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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05450094
Other study ID # IRB202200678
Secondary ID AD-2021C1-22495
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date February 28, 2027

Study information

Verified date May 2024
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare two versions of school-based mental health screening to improve the receipt of mental health services among elementary school students.


Description:

School-based mental health (SBMH) is a critical pathway for accessing mental health services for African American/Black (AAB) youth who experience the greatest gap in unmet mental health need in comparison to their White, non-Hispanic peers, but are twice as likely to access mental health services in schools as outpatient or specialty clinics. Unfortunately, AAB children's access to SBMH is dependent on school intervention team decision making, which often involves consideration of factors other than student need. School personnel on intervention teams disproportionately attribute AAB youth's behavior problems as disciplinary issues rather than mental health needs, reducing the likelihood AAB students receive SBMH services. Consistent with the empirical literature, patient families and stakeholders recommend universal mental health screening to better identify AAB children with mental health needs and enhancements to address unintentional racial biases and poor mental health literacy of school personnel making intervention referral decisions. Thus, we will evaluate the comparative effectiveness of the SBMH delivery system enhanced with screening to a package of enhancements implemented with screening in SBMH to increase the likelihood AAB students receive the services they critically need. The enhancements include three components: (1) unintentional racial bias training and (2) mental health literacy training for voluntary school team members, and (3) a refinement to school teams' data-based decision-making process in which they also voluntarily review screening, mental referral/receipt, and discipline data disaggregated by race/ethnicity to identify and problem solve system-level inequities. We will test both whether and how (i.e., mediational analyses of causal pathway including knowledge, attitudinal, and behavioral observation of unintentional bias and mental health literacy) these enhancements impact student-level intervention and disciplinary referral outcomes. In a mixed method process evaluation and comparative analysis, we will also examine school-level contextual factors (i.e., team member tenure, pre-intervention discipline rates, racial/ethnic and socioeconomic composition of student body, and perceptions of intervention impact and acceptability) and implementation outcomes (i.e., fidelity, dosage/exposure, and reach).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 19106
Est. completion date February 28, 2027
Est. primary completion date June 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 105 Years
Eligibility Inclusion Criteria: - Students at study school - School intervention teams at study school Exclusion Criteria: - Students who are wards of the state or any other institution, agency, or entity

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Screening Only
The Screening Only intervention integrates enhancements to school-based mental health (SBMH). Each school's typical SBMH service delivery system will be enhanced with biweekly meetings of voluntary school teams (comprised of administrators, school counselors, general and special education teachers, and other school-employed mental health professionals) to 1) follow standardized evidence-based intervention decision making process to identify students with mental health risk, plan and/or refer for an evidence-based intervention, monitor intervention progress, and adjust intervention plans as needed; 2) administer teacher-rated and student self-report universal screening twice annually; 3) review screening and related school records data to identify students with mental health risk; and 4) review screening, referral, and receipt data to monitor progress of entire SBMH service delivery system.
Enhanced Screening
The Enhanced Screening intervention involves the enhancements to school-based mental health (SBMH) of the Screening Only intervention with the addition of 3 empirically supported enhancements: 1) Voluntary school teams will review screening and service receipt data disaggregated by racial/ethnic subgroups to identify and problem solve inequities. 2) Unintentional bias training for voluntary school teams, involving teaching participants to conceptualize prejudice as well as strategies to reduce bias. 3) Mental Health Literacy training for voluntary school teams in awareness and understanding of students' mental health well-being and need for intervention.

Locations

Country Name City State
United States Name withheld to protect anonymity of study site Gainesville Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Florida Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change from baseline in student referral to a mental health intervention as measured by the number of students referred to mental health interventions each quarter Intervention referrals refer a student to a mental health intervention to address an identified mental health need. The number of students referred to a mental health intervention will be counted. The minimum score is 0 and there is no maximum score. From first day of school in year 1 to last day of school in year 2
Secondary Mean change from baseline in student disciplinary encounters as measured by the number of Office Discipline Referrals each quarter Office Discipline Referrals are official school records recorded for each school behavioral infraction warranting referral to the school office. Office Discipline referrals for aggressive behavior (i.e. bullying, fighting, making threats) will be counted. The minimum score is 0 and there is no maximum score. From first day of school in year 1 to last day of school in year 2
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