Reducing Unmet Mental Health Need of African-American Children

August 21, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 implicit social cognitions that impact decision-making processes 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 implementation supports, including training, coaching, and data-based feedback. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • Name withheld to protect anonymity of study site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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.
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-based implementation supports, including training, coaching, and data-based feedback. Enhancement aim to increase school teams' awareness and understanding of students' mental health well-being and need for intervention.
Behavioral: 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-based implementation supports, including training, coaching, and data-based feedback. Enhancement aim to increase school teams' awareness and understanding of students' mental health well-being and need for intervention. enhancements.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joni Splett, Ph.D, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB202200678
  • AD-2021C1-22495 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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