SAFETY-A for Promoting Equity in Suicide Prevention Outcomes in Schools

NCT ID: NCT05834660

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will adapt Safe Alternatives For Teens and Youth - Acute (SAFETY-A) for implementation in low-resourced school districts to reduce racial/ethnic disparities in mental health service use (MHS) following identification of suicide risk in youth. SAFETY-A will be adapted to fit the organizational context of school districts and to reduce mistrust of MHS, internalized stigma, and concealment of youth emotional distress that arise in school suicide risk assessments with Asian American and Latinx students. Following a prototyping case series, a feasibility trial will assign four districts to the timing of SAFETY-A implementation to generate preliminary data on feasibility and impacts on proposed mechanisms and youth MHS utilization and clinical outcomes across racial/ethnic groups.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The proposed study will adapt Safe Alternatives For Teens and Youth - Acute (SAFETY-A) for implementation in low-resourced school districts to target putative mechanisms underlying disparities in MHS use following youth suicide risk detection. SAFETY-A will be adapted to reduce mistrust of MHS, internalized stigma, and concealment of youth emotional distress that drive poor engagement in MHS among Asian American and Latinx students and families. Furthermore, SAFETY-A delivery parameters and implementation strategies will be adapted to fit the organizational context of school district policies and protocols, resource constraints, and workforce needs.

The proposed intervention development study will include three phases. First, stakeholders will be engaged to design adaptations to the intervention and implementation strategy. Provider, youth and caregiver input will be gathered using human-centered design approaches to adapting the SAFETY-A intervention content to address disparities mechanisms. School district leaders, school administrators, and MHS providers will help to develop a tailored implementation strategy to fit local training and support needs across a range of district contexts. Second, a prototyping case series will inform iterative refinements of SAFETY-A in one school district. Third, a pilot feasibility trial will assign school districts to the timing of implementation to provide preliminary data on the implementation outcomes of provider adherence, and perceptions of feasibility, acceptability and fit. The proposed project will provide preliminary data on feasibility and potential impacts on putative mechanisms to propose a definitive Hybrid Type 1 trial to test SAFETY-A as an intervention to reduce racial/ethnic disparities in MHS utilization among suicidal youth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Suicidal Ideation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Safe Alternatives for Teens and Youth-Acute for Schools (SAFETY-A for Schools)

SAFETY-A is a brief, family centered, cognitive-behavioral approach to therapeutic risk assessment and safety planning that can be delivered via school-based providers. The intervention is delivered in one session during which the youth at risk for suicidal behavior works with the provider to identify strengths, supports, understand emotional antecedents and warning signs, identify alternative coping behaviors and thoughts, and ways to keep the environment safe. Youth and families receive follow-up contacts after the SAFETY-A session. The primary focus is on the therapeutic mechanisms of hope, reduced intensity of suicidal urges, increased confidence in ability to keep safe. Adaptation of SAFETY-A for Schools will target mechanisms that are presumed to drive disparities in mental health service use among Asian American and Latinx youth: (1) trust in mental health services, (2) internalized stigma, and (3) comfort communicating distress.

Group Type EXPERIMENTAL

Safe Alternatives for Teens and Youth-Acute for Schools (SAFETY-A for Schools)

Intervention Type BEHAVIORAL

SAFETY-A is a brief, family centered, cognitive-behavioral approach to therapeutic risk assessment and safety planning that can be delivered via school-based providers. The intervention is delivered in one session during which the youth at risk for suicidal behavior works with the provider to identify strengths, supports, understand emotional antecedents and warning signs, identify alternative coping behaviors and thoughts, and ways to keep the environment safe. Youth and families receive follow-up contacts by phone at 1, 2, and 4 weeks after the SAFETY-A session. The primary focus is on the therapeutic mechanisms of hope, reduced intensity of suicidal urges, increased confidence in ability to keep safe. Adaptation of SAFETY-A for Schools will target mechanisms that are presumed to drive disparities in mental health service use among Asian American and Latinx youth: (1) trust in mental health services, (2) internalized stigma, and (3) comfort communicating distress.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Safe Alternatives for Teens and Youth-Acute for Schools (SAFETY-A for Schools)

SAFETY-A is a brief, family centered, cognitive-behavioral approach to therapeutic risk assessment and safety planning that can be delivered via school-based providers. The intervention is delivered in one session during which the youth at risk for suicidal behavior works with the provider to identify strengths, supports, understand emotional antecedents and warning signs, identify alternative coping behaviors and thoughts, and ways to keep the environment safe. Youth and families receive follow-up contacts by phone at 1, 2, and 4 weeks after the SAFETY-A session. The primary focus is on the therapeutic mechanisms of hope, reduced intensity of suicidal urges, increased confidence in ability to keep safe. Adaptation of SAFETY-A for Schools will target mechanisms that are presumed to drive disparities in mental health service use among Asian American and Latinx youth: (1) trust in mental health services, (2) internalized stigma, and (3) comfort communicating distress.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 11-19
2. Enrolled in participating school district
3. Present with suicide thoughts or behavior to school personnel
4. Have an identified caregiver who can participate in the intervention

Exclusion Criteria

1. School personnel determine the student to be at such imminent risk of danger to self that they are unable to benefit from the intervention and must be immediate transported for emergency care.
2. Student is unable to participate in the intervention due to indications of intellectual disability, psychosis, or intoxication
Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anna Lau

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anna S Lau, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anna S Lau, PhD

Role: CONTACT

310-206-5363

Ashley Flores

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anna S Lau, PhD

Role: primary

(310) 206-5363

Ashley Flores

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

092530369

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Preventing Suicide in African American Adolescents
NCT04253002 ACTIVE_NOT_RECRUITING NA