointe - Arlington, Dayton Children's Pediatrics - Main Campus, Dayton Children's Pediatrics - Hope Center, Cornerstone Pediatrics, Village Square Primary Care Center, Maumee Pediatric Associates, Holzer Jackson, Holzer Gallipolis, AxessPointe - Health Quarters
- Responsible party
- Sponsor-investigator, Cynthia Fontanella, Nationwide Children's Hospital
- Investigators
- Jeffrey Bridge, PhD, Principal investigator, Abigail Wexner Research Institute at NCHAlex Kemper, MD, MPH, MS, Principal investigator, Abigail Wexner Research Institute at NCHCynthia Fontanella, PhD, Study director, Abigail Wexner Research Institute at NCHJennifer Hughes, PhD, MPH, Principal investigator, Abigail Wexner Research Institue at NCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018285
- Sponsor's protocol ID
- STUDY00002515
- Other IDs
- 1P50MH127476, 7956
- Acronym
- STARRS-PC
- Status last verified
- May 2025
- First submitted
- 25 Aug 2023
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available through the National Institute of Mental Health (NIMH) Data Archive (NDA) system.
Publications
Web-based Injury Statistics Query and Reporting System (WISQARS) [online]. National Center for Injury Prevention and Control. Accessed October 9, 2020. www.cdc.gov/injury/wisqars
Burns BJ, Costello EJ, Angold A, Tweed D, Stangl D, Farmer EM, Erkanli A. Children's mental health service use across service sectors. Health Aff (Millwood). 1995 Fall;14(3):147-59. doi: 10.1377/hlthaff.14.3.147.
PubMed 7498888Kessler RC, Berglund P, Borges G, Nock M, Wang PS. Trends in suicide ideation, plans, gestures, and attempts in the United States, 1990-1992 to 2001-2003. JAMA. 2005 May 25;293(20):2487-95. doi: 10.1001/jama.293.20.2487.
PubMed 15914749Rushton J, Bruckman D, Kelleher K. Primary care referral of children with psychosocial problems. Arch Pediatr Adolesc Med. 2002 Jun;156(6):592-8. doi: 10.1001/archpedi.156.6.592.
PubMed 12038893Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/
PubMed 25057539Miller CL, Druss B. Datapoints: suicide and access to care. Psychiatr Serv. 2001 Dec;52(12):1566. doi: 10.1176/appi.ps.52.12.1566. No abstract available.
PubMed 11726741Brent DA, Perper JA, Moritz G, Allman C, Friend A, Roth C, Schweers J, Balach L, Baugher M. Psychiatric risk factors for adolescent suicide: a case-control study. J Am Acad Child Adolesc Psychiatry. 1993 May;32(3):521-9. doi: 10.1097/00004583-199305000-00006.
PubMed 8496115Shaffer D, Gould MS, Fisher P, Trautman P, Moreau D, Kleinman M, Flory M. Psychiatric diagnosis in child and adolescent suicide. Arch Gen Psychiatry. 1996 Apr;53(4):339-48. doi: 10.1001/archpsyc.1996.01830040075012.
PubMed 8634012Underwood JM, Brener N, Thornton J, Harris WA, Bryan LN, Shanklin SL, Deputy N, Roberts AM, Queen B, Chyen D, Whittle L, Lim C, Yamakawa Y, Leon-Nguyen M, Kilmer G, Smith-Grant J, Demissie Z, Jones SE, Clayton H, Dittus P. Overview and Methods for the Youth Risk Behavior Surveillance System - United States, 2019. MMWR Suppl. 2020 Aug 21;69(1):1-10. doi: 10.15585/mmwr.su6901a1.
PubMed 32817611Reinherz HZ, Tanner JL, Berger SR, Beardslee WR, Fitzmaurice GM. Adolescent suicidal ideation as predictive of psychopathology, suicidal behavior, and compromised functioning at age 30. Am J Psychiatry. 2006 Jul;163(7):1226-32. doi: 10.1176/ajp.2006.163.7.1226.
PubMed 16816228Harrington R, Bredenkamp D, Groothues C, Rutter M, Fudge H, Pickles A. Adult outcomes of childhood and adolescent depression. III. Links with suicidal behaviours. J Child Psychol Psychiatry. 1994 Oct;35(7):1309-19. doi: 10.1111/j.1469-7610.1994.tb01236.x.
PubMed 7806612Frankenfield DL, Keyl PM, Gielen A, Wissow LS, Werthamer L, Baker SP. Adolescent patients--healthy or hurting? Missed opportunities to screen for suicide risk in the primary care setting. Arch Pediatr Adolesc Med. 2000 Feb;154(2):162-8. doi: 10.1001/archpedi.154.2.162.
PubMed 10665603Cheung AH, Zuckerbrot RA, Jensen PS, Laraque D, Stein REK; GLAD-PC STEERING GROUP. Guidelines for Adolescent Depression in Primary Care (GLAD-PC): Part II. Treatment and Ongoing Management. Pediatrics. 2018 Mar;141(3):e20174082. doi: 10.1542/peds.2017-4082.
PubMed 29483201Zuckerbrot RA, Cheung A, Jensen PS, Stein REK, Laraque D; GLAD-PC STEERING GROUP. Guidelines for Adolescent Depression in Primary Care (GLAD-PC): Part I. Practice Preparation, Identification, Assessment, and Initial Management. Pediatrics. 2018 Mar;141(3):e20174081. doi: 10.1542/peds.2017-4081.
PubMed 29483200Cheung AH, Dewa CS, Levitt AJ, Zuckerbrot RA. Pediatric depressive disorders: management priorities in primary care. Curr Opin Pediatr. 2008 Oct;20(5):551-9. doi: 10.1097/MOP.0b013e32830fe3e3.
PubMed 18781118
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Approach to Reducing Risk of Suicide in Primary Care
- ClinicalTrials.gov ID
- NCT06018285
- Acronym / sponsor ID
- STARRS-PC / STUDY00002515
- Conditions
- Suicidal Ideation, Suicide, Attempted, Suicide Prevention
- Keywords
- Suicide, STARRS-PC, Adolescent, Risk Assessment, Triage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,572 participants (estimated)
- Lead sponsor
- Cynthia FontanellaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Ohio State University, Holzer Athens, Signature Health Ashtabula, Signature Health Willoughby, Signature Health Painesville, AxessPointe - Arlington, Dayton Children's Pediatrics - Main Campus, Dayton Children's Pediatrics - Hope Center, Cornerstone Pediatrics, Village Square Primary Care Center, Maumee Pediatric Associates, Holzer Jackson, Holzer Gallipolis, AxessPointe - Health Quarters
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
This five-year multi-site study consists of the following essential elements: (1) recruitment of 2,572 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 14 pediatric primary care practices.
The study consists of three phases of data collection: TAU, intervention, and sustainability. Eight hundred forty-nine suicidal youth will be enrolled during the TAU phase, and 1,723 suicidal youth will be enrolled during the intervention phase (total number of youth participants = 2,572). 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped Wedge Design
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | No intervention | –Treatment as Usual |
| STARRS-PC | Experimental | Behavioral: Stepped Approach to Reducing Risk of Suicide in Primary CareIntervention consists of implementation of clinical pathway for youth suicide risk |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
- Providers must work with patients at one of the participating PCCs.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepped Approach to Reducing Risk of Suicide in Primary CareIntervention consists of implementation of clinical pathway for youth suicide risk | Behavioural | STARRS-PC |
Primary outcome
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.
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.
5 secondary outcomes
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.
Client Satisfaction Questionnaire-8 (CSQ-8) [Family satisfaction]
Time frame: 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.
Service Assessment Child and Adolescent
Time frame: Baseline, 3, 6, & 12 Month Follow-ups. Parent ONLY receives this measure.
Social Determinants of Health
Time frame: Baseline. Parent ONLY Assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- BackgroundWeb-based Injury Statistics Query and Reporting System (WISQARS) [online]. National Center for Injury Prevention and Control. Accessed October 9, 2020. www.cdc.gov/injury/wisqars
- Background: PubMed 7498888Burns BJ, Costello EJ, Angold A, Tweed D, Stangl D, Farmer EM, Erkanli A. Children's mental health service use across service sectors. Health Aff (Millwood). 1995 Fall;14(3):147-59. doi: 10.1377/hlthaff.14.3.147.
- Background: PubMed 15914749Kessler RC, Berglund P, Borges G, Nock M, Wang PS. Trends in suicide ideation, plans, gestures, and attempts in the United States, 1990-1992 to 2001-2003. JAMA. 2005 May 25;293(20):2487-95. doi: 10.1001/jama.293.20.2487.
- Background: PubMed 12038893Rushton J, Bruckman D, Kelleher K. Primary care referral of children with psychosocial problems. Arch Pediatr Adolesc Med. 2002 Jun;156(6):592-8. doi: 10.1001/archpedi.156.6.592.
- Background: PubMed 25057539Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/
- Background: PubMed 11726741Miller CL, Druss B. Datapoints: suicide and access to care. Psychiatr Serv. 2001 Dec;52(12):1566. doi: 10.1176/appi.ps.52.12.1566. No abstract available.
- Background: PubMed 8496115Brent DA, Perper JA, Moritz G, Allman C, Friend A, Roth C, Schweers J, Balach L, Baugher M. Psychiatric risk factors for adolescent suicide: a case-control study. J Am Acad Child Adolesc Psychiatry. 1993 May;32(3):521-9. doi: 10.1097/00004583-199305000-00006.
- Background: PubMed 8634012Shaffer D, Gould MS, Fisher P, Trautman P, Moreau D, Kleinman M, Flory M. Psychiatric diagnosis in child and adolescent suicide. Arch Gen Psychiatry. 1996 Apr;53(4):339-48. doi: 10.1001/archpsyc.1996.01830040075012.
- Background: PubMed 32817611Underwood JM, Brener N, Thornton J, Harris WA, Bryan LN, Shanklin SL, Deputy N, Roberts AM, Queen B, Chyen D, Whittle L, Lim C, Yamakawa Y, Leon-Nguyen M, Kilmer G, Smith-Grant J, Demissie Z, Jones SE, Clayton H, Dittus P. Overview and Methods for the Youth Risk Behavior Surveillance System - United States, 2019. MMWR Suppl. 2020 Aug 21;69(1):1-10. doi: 10.15585/mmwr.su6901a1.
- Background: PubMed 16816228Reinherz HZ, Tanner JL, Berger SR, Beardslee WR, Fitzmaurice GM. Adolescent suicidal ideation as predictive of psychopathology, suicidal behavior, and compromised functioning at age 30. Am J Psychiatry. 2006 Jul;163(7):1226-32. doi: 10.1176/ajp.2006.163.7.1226.
- Background: PubMed 7806612Harrington R, Bredenkamp D, Groothues C, Rutter M, Fudge H, Pickles A. Adult outcomes of childhood and adolescent depression. III. Links with suicidal behaviours. J Child Psychol Psychiatry. 1994 Oct;35(7):1309-19. doi: 10.1111/j.1469-7610.1994.tb01236.x.
- Background: PubMed 10665603Frankenfield DL, Keyl PM, Gielen A, Wissow LS, Werthamer L, Baker SP. Adolescent patients--healthy or hurting? Missed opportunities to screen for suicide risk in the primary care setting. Arch Pediatr Adolesc Med. 2000 Feb;154(2):162-8. doi: 10.1001/archpedi.154.2.162.
- Individual participant dataSharing planned: Yes. Data will be made available through the National Institute of Mental Health (NIMH) Data Archive (NDA) system.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Bridge, PhD principal investigator
Abigail Wexner Research Institute at NCH
Alex Kemper, MD, MPH, MS principal investigator
Abigail Wexner Research Institute at NCH
Cynthia Fontanella, PhD study director
Abigail Wexner Research Institute at NCH
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped Approach to Reducing Risk of Suicide in Primary Care in people with Suicidal Ideation and Suicide, Attempted, run by Cynthia Fontanella at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Fontanella, PhD ((614) 938-0323, cynthia.fontanella@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia Suicide Severity Rating Scale (C-SSRS) [suicide attempt] (time frame: Baseline, 3, 6, 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06018285, which also lists 81 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.