Recruiting

Observational Study

Sponsor:

West Virginia University

Code:

NCT06808503

Conditions

Suicide Prevention

Suicide

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

Interventions

NIMH Clinical Pathway

Study Details

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.

Conditions

Suicide Prevention

Suicide

Study ID

NCT06808503

Start date

Oct 2, 2024

Status verified date

Sep, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

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.

Interventions

NIMH Clinical Pathway

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

Primary outcome measure

  • Percentage of Patients Screened for Suicidal Risk [ Time Frame: 9 Months ]
  • Percentage of Patients with a Positive Screen for Suicide Risk [ Time Frame: 9 Months ]

Central Contacts and Locations

Central contacts

Mary Christensen, PhD, LICSW

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

Locations

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26505

Contacts

Mary Christensen, PhD, LICSW

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

Principal Investigator:

Mary Christensen, PhD, LICSW

Oak Hill School Based Health Center

Recruiting

Oak Hill, West Virginia, United States, 26651

Contacts

Mary Christensen, PhD, LICSW

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

Summersville School Based Health Center

Recruiting

Summersville, West Virginia, United States, 26651

Contacts

Mary Christensen, PhD, LICSW

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

More Information

Sponsor

West Virginia University

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by West Virginia University on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.