Safe Treatment for Emergency Presentation for Suicidal Ideation and Behavior in Youth

NCT05304065 | Recruiting Phase 2 DMC

• 1 other identifier: SP-2020C3-21078
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Suicide; Suicidal; Self-Harm

Keywords

self-harm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Self-Harm: Secondary Clinical Outcome

  Through 12 months of follow-up

• Treatment engagement: Secondary Service Use Outcome

  Through 12 months of follow-up

Other Outcomes (2)

• Ordinal suicidality scale: Clinical

  Through 12 months of follow-up

• Quality of life and functioning: Clinical

  Change from baseline through 12 months of follow-up

Study Arms (2)

SAFETY-Acute within Usual ED Care

ACTIVE COMPARATOR

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

Combined

ACTIVE COMPARATOR

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

Interventions

SAFETY-A within usual ED Care BEHAVIORAL

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.

Also known as: Family Intervention for Suicide Prevention (FISP)

SAFETY-Acute within Usual ED Care

Combined SAFETY-A within usual ED Care + CLASP Therapeutic Follow-Up Contacts BEHAVIORAL

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.

Combined

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brown University: collaborator
• University of Utah: collaborator
• Olive View-UCLA Education & Research Institute: collaborator
• RAND: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• University of California, Los Angeles: lead
• Duke University: collaborator

Study Sites (5)

Ronald Reagan Medical Center

Los Angeles, California, 90095-6968, United States

RECRUITING

Olive View UCLA Education and Research Center

Sylmar, California, 91342, United States

RECRUITING

Duke University

Durham, North Carolina, 27708, United States

RECRUITING

Brown University

Providence, Rhode Island, 02912, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Links

• Study description on PCORI site

MeSH Terms

Conditions

Suicide; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Joan R Asarnow, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• David Goldston, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas Zullo, PhD

CONTACT

310 794-4962; lzullo@mednet.ucla.edu

Jocelyn I Meza, PhD

CONTACT

310 794-4962; jimeza@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: It is not possible to mask intervention condition from participants. Care providers in the ED will be masked to randomized condition. Outcomes assessors will be masked to randomized condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry & Biboehavioral Sciences

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 31, 2022
• Study Start: October 17, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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).
• 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.

Locations

US (5)