Stepped Care Suicide Prevention for Youth

(STARRS-PC Trial)

Recruiting at 18 trial locations

Overseen By Priyanka Desirazu, MSE

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Cynthia Fontanella

Disqualifiers: Medically unable, No permanent residence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

2572 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to reduce the chance of suicide among young people aged 12-17 who are at risk. The treatment, called the Stepped Approach to Reducing Risk of Suicide in Primary Care (STARRS-PC), uses a stepped care method, providing different levels of support based on individual needs. It is compared to the usual care in pediatric primary care settings. The trial aims to determine if this approach can better prevent suicide attempts, reduce harmful thoughts, and improve family satisfaction over a year. Young people visiting participating clinics and identified as at risk for suicide can join, even if they have other health issues like asthma. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could shape future care for at-risk youth.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that youth receiving medication for physical or psychiatric conditions can participate, so it seems likely you can continue your current medications.

What prior data suggests that the STARRS-PC clinical pathway is safe for youth?

Research has shown that stepped care approaches, such as the STARRS-PC program, are generally safe and well-tolerated. Previous studies found that these methods can effectively lower the risk of suicide in clinical settings. The STARRS-PC program follows a structured plan to assist young people at risk of suicide, including steps like identifying risk, assessing needs, and providing follow-up care if needed.

No direct evidence of harm or major side effects has been found with this approach, as it focuses on improving care delivery rather than introducing new medications or procedures. The goal is to identify and address suicide risks early, ensuring young people receive the help they need.

While specific safety data is not presented in the current sources, the use of evidence-based practices suggests it is a safe option. The STARRS-PC and similar programs aim to improve outcomes without adding risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stepped Approach to Reducing Risk of Suicide in Primary Care because it offers a structured method tailored specifically to youth, which is different from the more generalized approaches currently available. Unlike standard treatments that might rely heavily on medication or traditional talk therapy alone, this approach creates a clinical pathway that adapts to the individual's needs, potentially offering more personalized and effective support. The focus on primary care settings also means that it could be more accessible and integrated into regular health check-ups, catching risks early and providing timely intervention.

What evidence suggests that the STARRS-PC pathway is effective for reducing suicide risk in youth?

Research has shown that stepped care approaches can effectively reduce the risk of suicide, particularly in primary care clinics. Studies have found that these methods significantly decrease the likelihood of suicide attempts among young people. In this trial, participants will receive either the STARRS-PC method or Treatment As Usual. The STARRS-PC method involves steps such as identifying risk, assessing the situation, deciding on the best care, and providing follow-up support. This approach relies on proven methods that help healthcare providers support young people at risk of suicide. Overall, stepped care offers a promising way to address suicide risk in youth. ^{1 2 3 4 6}

Who Is on the Research Team?

Alex Kemper, MD, MPH, MS

Principal Investigator

Abigail Wexner Research Institute at NCH

Cynthia Fontanella, PhD

Principal Investigator

Abigail Wexner Research Institute at NCH

Jennifer Hughes, PhD, MPH

Principal Investigator

Abigail Wexner Research Institue at NCH

Jeffrey Bridge, PhD

Principal Investigator

Abigail Wexner Research Institute at NCH

Are You a Good Fit for This Trial?

This trial is for young people aged 12-17 who are at risk of suicide and receive care at one of the participating primary care clinics. It includes those with or without mental health issues, as well as those with physical illnesses or on medication, provided they meet other study criteria.

Inclusion Criteria

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

I am a young person with another illness or condition but still fit the study's main requirements.

I am between 12-17 years old, at risk for suicide, and receive care at a participating site.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

TAU (Treatment As Usual)

Participants receive usual and customary care, establishing baseline rates of suicide risk screening and detection

6-26 months

Intervention

Implementation of the STARRS-PC clinical pathway, including universal screening and risk assessment for suicide

11-30 months

Multiple assessments at baseline, 3, 6, and 12 months

Sustainability

Sites work on maintaining or improving gains made during the intervention phase

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Stepped Approach to Reducing Risk of Suicide in Primary Care

Trial Overview The STARRS-PC program, a quality improvement intervention aimed at reducing suicide risk in youth through a clinical pathway involving risk detection, assessment and triage, and follow-up care. The effectiveness will be compared to usual treatment over a period of 12 months.

How Is the Trial Designed?

Group I: STARRS-PC Experimental Treatment 1 Intervention

Intervention consists of implementation of clinical pathway for youth suicide risk

Group II: Treatment As Usual Active Control 1 Intervention

Treatment as Usual

Who Is Running the Clinical Trial?

Cynthia Fontanella

Lead Sponsor

Trials

1

Recruited

4,600+

Holzer Gallipolis

Collaborator

Holzer Jackson

Collaborator

Holzer Athens

Collaborator

Eastglen Pediatrics

Collaborator

Signature Health Ashtabula

Collaborator

Signature Health Willoughby

Collaborator

Signature Health Painesville

Collaborator

AxessPointe - Arlington

Collaborator

Dayton Children's Hospital

Collaborator

Trials

13

Recruited

5,029,000+

Published Research Related to This Trial

Project CATCH-IT is a low-cost, internet-based intervention designed to prevent depression in adolescents, incorporating motivational interviews and 14 web-based modules focused on behavioral and cognitive therapies.

In a pilot study with 25 adolescents, the intervention was successfully implemented in primary care settings, highlighting its potential for widespread use in existing healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From prototype to product: development of a primary care/internet based depression prevention intervention for adolescents (CATCH-IT). Landback, J., Prochaska, M., Ellis, J., et al.[2022]

Older adults have higher suicide rates and often visit their primary care physicians before completing suicide, making primary care a crucial setting for identifying and managing suicide risk.

Recent research suggests that broader screening for suicide risk in older patients is important, as suicidality can occur without major risk factors like depression, and collaborative care models have shown promise in preventing suicidal thoughts and behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide risk in primary care: identification and management in older adults. Raue, PJ., Ghesquiere, AR., Bruce, ML.[2022]

A study involving 286 general practitioners in the North West of England revealed that while there are more services and training available for general mental health issues, specific resources for suicide prevention are lacking.

GPs reported significant barriers in accessing and referring patients to mental health services, indicating that improving these services could enhance suicide prevention efforts in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide prevention in primary care: General practitioners' views on service availability. Saini, P., Windfuhr, K., Pearson, A., et al.[2023]

Implementing brief standardized screening for suicide risk in pediatric primary care significantly increased the detection rates of suicidal youth by 392% across three clinics, demonstrating its efficacy in identifying at-risk adolescents.

The increase in detection rates was sustained over six months and led to a corresponding rise in referral rates to outpatient behavioral health care, highlighting the importance of early intervention in preventing serious suicide attempts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized screening for suicidal adolescents in primary care. Wintersteen, MB.[2022]

Out of 2109 suicide cases studied, 971 had previous interactions with primary healthcare, highlighting that many individuals at risk were in contact with the system but may not have received adequate support.

Key risk factors for suicide identified included previous suicide attempts, psychiatric diagnoses, and recent mental health-related sick leave, suggesting that routine electronic medical records could be used to improve detection and prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can routine Primary Care Records Help in Detecting Suicide Risk? A Population-Based Case-Control Study in Barcelona. Fradera, M., Ouchi, D., Prat, O., et al.[2022]

The SUPRANET program in the Netherlands provided valuable training for primary care professionals (PCPs) in suicide prevention, but PCPs faced challenges such as self-perceived incompetence and heavy workloads that hindered their ability to assess suicide risk effectively.

While the training was well-received, the study highlighted the need for better collaboration between PCPs and specialized mental health services to enhance suicide prevention efforts, indicating that education alone is not enough to improve care for suicidal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging primary care professionals in suicide prevention: A qualitative study. Elzinga, E., de Kruif, AJTCM., de Beurs, DP., et al.[2022]

A brief online training webinar for primary care staff in rural West Virginia was found to be relevant and acceptable, with 73.3% of participants affirming its relevance to their practices and 75.0% willing to recommend it to colleagues.

While the training increased confidence (75.0%) and comfort (68.8%) in discussing suicide with patients, many participants still felt less prepared for conducting risk assessments (50.1%) and safety planning (56.3%), highlighting the need for more comprehensive training on these critical skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of a Brief Suicide Screening and Risk Assessment Training Webinar for Rural Primary Care Practices. LeCloux, M.[2020]

A systematic review of 14 studies found that while GP-led suicide prevention interventions showed a relative risk (RR) of 0.78 for reducing suicide deaths in regions before and after the program, the overall evidence was inconclusive and did not support a clear benefit.

The review indicated no significant treatment effect for GP training on suicide death rates, suggesting that current interventions may not be effective enough to warrant widespread implementation in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of suicide prevention delivered by GPs: A systematic review and meta-analysis. Milner, A., Witt, K., Pirkis, J., et al.[2022]

In a study of 476 suicide cases in Southwestern Ontario, hanging was the most common method (42.8%), and over half of the decedents (51.8%) were using psychotropic medications, highlighting the potential role of medication management in suicide risk.

Despite 87.1% of primary care visits including suicide risk assessments, a significant portion of patients (39.8%) were assessed as having no immediate risk, suggesting a need for improved assessment strategies to better identify individuals at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confidential Survey Into Southwestern Ontario Suicide: Implication for Primary Care Practice. Shah, R., Eynan, R., Heisel, MJ., et al.[2022]

The tailored interactive computer program, Men and Providers Preventing Suicide (MAPS), significantly increased the likelihood of middle-aged men discussing their suicide thoughts with primary care clinicians, with 65% of MAPS participants reporting such discussions compared to only 35% in the control group.

The study involved 48 men aged 35-74 with recent active suicide thoughts, and the MAPS program was shown to be effective in overcoming barriers to discussing suicide, indicating its potential as a valuable tool in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored Activation of Middle-Aged Men to Promote Discussion of Recent Active Suicide Thoughts: a Randomized Controlled Trial. Jerant, A., Duberstein, P., Kravitz, RL., et al.[2023]

In a study of 200 adolescents aged 12-20 who screened positive for suicidal risk in primary care, only 19.5% were deemed concerning by their physicians, highlighting a gap in recognition of serious risk factors.

Follow-up care for these adolescents was inconsistent, with only 13% being asked about weapons in the home and 7% about having a safety plan, indicating a need for improved guidelines in primary care settings for managing youth suicide risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescent suicide assessment and management in primary care. Aalsma, M., Keys, J., Ferrin, S., et al.[2023]

In a pilot project involving 271 pediatric patients aged 12-25, 11.4% screened positive for suicide risk, highlighting the importance of screening in identifying at-risk youth.

The implementation of suicide risk screening in pediatric primary care was found to be feasible and well-accepted by patients, families, and medical staff, leading to the development of a clinical pathway to guide future screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Suicide Risk Screening in a Pediatric Primary Care Setting: From Research to Practice. Horowitz, LM., Bridge, JA., Tipton, MV., et al.[2023]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06018285/stepped-approach-to-reducing-risk-of-suicide-in-primary-care

Stepped Approach to Reducing Risk of Suicide in Primary ... Stepped care approaches have been shown to be effective at reducing suicide risk in clinical settings, including primary care. ... STARRS-PC ...

2. reporter.nih.gov reporter.nih.gov/project-details/11139597

Signature Project Research is critically needed to test the effectiveness of evidence-informed practices to reduce suicide risk for youth treated in primary care. To address this ...

3. withpower.com withpower.com/trial/stepped-care-suicide-prevention-for-youth-43ce0

Stepped Care Suicide Prevention for Youth (STARRS-PC Trial) Stepped care approaches have been shown to be effective at reducing suicide risk in clinical settings, including primary care. ... STARRS-PC implements a clinical ...

4. ichgcp.net ichgcp.net/clinical-trials-registry/NCT06018285

Stepped Approach to Reducing Risk of Suicide in Primary Care in ... Stepped care approaches have been shown to be effective at reducing suicide risk in clinical settings, including primary care. ... STARRS-PC implements a clinical ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10832890/

Stepped Care for Suicide Prevention in Teens and Young ... This manuscript outlines the design and methods for a research study that compares two interventions aimed at reducing suicide and suicide attempts in youth.

6. childrenshospitals.org childrenshospitals.org/news/childrens-hospitals-today/2025/08/preventing-youth-suicide-with-evidence-based-care

Preventing Youth Suicide With Evidence-Based Care Discover how a quality improvement initiative using the Zero Suicide Framework decreased adolescent patients' suicidal thoughts by 54% at ...