NCT05834660

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
347

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 28, 2025

Status Verified

July 1, 2024

Enrollment Period

2.8 years

First QC Date

April 13, 2023

Last Update Submit

February 25, 2025

Conditions

Keywords

Implementation FeasibilityImplementation Acceptability

Outcome Measures

Primary Outcomes (1)

  • Referral Tracking System (Kim et al., 2018)

    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 Outcomes (1)

  • SAFE Alternatives for Teens and Youths - Acute Pre-to-Post intervention Questionnaire (Zullo et al., 2020).

    Change in youth ratings from beginning of the intervention session to the end of the intervention session.

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

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.

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

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • Student is unable to participate in the intervention due to indications of intellectual disability, psychosis, or intoxication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation

Interventions

Schools

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Officials

  • Anna S Lau, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna S Lau, PhD

CONTACT

Ashley Flores

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 13, 2023

First Posted

April 28, 2023

Study Start

November 1, 2022

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

February 28, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

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

Locations