Plan and Protect: Safety Planning for Teens in Rural Emergency Departments

January 27, 2026 updated by: JoAnna K. Leyenaar, Dartmouth-Hitchcock Medical Center

Development & Implementation of Culturally Sensitive Safety Planning to Reduce Suicide Risk in Adolescents Seeking Care in Rural Emergency Departments

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 with suicidality.

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

Study Overview

Detailed Description

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 or attempt, 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 4 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 suicidality 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.

Study Type

Interventional

Enrollment (Estimated)

550

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • New Hampshire
      • Keene, New Hampshire, United States, 03431
        • Cheshire Medical Center
        • Contact:
        • Principal Investigator:
          • Maia Rutman, MD
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
        • Contact:
        • Principal Investigator:
          • Maia Rutman, MD
      • Lebanon, New Hampshire, United States, 03766
        • Alice Peck Day Memorial Hospital
        • Principal Investigator:
          • Maia Rutman, MD
        • Contact:
      • New London, New Hampshire, United States, 03257

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved home safety (parent and youth)
Time Frame: 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
Concise Health Risk Tracking 9-item measure (youth)
Time Frame: 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.
30 and 90 days after ED visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicide Events (youth)
Time Frame: 30 and 90 days after ED visit
Four self-reported questions from the Youth Risk Behavior Survey focus on suicidal ideation, attempts, and attempt severity, augmented by electronic health record review for emergency room and hospital visits for suicide ideation and/or attempt and/or death.
30 and 90 days after ED visit
Mental Health Care Utilization (parent and youth)
Time Frame: 30 and 90 days following ED visit
Any mental or emotional health care received after their emergency department visit using a checklist adapted from nationally administered healthcare utilization surveys. 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 following ED visit
Reduced Access to Firearms at Home (parent and youth)
Time Frame: 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 (parent and youth)
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Parental Self-Efficacy to Support Teens During a Suicidal Crisis (parent)
Time Frame: 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
Change in Parental Perceptions of Teen Suicide Risk (parent)
Time Frame: 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 (youth)
Time Frame: 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 Efficacy to Cope with Suicidal Thoughts and Urges Scale (youth)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: JoAnna K Leyenaar, MD, PhD, MPH, Dartmouth College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY02002568
  • 5R01NR021638-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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 Sharing Access Criteria

Per NDA access requirements and protocols.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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