Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 8:04 PM
Study NCT ID:
NCT06808503
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2025-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092864', 'term': 'Suicide Prevention'}, {'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-29', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-01-29', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Screened for Suicidal Risks-Site 1', 'timeFrame': 'Total period of 3 Months', 'description': '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.'}, {'measure': 'Number of Patients Screened for Suicidal Risks-Site 2', 'timeFrame': 'Total period of 6 Months', 'description': '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.'}, {'measure': 'Number of Patients Reporting Suicidal Risks-Site 1', 'timeFrame': 'Total period of 6 Months', 'description': 'Review of patient records for the number of patients that reported having suicidal thoughts and/or behaviors. Review will occur for a total of 3 months during the Intervention Period.'}, {'measure': 'Number of Patients Reporting Suicidal Risks-Site 2', 'timeFrame': 'Total period of 3 Months', 'description': 'Review of patient records for the number of patients that reported having suicidal thoughts and/or behaviors. Review will occur for a total of 6 months during the Interventional Period'}], 'secondaryOutcomes': [{'measure': 'Safety Planning Rates (Number)- Site 1', 'timeFrame': 'Initial Visit', 'description': 'Number of at-risk patients that the providers documented safety planning was completed.'}, {'measure': 'Safety Planning Rates (Number)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of at-risk patients that the providers documented safety planning was completed.'}, {'measure': 'Safety Planning Rates (Number)- Site 2', 'timeFrame': 'Initial Visit', 'description': 'Number of at-risk patients that the providers documented safety planning was completed.'}, {'measure': 'Safety Planning Rates (Number)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of at-risk patients that the providers documented safety planning was completed.'}, {'measure': 'Safety Planning Rates (Percentage)- Site 1', 'timeFrame': 'Initial Visit', 'description': 'Percentage of at-risk patients that the providers documented safety planning was completed.'}, {'measure': 'Safety Planning Rates (Percentage)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of at-risk patients that the providers documented safety planning was completed.'}, {'measure': 'Safety Planning Rates (Percentage)- Site 2', 'timeFrame': 'Initial Visit', 'description': 'Percentage of at-risk patients that the providers documented safety planning was completed.'}, {'measure': 'Safety Planning Rates (Percentage)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of at-risk patients that the providers documented safety planning was completed.'}, {'measure': 'Follow-up Service Provision (Number)- Site 1', 'timeFrame': 'Chart review conducted within 3 months following initial visit', 'description': 'Number of at-risk patients that documentation confirms providers conducted follow-up appointments to re-assess suicidal symptoms.'}, {'measure': 'Follow-up Service Provision (Number)- Site 2', 'timeFrame': 'Chart review conducted within 3 months following initial visit', 'description': 'Number of at-risk patients that documentation confirms providers conducted follow-up appointments to re-assess suicidal symptoms.'}, {'measure': 'Participant rate of Suicidal Ideation: (SIQ-Jr)- Site 1', 'timeFrame': 'Initial Visit', 'description': 'Suicidal Ideation Questionnaire (SIQ-Jr) will be administered to participants at the initial visit and 3 months follow up. 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 23 and above indicate severe suicidal ideation and the need for clinical intervention.'}, {'measure': 'Participant rate of Suicidal Ideation: (SIQ-Jr)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Suicidal Ideation Questionnaire (SIQ-Jr) will be administered to participants at the initial visit and 3 months follow up. 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 23 and above indicate severe suicidal ideation and the need for clinical intervention.'}, {'measure': 'Participant rate of Suicidal Ideation: (SIQ-Jr)- Site 2', 'timeFrame': 'Initial visit', 'description': 'Suicidal Ideation Questionnaire (SIQ-Jr) will be administered to participants at the initial visit and 3 months follow up. 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 23 and above indicate severe suicidal ideation and the need for clinical intervention.'}, {'measure': 'Participant rate of Suicidal Ideation: (SIQ-Jr)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Suicidal Ideation Questionnaire (SIQ-Jr) will be administered to participants at the initial visit and 3 months follow up. 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 23 and above indicate severe suicidal ideation and the need for clinical intervention.'}, {'measure': 'Participant rate of Depression: (CES-D)- Site 1', 'timeFrame': 'Initial Visit', 'description': 'The Center for Epidemiological Studies Depression Scale (CES-D) will be administered to the participant at the initial visit and the 3 month follow up. 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.'}, {'measure': 'Participant rate of Depression: (CES-D)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'The Center for Epidemiological Studies Depression Scale (CES-D) will be administered to the participant at the initial visit and the 3 month follow up. 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.'}, {'measure': 'Participant rate of Depression: (CES-D)- Site 2', 'timeFrame': 'Initial Visit', 'description': 'The Center for Epidemiological Studies Depression Scale (CES-D) will be administered to the participant at the initial visit and the 3 month follow up. 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.'}, {'measure': 'Participant rate of Depression: (CES-D)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'The Center for Epidemiological Studies Depression Scale (CES-D) will be administered to the participant at the initial visit and the 3 month follow up. 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.'}, {'measure': 'Participants with Suicidal Behavior at Follow Up (Number)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of participants who indicate "yes" as per the following: Providers will administer the brief version of the Columbia Suicide-Severity Rating Scale (C-SSRS). 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.'}, {'measure': 'Participants with Suicidal Behavior at Follow Up (Number)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of participants who indicate "yes" as per the following: Providers will administer the brief version of the Columbia Suicide-Severity Rating Scale (C-SSRS). 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.'}, {'measure': 'Participants with Suicidal Behavior at Follow Up (Percentage)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of participants who indicate "yes" as per the following: Providers will administer the brief version of the Columbia Suicide-Severity Rating Scale (C-SSRS). 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.'}, {'measure': 'Participants with Suicidal Behavior at Follow Up (Percentage)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of participants who indicate "yes" as per the following: Providers will administer the brief version of the Columbia Suicide-Severity Rating Scale (C-SSRS). 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.'}, {'measure': 'Participants Reporting Safety Plan Usage (Number) - Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of participants who screen positive for suicide risk during the initial visit reporting use of the safety plan developed for the participant.'}, {'measure': 'Participants Reporting Safety Plan Usage (Number)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of participants who screen positive for suicide risk during the initial visit reporting use of the safety plan developed for the participant.'}, {'measure': 'Participants Reporting Safety Plan Usage (Percentage)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of participants who screen positive for suicide risk during the initial visit reporting use of the safety plan developed for the participant.'}, {'measure': 'Participants Reporting Safety Plan Usage (Percentage)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of participants who screen positive for suicide risk during the initial visit reporting use of the safety plan developed for the participant.'}, {'measure': 'Parents Reporting Safety Plan Usage (Number)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of parents whose child screened positive for suicide risk during the initial visit reporting the use of the safety plan that was developed for the participant (child).'}, {'measure': 'Parents Reporting Safety Plan Usage (Number)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of parents whose child screened positive for suicide risk during the initial visit reporting the use of the safety plan that was developed for the participant (child).'}, {'measure': 'Parents Reporting Safety Plan Usage (Percentage)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of parents whose child screened positive for suicide risk during the initial visit reporting the use of the safety plan that was developed for the participant (child).'}, {'measure': 'Parents Reporting Safety Plan Usage (Percentage)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of parents whose child screened positive for suicide risk during the initial visit reporting the use of the safety plan that was developed for the participant (child).'}, {'measure': 'Participants Reporting Frequency of Safety Plan Use (Number)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of participants who endorse each category related to Safety Plan Usage. Measured on a Likert Type scale with a range of 1-5 ("1-all the time," "2-often," "3-sometimes," "4-almost never," or "5-never") with 1 being more frequent usage and 5 being less frequent usage.'}, {'measure': 'Participants Reporting Frequency of Safety Plan Use (Number)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of participants who endorse each category related to Safety Plan Usage. Measured on a Likert Type scale with a range of 1-5 ("1-all the time," "2-often," "3-sometimes," "4-almost never," or "5-never") with 1 being more frequent usage and 5 being less frequent usage.'}, {'measure': 'Participants Reporting Frequency of Safety Plan Use (Percentage)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of participants who endorse each category related to Safety Plan Usage. Measured on a Likert Type scale with a range of 1-5 ("1-all the time," "2-often," "3-sometimes," "4-almost never," or "5-never") with 1 being more frequent usage and 5 being less frequent usage.'}, {'measure': 'Participants Reporting Frequency of Safety Plan Use (Percentage)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of participants who endorse each category related to Safety Plan Usage. Measured on a Likert Type scale with a range of 1-5 ("1-all the time," "2-often," "3-sometimes," "4-almost never," or "5-never") with 1 being more frequent usage and 5 being less frequent usage.'}, {'measure': 'Parents Reporting Frequency of Safety Plan Use (Number)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of parents who endorse each category related to Safety Plan Usage. Measured on a Likert Type scale with a range of 1-5 ("1-all the time," "2-often," "3-sometimes," "4-almost never," or "5-never") with 1 being more frequent usage and 5 being less frequent usage.'}, {'measure': 'Parents Reporting Frequency of Safety Plan Use (Number)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of parents who endorse each category related to Safety Plan Usage. Measured on a Likert Type scale with a range of 1-5 ("1-all the time," "2-often," "3-sometimes," "4-almost never," or "5-never") with 1 being more frequent usage and 5 being less frequent usage.'}, {'measure': 'Parents Reporting Frequency of Safety Plan Use (Percentage)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of parents who endorse each category related to Safety Plan Usage. Measured on a Likert Type scale with a range of 1-5 ("1-all the time," "2-often," "3-sometimes," "4-almost never," or "5-never") with 1 being more frequent usage and 5 being less frequent usage.'}, {'measure': 'Parents Reporting Frequency of Safety Plan Use (Percentage)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of parents who endorse each category related to Safety Plan Usage. Measured on a Likert Type scale with a range of 1-5 ("1-all the time," "2-often," "3-sometimes," "4-almost never," or "5-never") with 1 being more frequent usage and 5 being less frequent usage.'}, {'measure': 'Participants Reporting Helpfulness of Safety Plan (Number)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of participants who endorse each category related to Safety Plan Helpfulness. Measured on a Likert Type scale with a range of 1-4 ("1-very helpful," "2-helpful," "3-a little helpful," or "4-not at all helpful.") with 1 being most helpful and 4 being least helpful.'}, {'measure': 'Participants Reporting Helpfulness of Safety Plan (Number)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of participants who endorse each category related to Safety Plan Helpfulness. Measured on a Likert Type scale with a range of 1-4 ("1-very helpful," "2-helpful," "3-a little helpful," or "4-not at all helpful.") with 1 being most helpful and 4 being least helpful.'}, {'measure': 'Participants Reporting Helpfulness of Safety Plan (Percentage)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of participants who endorse each category related to Safety Plan Helpfulness. Measured on a Likert Type scale with a range of 1-4 ("1-very helpful," "2-helpful," "3-a little helpful," or "4-not at all helpful.") with 1 being most helpful and 4 being least helpful.'}, {'measure': 'Participants Reporting Helpfulness of Safety Plan (Percentage)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of participants who endorse each category related to Safety Plan Helpfulness. Measured on a Likert Type scale with a range of 1-4 ("1-very helpful," "2-helpful," "3-a little helpful," or "4-not at all helpful.") with 1 being most helpful and 4 being least helpful.'}, {'measure': 'Parents Reporting Helpfulness of Safety Plan (Number)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of parents who endorse each category related to Safety Plan Helpfulness. Measured on a Likert Type scale with a range of 1-4 ("1-very helpful," "2-helpful," "3-a little helpful," or "4-not at all helpful.") with 1 being most helpful and 4 being least helpful.'}, {'measure': 'Parents Reporting Helpfulness of Safety Plan (Number)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Number of parents who endorse each category related to Safety Plan Helpfulness. Measured on a Likert Type scale with a range of 1-4 ("1-very helpful," "2-helpful," "3-a little helpful," or "4-not at all helpful.") with 1 being most helpful and 4 being least helpful.'}, {'measure': 'Parents Reporting Helpfulness of Safety Plan (Percentage)- Site 1', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of parents who endorse each category related to Safety Plan Helpfulness. Measured on a Likert Type scale with a range of 1-4 ("1-very helpful," "2-helpful," "3-a little helpful," or "4-not at all helpful.") with 1 being most helpful and 4 being least helpful.'}, {'measure': 'Parents Reporting Helpfulness of Safety Plan (Percentage)- Site 2', 'timeFrame': '3 Month Follow Up Visit', 'description': 'Percentage of parents who endorse each category related to Safety Plan Helpfulness. Measured on a Likert Type scale with a range of 1-4 ("1-very helpful," "2-helpful," "3-a little helpful," or "4-not at all helpful.") with 1 being most helpful and 4 being least helpful.'}, {'measure': 'Participants Reporting Acute Care Usage (Number)- Site 1', 'timeFrame': 'Total period of 3 Months', 'description': '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.'}, {'measure': 'Participants Reporting Acute Care Usage (Number)- Site 2', 'timeFrame': 'Total period of 3 Months', 'description': 'Number of participants who reported acute care was utilized for help with suicidal symptoms between the initial visit and the 3 month follow up visit per participant report.'}, {'measure': 'Participants Reporting Acute Care Usage (Percentage)- Site 1', 'timeFrame': 'Total period of 3 Months', 'description': 'Percentage of participants that reported acute care was utilized for help with suicidal symptoms between the initial visit and the 3 month follow up visit.'}, {'measure': 'Participants Reporting Acute Care Usage (Percentage)- Site 2', 'timeFrame': 'Total period of 3 Months', 'description': 'Percentage of participants that reported acute care was utilized for help with suicidal symptoms between the initial visit and the 3 month follow up visit.'}, {'measure': 'Parents Reporting Acute Care Usage (Number)- Site 1', 'timeFrame': 'Total period of 3 Months', 'description': 'Number of parents who report a participant utilized acute care for help with suicidal symptoms between the initial visit and the 3 month follow up visit as per reported by the parent.'}, {'measure': 'Parents Reporting Acute Care Usage (Number)- Site 2', 'timeFrame': 'Total period of 3 Months', 'description': 'Number of parents who report a participant utilized acute care for help with suicidal symptoms between the initial visit and the 3 month follow up visit as per reported by the parent.'}, {'measure': 'Parents Reporting Acute Care Usage (Percentage)- Site 1', 'timeFrame': 'Total period of 3 Months', 'description': 'Percentage of parents that reported acute care was utilized for help with participant suicidal symptoms between the initial visit and the 3 month follow up visit.'}, {'measure': 'Parents Reporting Acute Care Usage (Percentage)- Site 2', 'timeFrame': 'Total period of 3 Months', 'description': 'Percentage of parents that reported acute care was utilized for help with participant suicidal symptoms between the initial visit and the 3 month follow up visit.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suicide Prevention', 'Suicide']}, 'descriptionModule': {'briefSummary': '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.\n\nInvestigators aim to do the following:\n\n1. 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).\n2. Gather preliminary data regarding the feasibility, acceptability, and effectiveness of the adapted intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Youth who are receiving services at the school-based health centers to participate\n* Parents must be able to give legal consent for themselves and their children to participate\n* Youth and Parent must be English-speaking\n* Youth must also be able to give signed assent to participate\n* Youth must be cognitively and medically able to participate in study activities\n\nExclusion Criteria:\n\n* Youth in state custody will be excluded from study participation due to challenges related to obtaining legal consent.'}, 'identificationModule': {'nctId': 'NCT06808503', 'briefTitle': 'NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics', 'organization': {'class': 'OTHER', 'fullName': 'West Virginia University'}, 'officialTitle': 'Implementing the NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics', 'orgStudyIdInfo': {'id': '2405972188'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Treatment As Usual (TAU)', 'description': '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.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NIMH Clinical Pathway', 'description': '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.', 'interventionNames': ['Behavioral: NIMH Clinical Pathway']}], 'interventions': [{'name': 'NIMH Clinical Pathway', 'type': 'BEHAVIORAL', 'description': 'Complete the implemented workflow and tools for suicide risk screening, assessment, safety planning and follow-up.', 'armGroupLabels': ['NIMH Clinical Pathway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26505', 'city': 'Morgantown', 'state': 'West Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Christensen, PhD, LICSW', 'role': 'CONTACT', 'email': 'mary.christensen@mail.wvu.edu', 'phone': '304-293-3501'}, {'name': 'Mary Christensen, PhD, LICSW', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'centralContacts': [{'name': 'Mary Christensen, PhD, LICSW', 'role': 'CONTACT', 'email': 'mary.christensen@mail.wvu.edu', 'phone': '304-293-3501'}], 'overallOfficials': [{'name': 'Mary Christensen, PhD, LICSW', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West Virginia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West Virginia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor and MSW Program Director', 'investigatorFullName': 'Mary Christensen', 'investigatorAffiliation': 'West Virginia University'}}}}