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

February 25, 2025 updated by: Anna Lau, University of California, Los Angeles
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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

347

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Referral Tracking System (Kim et al., 2018)
Time Frame: Six months following the intervention
As described in Kim, Kodish, Bear, El-Hendi, Duong & Lau (2018), we will extract mental health service use outcomes from administrative records maintained by each school district. The variable of interest will be Linkage to Outpatient Care, indexed by a receipt of at least one outpatient session following referral to care.
Six months following the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SAFE Alternatives for Teens and Youths - Acute Pre-to-Post intervention Questionnaire (Zullo et al., 2020).
Time Frame: Change in youth ratings from beginning of the intervention session to the end of the intervention session.
As described in Zullo, Meza, Rolon-Aroyoo, Vargas, Venables, Miranda & Asarnow (2020). Youths are asked to rate the intensity of their suicide urge, feelings of hope, and ability to keep safe on a scale from 1-5 at the beginning and end of session.
Change in youth ratings from beginning of the intervention session to the end of the intervention session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Anna S Lau, PhD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Deidentified individual level data will be shared according to the National Data Archive data submission plan.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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