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Enrolling by invitation NCT05450094

Reducing Unmet Mental Health Need of African-American Children

No phase Interventional Mental Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Screening Only, Enhanced Screening.
Who it may be relevant to
Registry conditions: Mental Health. Basic parameters: 5 years — 105 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Patient-Centered Enhancements to Reduce Unmet Mental Health Need of African-American Children

Overview

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).

Interventions

  • 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
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Name withheld to protect anonymity of study site — Gainesville

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. PMID 41021530

Identifiers

NCT: NCT05450094 · IRB202200678 · AD-2021C1-22495

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗