Mental HealthNCT05450094
Reducing Unmet Mental Health Need of African-American Children
A study testing Screening Only and Enhanced Screening in people with Mental Health, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Screening Only and Enhanced Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,106 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 105 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students at study school
- School intervention teams at study school
Who cannot join
- Students who are wards of the state or any other institution, agency, or entity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Name withheld to protect anonymity of study site
Gainesville, Florida, 32611
About this study
Official title: 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.
Read the 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).
- Conditions
- Mental Health
- Being tested
- Screening Only, Enhanced Screening
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening OnlyBehavioural
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 ScreeningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Active 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). Receives: Behavioral: Screening Only |
| Enhanced | Experimental | 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. Receives: Behavioral: Enhanced Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first day of school in year 1 to last day of school in year 2
Secondary outcomes (1)
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.
Measured: From first day of school in year 1 to last day of school in year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Nov 2022
- Primary completionJun 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19,106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Joni Splett, Ph.D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450094
- Sponsor's protocol ID
- IRB202200678
- Other IDs
- AD-2021C1-22495
- Status last verified
- Jun 2026
- First submitted
- 5 Jul 2022
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Splett JW, Gage NA, Chaparro EA, Lyon AR, Sonsteng-Person MA, Alfonso ZZ, Halliday CA. Differential item functioning of teacher-rated universal mental health screening in elementary schools. Sch Psychol. 2026 Mar;41(2):208-218. doi: 10.1037/spq0000712. Epub 2025 Sep 29.
PubMed 41021530
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Enhancements to Reduce Unmet Mental Health Need of African-American Children
- ClinicalTrials.gov ID
- NCT05450094
- Acronym / sponsor ID
- IRB202200678
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 19,106 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparator | Active comparator | Behavioral: Screening OnlyThe 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). |
| Enhanced | Experimental | Behavioral: Enhanced ScreeningThe 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. |
Who may qualify
- Ages
- 5 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Students at study school
- School intervention teams at study school
Key exclusion criteria (1 listed)
- Students who are wards of the state or any other institution, agency, or entity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening OnlyThe 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. | Behavioural | Comparator |
| Enhanced ScreeningThe 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. | Behavioural | Enhanced |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Derived from this study: PubMed 41021530Splett JW, Gage NA, Chaparro EA, Lyon AR, Sonsteng-Person MA, Alfonso ZZ, Halliday CA. Differential item functioning of teacher-rated universal mental health screening in elementary schools. Sch Psychol. 2026 Mar;41(2):208-218. doi: 10.1037/spq0000712. Epub 2025 Sep 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joni Splett, Ph.D principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening Only and Enhanced Screening in people with Mental Health, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05450094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.