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NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics

Implementing the NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06808503
Enrollment
70
Registered
2025-02-05
Start date
2024-10-02
Completion date
2027-08-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide, Suicide Prevention

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 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.

Interventions

BEHAVIORALNIMH Clinical Pathway

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

Sponsors

West Virginia University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Patients Screened for Suicidal Risk9 MonthsPercentage 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 Risk9 MonthsPercentage 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.

Secondary

MeasureTime frameDescription
Rate of Patients Receiving Safety PlanningIndex VisitPercentage 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.
Follow-Up Service Provision RateUp to 3 Months Post Index VisitPercentage of screen-positive patients who were seen by a provider at the school clinic within 3 months of index visit.
Suicidal Ideation Questionnaire (SIQ-Jr)Up to 3 Months Post Index VisitSuicidal 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.
Center for Epidemiological Studies Depression Scale (CES-D)Up to 3 Months Post Index VisitThe 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.
Client Satisfaction Questionnaire (CSQ)Up to 3 Months Post Index VisitThe 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.
Columbia Suicide-Severity Rating Scale (C-SSRS)Up to 3 Months Post Index VisitParticipants 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.
Percentage of Participants reporting Safety Plan UsageUp to 3 Months Post Index VisitPercentage 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.
Percentage of Parents Reporting Safety Plan UsageUp to 3 Months Post Index VisitPercentage 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.
Participant-Rated Helpfulness of Safety PlanUp to 3 Months Post Index VisitParticipant 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.
Parent-Rated Helpfulness of Safety PlanUp to 3 Months Post Index VisitParent 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.
Participants Reporting Acute Care UsageUp to 3 Months Post Index VisitNumber 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.
Parents Reporting Acute Care UsageUp to 3 Months Post Index VisitNumber 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.

Countries

United States

Contacts

CONTACTMary Christensen, PhD, LICSW
mary.christensen@mail.wvu.edu304-293-3501
PRINCIPAL_INVESTIGATORMary Christensen, PhD, LICSW

West Virginia University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026