Suicide PreventionNCT06808503
NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics
A study testing NIMH Clinical Pathway in people with Suicide Prevention and Suicide, run by West Virginia University at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide Prevention, Suicide
- What is being tested?
- NIMH Clinical Pathway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Oct 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 and Parent must be English-speaking
- Youth must also be able to give signed assent to participate
- Youth must be cognitively and medically able to participate in study activities
Who cannot join
- Youth in state custody will be excluded from study participation due to challenges related to obtaining legal consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
West Virginia University
Morgantown, West Virginia, 26505
Mary Christensen, PhD, LICSW, 304-293-3501, mary.christensen@mail.wvu.edu
Mary Christensen, PhD, LICSW
- Recruiting
Oak Hill School Based Health Center
Oak Hill, West Virginia, 26651
Mary Christensen, PhD, LICSW, 304-293-3501, mary.christensen@mail.wvu.edu
- Recruiting
Summersville School Based Health Center
Summersville, West Virginia, 26651
Mary Christensen, PhD, LICSW, 304-293-3501, mary.christensen@mail.wvu.edu
About this study
Official title: Implementing the NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics
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.
- Conditions
- Suicide Prevention, Suicide
- Being tested
- NIMH Clinical Pathway
- Medical subject headings
- Suicide Prevention, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIMH Clinical PathwayBehavioural
Complete the implemented workflow and tools for suicide risk screening, assessment, safety planning and follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | 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. |
| NIMH Clinical Pathway | Active comparator | 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. Receives: Behavioral: NIMH Clinical Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 9 Months
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 Months Post Baseline Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start2 Oct 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Mary Christensen, West Virginia University
- Investigators
- Mary Christensen, PhD, LICSW, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808503
- Sponsor's protocol ID
- 2405972188
- Other IDs
- R34MH137618
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing the NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics
- ClinicalTrials.gov ID
- NCT06808503
- Acronym / sponsor ID
- 2405972188
- Conditions
- Suicide Prevention, Suicide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | –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. |
| NIMH Clinical Pathway | Active comparator | Behavioral: NIMH Clinical PathwayImplementation 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 may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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 and Parent must be English-speaking
- Youth must also be able to give signed assent to participate
- Youth must be cognitively and medically able to participate in study activities
Key exclusion criteria (1 listed)
- Youth in state custody will be excluded from study participation due to challenges related to obtaining legal consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIMH Clinical PathwayComplete the implemented workflow and tools for suicide risk screening, assessment, safety planning and follow-up. | Behavioural | NIMH Clinical Pathway |
Primary outcome
Percentage of Patients Screened for Suicidal Risk
Time frame: 9 Months
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.
Percentage of Patients with a Positive Screen for Suicide Risk
Time frame: 9 Months
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.
12 secondary outcomes
Rate of Patients Receiving Safety Planning
Time frame: Baseline Visit
Follow-Up Service Provision Rate
Time frame: Up to 3 Months Post Baseline Visit
Suicidal Ideation Questionnaire (SIQ-Jr)
Time frame: Up to 3 Months Post Baseline Visit
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: Up to 3 Months Post Baseline Visit
Client Satisfaction Questionnaire (CSQ)
Time frame: Up to 3 Months Post Baseline Visit
Columbia Suicide-Severity Rating Scale (C-SSRS)
Time frame: Up to 3 Months Post Baseline Visit
Percentage of Participants reporting Safety Plan Usage
Time frame: Up to 3 Months Post Baseline Visit
Percentage of Parents Reporting Safety Plan Usage
Time frame: Up to 3 Months Post Baseline Visit
Participant-Rated Helpfulness of Safety Plan
Time frame: Up to 3 Months Post Baseline Visit
Parent-Rated Helpfulness of Safety Plan
Time frame: Up to 3 Months Post Baseline Visit
Participants Reporting Acute Care Usage
Time frame: Up to 3 Months Post Baseline Visit
Parents Reporting Acute Care Usage
Time frame: Up to 3 Months Post Baseline Visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Suicide Prevention
Not yet recruitingPhase 1/2
Reducing Firearm Suicide Among Veterans: Evaluating the Effectiveness of Peer-Delivered Lethal Means Counseling
Suicide, Secure Firearm Storage
Not yet recruitingPhase 2
Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
Suicidal Ideation, Suicidal Behavior
Recruiting
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
Clinical High Risk for Psychosis (CHR), Suicidal Ideation
Recruiting
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Not yet recruiting
THRIVE: A Recovery-Focused Suicide Prevention Intervention in Crisis Stabilization Centers
Suicide
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Christensen, PhD, LICSW principal investigator
West Virginia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIMH Clinical Pathway in people with Suicide Prevention and Suicide, run by West Virginia University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Christensen, PhD, LICSW (304-293-3501, mary.christensen@mail.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Screened for Suicidal Risk (time frame: 9 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.