NCT05450094

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19,106

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Nov 2022Feb 2029

First Submitted

Initial submission to the registry

July 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

February 27, 2026

Status Verified

May 1, 2025

Enrollment Period

5.6 years

First QC Date

July 5, 2022

Last Update Submit

February 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Mean change from baseline in student disciplinary encounters as measured by the number of Office Discipline Referrals each quarter

    From first day of school in year 1 to last day of school in year 2

Study Arms (2)

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).

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.

Behavioral: Enhanced Screening

Interventions

Screening OnlyBEHAVIORAL

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.

Comparator

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.

Enhanced

Eligibility Criteria

Age5 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Students at study school
  • School intervention teams at study school

You may not qualify if:

  • Students who are wards of the state or any other institution, agency, or entity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Name withheld to protect anonymity of study site

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Joni Splett, Ph.D

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 8, 2022

Study Start

November 1, 2022

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

February 27, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations