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临床试验/NCT07836972
NCT07836972尚未招募2 期

Novel Approaches to Supporting Students With ADHD in Multi-Tiered Systems of Support (MTSS)

Florida International University0 个研究点目标入组 544 人开始时间: 2027年1月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
尚未招募
入组人数
544
主要终点
Count of Child rule violations

研究概览

简要总结

Children with 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/Behavior 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/aggressive behavior or learning disabilities).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Elevated ADHD symptoms and impairment and referred to school-based support team for intervention.
  • •Attending grades kindergarten - fifth

排除标准

  • •Special education classification for academics or behavior
  • •Behavior concerns at a level that would make lead-in treatment inappropriate/of insufficient intensity

研究组 & 干预措施

School as Usual

Active Comparator

Lead-in Intervention followed by Assignment to School as Usual

干预措施: School as Usual Classroom Supports (Behavioral)

Academic Competency Enhancement (ACE) classroom

Experimental

Lead-in Intervention followed by Assignment to Academic Competency Enhancement (ACE) classroom

干预措施: Academic Competency Enhancement (ACE) classroom (Behavioral)

结局指标

主要结局

Count of Child rule violations

时间窗: Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2

Observation of frequency of rule violations

Impairment Rating Scale

时间窗: Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2

IOWA Connors Rating Scale

时间窗: Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2

Total Score on Inattentive/Overactive Factor

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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