Clinical trial NCT05834660: 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
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Keywords: Implementation Feasibility
Implementation Acceptability
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2023-04-28
Enrollment: 347
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Referral Tracking System (Kim et al., 2018)
timeFrame: Six months following the intervention
Secondary outcomes:
measure: SAFE Alternatives for Teens and Youths - Acute Pre-to-Post intervention Questionnaire (Zullo et al., 2020).
timeFrame: Change in youth ratings from beginning of the intervention session to the end of the intervention session.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Anna S Lau, PhD
role: PRINCIPAL_INVESTIGATOR
References: