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

Primary Purpose

Suicidal Ideation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safe Alternatives for Teens and Youth-Acute for Schools (SAFETY-A for Schools)
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Suicidal Ideation focused on measuring Implementation Feasibility, Implementation Acceptability

Eligibility Criteria

11 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • University of California Los AngelesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2023
Last Updated
April 27, 2023
Sponsor
University of California, Los Angeles
Collaborators
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05834660
Brief Title
SAFETY-A for Promoting Equity in Suicide Prevention Outcomes in Schools
Official Title
SAFETY-A for Promoting Equity in Suicide Prevention Outcomes in Schools
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
Keywords
Implementation Feasibility, Implementation Acceptability

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
347 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Safe Alternatives for Teens and Youth-Acute for Schools (SAFETY-A for Schools)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Safe Alternatives for Teens and Youth-Acute for Schools (SAFETY-A for Schools)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Referral Tracking System (Kim et al., 2018)
Description
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.
Time Frame
Six months following the intervention
Secondary Outcome Measure Information:
Title
SAFE Alternatives for Teens and Youths - Acute Pre-to-Post intervention Questionnaire (Zullo et al., 2020).
Description
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.
Time Frame
Change in youth ratings from beginning of the intervention session to the end of the intervention session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna S Lau, PhD
Phone
310-206-5363
Email
alau@psych.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Flores
Email
aflores@psych.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna S Lau, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna S Lau, PhD
Phone
310-206-5363
Email
alau@psych.ucla.edu
First Name & Middle Initial & Last Name & Degree
Ashley Flores
Email
aflores@psych.ucla.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Deidentified individual level data will be shared according to the National Data Archive data submission plan.

Learn more about this trial

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

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