- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06047041
Implementation Supports for Improving Identification and Delivery of School-based Mental Health Supports for Middle Schools Students (E-IMPACTS)
Evidence-Informed Mental Health Prevention, Assessment, Collaboration, and Treatment in Middle Schools
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The "Evidence-Informed Mental health Prevention, Assessment, Collaboration, & Treatment in Middle Schools" (E-IMPACTS) project will evaluate how different implementation supports promote the ability of school staff to identify, and support, the mental and behavioral health needs of middle school students.
The project will involve researchers from the University of Virginia, University of Missouri, and University of South Carolina and middle schools (i.e., grades 6-8) that have elected to use a brief, universal tool, called the Early Identification System (EIS). The EIS assesses mental and behavioral health of students and connects these data to intervention recommendations. The EIS is a fully developed and validated tool that was developed to help school staff to identify, and address, the mental or behavioral health needs in their school building. The EIS system was developed as a low/no cost system to 1) be administered fully online and 2) present school staff with actionable next steps for supporting youth mental health needs.
Using a school-level randomized controlled trial (RCT) design, this project will test if/how two different types of implementation support changes 1) the way school staff use EIS recommended practices and 2) student outcomes. Half of schools in the RCT will receive standard implementation supports for using EIS. This treatment condition, called "EIS only", involves the existing technical assistance and on-boarding provided to any school already choosing to use EIS. Schools in the other treatment condition, called EIS+ECHO, will receive additional professional development and implementation support. This will involve participating in 1) online professional learning communities following the "Extension for Community Healthcare Outcomes" (ECHO) model and 2) follow-up coaching. The E-IMPACTS ECHO model (a) connects student support teams (e.g., interdisciplinary groups of school staff) across schools with each other and with content experts (e.g., university faculty specializing in school mental health) to collaboratively problem solve challenges they may be experiencing related to supporting student mental and behavioral health needs, and (b) provides schools with follow-up supports to facilitate the implementation of strategies discussed in ECHO sessions.
The purpose of the RCT is to determine the "value-added" of the EIS + ECHO, compared to the EIS alone (EIS Only) in Virginia, Missouri, and South Carolina middle schools located in rural areas or small suburbs/cities (i.e., an active comparison condition). Researchers hypothesize that, relative to EIS Only, the EIS + ECHO condition will be associated with greater improvements in: (a) student emotional/behavioral and academic outcomes, (b) staff knowledge, self-efficacy, and practice outcomes, and (c) school-level implementation outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael D Lyons, Ph.D.
- Phone Number: 434-924-0790
- Email: mdl8s@virginia.edu
Study Contact Backup
- Name: Faith A Zabek, Ph.D.
- Phone Number: 434-243-4726
- Email: tak9uz@virginia.edu
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65211
- Recruiting
- University of Missouri
-
Contact:
- Keith C Herman, Ph.D.
- Phone Number: 573-884-2419
- Email: hermanke@missouri.edu
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- Recruiting
- University of South Carolina
-
Contact:
- Samuel D. McQuillin, Ph.D.
- Phone Number: 803-777-6725
- Email: mcquills@mailbox.sc.edu
-
-
Virginia
-
Charlottesville, Virginia, United States, 22904
- Recruiting
- University of Virginia
-
Contact:
- Michael D Lyons, Ph.D.
- Phone Number: 434-924-0790
- Email: mdl8s@virginia.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Public middle schools (must include grades 6-8) planning to implement the EIS
- Located in rural areas, towns, & suburbs / cities (NCES locales)
- All children attending the schools and staff employed by the schools are eligible for inclusion
Exclusion Criteria:
- Previous use of EIS (i.e., use of all screening data and intervention hub)
- <70% response rate on pre-intervention implementation of EIS
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: EIS Only
EIS Only (active comparator) condition schools involve technical assistance to support the implementation EIS.
|
The EIS Only Condition includes middle schools who have elected to implement the EIS. The EIS:
EIS Only Condition supports include:
|
Experimental: EIS + ECHO
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.
|
EIS + ECHO supports include supports from the EIS Only condition plus:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in youth mental health measured by the Early identification System
Time Frame: 2 time points (over 9 months)
|
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
Time Frame: 2 time points (over 9 months)
|
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
Time Frame: 2 time points (over 9 months)
|
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
Time Frame: 2 time points (over 9 months)
|
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
Time Frame: 2 time points (over 9 months)
|
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
Time Frame: 2 time points (over 9 months)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of students with disciplinary referrals
Time Frame: 2 time points (over 12 months)
|
De-identified data on school on student discipline referrals will be measured across treatment conditions.
|
2 time points (over 12 months)
|
Student grades
Time Frame: 2 time points (over 12 months)
|
De-identified data on school on student academic achievement will be measured across treatment conditions.
|
2 time points (over 12 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael D Lyons, Ph.D., University of Virginia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5320
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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