Safe Treatment for Emergency Presentation for Suicidal Ideation and Behavior in Youth
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- University of California, Los Angeles
- Study ID
- NCT05304065
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Self-Harm
- Suicidal
- Suicide
Eligibility Criteria
- Sex
- ALL
- Age
- 13 Years - 24 Years
- Healthy Volunteers
- Not accepted
Interventions
- SAFETY-A within usual ED Care — BEHAVIORALSAFETY-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 — BEHAVIORALCOMB, 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.
Study Details
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.
Key Dates
- Start date
- Oct 17, 2022
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 1,600 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: SAFETY-Acute within Usual ED CareThe 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: CombinedThe 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.
Primary Outcome Measure
Suicide Attempts: Primary Clinical Outcome [ Time Frame: Through 12 months of follow-up ]
Central Contacts
- Lucas Zullo, PhD310 794-4962
- Jocelyn I Meza, PhD310 794-4962
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ronald Reagan Medical Center | Los Angeles | California | 90095-6968 | |
| Olive View UCLA Education and Research Center | Sylmar | California | 91342 | |
| Duke University | Durham | North Carolina | 27708 | David Goldston, Ph.D. |
| Brown University | Providence | Rhode Island | 02912 | Anthony Spirito, Ph.D. |
| University of Utah | Salt Lake City | Utah | 84112 | Brooks Keeshin, MD |
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