Mental Health IssueE-IMPACTSNCT06047041
Implementation Supports for Improving Identification and Delivery of School-based Mental Health Supports for Middle Schools Students
A study testing EIS Only and EIS + ECHO in people with Mental Health Issue, run by University of Virginia at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- EIS Only and EIS + ECHO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,350 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Aug 2023to Jul 2026
- 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 10 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous use of EIS (i.e., use of all screening data and intervention hub)
- <70% response rate on pre-intervention implementation of EIS
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22904
Michael D Lyons, Ph.D., 434-924-0790, mdl8s@virginia.edu
- Recruiting
University of Missouri
Columbia, Missouri, 65211
Keith C Herman, Ph.D., 573-884-2419, hermanke@missouri.edu
- Recruiting
University of South Carolina
Columbia, South Carolina, 29208
Samuel D. McQuillin, Ph.D., 803-777-6725, mcquills@mailbox.sc.edu
About this study
Official title: Evidence-Informed Mental Health Prevention, Assessment, Collaboration, and Treatment in Middle Schools
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.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- EIS Only, EIS + ECHO
- Keywords
- Schools, Adolescent Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIS OnlyBehavioural
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 + ECHOBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EIS Only | Active comparator | EIS Only (active comparator) condition schools involve technical assistance to support the implementation EIS. Receives: 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. Receives: Behavioral: EIS + ECHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 2 time points (over 9 months)
Secondary outcomes (2)
Number of students with disciplinary referrals
De-identified data on school on student discipline referrals will be measured across treatment conditions.
Measured: 2 time points (over 12 months)
Student grades
De-identified data on school on student academic achievement will be measured across treatment conditions.
Measured: 2 time points (over 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start31 Aug 2023
- Primary completion1 Jul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- School-level randomization to treatment arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Carolina, University of Missouri-Columbia
- Responsible party
- Principal investigator, Michael Lyons, PhD, University of Virginia
- Investigators
- Michael D Lyons, Ph.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047041
- Sponsor's protocol ID
- 5320
- Acronym
- E-IMPACTS
- Status last verified
- Mar 2025
- First submitted
- 1 Sep 2023
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-Informed Mental Health Prevention, Assessment, Collaboration, and Treatment in Middle Schools
- ClinicalTrials.gov ID
- NCT06047041
- Acronym / sponsor ID
- E-IMPACTS / 5320
- Conditions
- Mental Health Issue
- Keywords
- Schools, Adolescent Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21,350 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- University of South Carolina, University of Missouri-Columbia
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 21 Sep 2023 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- School-level randomization to treatment arm.
| Arm | Type | Receives |
|---|---|---|
| EIS Only | Active comparator | Behavioral: EIS OnlyEIS Only (active comparator) condition schools involve technical assistance to support the implementation EIS. |
| EIS + ECHO | Experimental | Behavioral: EIS + ECHOEIS + 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. |
Who may qualify
- Ages
- 10 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Previous use of EIS (i.e., use of all screening data and intervention hub)
- <70% response rate on pre-intervention implementation of EIS
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 |
|---|---|---|
| EIS OnlyThe 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. | Behavioural | EIS Only |
| EIS + ECHOEIS + 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. | Behavioural | EIS + ECHO |
Primary outcome
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.
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).
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.
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).
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.
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 secondary outcomes
Number of students with disciplinary referrals
Time frame: 2 time points (over 12 months)
Student grades
Time frame: 2 time points (over 12 months)
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 19 Jun 2025.
- 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.
Michael D Lyons, Ph.D. principal investigator
University of Virginia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIS Only and EIS + ECHO in people with Mental Health Issue, run by University of Virginia at 3 sites 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Michael D Lyons, Ph.D. (434-924-0790, mdl8s@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in youth mental health measured by the Early identification System (time frame: 2 time points (over 9 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2025.