Recruiting
Phase 2

Observational Study

Sponsor:

UCLA

Code:

NCT05304065

Conditions

Suicide

Suicidal

Self-Harm

Eligibility Criteria

Sex: All

Age: 13 - 24

Healthy Volunteers: Not accepted

Interventions

SAFETY-A within usual ED Care

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

Study Details

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

Study ID

NCT05304065

Start date

Oct 17, 2022

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 24

Healthy Volunteers: Not accepted

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 Design

Enrollment

1600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Suicide Attempts: Primary Clinical Outcome [ Time Frame: Through 12 months of follow-up ]
  • Mental Health Treatment Initiation: Primary Service Use Outcome [ Time Frame: Observed through 12 months of follow-up, primary end point 6-month follow-up ]

Central Contacts and Locations

Central contacts

Lucas Zullo, PhD

310 794-4962lzullo@mednet.ucla.edu

Jocelyn I Meza, PhD

310 794-4962jimeza@mednet.ucla.edu

Locations

Ronald Reagan Medical Center

Recruiting

Los Angeles, California, United States, 90095-6968

Contacts

Joan Asarnow, PhD

310-794-4962jasarnow@mednet.ucla.edu

Olive View UCLA Education and Research Center

Recruiting

Sylmar, California, United States, 91342

Contacts

Naser Ahmadi, MD, Ph.D.

310-478-3711nahmadi@mednet.ucla.edu

Duke University

Recruiting

Durham, North Carolina, United States, 27708

Contacts

David Goldston, Ph.D.

david.goldston@duke.edu

Brown University

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

Anthony Spirito, Ph.D.

anthony_spirito@brown.edu

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Brooks Keeshin, MD

brooks.keeshin@hsc.utah.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Dec 31, 2025

Last verified

Dec, 2025

Keywords

  • self-harm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-12-31.