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Planlæg og Beskyt: Sikkerhedsplanlægning for Teenagere i Landdistrikternes Akutmodtagelser

29. september 2026 opdateret af: JoAnna K. Leyenaar, Dartmouth-Hitchcock Medical Center

Udvikling og implementering af kulturelt følsom sikkerhedsplanlægning for at reducere selvmordsrisiko hos unge, der søger behandling på landets akutmodtagelser

The goal of this observational study is to determine whether implementing a culturally sensitive, tablet-based safety planning program called Plan & Protect (P&P) within rural emergency departments can improve home safety and reduce suicide risk in adolescents presenting to the emergency department with suicide-related concerns.

The main questions it aims to answer are:

  • Will implementing P&P increase caregiver-reported home safety (reduce access to firearms and unsafe medication storage) for adolescents 12-17 years old presenting to rural EDs with suicidal ideation, self-harm, or mental health crisis?
  • Will implementing P&P decrease adolescent-reported perceived suicide risk and related outcomes (e.g., suicide events, and attendance at follow-up mental healthcare)?

Researchers will compare outcomes for adolescents and caregivers receiving P&P (implemented as the new standard of care at sites during the intervention periods) to those receiving usual care (prior to P&P implementation at those hospitals) to see if P&P increases home safety and decreases suicide risk and related healthcare utilization.

Participants will, if clinically appropriate:

  • Complete the tablet-based P&P modules during their ED visit
  • Complete self-report measures at baseline, ~30 days, and ~3 months post-discharge
  • A subset will also participate in semi-structured interviews

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

One-in-five children and adolescents in the United States (US) live in rural areas where they are more likely to live in poverty, have neurodevelopmental, behavioral and mental health conditions, and die during childhood than their urban-residing peers. Suicide is a leading cause of childhood mortality, and rural-residing youth are two times more likely to die from suicide than urban-residing youth. Nearly half of children and adolescents with mental health conditions do not receive treatment, and those in rural areas face unique barriers to care due to geographic isolation, stigma, and shortages of pediatric services and clinicians. Given barriers to community-based mental healthcare, youth with suicidal ideation and/or suicide attempt (hereafter "suicidality") increasingly present to emergency departments (EDs) for care. However, most clinicians practicing in rural EDs are under-prepared and under-resourced to care for this population.

In order to fill this gap, this project aims to improve home safety and decrease suicide risk in youth 12-17 years of age who present to rural EDs with suicidal ideation, attempt, or mental health crisis, leveraging community-based participatory research approaches and technology to implement, with high fidelity, culturally-sensitive and nationally recommended safety planning procedures. To achieve this goal, we will integrate P&P, a culturally sensitive, tablet-based safety planning program as a quality improvement intervention at 5 hospitals in the Dartmouth Health network using a hospital-randomized stepped wedge design and will evaluate the program using a type 1 hybrid implementation-effectiveness design.

Aim: To determine the effectiveness of P&P compared to usual care for youth with suicide-related concerns and their caregivers to increase home safety and decrease suicide risk; evaluate the extent to which these outcomes are mediated by caregiver and youth self-efficacy and expectations of suicide risk; and assess the reach, effectiveness, adoption, implementation and maintenance of P&P using a mixed methods approach.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

550

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • New Hampshire
      • Claremont, New Hampshire, Forenede Stater, 03756
      • Keene, New Hampshire, Forenede Stater, 03431
        • Rekruttering
        • Cheshire Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Maia Rutman, MD
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Rekruttering
        • Dartmouth-Hitchcock Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Maia Rutman, MD
      • Lebanon, New Hampshire, Forenede Stater, 03766
        • Rekruttering
        • Alice Peck Day Memorial Hospital
        • Ledende efterforsker:
          • Maia Rutman, MD
        • Kontakt:
      • New London, New Hampshire, Forenede Stater, 03257
        • Rekruttering
        • New London Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Maia Rutman, MD
    • Vermont
      • Windsor, Vermont, Forenede Stater, 05089

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

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria for children:

  • 12-17 years of age (and their parent/caregiver(s))
  • Ability to speak and complete surveys in English
  • History of emergency department visit for suicidality, self-harm or mental health crisis
  • Medically stable

Exclusion criteria for children:

  • Cognitive or developmental delays that preclude program participation based on clinical team assessment
  • Diagnosis of psychosis
  • Primary diagnosis of an eating disorder
  • Parent/guardian not able to provide consent in English
  • Clinical team concern for patient or staff safety based upon active behavioral concerns
  • Parent/guardian not available to provide consent (e.g youth is in child protective custody/ward of the state)

Inclusion criteria for parents/caregivers:

  • Parent or caregiver of an eligible child
  • 18 years old or older
  • Ability to speak and complete surveys in English

Exclusion criteria for parents/caregivers:

-Inability to understand key aspects of the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Plan & Protect

Plan and Protect is a tablet-based program that integrates a youth-facing safety-planning module with a caregiver-facing home safety planning decision aid to create culturally sensitive, locally tailored safety plans and promote caregiver engagement in home safety during rural ED visits for adolescent suicidality

Plan and Protect (P&P) is a tablet-based, family-centered quality improvement program targeted to rural Northern New England that combines a youth-facing safety-planning module with a caregiver-facing home safety decision aid and youth safety information. The goal is to help adolescents and their caregivers develop concrete, culturally-sensitive safety plans during emergency department visits.

Andet: Care as usual

Outcomes for adolescents and their caregivers enrolled during the pre-implementation (usual care) periods at each hospital will be compared to outcomes for those enrolled after their hospital implements the P&P program as quality improvement

Adolescents and caregivers will receive treatment as usual at the Emergency Department.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improved Home Safety (caregiver)
Tidsramme: 30 and 90 days after ED visit

Reduced access to firearms and medications at home. This will be collected with five questions about presence of medications and firearms at home, if they are stored unlocked, and if firearms are loaded. We will measure improvement in safety across the time frame.

30 and 90 days after ED visit
Suicide Risk (youth)
Tidsramme: 30 and 90 days after ED visit

The Concise Health Risk Tracking (CHRT) is a 9-item survey that assesses suicidal thoughts and behaviors in the past week, with response options ranging 0-4. Total scores range 0-36, with higher scores indicating more severe suicidality. Primary outcome will be assessed relative to the baseline assessment assessed at the time of study enrollment.

30 and 90 days after ED visit

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Suicide Events (youth)
Tidsramme: 30 and 90 days after ED visit

A composite measure that includes suicide deaths (ascertained by family report and electronic health record (EHR) review), return ED visits and/or rehospitalization for suicidality (ascertained using survey and EHR review), and suicide attempts (evaluated using four questions from the Youth Risk Behavior Survey augmented by structured EHR review).

30 and 90 days after ED visit
Attendance at Follow-up Mental Healthcare (youth and caregiver)
Tidsramme: 30 and 90 days after ED visit

Any mental or emotional health care received after their emergency department visit using a checklist adapted from nationally administered healthcare utilization surveys, augmented by EHR review. Survey response categories (primary care, mental health provider, outpatient/urgent care, emergency department, school based care) were derived from health service use domains captured in the Medical Expenditure Panel Survey.

30 and 90 days after ED visit
Reduced Access to Firearms at Home (caregiver)
Tidsramme: 30 and 90 days after ED visit

Improved home safety with respect to firearm access. This will be collected with three questions about presence of firearms at home, if they are stored unlocked, and if they are loaded. We will measure improvement in safety across the time frame.

30 and 90 days after ED visit
Reduced Access to Medications at Home (caregiver)
Tidsramme: 30 and 90 days after ED visit

Improved home safety with safer storage of medications. This will be collected with two questions about presence of medications at home and if they are stored unlocked. We will measure improvement in safety across the time frame.

30 and 90 days after ED visit
Pessimism (youth)
Tidsramme: 30 and 90 days post-ED visit

A 2-item subscale of the Concise Health Risk Tracking (CHRT) that measures negative outlook, with response options ranging 0-4. Total scores range 0-8, with higher scores indicating greater pessimism.

30 and 90 days post-ED visit
Helplessness (youth)
Tidsramme: 30 and 90 days after ED visit

A 2-item subscale of the Concise Health Risk Tracking (CHRT) that measures perceived lack of self-control, with response options ranging 0-4. Total scores range 0-8, with higher scores indicating greater feelings of helplessness.

30 and 90 days after ED visit
Despair (youth)
Tidsramme: 30 and 90 days after ED visit

A 2-item subscale of the Concise Health Risk Tracking (CHRT) that measures despair, with response options ranging 0-4. Total scores range 0-8, with higher scores indicating more severe discouragement.

30 and 90 days after ED visit
Suicidal thoughts (youth)
Tidsramme: 30 and 90 days after ED visit

A 3-item subscale of the Concise Health Risk Tracking (CHRT) that measures suicidal thoughts and planning, with response options ranging 0-4. Total scores range 0-12, with higher scores indicating increased suicidal thoughts and planning.

30 and 90 days after ED visit

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Efficacy to Cope with Suicidal Thoughts and Urges Scale (primary target mechanism)
Tidsramme: 30 and 90 days after ED visit

The Efficacy to Cope with Suicidal Thoughts and Urges Scale was designed to measure children's abilities to manage suicide-related thoughts and impulses. It contains 10 coping skills and children rate their confidence in their ability to use each coping skill to manage their suicidality. Responses range from 0 to 10 with 0 = Not at all confident, 5 = Somewhat confident, and 10 = Extremely confident.

30 and 90 days after ED visit
Change in Parental Perceptions of Teen Suicide Risk (secondary target mechanism)
Tidsramme: 30 and 90 days after ED visit

This 3-item measure looks at parental understanding of their teen's suicide risk. Answer choices range from 0 (not at all confident) to 10 (completely confident), with an anchor of 5 (somewhat confident).

30 and 90 days after ED visit
Change in Patient Perceptions of Their Own Suicide Risk (secondary target mechanism)
Tidsramme: 30 and 90 days after ED visit

This 3-item self-report measure examines how at risk a patient believes they are. It is scored on a 5-point Likert from 0-4 where higher = greater perceived risk and has a total possible score of 15.

30 and 90 days after ED visit
Change in Parental Self-Efficacy to Support Teens During a Suicidal Crisis (secondary target mechanism)
Tidsramme: 30 and 90 days after ED visit

This 9-item scale measures parent confidence regarding their ability to engage in activities to prevent or assist their child in managing a suicidal crisis. Answer choices range from 0 (not at all confident) to 10 (completely confident), with an anchor of 5 (somewhat confident).

30 and 90 days after ED visit

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: JoAnna K Leyenaar, MD, PhD, MPH, Dartmouth College

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)

3. august 2026

Primær færdiggørelse (Anslået)

30. april 2029

Studieafslutning (Anslået)

30. april 2029

Datoer for studieregistrering

Først indsendt

19. december 2025

Først indsendt, der opfyldte QC-kriterier

6. januar 2026

Først opslået (Faktiske)

8. januar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • STUDY02002568
  • 5R01NR021638-02 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Data will be uploaded into the NIMH Data Archive (NDA).

Data will be collected from approximately 275 adolescents 12-17 years of age and 275 parents or caregivers. Measures include:

  1. Sociodemographic characteristics of adolescents and caregivers
  2. Follow-up mental health care
  3. DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure for Youth Self-report
  4. Efficacy to Cope with Suicidal Thoughts and Urges Scale for Youth Self-report
  5. Self-Assessed Expectations of Suicide Risk for Youth
  6. Parental Self-Efficacy to Support Teens During a Suicidal Crisis
  7. Concise Health Risk Tracking - Self-Report (CHRT-SR)
  8. Caregiver and adolescent-reported firearms in home/on property (yes/no) and firearm storage practices
  9. Caregiver- and adolescent-reported medications in home (yes/no) and medication storage practices

IPD-delingstidsramme

All data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates.

IPD-delingsadgangskriterier

Per NDA access requirements and protocols.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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