[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06047041":3,"trial-entities:NCT06047041":136,"trial-summary:NCT06047041":140},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":40,"secondary_outcomes":60,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":81,"locations":85,"central_contacts":125,"overall_officials":131,"references":134,"see_also_links":135},"NCT06047041","5320","Implementation Supports for Improving Identification and Delivery of School-based Mental Health Supports for Middle Schools Students","Evidence-Informed Mental Health Prevention, Assessment, Collaboration, and Treatment in Middle Schools","RECRUITING","2026-07","2025-03","2025-06-19","2023-08-31","University of Virginia","OTHER",false,"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\u002Ftraining versus 2) participating in professional learning communities and coaching.","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.\n\nThe 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\u002Fno cost system to 1) be administered fully online and 2) present school staff with actionable next steps for supporting youth mental health needs.\n\nUsing a school-level randomized controlled trial (RCT) design, this project will test if\u002Fhow 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.\n\nThe 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\u002Fcities (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\u002Fbehavioral and academic outcomes, (b) staff knowledge, self-efficacy, and practice outcomes, and (c) school-level implementation outcomes.",[19],"Mental Health Issue",[21,22],"Schools","Adolescent Health","INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},21350,"ESTIMATED",[31,36],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","EIS Only","The EIS Only Condition includes middle schools who have elected to implement the EIS. The EIS:\n\n* 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.\n* Asks teachers and students to report on 7 areas of student social-emotional functioning\n* 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).\n\nEIS Only Condition supports include:\n\n* Technical assistance professional development sessions to support the implementation of EIS and schoolwide practices related to identifying and supporting student mental health needs.\n* Individualized technical assistance for schools to support EIS implementation.",[33],{"type":32,"name":37,"description":38,"armGroupLabels":39},"EIS + ECHO","EIS + ECHO supports include supports from the EIS Only condition plus:\n\n* Monthly ECHO sessions for student support teams (SSTs; e.g., interdisciplinary groups of staff tasked to support student mental health). The ECHO experience involves:\n\n  * Didactic training to support EIS implementation and effective identification and support of student mental and behavioral health needs.\n  * Case-based learning and collaborative problem-solving related to EIS implementation and effective identification and support of student mental and behavioral health needs.\n  * Collaboration with colleagues in schools that are also implementing the EIS.\n  * Opportunities to consult with university faculty and content experts in school mental health.\n* Individualized SST coaching supports to facilitate the implementation of mental and behavioral health practices and strategies discussed during ECHO sessions.",[37],[41,45,48,51,54,57],{"measure":42,"description":43,"timeFrame":44},"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)",{"measure":46,"description":47,"timeFrame":44},"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).",{"measure":49,"description":50,"timeFrame":44},"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.",{"measure":52,"description":53,"timeFrame":44},"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).",{"measure":55,"description":56,"timeFrame":44},"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.",{"measure":58,"description":59,"timeFrame":44},"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.",[61,65],{"measure":62,"description":63,"timeFrame":64},"Number of students with disciplinary referrals","De-identified data on school on student discipline referrals will be measured across treatment conditions.","2 time points (over 12 months)",{"measure":66,"description":67,"timeFrame":64},"Student grades","De-identified data on school on student academic achievement will be measured across treatment conditions.","ALL","10 Years","99 Years",true,{"inclusion":73,"exclusion":77,"raw_text":80},[74,75,76],"Public middle schools (must include grades 6-8) planning to implement the EIS","Located in rural areas, towns, \\& suburbs \u002F cities (NCES locales)","All children attending the schools and staff employed by the schools are eligible for inclusion",[78,79],"Previous use of EIS (i.e., use of all screening data and intervention hub)","\\\u003C70% response rate on pre-intervention implementation of EIS","Inclusion Criteria:\n\n* Public middle schools (must include grades 6-8) planning to implement the EIS\n* Located in rural areas, towns, \\& suburbs \u002F cities (NCES locales)\n* All children attending the schools and staff employed by the schools are eligible for inclusion\n\nExclusion Criteria:\n\n* Previous use of EIS (i.e., use of all screening data and intervention hub)\n* \\\u003C70% response rate on pre-intervention implementation of EIS",[82,83,84],"CHILD","ADULT","OLDER_ADULT",[86,101,113],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":98},"University of Missouri","Columbia","Missouri","65211","United States",[93],{"name":94,"role":95,"phone":96,"email":97},"Keith C Herman, Ph.D.","CONTACT","573-884-2419","hermanke@missouri.edu",{"lat":99,"lon":100},38.95171,-92.33407,{"facility":102,"status":8,"city":88,"state":103,"zip":104,"country":91,"contacts":105,"geoPoint":110},"University of South Carolina","South Carolina","29208",[106],{"name":107,"role":95,"phone":108,"email":109},"Samuel D. McQuillin, Ph.D.","803-777-6725","mcquills@mailbox.sc.edu",{"lat":111,"lon":112},34.00071,-81.03481,{"facility":13,"status":8,"city":114,"state":115,"zip":116,"country":91,"contacts":117,"geoPoint":122},"Charlottesville","Virginia","22904",[118],{"name":119,"role":95,"phone":120,"email":121},"Michael D Lyons, Ph.D.","434-924-0790","mdl8s@virginia.edu",{"lat":123,"lon":124},38.02931,-78.47668,[126,127],{"name":119,"role":95,"phone":120,"email":121},{"name":128,"role":95,"phone":129,"email":130},"Faith A Zabek, Ph.D.","434-243-4726","tak9uz@virginia.edu",[132],{"name":119,"affiliation":13,"role":133},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":137,"biomarkers":139},[138],"Mental Health",[],{"nct_id":4,"found":71,"summary":141,"prompt_version":151},{"design":142,"status":143,"heading":144,"summary":145,"follow_up":146,"word_count":147,"commitments":148,"compensation":149,"drugs_mentioned":150},"This is an interventional study with a planned enrollment of 21,350 participants, using a school-level randomized controlled trial design.","completed","Improving Mental Health Support in Middle Schools","This study is looking at how different training and support programs help middle school staff identify and respond to students' mental and behavioral health needs. Researchers are working with schools that use an online tool called the Early Identification System (EIS), which helps identify students needing support and suggests evidence-based practices. The study compares two types of support: EIS Only (standard training) versus EIS + ECHO (standard training plus monthly group sessions for school support teams). The goal is to see how these different supports change staff knowledge and behaviors, and ultimately improve youth mental health. This study is open to public middle schools (grades 6-8) in rural, town, and suburban\u002Fcity areas that plan to use the EIS.","Youth mental health and staff knowledge\u002Fbehaviors will be measured at two time points over nine months.",118,"Not specified in the trial record.","Not stated in the trial record.",[33,37],"v2"]