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

September 23, 2026 updated by: Florida International University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
544

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Gregory A. Fabiano, Ph.D.
  • Phone Number: 716-359-7823
  • Email: gfabiano@fiu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: School as Usual

Lead-in Intervention followed by Assignment to School as Usual
Behavioral: School as Usual Classroom Supports

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
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Count of Child rule violations
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gregory A. Fabiano, Ph.D., Florida International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH144202 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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