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- Ensaio Clínico 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)
Children with attention-deficit/hyperactivity 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/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).
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Gregory A. Fabiano, Ph.D.
- Número de telefone: 716-359-7823
- E-mail: gfabiano@fiu.edu
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Elevated ADHD symptoms and impairment and referred to school-based support team for intervention.
- Attending grades kindergarten - fifth
Exclusion Criteria:
- Special education classification for academics or behavior
- Behavior concerns at a level that would make lead-in treatment inappropriate/of insufficient intensity
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: School as Usual
Lead-in Intervention followed by Assignment to School as Usual |
This arm will include school as usual procedures for students. |
|
Experimental: Academic Competency Enhancement (ACE) classroom
Lead-in Intervention followed by Assignment to Academic Competency Enhancement (ACE) classroom |
Children assigned to ACE will enroll in a classroom with a teacher trained to implement contingency management components throughout the school year. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Count of Child rule violations
Prazo: 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 |
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
Prazo: 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 |
Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2
|
|
Impairment Rating Scale
Prazo: Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2
|
Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gregory A. Fabiano, Ph.D., Florida International University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R01MH144202 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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