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

NCT07836972 | Not Yet Recruiting Phase 2

• 1 other identifier: R01MH144202
• Study Type: interventional
• Target: 544
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Attention Deficit Hyerpactivity Disorder

Keywords

ADHD; school intervention; positive behavior support

Outcome Measures

Primary Outcomes (3)

• 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

• IOWA Connors Rating Scale

  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

  Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2

Study Arms (2)

School as Usual

ACTIVE COMPARATOR

Lead-in Intervention followed by Assignment to School as Usual

Behavioral: School as Usual Classroom Supports

Academic Competency Enhancement (ACE) classroom

EXPERIMENTAL

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

Behavioral: Academic Competency Enhancement (ACE) classroom

Interventions

School as Usual Classroom Supports BEHAVIORAL

This arm will include school as usual procedures for students.

School as Usual

Academic Competency Enhancement (ACE) classroom BEHAVIORAL

Children assigned to ACE will enroll in a classroom with a teacher trained to implement contingency management components throughout the school year.

Academic Competency Enhancement (ACE) classroom

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Florida International University: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Schools

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Officials

• Gregory A. Fabiano, Ph.D.

  Florida International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory A. Fabiano, Ph.D.

CONTACT

716-359-7823; gfabiano@fiu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2031
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF