- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05450094
Reducing Unmet Mental Health Need of African-American Children
May 8, 2023 updated by: University of Florida
Patient-Centered Enhancements to Reduce Unmet Mental Health Need of African-American Children
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Interventional
Enrollment (Anticipated)
19106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joni Splett, Ph.D
- Phone Number: (352) 273-4062
- Email: splett@coe.ufl.edu
Study Locations
-
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Florida
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Gainesville, Florida, United States, 32611
- Name withheld to protect anonymity of study site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 105 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Comparator
The comparator arm enhances school-based mental health (SBMH) with universal screening and trains voluntary school teams to use the school-wide data to plan and make intervention referrals using an evidence-based in-service training and coaching model called Team-Initiated Problem Solving (TIPS).
|
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.
|
Experimental: Enhanced
The enhanced arm involves the enhancements to school-based mental health (SBMH) of the comparator arm with the addition of 3 additional empirically supported enhancements to mental health screening: 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; and 3) Mental Health Literacy training for voluntary school teams in awareness and understanding of students' mental health well-being and need for intervention.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: From first day of school in year 1 to last day of school in year 2
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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.
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From first day of school in year 1 to last day of school in year 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change from baseline in student disciplinary encounters as measured by the number of Office Discipline Referrals each quarter
Time Frame: From first day of school in year 1 to last day of school in year 2
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joni Splett, Ph.D, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Anticipated)
June 30, 2026
Study Completion (Anticipated)
February 28, 2027
Study Registration Dates
First Submitted
July 5, 2022
First Submitted That Met QC Criteria
July 5, 2022
First Posted (Actual)
July 8, 2022
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- IRB202200678
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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