ClinicalTrials.gg
Not yet recruitingNCT07836972Updated Sep 28, 2026

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

A Phase 2/3 interventional study of Academic Competency Enhancement (ACE) classroom and School as Usual Classroom Supports in Attention Deficit Hyerpactivity Disorder, sponsored by Florida International University. Not yet recruiting. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Florida International University · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
544
Allocation
Randomized
Ages
4 Years to 12 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Attention Deficit Hyerpactivity Disorder

Keywords

  • ADHD
  • school intervention
  • positive behavior support
03

In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's planned enrollment of 544 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Florida International University is the lead sponsor of 104 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Special education classification for academics or behavior
  • Behavior concerns at a level that would make lead-in treatment inappropriate/of insufficient intensity
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
544 participants (estimated)

Study arms

  • Active comparator
    School as Usual

    Lead-in Intervention followed by Assignment to School as Usual

    Behavioral: School as Usual Classroom Supports

  • Experimental
    Academic Competency Enhancement (ACE) classroom

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

    Behavioral: Academic Competency Enhancement (ACE) classroom

Interventions

  • BehavioralAcademic 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.

  • BehavioralSchool as Usual Classroom Supports

    This arm will include school as usual procedures for students.

06

What researchers measure

Primary outcomes

  1. Count of Child rule violations

    Observation of frequency of 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

  2. IOWA Connors Rating Scale

    Total Score on Inattentive/Overactive Factor

    Time frame: Baseline, End of School year 1, Beginning of School year 2, Middle of School year 2, End of School year 2

  3. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2027; primary completion for Aug 2030, 43 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2026
First posted
Sep 23, 2026
StartEst.
Jan 1, 2027
Primary completionEst.
Aug 31, 2030
CompletionEst.
Aug 31, 2031
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: description
1 update, last Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07836972
Responsible party
Sponsor
First posted
Sep 23, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Aug 31, 2030 (estimated)
Completion
Aug 31, 2031 (estimated)
Last update
Sep 28, 2026

Study contacts

Gregory A. Fabiano, Ph.D.
Contact
gfabiano@fiu.edu
716-359-7823
Gregory A. Fabiano, Ph.D.
principal investigator · Florida International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion