NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics

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.

Study Overview

• Status: Recruiting
• Conditions: Suicide; Suicide Prevention
• Intervention / Treatment: Behavioral: NIMH Clinical Pathway

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Christensen, PhD, LICSW; Phone Number: 304-293-3501; Email: mary.christensen@mail.wvu.edu

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Recruiting
      • West Virginia University
      • Contact: Mary Christensen, PhD, LICSW; Phone Number: 304-293-3501; Email: mary.christensen@mail.wvu.edu
      • Principal Investigator: Mary Christensen, PhD, LICSW
    • Oak Hill, West Virginia, United States, 26651
      • Recruiting
      • Oak Hill School Based Health Center
      • Contact: Mary Christensen, PhD, LICSW; Phone Number: 304-293-3501; Email: mary.christensen@mail.wvu.edu
    • Summersville, West Virginia, United States, 26651
      • Recruiting
      • Summersville School Based Health Center
      • Contact: Mary Christensen, PhD, LICSW; Phone Number: 304-293-3501; Email: mary.christensen@mail.wvu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NIMH Clinical Pathway; 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.
No Intervention: Treatment As Usual (TAU); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	9 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Patients Receiving Safety Planning	Percentage of screen-positive patients who received a safety plan intervention during the index visit. The index visit is defined as the clinic visit during which a participant screens positive for suicide risk and is identified for study follow-up procedures.	Index 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 index visit.	Up to 3 Months Post Index Visit
Suicidal Ideation Questionnaire (SIQ-Jr)	Suicidal Ideation Questionnaire (SIQ-Jr) will be administered to participants two times within 3 months of the index 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.	Up to 3 Months Post Index 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 index 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.	Up to 3 Months Post Index Visit
Client Satisfaction Questionnaire (CSQ)	The Client Satisfaction Questionnaire (CSQ) will be administered to participants two times within 3 months of the index 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.	Up to 3 Months Post Index 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 index 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.	Up to 3 Months Post Index 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 index visit. Safety plan use will be assessed during follow-up evaluations conducted after the index visit.	Up to 3 Months Post Index 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 index visit. Safety plan use will be assessed during follow-up evaluations conducted after the index visit.	Up to 3 Months Post Index 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.	Up to 3 Months Post Index 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.	Up to 3 Months Post Index Visit
Participants Reporting Acute Care Usage	Number of participants who report acute care was utilized for help with suicidal symptoms between the initial visit and the 3 month follow up visit per participant report.	Up to 3 Months Post Index 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 initial visit and the 3 month follow up visit per participant report.	Up to 3 Months Post Index Visit

Collaborators and Investigators

• Sponsor: West Virginia University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Mary Christensen, PhD, LICSW, West Virginia University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 4, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Behavior; Suicide Prevention; Suicide
• Other Study ID Numbers: 2405972188; R34MH137618 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No