Safe Treatment for Emergency Presentation for Suicidal Ideation and Behavior in Youth (SAFE STEPS)

Youth Partners in Care for Suicide Prevention

This randomized comparative effectiveness trial will compare two evidence-based approaches to emergency care for youth ages 13-24 who present to the Emergency Department (ED) with suicidal ideation or behavior. Outcomes will be monitored at baseline and at 3, 6 & 12 month follow-up assessments.

Study Overview

• Status: Recruiting
• Conditions: Suicide; Self-Harm; Suicidal
• Intervention / Treatment: Behavioral: SAFETY-A within usual ED Care; Behavioral: Combined SAFETY-A within usual ED Care + CLASP Therapeutic Follow-Up Contacts

Detailed Description

Rationale and Importance of Study:

Suicide is currently the second leading cause of death for U.S. youth ages 13-24, responsible for more deaths than any major illness. Youth with serious suicidal behavior or thoughts often present to the nation's Emergency Departments (EDs), particularly youth who make potentially deadly suicide attempts. Evidence is limited regarding optimal interventions for reducing the risk of fatal and nonfatal suicide attempts in these youth, and tested interventions include multiple components. One dimension along which these interventions vary is timing. Some interventions are delivered in the ED, others focus on aftercare, and others combine ED and aftercare interventions. Current evidence supports effectiveness of some interventions for reducing later suicide attempts and improving the likelihood that youth will receive mental health treatment after leaving the ED. However, evidence gaps exist regarding: 1) whether it is sufficient to focus on providing an evidence-based intervention in the ED, or whether a post-ED aftercare intervention is needed to improve youth outcomes; and 2) for which patient subgroups a combined ED and aftercare treatment may be indicated. Answering these questions is vital for guiding resource allocation, as ED care emphasizes care in the ED with limited resources for aftercare.

Study Aims:

The study addresses this evidence gap by comparing two evidence-based interventions for reducing suicide attempts and improving outcomes for youth presenting to EDs with suicidal episodes: 1) Safety-Acute(A) integrated within ED care, a crisis therapy/safety planning intervention in the ED focused on enhancing safety (previously called Family Intervention for Suicide Prevention, FISP); and 2) SAFETY-A/ED care plus the Coping Long-term with Active Suicide Program (CLASP), comprised of brief therapeutic follow-up contacts after discharge from the ED/hospital. Evidence supports benefits of both interventions individually. SAFETY-A/FISP is listed in the National Register of Evidence-Based Practices, and CLASP is being implemented in some Veterans Administration Hospitals. The first aim is to evaluate whether SAFETY-A/ED Care combined with CLASP aftercare is superior to SAFETY- A/ED Care alone for reducing the risk of suicide attempts and increasing initiation of follow-up mental health treatment. Second, the investigators examine heterogeneity of treatment effects among subgroups, hypothesizing that in this large diverse sample the strongest benefits of the combined SAFETY-A/ED Care plus CLASP intervention will be seen in youth who are from ethnic or racial minority groups, socioeconomically disadvantaged, and from rural communities. Third, the investigators aim to increase the value and relevance of the study by engaging patients, parents, family members, providers, and health and mental healthcare system stakeholders in project leadership and activities throughout the study and implement a partnered dissemination plan to enhance the potential for study findings to inform clinical practice and health care delivery.

Study Description:

The patient population includes 1,600 youth ages 13-24 presenting to EDs with suicidal ideation or behavior in 4 communities across the country selected to include a diverse population (racial, ethnic, rural vs urban, public vs private insurance): California/Los Angeles; North Carolina; Rhode Island; Utah. Youth are randomly assigned to: 1) SAFETY-A/ED Care; or 2) SAFETY-A/ED Care plus CLASP. Assessments are conducted at the start of the study and at 3, 6, and 12-month follow-ups. Primary outcomes are suicide attempts and mental health treatment initiation. Secondary outcomes are overall self-harm (including suicide attempts and non-suicidal self-harm) and treatment engagement/dose. Exploratory outcomes are: severity of youth suicidality; youth functioning and quality of life; and improvement on three problems prioritized by the youth and parent or significant other as "top problems." The investigators also examine change in identified protective and risk factors (e.g. connectedness, hopelessness, and perceived barriers to treatment). The investigators partner with diverse stakeholders, develop a Stakeholder Council, and include stakeholder partners in project leadership and activities with the goals of promoting 2-way knowledge exchange and enhancing the value of the study for improving patient care and outcomes.

Significance:

Study results will clarify whether the additional resources needed to provide brief therapeutic follow-up calls after an ED intervention leads to improved outcomes, and which patient subgroups are most likely to benefit from a treatment approach that provides therapeutic contact both during the ED visit and after discharge from the ED. This information can guide decision makers regarding how to best develop services and service systems to improve patient outcomes and achieve national suicide prevention goals, including for diverse groups to improve equity.

• Study Type: Interventional
• Enrollment (Estimated): 1600
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lucas Zullo, PhD; Phone Number: 310 794-4962; Email: lzullo@mednet.ucla.edu
• Study Contact Backup: Name: Jocelyn I Meza, PhD; Phone Number: 310 794-4962; Email: jimeza@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095-6968
      • Recruiting
      • Ronald Reagan Medical Center
      • Contact: Joan Asarnow, PhD; Phone Number: 310-794-4962; Email: jasarnow@mednet.ucla.edu
    • Sylmar, California, United States, 91342
      • Recruiting
      • Olive View UCLA Education and Research Center
      • Contact: Naser Ahmadi, MD, Ph.D.; Phone Number: 310-478-3711; Email: nahmadi@mednet.ucla.edu
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Recruiting
      • Duke University
      • Contact: David Goldston, Ph.D.; Email: david.goldston@duke.edu
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Recruiting
      • Brown University
      • Contact: Anthony Spirito, Ph.D.; Email: anthony_spirito@brown.edu
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah
      • Contact: Brooks Keeshin, MD; Email: brooks.keeshin@hsc.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age 13-24;
• past-week suicidal behavior or ideation with plan or intent

Exclusion Criteria:

• symptoms or illness that precludes informed consent or engagement in study procedures (e.g., active psychosis; drug dependence, no locator information);
• youth not fluent in English
• parent not fluent in English or Spanish.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SAFETY-Acute within Usual ED Care; The SAFETY-Acute (A) approach to safety planning and stabilization will be integrated within usual ED Care. SAFETY-A was formerly called the Family Intervention for Suicide Prevention, FISP.	Behavioral: SAFETY-A within usual ED Care; SAFETY-A is a single session collaborative, strengths-based, developmentally nuanced, cognitive-behavioral intervention (CBT) to increase safety and mental health treatment initiation. The therapist works with the youth and family (or significant other, SO) separately and together to build hope and reasons for living, develop a personal safety plan, increase protective supports; and increase motivation for and linkage to treatment.; Other Names: Family Intervention for Suicide Prevention (FISP)
Active Comparator: Combined; The combined treatment arm includes both 1) SAFETY-A integrated within usual ED Care, and 2) therapeutic follow-up contacts using the Coping Long Term with Active Suicidality Program (CLASP) model.	Behavioral: Combined SAFETY-A within usual ED Care + CLASP Therapeutic Follow-Up Contacts; COMB, includes SAFETY-A within usual ED care plus CLASP therapeutic and caring follow-up contacts designed to strengthen safety and treatment initiation and engagement. Core functions of CLASP include: building hope/reducing hopelessness; enhancing social/family support; strengthening problem-solving; and increasing treatment initiation and engagement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide Attempts: Primary Clinical Outcome	suicide attempts fatal, nonfatal, and interrupted	Through 12 months of follow-up
Mental Health Treatment Initiation: Primary Service Use Outcome	initiation of mental health treatment after discharge from ED/hospital	Observed through 12 months of follow-up, primary end point 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Harm: Secondary Clinical Outcome	Any self-harm including suicidal, nonsuicidal, and ambiguous self-harm	Through 12 months of follow-up
Treatment engagement: Secondary Service Use Outcome	Treatment dose received	Through 12 months of follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ordinal suicidality scale: Clinical	Ranges from nonsuicidal through ideation, behavior, attempts, and deaths	Through 12 months of follow-up
Quality of life and functioning: Clinical	PROMIS Global Health Questionnaire , 0-100	Change from baseline through 12 months of follow-up

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Patient-Centered Outcomes Research Institute; Brown University; Duke University; University of Utah; RAND; Olive View-UCLA Education & Research Institute
• Investigators: Principal Investigator: Joan R Asarnow, PhD, University of California, Los Angeles; Principal Investigator: David Goldston, PhD, Duke University

Publications and helpful links

Helpful Links

• Study description on PCORI site

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: self-harm
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior
• Other Study ID Numbers: SP-2020C3-21078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Decision will be made with PCORI, project investigators, and stakeholders regarding any data sharing. Given relative rarity of suicide attempts it is critical that participant confidentiality be maintained and steps be taken to protect against the possible of unintended loss of anonymity due to focus on rare outcome.
• IPD Sharing Time Frame: A limited data set may be available after all data are complete, analyzed, and published. Time frame and plan will be developed by investigators in collaboration with stakeholders and funding agency (PCORI).
• IPD Sharing Access Criteria: Decision will be made with PCORI, project investigators, and stakeholders regarding any data access. Given rarity of suicide attempts it is critical that participant confidentiality be maintained and steps be taken to protect against the possibility of unintended loss of anonymity due to focus on rare outcomes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No