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SuicidePhase 2SAFE STEPSNCT05304065

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

A Phase 2 study testing SAFETY-A within usual ED Care and Combined SAFETY-A within usual ED Care + CLASP Therapeutic Follow-Up Contacts in people with Suicide and Suicidal, run by University of California, Los Angeles at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 24 years
Conditions the study is for
Suicide, Suicidal, Self-Harm
What is being tested?
SAFETY-A within usual ED Care and Combined SAFETY-A within usual ED Care + CLASP Therapeutic Follow-Up Contacts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
5 sitesUnited States
Study dates
17 Oct 2022to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lucas Zullo, PhD contact

310 794-4962

lzullo@mednet.ucla.edu

Jocelyn I Meza, PhD contact

310 794-4962

jimeza@mednet.ucla.edu

5 sites in 1 country

United States5 sites, 5 recruiting
  • Duke University

    Durham, North Carolina, 27708

    David Goldston, Ph.D., david.goldston@duke.edu

    Recruiting
  • Ronald Reagan Medical Center

    Los Angeles, California, 90095-6968

    Joan Asarnow, PhD, 310-794-4962, jasarnow@mednet.ucla.edu

    Recruiting
  • Brown University

    Providence, Rhode Island, 02912

    Anthony Spirito, Ph.D., anthony_spirito@brown.edu

    Recruiting
  • University of Utah

    Salt Lake City, Utah, 84112

    Brooks Keeshin, MD, brooks.keeshin@hsc.utah.edu

    Recruiting
  • Olive View UCLA Education and Research Center

    Sylmar, California, 91342

    Naser Ahmadi, MD, Ph.D., 310-478-3711, nahmadi@mednet.ucla.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
SAFETY-A within usual ED Care, Combined SAFETY-A within usual ED Care + CLASP Therapeutic Follow-Up Contacts
Keywords
self-harm
Medical subject headings
Suicide, Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAFETY-A within usual ED CareBehavioural

    Also called Family Intervention for Suicide Prevention (FISP)

    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 ContactsBehavioural

    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.

Study groups in NCT05304065
Study groupRoleWhat they receive
SAFETY-Acute within Usual ED CareActive comparatorThe 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.
Receives: Behavioral: SAFETY-A within usual ED Care
CombinedActive comparatorThe 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.
Receives: Behavioral: Combined SAFETY-A within usual ED Care + CLASP Therapeutic Follow-Up Contacts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Suicide Attempts: Primary Clinical Outcome

    suicide attempts fatal, nonfatal, and interrupted

    Measured: Through 12 months of follow-up

  2. Mental Health Treatment Initiation: Primary Service Use Outcome

    initiation of mental health treatment after discharge from ED/hospital

    Measured: Observed through 12 months of follow-up, primary end point 6-month follow-up

Secondary outcomes (2)
  1. Self-Harm: Secondary Clinical Outcome

    Any self-harm including suicidal, nonsuicidal, and ambiguous self-harm

    Measured: Through 12 months of follow-up

  2. Treatment engagement: Secondary Service Use Outcome

    Treatment dose received

    Measured: Through 12 months of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start17 Oct 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05304065
Sponsor's protocol ID
SP-2020C3-21078
Acronym
SAFE STEPS
Status last verified
Dec 2025
First submitted
11 Mar 2022
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAFETY-A within usual ED Care and Combined SAFETY-A within usual ED Care + CLASP Therapeutic Follow-Up Contacts in people with Suicide and Suicidal, run by University of California, Los Angeles at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lucas Zullo, PhD (310 794-4962, lzullo@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Suicide Attempts: Primary Clinical Outcome (time frame: Through 12 months of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.

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SAFE STEPS Clinical Trial NCT05304065 | AzTrials