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

NCT ID: NCT05469386

Last Updated: 2025-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-13

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo capsule administered in the morning

Group Type PLACEBO_COMPARATOR

Behavioral classroom

Intervention Type BEHAVIORAL

Enhanced positive behavior supports implemented in classroom

General Classroom

Intervention Type BEHAVIORAL

General education classroom procedures

Academic Accommodations

Intervention Type BEHAVIORAL

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

Methylphenidate ER (.3 mg/kg dose)

Methylphenidate ER (.3 mg/kg dose)administered in the morning

Group Type EXPERIMENTAL

Behavioral classroom

Intervention Type BEHAVIORAL

Enhanced positive behavior supports implemented in classroom

General Classroom

Intervention Type BEHAVIORAL

General education classroom procedures

Academic Accommodations

Intervention Type BEHAVIORAL

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

General Classroom

General classroom procedures

Group Type ACTIVE_COMPARATOR

Methylphenidate Hydrochloride ER

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo capsule

Academic Accommodations

Intervention Type BEHAVIORAL

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

Positive Behavior Support Classroom

Positive Behavior Support Classroom procedures

Group Type EXPERIMENTAL

Methylphenidate Hydrochloride ER

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo capsule

Academic Accommodations

Intervention Type BEHAVIORAL

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

Academic accommodations

Academic accommodations are used during seat work and quiz

Group Type EXPERIMENTAL

Methylphenidate Hydrochloride ER

Intervention Type DRUG

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

Behavioral classroom

Intervention Type BEHAVIORAL

Enhanced positive behavior supports implemented in classroom

Placebo

Intervention Type DRUG

Placebo capsule

General Classroom

Intervention Type BEHAVIORAL

General education classroom procedures

Interventions

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Methylphenidate Hydrochloride ER

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

Intervention Type DRUG

Behavioral classroom

Enhanced positive behavior supports implemented in classroom

Intervention Type BEHAVIORAL

Placebo

Placebo capsule

Intervention Type DRUG

General Classroom

General education classroom procedures

Intervention Type BEHAVIORAL

Academic Accommodations

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* ADHD Diagnosis
* IQ \>= 70

Exclusion Criteria

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

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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FIU Center for Childern and Families

Miami, Florida, United States

Site Status

Center for Children and Families

Amherst, New York, United States

Site Status

Countries

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United States

Other Identifiers

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800013424

Identifier Type: -

Identifier Source: org_study_id

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