Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT05834660
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2023-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SAFETY-A for Promoting Equity in Suicide Prevention Outcomes in Schools
Sponsor:
University of California, Los Angeles
Organization:
Study Overview
Official Title:
SAFETY-A for Promoting Equity in Suicide Prevention Outcomes in Schools
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: