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Not yet recruiting NCT07325474

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

No phase Interventional Suicide Ideation Suicide Attempt

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plan & Protect safety planning intervention, Care as usual.
Who it may be relevant to
Registry conditions: Suicide Ideation, Suicide Attempt. Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Plan & Protect safety planning intervention
    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.
  • Behavioral Care as usual
    Adolescents and caregivers will receive treatment as usual at the Emergency Department.

Primary outcome measures

  • Improved home safety (parent and youth) [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]
Secondary outcome measures (4)
  • Suicide Events (youth) [Time frame: 30 and 90 days after ED visit]
  • Youth Mental Health Care Utilization (parent and youth) [Time frame: 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]
  • Reduced Access to Medications at Home (parent and youth) [Time frame: 30 and 90 days after ED visit]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 4 centers
  • Cheshire Medical Center — Keene
  • Dartmouth-Hitchcock Medical Center — Lebanon
  • Alice Peck Day Memorial Hospital — Lebanon
  • New London Hospital — New London

Identifiers

NCT: NCT07325474 · STUDY02002568 · 5R01NR021638-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗