NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics

NCT06808503 | Recruiting

• 1 other identifier: 2405972188
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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, completing risk assessments, safety planning, lethal means restriction, follow-up referrals, and other disposition planning as appropriate. Investigators aim to do the following:

1. 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. 2.Gather preliminary data regarding the feasibility, acceptability, and effectiveness of the adapted intervention.

Conditions

Suicide Prevention; Suicide

Outcome Measures

Primary Outcomes (4)

• Number of Patients Screened for Suicidal Risks-Site 1

  Review of patient records for the number of patients that were asked about suicidal thoughts and/or behaviors during their visit. Review will occur for a total of 3 months during the Treatment as Usual Period.

  Total period of 3 Months

• Number of Patients Screened for Suicidal Risks-Site 2

  Review of patient records for the number of patients that were asked about suicidal thoughts and/or behaviors during their visit. Review will occur for a total of 6 months during the Treatment as Usual Period.

  Total period of 6 Months

• Number of Patients Reporting Suicidal Risks-Site 1

  Review of patient records for the number of patients that reported having suicidal thoughts and/or behaviors. Review will occur for a total of 12 months during the Intervention Period.

  Total period of 12 Months

• Number of Patients Reporting Suicidal Risks-Site 2

  Review of patient records for the number of patients that reported having suicidal thoughts and/or behaviors. Review will occur for a total of 12 months during the Interventional Period

  Total period of 12 Months

Secondary Outcomes (54)

• Safety Planning Rates (Number)- Site 1

  Initial Visit

• Safety Planning Rates (Number)- Site 1

  3 Month Follow Up Visit

• Safety Planning Rates (Number)- Site 2

  Initial Visit

• Safety Planning Rates (Number)- Site 2

  3 Month Follow Up Visit

• Safety Planning Rates (Percentage)- Site 1

  Initial Visit

Study Arms (2)

Treatment As Usual (TAU)

NO 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.

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.

Behavioral: NIMH Clinical Pathway

Interventions

NIMH Clinical Pathway BEHAVIORAL

Complete the implemented workflow and tools for suicide risk screening, assessment, safety planning and follow-up.

NIMH Clinical Pathway

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26505, United States

RECRUITING

MeSH Terms

Conditions

Suicide Prevention; Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Mary Christensen, PhD, LICSW

  West Virginia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Christensen, PhD, LICSW

CONTACT

304-293-3501; mary.christensen@mail.wvu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and MSW Program Director

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 5, 2025
• Study Start: October 2, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)