30 Participants Needed

NIMH Clinical Pathway for Suicide Prevention

MC
Overseen ByMary Christensen, PhD, LICSW
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: West Virginia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the NIMH Clinical Pathway treatment for suicide prevention?

Research shows that clinical pathways, which are structured plans of care, can improve treatment outcomes in psychiatric settings, such as for depression. These pathways help ensure that care is consistent and based on the best available evidence, which can be beneficial in managing conditions like suicidality.12345

What safety data exists for the NIMH Clinical Pathway for Suicide Prevention?

The NIMH guidelines for managing suicidal risk in clinical trials include procedures to detect, monitor, and manage suicidal subjects, as demonstrated in the STAR*D study. However, there is a lack of clear and consistent definitions and reporting of adverse events, which makes evaluating the safety of interventions challenging.16789

How is the NIMH Clinical Pathway treatment for suicide prevention different from other treatments?

The NIMH Clinical Pathway for suicide prevention is unique because it uses a structured approach to assess and manage suicidality, focusing on evidence-based guidelines and comprehensive procedures to monitor and reduce suicide risk, unlike traditional treatments that may not have such a systematic framework.125810

What is the purpose of this trial?

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. The suicide screening program is titled the "NIMH Clinical Pathway" and provides tools and procedures for routinely screening adolescents for suicide risk, completing risk assessments, safety planning, lethal means restriction, follow-up referrals, and other disposition planning as appropriate.Investigators aim to do the following:1. Gather formative data from providers, parents, and youth to inform ways to adapt and implement the NIMH Clinical Pathway so that it can be effectively implemented in rural, Appalachian School-Based Health Centers (SBHCs).2. Gather preliminary data regarding the feasibility, acceptability, and effectiveness of the adapted intervention.

Research Team

MC

Mary Christensen, PhD, LICSW

Principal Investigator

West Virginia University

Eligibility Criteria

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
See 1 more

Exclusion Criteria

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

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Group I: Treatment As Usual (TAU)Active Control1 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 PathwayActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials
192
Recruited
64,700+

Findings from Research

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.
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 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.
[Clinical pathways in psychiatry and psychotherapy].Dick, B., Sitter, H., Blau, E., 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.
Effectiveness of an Integrated Care Pathway for Adolescents with Depression: A Pilot Clinical Trial Protocol.Courtney, DB., Cheung, A., Henderson, J., et al.[2022]

References

Development of a Clinical Pathway for the Assessment and Management of Suicidality on a Pediatric Psychiatric Inpatient Unit. [2022]
[Clinical pathways in psychiatry and psychotherapy]. [2022]
Effectiveness of an Integrated Care Pathway for Adolescents with Depression: A Pilot Clinical Trial Protocol. [2022]
The Impact of an Adolescent Depressive Disorders Clinical Pathway on Healthcare Utilization. [2021]
A completed audit cycle and integrated care pathway for the management of depression following brain injury in a rehabilitation setting. [2019]
Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study. [2023]
Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. [2022]
Suicide risk management for the sequenced treatment alternatives to relieve depression study: applied NIMH guidelines. [2022]
Integrated risk assessment of suicidal ideation and behavior in drug development. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
A Pragmatic Clinical Trial Approach to Assessing and Monitoring Suicidal Ideation: Results from A National US Trauma Care System Study. [2023]
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