Stepped Approach to Reducing Risk of Suicide in Primary Care
NCT ID: NCT06018285
Last Updated: 2025-08-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
2572 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-08-08
Study Completion Date
2027-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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?
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?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Preventing Youth Suicide in Primary Care: A Family Model
NCT00604097
Suicide
COMPLETED
PHASE3
Practice Facilitation to Enhance Implementation of a Pediatric Suicide Prevention Pathway
NCT06619782
Suicide Prevention
NOT_YET_RECRUITING
NA
Optimizing Suicide Prevention Strategies for Pediatric Primary Care
NCT06194331
Suicidal Ideation
Suicidal and Self-injurious Behavior
Depression
RECRUITING
NA
Adapting a Brief Suicide Intervention for Pediatric Primary Care: Enhancing Uptake and Impact
NCT06499740
Suicide Prevention
NOT_YET_RECRUITING
NA
Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
NCT06151158
Suicide, Attempted
Suicide Ideation
Suicide
+1 more
RECRUITING
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Suicidal Ideation
Suicide, Attempted
Suicide Prevention
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
SEQUENTIAL
Stepped Wedge Design
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment As Usual
Treatment as Usual
Group Type
NO_INTERVENTION
No interventions assigned to this group
STARRS-PC
Intervention consists of implementation of clinical pathway for youth suicide risk
Group Type
EXPERIMENTAL
Stepped Approach to Reducing Risk of Suicide in Primary Care
Intervention Type
BEHAVIORAL
Intervention consists of implementation of clinical pathway for youth suicide risk
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stepped Approach to Reducing Risk of Suicide in Primary Care
Intervention consists of implementation of clinical pathway for youth suicide risk
Intervention Type
BEHAVIORAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
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.
* 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.
Minimum Eligible Age
12 Years
Maximum Eligible Age
17 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
Sponsor Role
collaborator
Ohio State University
OTHER
Sponsor Role
collaborator
Holzer Athens
OTHER
Sponsor Role
collaborator
Signature Health Ashtabula
OTHER
Sponsor Role
collaborator
Signature Health Willoughby
OTHER
Sponsor Role
collaborator
Signature Health Painesville
OTHER
Sponsor Role
collaborator
AxessPointe - Arlington
OTHER
Sponsor Role
collaborator
Dayton Children's Pediatrics - Main Campus
UNKNOWN
Sponsor Role
collaborator
Dayton Children's Pediatrics - Hope Center
UNKNOWN
Sponsor Role
collaborator
Cornerstone Pediatrics
OTHER
Sponsor Role
collaborator
Village Square Primary Care Center
OTHER
Sponsor Role
collaborator
Maumee Pediatric Associates
UNKNOWN
Sponsor Role
collaborator
Holzer Jackson
OTHER
Sponsor Role
collaborator
Holzer Gallipolis
OTHER
Sponsor Role
collaborator
AxessPointe - Health Quarters
UNKNOWN
Sponsor Role
collaborator
Cynthia Fontanella
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Cynthia Fontanella
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffrey Bridge, PhD
Role: PRINCIPAL_INVESTIGATOR
Abigail Wexner Research Institute at NCH
Alex Kemper, MD, MPH, MS
Role: PRINCIPAL_INVESTIGATOR
Abigail Wexner Research Institute at NCH
Cynthia Fontanella, PhD
Role: STUDY_DIRECTOR
Abigail Wexner Research Institute at NCH
Jennifer Hughes, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Abigail Wexner Research Institue at NCH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AxessPointe Community Health Centers/Health Quarters
Akron, Ohio, United States
Site Status
RECRUITING
Signature Health
Ashtabula, Ohio, United States
Site Status
RECRUITING
Holzer Health System
Athens, Ohio, United States
Site Status
RECRUITING
Nationwide Children's Hospital
Columbus, Ohio, United States
Site Status
NOT_YET_RECRUITING
Dayton Children's Hospital - Hope Center
Dayton, Ohio, United States
Site Status
RECRUITING
Dayton Children's Hospital - Main
Dayton, Ohio, United States
Site Status
RECRUITING
Holzer Health System
Gallipolis, Ohio, United States
Site Status
RECRUITING
Hilliard Pediatrics
Hilliard, Ohio, United States
Site Status
RECRUITING
Holzer Health System
Jackson, Ohio, United States
Site Status
RECRUITING
Maumee Pediatric Associates
Maumee, Ohio, United States
Site Status
RECRUITING
Cornerstone Pediatrics
Miamisburg, Ohio, United States
Site Status
RECRUITING
Signature Health
Painesville, Ohio, United States
Site Status
RECRUITING
Village Square Primary Care Center
Perrysburg, Ohio, United States
Site Status
NOT_YET_RECRUITING
Franklin Avenue Primary Care Center
Toledo, Ohio, United States
Site Status
TERMINATED
Signature Health
Willoughby, Ohio, United States
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Kessler 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.
Reference Type
BACKGROUND
Rushton 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.
Reference Type
BACKGROUND
Institute 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/
Reference Type
BACKGROUND
Miller 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.
Reference Type
BACKGROUND
Brent 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.
Reference Type
BACKGROUND
Shaffer 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.
Reference Type
BACKGROUND
Underwood 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.
Reference Type
BACKGROUND
Reinherz 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.
Reference Type
BACKGROUND
Harrington 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.
Reference Type
BACKGROUND
Frankenfield 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.
Reference Type
BACKGROUND
Cheung 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.
Reference Type
BACKGROUND
Zuckerbrot 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.
Reference Type
BACKGROUND
Cheung 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.
Reference Type
BACKGROUND
Kelleher KJ, Hohmann AA, Larson DB. Prescription of psychotropics to children in office-based practice. Am J Dis Child. 1989 Jul;143(7):855-9. doi: 10.1001/archpedi.1989.02150190105033.
Reference Type
BACKGROUND
Vannoy SD, Tai-Seale M, Duberstein P, Eaton LJ, Cook MA. Now what should I do? Primary care physicians' responses to older adults expressing thoughts of suicide. J Gen Intern Med. 2011 Sep;26(9):1005-11. doi: 10.1007/s11606-011-1726-5. Epub 2011 May 4.
Reference Type
BACKGROUND
Vannoy SD, Robins LS. Suicide-related discussions with depressed primary care patients in the USA: gender and quality gaps. A mixed methods analysis. BMJ Open. 2011 Jan 1;1(2):e000198. doi: 10.1136/bmjopen-2011-000198.
Reference Type
BACKGROUND
Schwartz-Lifshitz M, Zalsman G, Giner L, Oquendo MA. Can we really prevent suicide? Curr Psychiatry Rep. 2012 Dec;14(6):624-33. doi: 10.1007/s11920-012-0318-3.
Reference Type
BACKGROUND
O'Connor E, Gaynes BN, Burda BU, Soh C, Whitlock EP. Screening for and treatment of suicide risk relevant to primary care: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013 May 21;158(10):741-54. doi: 10.7326/0003-4819-158-10-201305210-00642.
Reference Type
BACKGROUND
McDowell AK, Lineberry TW, Bostwick JM. Practical suicide-risk management for the busy primary care physician. Mayo Clin Proc. 2011 Aug;86(8):792-800. doi: 10.4065/mcp.2011.0076. Epub 2011 Jun 27.
Reference Type
BACKGROUND
LeFevre ML; U.S. Preventive Services Task Force. Screening for suicide risk in adolescents, adults, and older adults in primary care: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 May 20;160(10):719-26. doi: 10.7326/M14-0589.
Reference Type
BACKGROUND
Raue PJ, Ghesquiere AR, Bruce ML. Suicide risk in primary care: identification and management in older adults. Curr Psychiatry Rep. 2014 Sep;16(9):466. doi: 10.1007/s11920-014-0466-8.
Reference Type
BACKGROUND
Bower P, Gilbody S. Stepped care in psychological therapies: access, effectiveness and efficiency. Narrative literature review. Br J Psychiatry. 2005 Jan;186:11-7. doi: 10.1192/bjp.186.1.11.
Reference Type
BACKGROUND
Asarnow JR, Jaycox LH, Duan N, LaBorde AP, Rea MM, Murray P, Anderson M, Landon C, Tang L, Wells KB. Effectiveness of a quality improvement intervention for adolescent depression in primary care clinics: a randomized controlled trial. JAMA. 2005 Jan 19;293(3):311-9. doi: 10.1001/jama.293.3.311.
Reference Type
BACKGROUND
Richardson LP, Ludman E, McCauley E, Lindenbaum J, Larison C, Zhou C, Clarke G, Brent D, Katon W. Collaborative care for adolescents with depression in primary care: a randomized clinical trial. JAMA. 2014 Aug 27;312(8):809-16. doi: 10.1001/jama.2014.9259.
Reference Type
BACKGROUND
Hogan MF, Grumet JG. Suicide Prevention: An Emerging Priority For Health Care. Health Aff (Millwood). 2016 Jun 1;35(6):1084-90. doi: 10.1377/hlthaff.2015.1672.
Reference Type
BACKGROUND
Asarnow JR, Jaycox LH, Tang L, Duan N, LaBorde AP, Zeledon LR, Anderson M, Murray PJ, Landon C, Rea MM, Wells KB. Long-term benefits of short-term quality improvement interventions for depressed youths in primary care. Am J Psychiatry. 2009 Sep;166(9):1002-10. doi: 10.1176/appi.ajp.2009.08121909. Epub 2009 Aug 3.
Reference Type
BACKGROUND
Wells KB, Sherbourne C, Schoenbaum M, Duan N, Meredith L, Unutzer J, Miranda J, Carney MF, Rubenstein LV. Impact of disseminating quality improvement programs for depression in managed primary care: a randomized controlled trial. JAMA. 2000 Jan 12;283(2):212-20. doi: 10.1001/jama.283.2.212.
Reference Type
BACKGROUND
Wells K, Sherbourne C, Schoenbaum M, Ettner S, Duan N, Miranda J, Unutzer J, Rubenstein L. Five-year impact of quality improvement for depression: results of a group-level randomized controlled trial. Arch Gen Psychiatry. 2004 Apr;61(4):378-86. doi: 10.1001/archpsyc.61.4.378.
Reference Type
BACKGROUND
Kemper AR, Hostutler CA, Beck K, Fontanella CA, Bridge JA. Depression and Suicide-Risk Screening Results in Pediatric Primary Care. Pediatrics. 2021 Jul;148(1):e2021049999. doi: 10.1542/peds.2021-049999. Epub 2021 Jun 7.
Reference Type
BACKGROUND
Improvement IfH. How to Improve. Accessed October 18, 2020. http://www.ihi.org/resources/Pages/HowtoImprove/default.aspx
Reference Type
BACKGROUND
Horowitz LM, Bridge JA, Teach SJ, Ballard E, Klima J, Rosenstein DL, Wharff EA, Ginnis K, Cannon E, Joshi P, Pao M. Ask Suicide-Screening Questions (ASQ): a brief instrument for the pediatric emergency department. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1170-6. doi: 10.1001/archpediatrics.2012.1276.
Reference Type
BACKGROUND
Langley GJ, Moen RD, Nolan KM, Nolan TW, Norman CL, Provost LP. The Improvement Guide: A Practical Approach to Enhancing Organizational Performance. 2nd ed. Jossey-Bass 2009.
Reference Type
BACKGROUND
Crowl A, Sharma A, Sorge L, Sorensen T. Accelerating quality improvement within your organization: Applying the Model for Improvement. J Am Pharm Assoc (2003). 2015 Jul-Aug;55(4):e364-74; quiz e375-6. doi: 10.1331/JAPhA.2015.15533.
Reference Type
BACKGROUND
Lopreiato JO. Healthcare Simulation Dictionary Agency for Healthcare Research and Quality; 2016.
Reference Type
BACKGROUND
Harwayne-Gidansky I, Bellis JM, McLaren SH, et al. Mannequin-Based Immersive Simulation Improves Resident Understanding of a Clinical Decision Rule. Simulation & Gaming. 2017;48(5):657-669. doi:10.1177/1046878117719483
Reference Type
BACKGROUND
Adams AJ, Wasson EA, Admire JR, Pablo Gomez P, Babayeuski RA, Sako EY, Willis RE. A Comparison of Teaching Modalities and Fidelity of Simulation Levels in Teaching Resuscitation Scenarios. J Surg Educ. 2015 Sep-Oct;72(5):778-85. doi: 10.1016/j.jsurg.2015.04.011. Epub 2015 May 20.
Reference Type
BACKGROUND
Fallucco EM, Seago RD, Cuffe SP, Kraemer DF, Wysocki T. Primary care provider training in screening, assessment, and treatment of adolescent depression. Acad Pediatr. 2015 May-Jun;15(3):326-32. doi: 10.1016/j.acap.2014.12.004. Epub 2015 Mar 29.
Reference Type
BACKGROUND
Ventre KM, Barry JS, Davis D, Baiamonte VL, Wentworth AC, Pietras M, Coughlin L, Barley G. Using in situ simulation to evaluate operational readiness of a children's hospital-based obstetrics unit. Simul Healthc. 2014 Apr;9(2):102-11. doi: 10.1097/SIH.0000000000000005.
Reference Type
BACKGROUND
Yager P, Collins C, Blais C, O'Connor K, Donovan P, Martinez M, Cummings B, Hartnick C, Noviski N. Quality improvement utilizing in-situ simulation for a dual-hospital pediatric code response team. Int J Pediatr Otorhinolaryngol. 2016 Sep;88:42-6. doi: 10.1016/j.ijporl.2016.06.026. Epub 2016 Jun 7.
Reference Type
BACKGROUND
Wallin K, Kelly F, Sembera K. Building High Reliability Through Simulation. In: Oster CA, Braaten JS, eds. High Reliability Organizations: A Healthcare Handbook for Patient Safety & Quality. 2 ed. Sigma Theta Tau International; 2021.
Reference Type
BACKGROUND
Brahmbhatt K, Kurtz BP, Afzal KI, Giles LL, Kowal ED, Johnson KP, Lanzillo E, Pao M, Plioplys S, Horowitz LM; PaCC Workgroup. Suicide Risk Screening in Pediatric Hospitals: Clinical Pathways to Address a Global Health Crisis. Psychosomatics. 2019 Jan-Feb;60(1):1-9. doi: 10.1016/j.psym.2018.09.003. Epub 2018 Sep 22.
Reference Type
BACKGROUND
Aguinaldo LD, Sullivant S, Lanzillo EC, Ross A, He JP, Bradley-Ewing A, Bridge JA, Horowitz LM, Wharff EA. Validation of the ask suicide-screening questions (ASQ) with youth in outpatient specialty and primary care clinics. Gen Hosp Psychiatry. 2021 Jan-Feb;68:52-58. doi: 10.1016/j.genhosppsych.2020.11.006. Epub 2020 Nov 13.
Reference Type
BACKGROUND
PhenX Toolkit: Mental Health Research Core Tier 1 Demographic and Social Environment Measures. RTI International. Accessed October 4, 2020. https://www.phenxtoolkit.org/sub-collections/view/1
Reference Type
BACKGROUND
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Reference Type
BACKGROUND
Cameron IM, Crawford JR, Lawton K, Reid IC. Psychometric comparison of PHQ-9 and HADS for measuring depression severity in primary care. Br J Gen Pract. 2008 Jan;58(546):32-6. doi: 10.3399/bjgp08X263794.
Reference Type
BACKGROUND
Posner K, Brent D, Lucas C, et al. Columbia-Suicide Severity Rating Scale (C-SSRS) New York State Psychiatric Institute https://cssrs.columbia.edu/wp-content/uploads/C-SSRS_Pediatric-SLC_11.14.16.pdf
Reference Type
BACKGROUND
Pierce DW. Suicidal intent in self-injury. Br J Psychiatry. 1977 Apr;130:377-85. doi: 10.1192/bjp.130.4.377.
Reference Type
BACKGROUND
Brent D, Emslie G, Clarke G, Wagner KD, Asarnow JR, Keller M, Vitiello B, Ritz L, Iyengar S, Abebe K, Birmaher B, Ryan N, Kennard B, Hughes C, DeBar L, McCracken J, Strober M, Suddath R, Spirito A, Leonard H, Melhem N, Porta G, Onorato M, Zelazny J. Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial. JAMA. 2008 Feb 27;299(8):901-913. doi: 10.1001/jama.299.8.901.
Reference Type
BACKGROUND
March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J; Treatment for Adolescents With Depression Study (TADS) Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA. 2004 Aug 18;292(7):807-20. doi: 10.1001/jama.292.7.807.
Reference Type
BACKGROUND
Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299-313. doi: 10.1016/0149-7189(83)90010-1.
Reference Type
BACKGROUND
Horwitz SM, Hoagwood K, Stiffman AR, Summerfeld T, Weisz JR, Costello EJ, Rost K, Bean DL, Cottler L, Leaf PJ, Roper M, Norquist G. Reliability of the services assessment for children and adolescents. Psychiatr Serv. 2001 Aug;52(8):1088-94. doi: 10.1176/appi.ps.52.8.1088.
Reference Type
BACKGROUND
Stiffman AR, Horwitz SM, Hoagwood K, Compton W 3rd, Cottler L, Bean DL, Narrow WE, Weisz JR. The Service Assessment for Children and Adolescents (SACA): adult and child reports. J Am Acad Child Adolesc Psychiatry. 2000 Aug;39(8):1032-9. doi: 10.1097/00004583-200008000-00019.
Reference Type
BACKGROUND
Association AP. DSM-5-TR Online Assessment Measures. Accessed July 21, 2022. https://www.psychiatry.org/psychiatrists/practice/dsm/educational-resources/assessment-measures
Reference Type
BACKGROUND
Chorpita BFS, Susan H. Child Depression and Anxiety RCADS 25 Accessed July 22, 2022. https://help.greenspacehealth.com/article/50-child-depression-and-anxiety-rcads-25
Reference Type
BACKGROUND
Herron J, Ticehurst H, Appleby L, Perry A, Cordingley L. Attitudes toward suicide prevention in front-line health staff. Suicide Life Threat Behav. 2001 Fall;31(3):342-7. doi: 10.1521/suli.31.3.342.24252.
Reference Type
BACKGROUND
Gamarra JM, Luciano MT, Gradus JL, Wiltsey Stirman S. Assessing Variability and Implementation Fidelity of Suicide Prevention Safety Planning in a Regional VA Healthcare System. Crisis. 2015;36(6):433-9. doi: 10.1027/0227-5910/a000345.
Reference Type
BACKGROUND
Hoekstra F, van Offenbeek MAG, Dekker R, Hettinga FJ, Hoekstra T, van der Woude LHV, van der Schans CP; ReSpAct group. Implementation fidelity trajectories of a health promotion program in multidisciplinary settings: managing tensions in rehabilitation care. Implement Sci. 2017 Dec 1;12(1):143. doi: 10.1186/s13012-017-0667-8.
Reference Type
BACKGROUND
Mullin DJ, Hargreaves L, Auxier A, Brennhofer SA, Hitt JR, Kessler RS, Littenberg B, Macchi CR, Martin M, Rose G, Trembath F, van Eeghen C. Measuring the integration of primary care and behavioral health services. Health Serv Res. 2019 Apr;54(2):379-389. doi: 10.1111/1475-6773.13117. Epub 2019 Feb 6.
Reference Type
BACKGROUND
Kessler RS, Auxier A, Hitt JR, Macchi CR, Mullin D, van Eeghen C, Littenberg B. Development and validation of a measure of primary care behavioral health integration. Fam Syst Health. 2016 Dec;34(4):342-356. doi: 10.1037/fsh0000227. Epub 2016 Oct 13.
Reference Type
BACKGROUND
Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci. 2014 Jan 10;9:7. doi: 10.1186/1748-5908-9-7.
Reference Type
BACKGROUND
Armat MR, Assarroudi A, Rad M, Sharifi H, Heydari A. Inductive and Deductive: Ambiguous Labels in Qualitative Content Analysis. The Qualitative Report. 2018;doi:10.46743/2160-3715/2018.2872
Reference Type
BACKGROUND
Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008 Apr;34(4):228-43. doi: 10.1016/s1553-7250(08)34030-6.
Reference Type
BACKGROUND
McCreight MS, Rabin BA, Glasgow RE, Ayele RA, Leonard CA, Gilmartin HM, Frank JW, Hess PL, Burke RE, Battaglia CT. Using the Practical, Robust Implementation and Sustainability Model (PRISM) to qualitatively assess multilevel contextual factors to help plan, implement, evaluate, and disseminate health services programs. Transl Behav Med. 2019 Nov 25;9(6):1002-1011. doi: 10.1093/tbm/ibz085.
Reference Type
BACKGROUND
Constas MA. Qualitative Analysis as a Public Event: The Documentation of Category Development Procedures. American Educational Research Journal. 1992;29(2):253-266. doi:10.3102/00028312029002253
Reference Type
BACKGROUND
Crabtree BF, Miller WL. Doing Qualitative Research 2nd ed. Sage Publications Inc; 1999.
Reference Type
BACKGROUND
Hemming K, Taljaard M, Grimshaw J. Introducing the new CONSORT extension for stepped-wedge cluster randomised trials. Trials. 2019 Jan 18;20(1):68. doi: 10.1186/s13063-018-3116-3.
Reference Type
BACKGROUND
Foster ED, Deardorff A. Open Science Framework (OSF). Journal of the Medical Library Association. 2017;105(2)doi:10.5195/jmla.2017.88
Reference Type
BACKGROUND
Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
Reference Type
BACKGROUND
Grambsch PM, Therneau TM. Proportional Hazards Tests and Diagnostics Based on Weighted Residuals. Biometrika. 1994;81(3):515-526. doi:10.2307/2337123
Reference Type
BACKGROUND
Flury BK, Riedwyl H. Standard Distance in Univariate and Multivariate Analysis. The American Statistician. 1986;40(3):249-251. doi:10.1080/00031305.1986.10475403
Reference Type
BACKGROUND
Austin PC. Using the Standardized Difference to Compare the Prevalence of a Binary Variable Between Two Groups in Observational Research. Communications in Statistics - Simulation and Computation. 2009;38(6):1228-1234. doi:10.1080/03610910902859574
Reference Type
BACKGROUND
Tingley D, Yamamoto T, Hirose K, Keele L, Imai K. mediation: R Package for Causal Mediation Analysis. Journal of Statistical Software. 2014;59(5):1 - 38. doi:10.18637/jss.v059.i05
Reference Type
BACKGROUND
Sales A. Review: mediation Package in R. Journal of Educational and Behavioral Statistics. 2016;42doi:10.3102/1076998616670371
Reference Type
BACKGROUND
Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017 Dec 6;17(1):162. doi: 10.1186/s12874-017-0442-1.
Reference Type
BACKGROUND
Xie H, Gao W, Xing B, Heitjan DF, Hedeker D, Yuan C. Measuring the Impact of Nonignorable Missingness Using the R Package isni. Comput Methods Programs Biomed. 2018 Oct;164:207-220. doi: 10.1016/j.cmpb.2018.06.014. Epub 2018 Jul 4.
Reference Type
BACKGROUND
Nock MK, Green JG, Hwang I, McLaughlin KA, Sampson NA, Zaslavsky AM, Kessler RC. Prevalence, correlates, and treatment of lifetime suicidal behavior among adolescents: results from the National Comorbidity Survey Replication Adolescent Supplement. JAMA Psychiatry. 2013 Mar;70(3):300-10. doi: 10.1001/2013.jamapsychiatry.55.
Reference Type
BACKGROUND
Baio G, Copas A, Ambler G, Hargreaves J, Beard E, Omar RZ. Sample size calculation for a stepped wedge trial. Trials. 2015 Aug 17;16:354. doi: 10.1186/s13063-015-0840-9.
Reference Type
BACKGROUND
Agency for Healthcare Research and Quality (AHRQ). https://www.ahrq.gov/health-literacy/improve/precautions/tool2b.html#:~:text=The%20Plan%2DDo%2DStudy%2D,on%20it%2C%20and%20testing%20again
Reference Type
BACKGROUND
Palinkas LA, Horwitz SM, Green CA, Wisdom JP, Duan N, Hoagwood K. Purposeful Sampling for Qualitative Data Collection and Analysis in Mixed Method Implementation Research. Adm Policy Ment Health. 2015 Sep;42(5):533-44. doi: 10.1007/s10488-013-0528-y.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
7956
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY00002515
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Promote Access to Stop Suicide: Comparison of Follow up Services for Youth at Risk for Suicide
NCT03016572
COMPLETED
NA
Advancing Suicide Intervention Strategies for Teens During High Risk Periods
NCT05078970
RECRUITING
NA
Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
NCT00451282
COMPLETED
PHASE3
Suicide Prevention for Substance Using Youth Experiencing Homelessness
NCT05994612
RECRUITING
NA
Feasibility Trial of a Single Session of Crisis Response Planning for Youth at High Risk for Suicide
NCT06164106
COMPLETED
NA
Skills to Enhance Positivity in Suicidal Youth
NCT04994873
RECRUITING
NA
Stepped-Care for Suicidal Youth and Children
NCT07321171
RECRUITING
NA
Implementing a Brief Suicide Intervention for High Risk Youth With Front-Line Juvenile Justice Staff
NCT02981420
UNKNOWN
NA
Safer Still (Exploratory Project 3)
NCT06558409
RECRUITING
NA
Adjunctive Team Enhanced Intervention to Improve Suicide Prevention Evidence-Based Practices in Primary Care
NCT04606173
COMPLETED
NA
Focused Suicide Prevention Strategy for Youth Presenting to the Emergency Department With Suicide Related Behaviour
NCT06225661
ACTIVE_NOT_RECRUITING
NA
Randomized Trial of Stepped Care for Suicide Prevention in Teens and Young Adults
NCT03092271
COMPLETED
NA
Validation of the Ask Suicide-Screening Questions (ASQ) in the Inpatient Medical Setting
NCT02050867
TERMINATED
Swift Outpatient Alternatives for Rapid Stabilization
NCT05996172
RECRUITING
NA
Integrating Suicide Prevention Packages Into Task-shifted Mental Health Interventions in Low-resourced Contexts
NCT06094959
COMPLETED
NA
Effectiveness of a Family-Based Intervention for Adolescent Suicide Attempters (The SAFETY Study)
NCT00692302
COMPLETED
PHASE1/PHASE2
Focused Suicide Prevention Strategy for Youth
NCT03488602
UNKNOWN
NA
Implementation of Suicide Risk Models in Health Systems
NCT06060535
ENROLLING_BY_INVITATION
NA
Brief Intervention for Suicide Risk Reduction in High Risk Adolescents
NCT02272179
COMPLETED
PHASE1
Improving Adolescent Health Outcomes Through Preventive Care Transformation
NCT02244138
COMPLETED
Mixed-method Evaluation of a Parental Psychoeducation Programme in a Suicide Risk Prevention Group
NCT06576453
RECRUITING
Evaluating Primary Suicide Prevention in Adolescents With Risk Factors
NCT06551038
RECRUITING
NA
Evaluation of the Safety Plan to Prevent Suicidal Reiteration
NCT05609487
RECRUITING
NA
Safety Planning in Juvenile Justice for Suicidal Youth
NCT03655470
COMPLETED
NA
Family Intervention for Suicidal Youth: Emergency Care
NCT00558805
COMPLETED
PHASE2