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NCT Number: NCT06808503

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University, Morgantown, West Virginia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NIMH Clinical Pathway

Behavioral

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

Primary outcomes

  1. Percentage of Patients Screened for Suicidal Risk

    Time frame: 9 Months

    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.

  2. Percentage of Patients with a Positive Screen for Suicide Risk

    Time frame: 9 Months

    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.

Secondary outcomes

  1. Rate of Patients Receiving Safety Planning

    Time frame: Index Visit

    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.

  2. Follow-Up Service Provision Rate

    Time frame: Up to 3 Months Post Index Visit

    Percentage of screen-positive patients who were seen by a provider at the school clinic within 3 months of index visit.

  3. Suicidal Ideation Questionnaire (SIQ-Jr)

    Time frame: Up to 3 Months Post Index Visit

    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.

  4. Center for Epidemiological Studies Depression Scale (CES-D)

    Time frame: Up to 3 Months Post Index Visit

    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.

  5. Client Satisfaction Questionnaire (CSQ)

    Time frame: Up to 3 Months Post Index Visit

    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.

  6. Columbia Suicide-Severity Rating Scale (C-SSRS)

    Time frame: Up to 3 Months Post Index Visit

    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.

  7. Percentage of Participants reporting Safety Plan Usage

    Time frame: Up to 3 Months Post Index Visit

    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.

  8. Percentage of Parents Reporting Safety Plan Usage

    Time frame: Up to 3 Months Post Index Visit

    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.

  9. Participant-Rated Helpfulness of Safety Plan

    Time frame: Up to 3 Months Post Index Visit

    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.

  10. Parent-Rated Helpfulness of Safety Plan

    Time frame: Up to 3 Months Post Index Visit

    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.

  11. Participants Reporting Acute Care Usage

    Time frame: Up to 3 Months Post Index Visit

    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.

  12. Parents Reporting Acute Care Usage

    Time frame: Up to 3 Months Post Index Visit

    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.

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2025
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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