NIMH Clinical Pathway for Suicide Prevention

Overseen By Mary Christensen, PhD, LICSW

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: West Virginia University

Disqualifiers: State custody

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

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a suicide risk screening and follow-up program, known as the NIMH Clinical Pathway, in two school-based health centers in West Virginia. The program identifies students at risk, creates safety plans, and provides referrals and follow-up care. Researchers aim to evaluate the program's effectiveness and ease of use in rural schools. The trial seeks English-speaking students who already use services at these school health centers and can participate in study activities. As an unphased trial, this study offers students the chance to contribute to important research that could enhance mental health support in schools.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the NIMH Clinical Pathway is safe for adolescents?

Research has shown that the NIMH Clinical Pathway for suicide prevention safely identifies teenagers at risk of suicide. It employs a simple three-step process, beginning with a quick 20-second questionnaire called ASQ (Ask Suicide-Screening Questions) to assess risk. Past studies have successfully identified 97% of at-risk youth using this method without causing harm.

The pathway is evidence-based, having been tested and proven effective in various settings. This trial focuses on adapting the pathway for use in school health centers, not on testing a new drug or treatment. Therefore, there is no risk of drug-related side effects. The main goal is to ensure it works well in schools and is easy for them to implement. Overall, the process is safe and aims to enhance how schools support students who might be at risk for suicide. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NIMH Clinical Pathway for suicide prevention because it offers a more structured and proactive approach compared to the traditional methods. Unlike standard care, which often relies on varying assessments, this pathway standardizes the process with a clear workflow and tools for routine suicide risk screening, assessment, safety planning, and follow-up. This means potential risks can be identified more consistently and addressed promptly, possibly improving outcomes for individuals at risk of suicide.

What evidence suggests that the NIMH Clinical Pathway is effective for suicide prevention?

Research has shown that the NIMH Clinical Pathway is a proven program for identifying and managing suicide risk. In this trial, participants will receive either the NIMH Clinical Pathway, which includes tools for screening, assessing risk, planning for safety, and follow-up, or Treatment As Usual (TAU), which involves reviewing standard care practices at the facility. Similar programs, such as the Zero Suicide Model, have reduced suicide deaths by nearly 80% over ten years. The NIMH Clinical Pathway has successfully connected people at risk with appropriate care. These findings suggest that the NIMH Clinical Pathway could effectively reduce suicide risk in schools. ^{4 6 7 8 9}

Who Is on the Research Team?

Mary Christensen, PhD, LICSW

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

This trial is for adolescents attending school-based health centers in West Virginia. It's focused on those who may be at risk of suicide and can benefit from routine screening and follow-up care. The study seeks input from providers, parents, and youth to tailor the program effectively.

Inclusion Criteria

Youth who are receiving services at the school-based health centers to participate

Parents must be able to give legal consent for themselves and their children to participate

Youth must also be able to give signed assent to participate

Exclusion Criteria

Youth in state custody will be excluded from study participation due to challenges related to obtaining legal consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the NIMH Clinical Pathway for routine suicide risk screening, assessment, safety planning, and follow-up

6 months

Regular visits as per school-based health center schedule

Follow-up

Participants are monitored for safety and effectiveness after intervention, including follow-up appointments to re-assess suicidal symptoms

3 months

3 Month Follow Up Visit

What Are the Treatments Tested in This Trial?

Interventions

• NIMH Clinical Pathway

Trial Overview The 'NIMH Clinical Pathway' is being tested for its ability to screen for suicide risk and provide appropriate follow-up actions like safety planning and referrals. This trial will adapt this evidence-based program specifically for rural Appalachian school settings.

How Is the Trial Designed?

Group I: Treatment As Usual (TAU) Active Control 1 Intervention

Review all medical records for patients for the standard of care used at the facility for suicide assessment and risk. Determine if the enrolled patients were assessed and if risks are present.

Group II: NIMH Clinical Pathway Active Control 1 Intervention

Implementation of an adapted/tailored version of the NIMH Clinical Pathway, which identifies a workflow and tools for routine suicide risk screening, assessment, safety planning and follow-up.

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

Published Research Related to This Trial

The development and implementation of an integrated care pathway (ICP) for managing depression after brain injury significantly improved documentation standards in a rehabilitation unit, with compliance rates rising to 94-100% for most areas assessed.

The ICP not only enhanced documentation practices but also increased staff awareness of depression management, which may lead to better overall care for patients recovering from brain injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A completed audit cycle and integrated care pathway for the management of depression following brain injury in a rehabilitation setting. Hassan, N., Turner-Stokes, L., Pierce, K., et al.[2019]

The STAR*D study successfully implemented NIMH guidelines to manage suicidal risk in a large clinical trial involving an anticipated 4000 participants, focusing on treatment-resistant depression.

Innovative methods, such as an interactive voice response system, were utilized to enhance safety monitoring and ensure timely alerts for clinicians and safety officers regarding suicidal subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide risk management for the sequenced treatment alternatives to relieve depression study: applied NIMH guidelines. Nierenberg, AA., Trivedi, MH., Ritz, L., et al.[2022]

The Integrated Care Pathway (ICP) developed for treating adolescents with depression aims to improve treatment response by following a Clinical Practice Guideline and a measurement-based care framework, with outcomes assessed using the Childhood Depression Rating Scale - Revised (CDRS-R) over a 20-week period.

The study plans to recruit 30 participants at two outpatient sites, with the hypothesis that the ICP will lead to greater reductions in depressive symptoms compared to standard treatment, and if successful, will pave the way for a larger multi-center randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Integrated Care Pathway for Adolescents with Depression: A Pilot Clinical Trial Protocol. Courtney, DB., Cheung, A., Henderson, J., et al.[2022]

The University Hospital of Marburg developed clinical pathways for managing suicidal ideation and attempts, based on a thorough review of existing guidelines and local care processes, to enhance the quality of psychiatric care.

These pathways include tailored algorithms and checklists that improve patient transfer, team coordination, and suicide risk diagnosis, ultimately aiming to increase care efficiency and patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical pathways in psychiatry and psychotherapy]. Dick, B., Sitter, H., Blau, E., et al.[2022]

A multidisciplinary team developed a clinical pathway for assessing and managing suicidality in a pediatric psychiatric inpatient unit, which included six structured steps from admission to discharge.

The framework created aims to standardize care for suicidal children and adolescents, making it adaptable for use in similar healthcare settings, enhancing the safety and efficacy of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Clinical Pathway for the Assessment and Management of Suicidality on a Pediatric Psychiatric Inpatient Unit. Boafo, A., Greenham, S., Cloutier, P., et al.[2022]

The study analyzed adverse events related to suicidality in 9 randomized placebo-controlled trials of duloxetine, revealing that while suicides were clearly identifiable, suicidal ideation and preparatory behaviors were often obscured due to the limitations of the medical coding dictionaries used, particularly COSTART.

The findings suggest that adverse event data in clinical study reports may not fully represent patient experiences, highlighting the importance of using detailed narratives and individual patient listings to capture a more accurate picture of potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study. Maund, E., Tendal, B., Hróbjartsson, A., et al.[2023]

The study presents a consensus framework for assessing the risk of treatment-related suicidal ideation and behavior (SIB) during drug development, addressing a growing concern among health authorities.

This framework considers various factors, including the chemical and pharmacological properties of drugs, patient populations, and regulatory precedents, to better identify and manage SIB risks in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated risk assessment of suicidal ideation and behavior in drug development. Muller, PY., Dambach, D., Gemzik, B., et al.[2022]

In a study examining adherence to an inpatient clinical pathway for adolescent depression, patients with high adherence had longer hospital stays and higher costs compared to those with low adherence.

Despite the increased length of stay and costs, there was no significant difference in the rates of 30-day emergency department visits or readmissions, suggesting that high adherence does not necessarily lead to better short-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of an Adolescent Depressive Disorders Clinical Pathway on Healthcare Utilization. Lifland, B., Wright, DR., Mangione-Smith, R., et al.[2021]

In a study involving 635 injury survivors at 25 trauma centers, over 50% reported suicidal ideation at least once, highlighting the prevalence of this issue in trauma patients.

While the collaborative care intervention showed a trend towards reduced suicidal ideation compared to the control group, the differences were not statistically significant, suggesting that further research is needed to determine the effectiveness of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pragmatic Clinical Trial Approach to Assessing and Monitoring Suicidal Ideation: Results from A National US Trauma Care System Study. Engstrom, A., Moloney, K., Nguyen, J., et al.[2023]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

Citations

1. nimh.nih.gov nimh.nih.gov/health/trials/suicide-prevention

Suicide Prevention - National Institute of Mental Health (NIMH) The STARRS-PC pathway consists of three evidence-based suicide clinical care processes: risk detection, assessment and triage, and, if needed, follow-up ...

2. nimh.nih.gov nimh.nih.gov/news/science-updates/suicide

Science Updates About Suicide An NIMH-supported workgroup developed an evidence-based screening pathway to help primary care doctors identify adults at risk of suicide and bridge them to ...

3. withpower.com withpower.com/trial/nimh-clinical-pathway-for-suicide-prevention-e7149

NIMH Clinical Pathway for Suicide Prevention This study will adapt and evaluate an evidence-based suicide risk screening and follow-up program in two school-based health centers in West Virginia.

4. nimh.nih.gov nimh.nih.gov/funding/clinical-research/conducting-research-with-participants-at-elevated-risk-for-suicide-considerations-for-researchers

Conducting Research with Participants at Elevated Risk for ... This document serves to update National Institute of Mental Health (NIMH) guidance on suicide intervention research.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832230

Zero Suicide Model Implementation and Suicide Attempt ... After implementation, the model was associated with a near 80% reduction in suicide deaths sustained for more than 10 years in behavioral health ...

6. nimh.nih.gov nimh.nih.gov/sites/default/files/documents/suicide_risk_screening_clinical_pathway_ed_final_with_supplement.pdf

SUICIDE RISK SCREENING PATHWAY The pathway proposes a three-tiered approach to screening: 1) screening for suicide risk with the ASQ (≈ 20 seconds), 2) a brief suicide safety assessment (BSSA) ...

7. nimh.nih.gov nimh.nih.gov/research/research-conducted-at-nimh/asq-toolkit-materials

Ask Suicide-Screening Questions (ASQ) Toolkit In an NIMH study , a “yes” response to one or more of the four questions identified 97% of youth (aged 10 to 21 years) at risk for suicide. Led by the NIMH, a ...

8. nimh.nih.gov nimh.nih.gov/research/research-conducted-at-nimh/asq-toolkit-materials/youth-ed/suicide-risk-screening-pathway-emergency-department-chart-description

Suicide Risk Screening Pathway: Emergency Department ... The pathway proposes a three-tiered approach to screening: 1) screening for suicide risk with the ASQ (≈ 20 seconds), 2) a brief suicide safety assessment ( ...

9. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.focus.20220086

Screening and Assessing Suicide Risk in Medical Settings This article discusses the importance of identifying people at elevated suicide risk through screening, differentiates screening from assessment procedures,