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

NCT07325474 | Not Yet Recruiting

• 2 other identifiers: STUDY020025685R01NR021638-02
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 4

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

Conditions

Suicide Ideation; Suicide Attempt

Keywords

Suicide; Safety Planning; Adolescent; Mental Health Services; Emergency Services

Outcome Measures

Primary Outcomes (2)

• Improved home safety (parent and youth)

  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.

  30 and 90 days after ED visit

• Concise Health Risk Tracking 9-item measure (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.

  30 and 90 days after ED visit

Secondary Outcomes (4)

• 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

Other Outcomes (4)

• Change in Parental Self-Efficacy to Support Teens During a Suicidal Crisis (parent)

  30 and 90 days after ED visit

• Change in Parental Perceptions of Teen Suicide Risk (parent)

  30 and 90 days after ED visit

• Change in Patient Perceptions of Their Own Suicide Risk (youth)

  30 and 90 days after ED visit

Study Arms (2)

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

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

Behavioral: Care as usual

Interventions

Care as usual BEHAVIORAL

Adolescents and caregivers will receive treatment as usual at the Emergency Department.

Care as usual

Plan & Protect safety planning intervention BEHAVIORAL

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.

Plan & Protect

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Parent or caregiver of an eligible child
• years old or older
• Ability to speak and complete surveys in English
• Inability to understand key aspects of the study

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): collaborator
• Trustees of Dartmouth College: collaborator
• Dartmouth-Hitchcock Medical Center: lead

Study Sites (4)

Cheshire Medical Center

Keene, New Hampshire, 03431, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Alice Peck Day Memorial Hospital

Lebanon, New Hampshire, 03766, United States

Location

New London Hospital

New London, New Hampshire, 03257, United States

Location

MeSH Terms

Conditions

Suicide, Attempted; Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• JoAnna K Leyenaar, MD, PhD, MPH

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Pogue, MPH

CONTACT

603-646-5614; jacqueline.a.pogue@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Professor of the Dartmouth Institute

Model Details: Stepped wedge randomized controlled trial

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 8, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (4)