Single and Combined Effects of Behavioral, Academic, and Medication Treatments for ADHD in the Classroom

Single and Combined Effects of Positive Behavior Support, Medication and Academic Accommodation for Children With ADHD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05469386

Enrollment

288

Registered

2022-07-21

Start date

2022-06-13

Completion date

2026-08-31

Last updated

2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Brief 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. 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.

Interventions

DRUGMethylphenidate Hydrochloride ER

Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)

BEHAVIORALBehavioral classroom

Enhanced positive behavior supports implemented in classroom

DRUGPlacebo

Placebo capsule

BEHAVIORALGeneral Classroom

General education classroom procedures

BEHAVIORALAcademic Accommodations

Accommodations are introduced to support the child's independent seat work completion and quiz scores

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 12 Years

Healthy volunteers

Inclusion criteria

* ADHD Diagnosis * IQ \>= 70

Exclusion criteria

* Prior adverse reaction to methylphenidate * Autism Spectrum disorder level 2/3 * Child is home schooled

Design outcomes

Primary

Measure	Time frame	Description
Behavioral frequency count of rule violations	Through study completion, a maximum of eight weeks	Behavioral frequency count of rule violations. Lower scores are better.
Seatwork completion	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	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026