An interventional study of NIMH Clinical Pathway in Suicide Prevention and Suicide, sponsored by West Virginia University. Recruiting at 3 sites in United States. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by West Virginia University · Not applicable, Interventional, and Screening
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 screening, suicide risk assessment, safety planning, referral procedures, and follow-up care activities for adolescents receiving health services.
The study will assess implementation outcomes, including suicide screening practices, identification of suicide risk, safety planning, and follow-up service delivery, as well as participant outcomes including suicidal ideation, depressive symptoms, satisfaction with services, suicidal behavior, safety plan utilization, and acute care utilization. Data collected across participating sites will be combined to evaluate the feasibility, acceptability, and preliminary effectiveness of the adapted Clinical Pathway. Protocol amendments resulted in consolidation of site-specific outcome measures into combined analyses across participating school-based health centers. The ClinicalTrials.gov record was updated to reflect the current protocol, study procedures, and planned statistical analyses.
186 studies on the registry are indexed under Suicide Prevention; 92 are open to participants now.
This study's planned enrollment of 70 is below the median of 140 across 167 interventional studies indexed under Suicide Prevention.
Browse Suicide Prevention studies →West Virginia University is the lead sponsor of 157 studies on the registry; 36 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Review of medical records for patients that the standard of care was used at the facility for suicide assessment and risk. Determine if the enrolled patients were assessed and if risks are present.
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.
Behavioral: NIMH Clinical Pathway
Complete the implemented workflow and tools for suicide risk screening, assessment, safety planning and follow-up.
Percentage of Patients Screened for Suicidal Risk
Percentage of patients to determine how many received documented screening for suicide risk during their visit. Data will be combined across both study sites. The outcome will be calculated as the number of patients screened for suicide risk divided by the total number of eligible patients receiving services during the review. Review will occur for 9 months during the baseline and intervention phases.
Time frame: 9 Months
Percentage of Patients with a Positive Screen for Suicide Risk
Percentage of patients were identified as a positive screen for suicide risk. Data will be combined across both study sites. The outcome will be calculated as the number of patients with a positive suicide risk screen divided by the total number of patients screened during the review period. Review will occur for 9 months, which will include the baseline and intervention phases.
Time frame: 9 Months
Rate of Patients Receiving Safety Planning
Percentage of screen-positive patients who received a safety plan intervention during the baseline visit. The baseline visit is defined as the clinic visit during which a participant screens positive for suicide risk and is identified for study follow-up procedures.
Time frame: Baseline Visit
Follow-Up Service Provision Rate
Percentage of screen-positive patients who were seen by a provider at the school clinic within 3 months of baseline visit.
Time frame: Up to 3 Months Post Baseline Visit
Suicidal Ideation Questionnaire (SIQ-Jr)
Suicidal Ideation Questionnaire (SIQ-Jr) will be administered to participants two times within 3 months of the baseline visit. The SIQ-Jr is a 15-item self-report questionnaire that measures suicidal thoughts on a 7-point scale ("0- I never had this thought" to "6- I have this thought every day"). Scores range from 0-90, SIQ-Jr scores of 30 and above indicate severe suicidal ideation and the need for clinical intervention.
Time frame: Up to 3 Months Post Baseline Visit
Center for Epidemiological Studies Depression Scale (CES-D)
The Center for Epidemiological Studies Depression Scale (CES-D) will be administered to participants two times within 3 months of the baseline visit. The CES-D is a self-report measure with 10 items asking about the frequency with which individuals have experienced various symptoms of depression within the last week. Each item is rated on a Likert scale, typically ranging from 0 (rarely or none of the time) to 3 (most or all of the time). Total scores range is from 0-30, with higher scores indicating higher levels of depression.
Time frame: Up to 3 Months Post Baseline Visit
Client Satisfaction Questionnaire (CSQ)
The Client Satisfaction Questionnaire (CSQ) will be administered to participants two times within 3 months of the baseline visit. The CSQ is a self-report measure with 8 Likert-style items asking about satisfaction with services received at the clinic. Total scores range is from 8-32, with higher scores indicating higher levels of service satisfaction.
Time frame: Up to 3 Months Post Baseline Visit
Columbia Suicide-Severity Rating Scale (C-SSRS)
Participants will be administered the brief version of the Columbia Suicide-Severity Rating Scale (C-SSRS) two times within 3 months of the baseline visit. The C-SSRS is a screening tool that asks two initial questions about suicidal ideation. For participants who state "yes" to either of these questions, they are asked additional questions about suicidal intent, plans, and behavior. Investigators will measure suicidal behavior as a dichotomous "yes"/"no" variable. A participant will be considered a "yes" for this measure if they answer "yes" to the final question about engaging in suicidal preparation and/or attempts on the C-SSRS and to the question asking whether or not they have done so in the past 3 months.
Time frame: Up to 3 Months Post Baseline Visit
Percentage of Participants reporting Safety Plan Usage
Percentage of participants with a positive suicide risk screen who report using the safety plan developed during the baseline visit. Safety plan use will be assessed during follow-up evaluations conducted after the baseline visit.
Time frame: Up to 3 Months Post Baseline Visit
Percentage of Parents Reporting Safety Plan Usage
Percentage of Parents of screen-positive participants reporting use of the safety plan developed during the participant's baseline visit. Safety plan use will be assessed during follow-up evaluations conducted after the baseline visit.
Time frame: Up to 3 Months Post Baseline Visit
Participant-Rated Helpfulness of Safety Plan
Participant ratings of safety plan helpfulness measured using a 4-point Likert scale ranging from 1 (Very Helpful) to 4 (Not at All Helpful). Lower scores indicate greater perceived helpfulness of the safety plan.
Time frame: Up to 3 Months Post Baseline Visit
Parent-Rated Helpfulness of Safety Plan
Parent ratings of safety plan helpfulness measured using a 4-point Likert scale ranging from 1 (Very Helpful) to 4 (Not at All Helpful). Lower scores indicate greater perceived helpfulness of the safety plan.
Time frame: Up to 3 Months Post Baseline Visit
Participants Reporting Acute Care Usage
Number of participants who report acute care was utilized for help with suicidal symptoms between the baseline visit and the 3 month follow up visit per participant report.
Time frame: Up to 3 Months Post Baseline Visit
Parents Reporting Acute Care Usage
Number of parents who report acute care was utilized for help with suicidal symptoms of the participant between the baseline visit and the 3 month follow up visit per participant report.
Time frame: Up to 3 Months Post Baseline Visit
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Aug 2027, 34 months after the start.
Of 127 non-industry interventional studies with no phase under Suicide Prevention, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 53. This study's planned 34 months is above that.
Counting every sponsor, half of 129 studies reached it within 28 months; a quarter within 12 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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