ADHDPhase 4NCT05469386
Single and Combined Effects of Behavioral, Academic, and Medication Treatments for ADHD in the Classroom
A Phase 4 study testing Methylphenidate Hydrochloride ER, Behavioral classroom and General Classroom in people with ADHD, run by Florida International University at 2 sites in United States.
Trial summary
This study is the first to systematically evaluate the efficacy of single and combined academic accommodation, behavioral treatment, and medication treatment in a large sample of children with ADHD. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- Methylphenidate Hydrochloride ER, Behavioral classroom and General Classroom
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jun 2022to 31 Aug 2026
- Phase
- Phase 4
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ADHD Diagnosis
- IQ >= 70
Who cannot join
- Prior adverse reaction to methylphenidate
- Autism Spectrum disorder level 2/3
- Child is home schooled
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Children and Families
Amherst, New York, 14226
FIU Center for Childern and Families
Miami, Florida, 33199
About this study
Official title: Single and Combined Effects of Positive Behavior Support, Medication and Academic Accommodation for Children With ADHD
This study is the first to systematically evaluate the efficacy of single and combined academic accommodation, behavioral treatment, and medication treatment in a large sample of children with ADHD. Using a scientifically rigorous, cross-over design the impact of these approaches on ecologically valid measures of outcome (on-task behavior, quiz scores, academic productivity) will be assessed to inform effective school intervention.
- Conditions
- ADHD
- Being tested
- Methylphenidate Hydrochloride ER, Behavioral classroom, Placebo, General Classroom, Academic Accommodations
- 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.
Methylphenidate Hydrochloride ERDrug
Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)
Behavioral classroomBehavioural
Enhanced positive behavior supports implemented in classroom
PlaceboDrug
Placebo capsule
General ClassroomBehavioural
General education classroom procedures
Academic AccommodationsBehavioural
Accommodations are introduced to support the child's independent seat work completion and quiz scores
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsule administered in the morning Receives: Behavioral: Behavioral classroom; Behavioral: General Classroom; Behavioral: Academic Accommodations |
| Methylphenidate ER (.3 mg/kg dose) | Experimental | Methylphenidate ER (.3 mg/kg dose)administered in the morning Receives: Behavioral: Behavioral classroom; Behavioral: General Classroom; Behavioral: Academic Accommodations |
| General Classroom | Active comparator | General classroom procedures Receives: Drug: Methylphenidate Hydrochloride ER; Drug: Placebo; Behavioral: Academic Accommodations |
| Positive Behavior Support Classroom | Experimental | Positive Behavior Support Classroom procedures Receives: Drug: Methylphenidate Hydrochloride ER; Drug: Placebo; Behavioral: Academic Accommodations |
| Academic accommodations | Experimental | Academic accommodations are used during seat work and quiz Receives: Drug: Methylphenidate Hydrochloride ER; Behavioral: Behavioral classroom; Drug: Placebo; Behavioral: General Classroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral frequency count of rule violations
Behavioral frequency count of rule violations. Lower scores are better.
Measured: Through study completion, a maximum of eight weeks
Seatwork completion
Percentage of assigned seat work items completed correctly. Range of scores is from 0-100%. Higher scores are better.
Measured: Through study completion, a maximum of eight weeks
Quiz Scores
Percentage correct out of 10 quiz questions. Range of scores is from 0-100%. Higher scores are better.
Measured: Through study completion, a maximum of eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start13 Jun 2022
- Primary completion8 Aug 2025
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469386
- Sponsor's protocol ID
- 800013424
- Status last verified
- Aug 2025
- First submitted
- 14 Jul 2022
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single and Combined Effects of Positive Behavior Support, Medication and Academic Accommodation for Children With ADHD
- ClinicalTrials.gov ID
- NCT05469386
- Acronym / sponsor ID
- 800013424
- Conditions
- ADHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 21 Jul 2022 (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.
This study is the first to systematically evaluate the efficacy of single and combined academic accommodation, behavioral treatment, and medication treatment in a large sample of children with ADHD. Using a scientifically rigorous, cross-over design the impact of these approaches on ecologically valid measures of outcome (on-task behavior, quiz scores, academic productivity) will be assessed to inform effective school intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Behavioral: Behavioral classroom, Behavioral: General Classroom, Behavioral: Academic AccommodationsPlacebo capsule administered in the morning |
| Methylphenidate ER (.3 mg/kg dose) | Experimental | Behavioral: Behavioral classroom, Behavioral: General Classroom, Behavioral: Academic AccommodationsMethylphenidate ER (.3 mg/kg dose)administered in the morning |
| General Classroom | Active comparator | Drug: Methylphenidate Hydrochloride ER, Drug: Placebo, Behavioral: Academic AccommodationsGeneral classroom procedures |
| Positive Behavior Support Classroom | Experimental | Drug: Methylphenidate Hydrochloride ER, Drug: Placebo, Behavioral: Academic AccommodationsPositive Behavior Support Classroom procedures |
| Academic accommodations | Experimental | Drug: Methylphenidate Hydrochloride ER, Behavioral: Behavioral classroom, Drug: Placebo, Behavioral: General ClassroomAcademic accommodations are used during seat work and quiz |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ADHD Diagnosis
- IQ >= 70
Key exclusion criteria (3 listed)
- Prior adverse reaction to methylphenidate
- Autism Spectrum disorder level 2/3
- Child is home schooled
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 |
|---|---|---|
| Methylphenidate Hydrochloride ERMethylphenidate Hydrochloride ER (.3 mg/kg dose q.d.) | Drug | Academic accommodations, General Classroom, Positive Behavior Support Classroom |
| Behavioral classroomEnhanced positive behavior supports implemented in classroom | Behavioural | Academic accommodations, Methylphenidate ER (.3 mg/kg dose), Placebo |
| PlaceboPlacebo capsule | Drug | Academic accommodations, General Classroom, Positive Behavior Support Classroom |
| General ClassroomGeneral education classroom procedures | Behavioural | Academic accommodations, Methylphenidate ER (.3 mg/kg dose), Placebo |
| Academic AccommodationsAccommodations are introduced to support the child's independent seat work completion and quiz scores | Behavioural | General Classroom, Methylphenidate ER (.3 mg/kg dose), Placebo, Positive Behavior Support Classroom |
Primary outcome
Behavioral frequency count of rule violations
Time frame: Through study completion, a maximum of eight weeks
Behavioral frequency count of rule violations. Lower scores are better.
Seatwork completion
Time frame: Through study completion, a maximum of eight weeks
Percentage of assigned seat work items completed correctly. Range of scores is from 0-100%. Higher scores are better.
Quiz Scores
Time frame: Through study completion, a maximum of eight weeks
Percentage correct out of 10 quiz questions. Range of scores is from 0-100%. Higher scores are better.
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 27 Aug 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate Hydrochloride ER, Behavioral classroom and General Classroom in people with ADHD, run by Florida International University at 2 sites in United States.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral frequency count of rule violations (time frame: Through study completion, a maximum of eight weeks). 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 27 Aug 2025.