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

Dartmouth Health

Status: Begins enrollment in 3 months

Conditions: Suicide Attempt; Suicide Ideation

Treatments: Behavioral: Plan & Protect safety planning intervention; Behavioral: Care as usual

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07325474

STUDY02002568

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

Details and patient eligibility

About

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

Full 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.

Enrollment: 550 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

Plan & Protect

Experimental group

Description:

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

Treatment:

Behavioral: Plan & Protect safety planning intervention

Care as usual

Other group

Description:

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

Treatment:

Behavioral: Care as usual