Suicide IdeationNCT07325474
Plan and Protect: Safety Planning for Teens in Rural Emergency Departments
A study testing Plan & Protect safety planning intervention and Care as usual in people with Suicide Ideation and Suicide Attempt, run by Dartmouth-Hitchcock Medical Center at 6 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Suicide Ideation, Suicide Attempt
- What is being tested?
- Plan & Protect safety planning intervention and Care as usual
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 6 sitesUnited States
- Study dates
- 3 Aug 2026to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- Parent or caregiver of an eligible child
- 18 years old or older
- Ability to speak and complete surveys in English
Who cannot join
- 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)
- -Inability to understand key aspects of the study
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
Valley Regional Hospital
Claremont, New Hampshire, 03756
JoAnna Leyenaar, MD, 603-650-5000, joanna.k.leyenaar@hitchcock.org
- Recruiting
Cheshire Medical Center
Keene, New Hampshire, 03431
Jacqueline Pogue, MPH, 603-646-5614, jacqueline.a.pogue@dartmouth.edu
Maia Rutman, MD
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Jacqueline Pogue, MPH, 603-646-5614, jacqueline.a.pogue@dartmouth.edu
Maia Rutman, MD
- Recruiting
Alice Peck Day Memorial Hospital
Lebanon, New Hampshire, 03766
Jacqueline A Pogue, MPH, 603-646-5614, jacqueline.a.pogue@dartmouth.edu
Maia Rutman, MD
- Recruiting
New London Hospital
New London, New Hampshire, 03257
Jacqueline Pogue, MPH, 603-646-5614, jacqueline.a.pogue@dartmouth.edu
Maia Rutman, MD
- Recruiting
Mount Ascutney Hospital
Windsor, Vermont, 05089
Alexis Cardone, MD, 603-650-5000, Alexis.C.Cordone@hitchcock.org
About this study
Official title: 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 to the emergency department with suicide-related concerns.
The main questions it aims to answer are:
Read more
- 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
Read the 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, 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.
- Conditions
- Suicide Ideation, Suicide Attempt
- Being tested
- Plan & Protect safety planning intervention, Care as usual
- Keywords
- Suicide, Safety Planning, Adolescent, Mental Health Services, Emergency Services
- Medical subject headings
- Suicide, Attempted, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plan & Protect safety planning interventionBehavioural
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.
Care as usualBehavioural
Adolescents and caregivers will receive treatment as usual at the Emergency Department.
| Study group | Role | What they receive |
|---|---|---|
| Plan & Protect | Experimental | 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 Receives: Behavioral: Plan & Protect safety planning intervention |
| Care as usual | Other | 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 Receives: Behavioral: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Home Safety (caregiver)
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.
Measured: 30 and 90 days after ED visit
Suicide Risk (youth)
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.
Measured: 30 and 90 days after ED visit
Secondary outcomes (8)
Suicide Events (youth)
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).
Measured: 30 and 90 days after ED visit
Attendance at Follow-up Mental Healthcare (youth and caregiver)
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.
Measured: 30 and 90 days after ED visit
Reduced Access to Firearms at Home (caregiver)
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.
Measured: 30 and 90 days after ED visit
Reduced Access to Medications at Home (caregiver)
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.
Measured: 30 and 90 days after ED visit
Pessimism (youth)
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.
Measured: 30 and 90 days post-ED visit
Helplessness (youth)
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.
Measured: 30 and 90 days after ED visit
Despair (youth)
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.
Measured: 30 and 90 days after ED visit
Suicidal thoughts (youth)
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.
Measured: 30 and 90 days after ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start3 Aug 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide IdeationStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped wedge randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Trustees of Dartmouth College
- Responsible party
- Principal investigator, JoAnna K. Leyenaar, Trustees of Dartmouth College
- Investigators
- JoAnna K Leyenaar, MD, PhD, MPH, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325474
- Sponsor's protocol ID
- STUDY02002568
- Other IDs
- 5R01NR021638-02
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development & Implementation of Culturally Sensitive Safety Planning to Reduce Suicide Risk in Adolescents Seeking Care in Rural Emergency Departments
- ClinicalTrials.gov ID
- NCT07325474
- Acronym / sponsor ID
- STUDY02002568
- Conditions
- Suicide Ideation, Suicide Attempt
- Keywords
- Suicide, Safety Planning, Adolescent, Mental Health Services, Emergency Services
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Trustees of Dartmouth College
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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, 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Plan & Protect | Experimental | Behavioral: Plan & Protect safety planning interventionPlan 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 |
| Care as usual | Other | Behavioral: Care as usualOutcomes 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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Parent or caregiver of an eligible child
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plan & Protect safety planning interventionPlan 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. | Behavioural | Plan & Protect |
| Care as usualAdolescents and caregivers will receive treatment as usual at the Emergency Department. | Behavioural | Care as usual |
Primary outcome
Improved Home Safety (caregiver)
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.
Suicide Risk (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. Primary outcome will be assessed relative to the baseline assessment assessed at the time of study enrollment.
8 secondary outcomes
Suicide Events (youth)
Time frame: 30 and 90 days after ED visit
Attendance at Follow-up Mental Healthcare (youth and caregiver)
Time frame: 30 and 90 days after ED visit
Reduced Access to Firearms at Home (caregiver)
Time frame: 30 and 90 days after ED visit
Reduced Access to Medications at Home (caregiver)
Time frame: 30 and 90 days after ED visit
Pessimism (youth)
Time frame: 30 and 90 days post-ED visit
Helplessness (youth)
Time frame: 30 and 90 days after ED visit
Despair (youth)
Time frame: 30 and 90 days after ED visit
Suicidal thoughts (youth)
Time frame: 30 and 90 days after ED visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JoAnna K Leyenaar, MD, PhD, MPH principal investigator
Dartmouth College
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plan & Protect safety planning intervention and Care as usual in people with Suicide Ideation and Suicide Attempt, run by Dartmouth-Hitchcock Medical Center at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline Pogue, MPH (603-646-5614, jacqueline.a.pogue@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved Home Safety (caregiver) (time frame: 30 and 90 days after ED visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.