NCT06047041

Brief Summary

This study will assess how different types of training and support influence the way that school staff understand, and respond to, the mental and behavioral health needs of middle school students. Researchers will work with middle schools using a developed screening system (called the Early Identification System; EIS) and compare how staff and student outcomes change when schools receive two different types of training and support: 1) standard onboarding/training versus 2) participating in professional learning communities and coaching.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
21,350

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Aug 2023Jul 2026

Study Start

First participant enrolled

August 31, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 1, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

June 19, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

September 1, 2023

Last Update Submit

June 16, 2025

Conditions

Keywords

SchoolsAdolescent Health

Outcome Measures

Primary Outcomes (6)

  • Change in youth mental health measured by the Early identification System

    De-identified, student-level behavioral data collected via the Early Identification System. The measure is a psychometrically validated mental and behavioral health screening system measuring domains including attention problems, internalizing problems, and externalizing problems.

    2 time points (over 9 months)

  • Change in staff knowledge of evidence-based school mental health practices as measured by the Perceptions of Response To Intervention Skills Survey

    Staff perceptions of the skills they possess related to evidence-based screening, monitoring, and intervention will be measured using a modified version of the Perceptions of Response To Intervention Skills Survey - Revised (PRSS; α \> .90 for all factors). Response options range from not skilled (1) to very highly scaled (5).

    2 time points (over 9 months)

  • Change in staff behaviors of evidence-based school mental health practices as measured by the Perceptions of Practices Survey

    Perceptions of Practices Survey (PPS; Castillo et al., 2016) measures the extent to which schools implement evidence-based screening, intervention, and progress monitoring practices to support student mental health (α = .96 for the behavior factor; Marshall, 2016). Staff will indicate on a 5-point scale how frequently the practice occurred in their school.

    2 time points (over 9 months)

  • Change in staff burnout as measured by the Maslach Burnout Inventory

    Maslach Burnout Inventory (MBI; Maslach \& Jackson, 1981). Measures staff experiences of emotional exasperation and fatigue. Staff will complete the emotional exhaustion factor from the MBI - Educators Survey (MBI-ES, α \> .80; Wheeler et a., 2011). Response options range from never (0) to daily (6).

    2 time points (over 9 months)

  • Change in schoolwide school mental health implementation outcomes as measured by the School-wide Evaluation Tool

    The School-Wide Evaluation Tool (SET; Sugai et al., 2001) measure the implementation of evidence-based programs within a tiered system. The SET measures school-wide activities related to the implementation of school mental health systems, targeted interventions, and individualized interventions. A trained assessor will track implementation of evidence-based programs in both conditions.

    2 time points (over 9 months)

  • Change in schoolwide school mental health implementation outcomes as measured by the Individual School-wide Evaluation Tool

    The Individual Student Systems Evaluation Tool (ISSET; Debnam, Pas, \& Bradshaw, 2012) measures the implementation of evidence-based programs within a tiered system. The ISSET measures foundations, targeted interventions, and individualized interventions. A trained assessor will track implementation in both conditions.

    2 time points (over 9 months)

Secondary Outcomes (2)

  • Number of students with disciplinary referrals

    2 time points (over 12 months)

  • Student grades

    2 time points (over 12 months)

Study Arms (2)

EIS Only

ACTIVE COMPARATOR

EIS Only (active comparator) condition schools involve technical assistance to support the implementation EIS.

Behavioral: EIS Only

EIS + ECHO

EXPERIMENTAL

EIS + ECHO (experimental) condition involves all of the activities included in the "EIS Only" condition and will include enhanced implementation supports. Enhanced implementation supports involve 1) monthly collaborative learning ECHO sessions for school student support team staff to support implementation of EIS and evidence-based mental and behavioral health practices and 2) individual school teams will also receive follow-up supports to promote the implementation strategies presented during ECHO sessions.

Behavioral: EIS + ECHO

Interventions

EIS OnlyBEHAVIORAL

The EIS Only Condition includes middle schools who have elected to implement the EIS. The EIS: * Is an online tool to that enables schools to identify students in need of additional mental or behavioral health support and provides recommendations for evidence-based practices. * Asks teachers and students to report on 7 areas of student social-emotional functioning * Facilitates schools' understanding of social-emotional student needs and recommended evidence-based practices at a variety of levels (e.g., school-, grade-, and individual-level). EIS Only Condition supports include: * Technical assistance professional development sessions to support the implementation of EIS and schoolwide practices related to identifying and supporting student mental health needs. * Individualized technical assistance for schools to support EIS implementation.

EIS Only
EIS + ECHOBEHAVIORAL

EIS + ECHO supports include supports from the EIS Only condition plus: * Monthly ECHO sessions for student support teams (SSTs; e.g., interdisciplinary groups of staff tasked to support student mental health). The ECHO experience involves: * Didactic training to support EIS implementation and effective identification and support of student mental and behavioral health needs. * Case-based learning and collaborative problem-solving related to EIS implementation and effective identification and support of student mental and behavioral health needs. * Collaboration with colleagues in schools that are also implementing the EIS. * Opportunities to consult with university faculty and content experts in school mental health. * Individualized SST coaching supports to facilitate the implementation of mental and behavioral health practices and strategies discussed during ECHO sessions.

EIS + ECHO

Eligibility Criteria

Age10 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Public middle schools (must include grades 6-8) planning to implement the EIS
  • Located in rural areas, towns, \& suburbs / cities (NCES locales)

You may not qualify if:

  • Previous use of EIS (i.e., use of all screening data and intervention hub)
  • \<70% response rate on pre-intervention implementation of EIS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Missouri

Columbia, Missouri, 65211, United States

RECRUITING

University of South Carolina

Columbia, South Carolina, 29208, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22904, United States

RECRUITING

Study Officials

  • Michael D Lyons, Ph.D.

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael D Lyons, Ph.D.

CONTACT

Faith A Zabek, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors of schoolwide implementation outcomes (i.e., the School-Wide Evaluation Tool \[SET\] and the Individual Student Systems Evaluation Tool \[ISSET\]) will be masked.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: School-level randomization to treatment arm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 1, 2023

First Posted

September 21, 2023

Study Start

August 31, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

June 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations