[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657284":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":26,"interventions":39,"overallOfficials":48,"centralContacts":52,"locations":18,"responsibleParty":57,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":18,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":83,"whyStopped":18,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":18},{"fullName":5,"class":6},"Florida International University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":18},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Count of Child rule violations","Observation of frequency of rule violations","Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2",{"measure":14,"description":15,"timeFrame":12},"IOWA Connors Rating Scale","Total Score on Inattentive\u002FOveractive Factor",{"measure":17,"description":18,"timeFrame":12},"Impairment Rating Scale",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","All participants will receive a lead-in positive behavior support intervention; those who exhibit continued impairment will be randomly assigned to the intervention classroom or school as usual.","TREATMENT",{"masking":25,"maskingDescription":18,"whoMasked":18},"NONE",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"School as Usual","ACTIVE_COMPARATOR","Lead-in Intervention followed by Assignment to School as Usual",[32],"Behavioral: School as Usual Classroom Supports",{"label":34,"type":35,"description":36,"interventionNames":37},"Academic Competency Enhancement (ACE) classroom","EXPERIMENTAL","Lead-in Intervention followed by Assignment to Academic Competency Enhancement (ACE) classroom",[38],"Behavioral: Academic Competency Enhancement (ACE) classroom",[40,44],{"type":41,"name":34,"description":42,"armGroupLabels":43,"otherNames":18},"BEHAVIORAL","Children assigned to ACE will enroll in a classroom with a teacher trained to implement contingency management components throughout the school year.",[34],{"type":41,"name":45,"description":46,"armGroupLabels":47,"otherNames":18},"School as Usual Classroom Supports","This arm will include school as usual procedures for students.",[28],[49],{"name":50,"affiliation":5,"role":51},"Gregory A. Fabiano, Ph.D.","PRINCIPAL_INVESTIGATOR",[53],{"name":50,"role":54,"phone":55,"phoneExt":18,"email":56},"CONTACT","716-359-7823","gfabiano@fiu.edu",{"type":58,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100657284","phase-2-novel-approaches-to-supporting-students-with-adhd-in-multi-tiered-systems-of-support-100657284",false,"NCT07836972","Novel Approaches to Supporting Students With ADHD in Multi-Tiered Systems of Support","Novel Approaches to Supporting Students With ADHD in Multi-Tiered Systems of Support (MTSS)","Inclusion Criteria:\n\n* Elevated ADHD symptoms and impairment and referred to school-based support team for intervention.\n* Attending grades kindergarten - fifth\n\nExclusion Criteria:\n\n* Special education classification for academics or behavior\n* Behavior concerns at a level that would make lead-in treatment inappropriate\u002Fof insufficient intensity","ALL","4 Years","12 Years",{"count":70,"type":71},544,"ESTIMATED","INTERVENTIONAL",[74,75],"PHASE2","PHASE3","Children with attention-deficit\u002Fhyperactivity disorder (ADHD) are likely to exhibit behavioral difficulties in the classroom that inhibit learning (Daley \\& Birchwood, 2010; DuPaul \\& Stoner, 2003; Fabiano et al., 2006; Friedman \\& Pfiffner, 2020; Loe \\& Feldman, 2007; Raggi \\& Chronis, 2006; Rapport, Chung, Shore, \\& Isaacs, 2001). These issues make addressing ADHD an area in need of continuous and contemporary support, particularly during early elementary school (Bitsko et al., 2022), in order to prevent the worsening, life-long issues that individuals with ADHD may confront throughout the lifespan. The present application focuses on supports and interventions for students in elementary school, as that is where initial identification and intervention typically occurs (Visser et al., 2014). With the advent of Multi-Tiered Systems of Support (MTSS) within school settings, a systematic approach to the delivery of universal, targeted, and indicated school mental health and educational supports may be enhanced. The most intensive tier of the MTSS (i.e., Tier 3) is currently the most under-developed. The creation of a positive behavioral support classroom through Tier 3 of the MTSS will assist teachers in improving the positive behavioral support provided to the student with ADHD. Thus, the present investigation will be situated within everyday school procedures for supporting a student with behaviors consistent with ADHD. Participants will be 288 elementary school children recruited from participating school districts within the existing school-based problem solving teams. We will work with grades kindergarten to sixth. Referred children will then all receive a lead-in, Tier 2 intervention to include a daily report card (DRC) intervention. Those who continue to need additional behavior supports in the Spring -- Tier 3 intervention -- will be allocated through random assignment to School as Usual or Academic\u002FBehavior Competency (ACE) classroom in a Hybrid Type 1 design. The ACE classroom is an approach based on decades of research in summer treatment program classrooms (Fabiano et al., 2007; Pelham et al., 2025). Aim 1 evaluates the outcomes of the approach relative to school as usual. Aim 2 evaluates the implementation of the approach and explores components of user implementation that promote fidelity. Aim 3 explores moderators of the intervention outcomes (e.g., comorbid oppositional\u002Faggressive behavior or learning disabilities).",[78],"Attention Deficit Hyerpactivity Disorder",[80,81,82],"ADHD","school intervention","positive behavior support","NOT_YET_RECRUITING","2026-09-23",{"date":86,"type":87},"2026-09-28","ACTUAL",{"date":89,"type":71},"2027-01-01",{"date":91,"type":71},"2031-08-31",{"name":5,"class":6}]