- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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).
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Gregory A. Fabiano, Ph.D.
- Numéro de téléphone: 716-359-7823
- E-mail: gfabiano@fiu.edu
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: School as Usual
Lead-in Intervention followed by Assignment to School as Usual |
This arm will include school as usual procedures for students. |
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Count of Child rule violations
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gregory A. Fabiano, Ph.D., Florida International University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01MH144202 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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