Nimh Clinical Pathway i landdistrikterne Appalachian School-baserede sundhedsklinikker
4. september 2026 opdateret af: Mary Christensen, West Virginia University
Implementering af NIMH-klinisk vej i det landlige Appalachian School-baserede sundhedsklinikker
Denne undersøgelse vil tilpasse og evaluere et evidensbaseret selvmordsrisikoscreening og opfølgningsprogram i to skolebaserede sundhedscentre i West Virginia. Selvmordsscreeningsprogrammet har titlen "NIMH Clinical Pathway" og leverer værktøjer og procedurer til rutinemæssigt screening af unge for selvmordsrisiko, gennemførelse af risikovurderinger, sikkerhedsplanlægning, dødbringende betyder begrænsning, opfølgningshenvisninger og anden dispositionsplanlægning efter behov.
Efterforskere sigter mod at gøre følgende:
- Saml formative data fra udbydere, forældre og unge for at informere måder at tilpasse sig og implementere NIMH-klinisk vej, så de effektivt kan implementeres i landdistrikterne, Appalachian School-baserede sundhedscentre (SBHC'er).
- Indsamle foreløbige data om gennemførligheden, acceptabiliteten og effektiviteten af den tilpassede intervention.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
70
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mary Christensen, PhD, LICSW
- Telefonnummer: 304-293-3501
- E-mail: mary.christensen@mail.wvu.edu
Studiesteder
-
-
West Virginia
-
Morgantown, West Virginia, Forenede Stater, 26505
- Rekruttering
- West Virginia University
-
Kontakt:
- Mary Christensen, PhD, LICSW
- Telefonnummer: 304-293-3501
- E-mail: mary.christensen@mail.wvu.edu
-
Ledende efterforsker:
- Mary Christensen, PhD, LICSW
-
Oak Hill, West Virginia, Forenede Stater, 26651
- Rekruttering
- Oak Hill School Based Health Center
-
Kontakt:
- Mary Christensen, PhD, LICSW
- Telefonnummer: 304-293-3501
- E-mail: mary.christensen@mail.wvu.edu
-
Summersville, West Virginia, Forenede Stater, 26651
- Rekruttering
- Summersville School Based Health Center
-
Kontakt:
- Mary Christensen, PhD, LICSW
- Telefonnummer: 304-293-3501
- E-mail: mary.christensen@mail.wvu.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ja
Beskrivelse
Inkluderingskriterier:
- Ungdom, der modtager tjenester på de skolebaserede sundhedscentre for at deltage
- Forældre skal være i stand til at give juridisk samtykke til sig selv og deres børn for at deltage
- Ungdom og forælder skal være engelsktalende
- Ungdom skal også være i stand til at give underskrevet samtykke til at deltage
- Ungdom skal være kognitivt og medicinsk i stand til at deltage i studieaktiviteter
Ekskluderingskriterier:
- Ungdom i statens forældremyndighed vil blive udelukket fra undersøgelsesdeltagelse på grund af udfordringer i forbindelse med opnåelse af juridisk samtykke.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: NIMH Clinical Pathway
Implementering af en tilpasset/skræddersyet version af NIMH Clinical Pathway, der identificerer en arbejdsgang og værktøjer til rutinemæssig risiko for selvmordsrisiko, vurdering, sikkerhedsplanlægning og opfølgning.
|
Fuldfør den implementerede arbejdsgang og værktøjer til screening af selvmordsrisiko, vurdering, sikkerhedsplanlægning og opfølgning.
|
|
Ingen indgriben: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Patients Screened for Suicidal Risk
Tidsramme: 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.
|
9 Months
|
|
Percentage of Patients with a Positive Screen for Suicide Risk
Tidsramme: 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.
|
9 Months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of Patients Receiving Safety Planning
Tidsramme: 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.
|
Index Visit
|
|
Follow-Up Service Provision Rate
Tidsramme: 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.
|
Up to 3 Months Post Index Visit
|
|
Suicidal Ideation Questionnaire (SIQ-Jr)
Tidsramme: 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.
|
Up to 3 Months Post Index Visit
|
|
Center for Epidemiological Studies Depression Scale (CES-D)
Tidsramme: 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.
|
Up to 3 Months Post Index Visit
|
|
Client Satisfaction Questionnaire (CSQ)
Tidsramme: 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.
|
Up to 3 Months Post Index Visit
|
|
Columbia Suicide-Severity Rating Scale (C-SSRS)
Tidsramme: 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.
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Up to 3 Months Post Index Visit
|
|
Percentage of Participants reporting Safety Plan Usage
Tidsramme: 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.
|
Up to 3 Months Post Index Visit
|
|
Percentage of Parents Reporting Safety Plan Usage
Tidsramme: 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.
|
Up to 3 Months Post Index Visit
|
|
Participant-Rated Helpfulness of Safety Plan
Tidsramme: 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.
|
Up to 3 Months Post Index Visit
|
|
Parent-Rated Helpfulness of Safety Plan
Tidsramme: 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.
|
Up to 3 Months Post Index Visit
|
|
Participants Reporting Acute Care Usage
Tidsramme: 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.
|
Up to 3 Months Post Index Visit
|
|
Parents Reporting Acute Care Usage
Tidsramme: 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.
|
Up to 3 Months Post Index Visit
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mary Christensen, PhD, LICSW, West Virginia University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. oktober 2024
Primær færdiggørelse (Anslået)
1. august 2027
Studieafslutning (Anslået)
1. august 2027
Datoer for studieregistrering
Først indsendt
29. januar 2025
Først indsendt, der opfyldte QC-kriterier
29. januar 2025
Først opslået (Faktiske)
5. februar 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2405972188
- R34MH137618 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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