Clinical trial NCT06808503: NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics
Official title: Implementing the NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide Prevention
Suicide
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients Screened for Suicidal Risks-Site 1
timeFrame: Total period of 3 Months
measure: Number of Patients Screened for Suicidal Risks-Site 2
timeFrame: Total period of 6 Months
measure: Number of Patients Reporting Suicidal Risks-Site 1
timeFrame: Total period of 6 Months
measure: Number of Patients Reporting Suicidal Risks-Site 2
timeFrame: Total period of 3 Months
Secondary outcomes:
measure: Safety Planning Rates (Number)- Site 1
timeFrame: Initial Visit
measure: Safety Planning Rates (Number)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Safety Planning Rates (Number)- Site 2
timeFrame: Initial Visit
measure: Safety Planning Rates (Number)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Safety Planning Rates (Percentage)- Site 1
timeFrame: Initial Visit
measure: Safety Planning Rates (Percentage)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Safety Planning Rates (Percentage)- Site 2
timeFrame: Initial Visit
measure: Safety Planning Rates (Percentage)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Follow-up Service Provision (Number)- Site 1
timeFrame: Chart review conducted within 3 months following initial visit
measure: Follow-up Service Provision (Number)- Site 2
timeFrame: Chart review conducted within 3 months following initial visit
measure: Participant rate of Suicidal Ideation: (SIQ-Jr)- Site 1
timeFrame: Initial Visit
measure: Participant rate of Suicidal Ideation: (SIQ-Jr)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Participant rate of Suicidal Ideation: (SIQ-Jr)- Site 2
timeFrame: Initial visit
measure: Participant rate of Suicidal Ideation: (SIQ-Jr)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Participant rate of Depression: (CES-D)- Site 1
timeFrame: Initial Visit
measure: Participant rate of Depression: (CES-D)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Participant rate of Depression: (CES-D)- Site 2
timeFrame: Initial Visit
measure: Participant rate of Depression: (CES-D)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Participants with Suicidal Behavior at Follow Up (Number)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Participants with Suicidal Behavior at Follow Up (Number)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Participants with Suicidal Behavior at Follow Up (Percentage)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Participants with Suicidal Behavior at Follow Up (Percentage)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Participants Reporting Safety Plan Usage (Number) - Site 1
timeFrame: 3 Month Follow Up Visit
measure: Participants Reporting Safety Plan Usage (Number)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Participants Reporting Safety Plan Usage (Percentage)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Participants Reporting Safety Plan Usage (Percentage)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Parents Reporting Safety Plan Usage (Number)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Parents Reporting Safety Plan Usage (Number)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Parents Reporting Safety Plan Usage (Percentage)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Parents Reporting Safety Plan Usage (Percentage)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Participants Reporting Frequency of Safety Plan Use (Number)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Participants Reporting Frequency of Safety Plan Use (Number)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Participants Reporting Frequency of Safety Plan Use (Percentage)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Participants Reporting Frequency of Safety Plan Use (Percentage)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Parents Reporting Frequency of Safety Plan Use (Number)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Parents Reporting Frequency of Safety Plan Use (Number)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Parents Reporting Frequency of Safety Plan Use (Percentage)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Parents Reporting Frequency of Safety Plan Use (Percentage)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Participants Reporting Helpfulness of Safety Plan (Number)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Participants Reporting Helpfulness of Safety Plan (Number)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Participants Reporting Helpfulness of Safety Plan (Percentage)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Participants Reporting Helpfulness of Safety Plan (Percentage)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Parents Reporting Helpfulness of Safety Plan (Number)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Parents Reporting Helpfulness of Safety Plan (Number)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Parents Reporting Helpfulness of Safety Plan (Percentage)- Site 1
timeFrame: 3 Month Follow Up Visit
measure: Parents Reporting Helpfulness of Safety Plan (Percentage)- Site 2
timeFrame: 3 Month Follow Up Visit
measure: Participants Reporting Acute Care Usage (Number)- Site 1
timeFrame: Total period of 3 Months
measure: Participants Reporting Acute Care Usage (Number)- Site 2
timeFrame: Total period of 3 Months
measure: Participants Reporting Acute Care Usage (Percentage)- Site 1
timeFrame: Total period of 3 Months
measure: Participants Reporting Acute Care Usage (Percentage)- Site 2
timeFrame: Total period of 3 Months
measure: Parents Reporting Acute Care Usage (Number)- Site 1
timeFrame: Total period of 3 Months
measure: Parents Reporting Acute Care Usage (Number)- Site 2
timeFrame: Total period of 3 Months
measure: Parents Reporting Acute Care Usage (Percentage)- Site 1
timeFrame: Total period of 3 Months
measure: Parents Reporting Acute Care Usage (Percentage)- Site 2
timeFrame: Total period of 3 Months
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Mary Christensen, PhD, LICSW
role: PRINCIPAL_INVESTIGATOR
References: