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Clinical Trials/NCT07325474
NCT07325474
Not yet recruiting
Not Applicable

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

Dartmouth-Hitchcock Medical Center8 sites in 1 country550 target enrollmentStarted: June 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
550
Locations
8
Primary Endpoint
Improved home safety (parent and youth)

Overview

Brief 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 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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
12 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: Plan & Protect safety planning intervention (Behavioral)

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

Intervention: Care as usual (Behavioral)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Suicide Events (youth)(30 and 90 days after ED visit)
  • Mental Health Care Utilization (parent and youth)(30 and 90 days following ED visit)
  • Reduced Access to Firearms at Home (parent and youth)(30 and 90 days after ED visit)
  • Reduced Access to Medications at Home (parent and youth)(30 and 90 days after ED visit)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

JoAnna K. Leyenaar

Professor of Pediatrics, Professor of the Dartmouth Institute

Trustees of Dartmouth College

Study Sites (8)

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