Attention Deficit Hyerpactivity DisorderPhase 2/3NCT07836972
Novel Approaches to Supporting Students With ADHD in Multi-Tiered Systems of Support
A Phase 2/3 study testing Academic Competency Enhancement (ACE) classroom and School as Usual Classroom Supports in people with Attention Deficit Hyerpactivity Disorder, run by Florida International University.
Trial 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, \&… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Attention Deficit Hyerpactivity Disorder
- What is being tested?
- Academic Competency Enhancement (ACE) classroom and School as Usual Classroom Supports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Aug 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elevated ADHD symptoms and impairment and referred to school-based support team for intervention.
- Attending grades kindergarten - fifth
Who cannot join
- Special education classification for academics or behavior
- Behavior concerns at a level that would make lead-in treatment inappropriate/of insufficient intensity
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
- Conditions
- Attention Deficit Hyerpactivity Disorder
- Being tested
- Academic Competency Enhancement (ACE) classroom, School as Usual Classroom Supports
- Keywords
- ADHD, school intervention, positive behavior support
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Academic Competency Enhancement (ACE) classroomBehavioural
Children assigned to ACE will enroll in a classroom with a teacher trained to implement contingency management components throughout the school year.
School as Usual Classroom SupportsBehavioural
This arm will include school as usual procedures for students.
| Study group | Role | What they receive |
|---|---|---|
| School as Usual | Active comparator | Lead-in Intervention followed by Assignment to School as Usual Receives: Behavioral: School as Usual Classroom Supports |
| Academic Competency Enhancement (ACE) classroom | Experimental | Lead-in Intervention followed by Assignment to Academic Competency Enhancement (ACE) classroom Receives: Behavioral: Academic Competency Enhancement (ACE) classroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Child rule violations
Observation of frequency of rule violations
Measured: 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
Measured: Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2
Impairment Rating Scale
Measured: Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyerpactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 544 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory A. Fabiano, Ph.D., Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836972
- Sponsor's protocol ID
- R01MH144202
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approaches to Supporting Students With ADHD in Multi-Tiered Systems of Support (MTSS)
- ClinicalTrials.gov ID
- NCT07836972
- Acronym / sponsor ID
- R01MH144202
- Conditions
- Attention Deficit Hyerpactivity Disorder
- Keywords
- ADHD, school intervention, positive behavior support
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 544 participants (estimated)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| School as Usual | Active comparator | Behavioral: School as Usual Classroom SupportsLead-in Intervention followed by Assignment to School as Usual |
| Academic Competency Enhancement (ACE) classroom | Experimental | Behavioral: Academic Competency Enhancement (ACE) classroomLead-in Intervention followed by Assignment to Academic Competency Enhancement (ACE) classroom |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Elevated ADHD symptoms and impairment and referred to school-based support team for intervention.
- Attending grades kindergarten - fifth
Key exclusion criteria (2 listed)
- Special education classification for academics or behavior
- Behavior concerns at a level that would make lead-in treatment inappropriate/of insufficient intensity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Academic Competency Enhancement (ACE) classroomChildren assigned to ACE will enroll in a classroom with a teacher trained to implement contingency management components throughout the school year. | Behavioural | Academic Competency Enhancement (ACE) classroom |
| School as Usual Classroom SupportsThis arm will include school as usual procedures for students. | Behavioural | School as Usual |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory A. Fabiano, Ph.D. principal investigator
Florida International University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Academic Competency Enhancement (ACE) classroom and School as Usual Classroom Supports in people with Attention Deficit Hyerpactivity Disorder, run by Florida International University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory A. Fabiano, Ph.D. (716-359-7823, gfabiano@fiu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.