An interventional study of Plan & Protect safety planning intervention and Care as usual in Suicide Ideation and Suicide Attempt, sponsored by Dartmouth-Hitchcock Medical Center. Recruiting at 6 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Health services research
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:
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:
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.
281 studies on the registry are indexed under Suicide, Attempted; 91 are open to participants now.
This study's planned enrollment of 550 is above the median of 129 across 224 interventional studies indexed under Suicide, Attempted.
Browse Suicide, Attempted studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 488 studies on the registry; 71 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for children:
Exclusion criteria for children:
Inclusion criteria for parents/caregivers:
Exclusion criteria for parents/caregivers:
-Inability to understand key aspects of the study
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
Behavioral: Plan & Protect safety planning intervention
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
Behavioral: Care as usual
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.
Adolescents and caregivers will receive treatment as usual at the Emergency Department.
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.
Time frame: 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.
Time frame: 30 and 90 days after ED visit
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 and 90 days after ED visit
Change in Efficacy to Cope with Suicidal Thoughts and Urges Scale (primary target mechanism)
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.
Time frame: 30 and 90 days after ED visit
Change in Parental Perceptions of Teen Suicide Risk (secondary target mechanism)
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).
Time frame: 30 and 90 days after ED visit
Change in Patient Perceptions of Their Own Suicide Risk (secondary target mechanism)
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.
Time frame: 30 and 90 days after ED visit
Change in Parental Self-Efficacy to Support Teens During a Suicidal Crisis (secondary target mechanism)
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).
Time frame: 30 and 90 days after ED visit
Plan to share: 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: Sociodemographic characteristics of adolescents and caregivers Follow-up mental health care DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure for Youth Self-report Efficacy to Cope with Suicidal Thoughts and Urges Scale for Youth Self-report Self-Assessed Expectations of Suicide Risk for Youth Parental Self-Efficacy to Support Teens During a Suicidal Crisis Concise Health Risk Tracking - Self-Report (CHRT-SR) Caregiver and adolescent-reported firearms in home/on property (yes/no) and firearm storage practices Caregiver- and adolescent-reported medications in home (yes/no) and medication storage practices
Supporting information: Study protocol
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.
Access criteria: Per NDA access requirements and protocols.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Apr 2029, 32 months after the start.
Of 145 non-industry interventional studies with no phase under Suicide, Attempted, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 56. This study's planned 32 months is below that.
Counting every sponsor, half of 147 studies reached it within 37 months; a quarter within 20 and three quarters within 56.
Primary completion moved once since we started tracking on Sep 25, 2026: Jan 2029 → Apr 2029, on Oct 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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