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

Florida International University (FIU)

Status and phase: Enrolling; Phase 4

Conditions: ADHD

Treatments: Behavioral: General Classroom; Behavioral: Academic Accommodations; Drug: Methylphenidate Hydrochloride ER; Drug: Placebo; Behavioral: Behavioral classroom

Study type: Interventional

Funder types: Other

Identifiers

NCT05469386

800013424

Details and patient eligibility

About

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.

Enrollment: 288 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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288 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo capsule administered in the morning

Treatment:

Behavioral: General Classroom

Behavioral: Academic Accommodations

Behavioral: Behavioral classroom

Methylphenidate ER (.3 mg/kg dose)

Experimental group

Description:

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

Treatment:

Behavioral: General Classroom

Behavioral: Academic Accommodations

Behavioral: Behavioral classroom

General Classroom

Active Comparator group

Description:

General classroom procedures

Treatment:

Drug: Placebo

Behavioral: Academic Accommodations

Drug: Methylphenidate Hydrochloride ER

Positive Behavior Support Classroom

Experimental group

Description:

Positive Behavior Support Classroom procedures

Treatment:

Drug: Placebo

Behavioral: Academic Accommodations

Drug: Methylphenidate Hydrochloride ER

Academic accommodations

Experimental group

Description:

Academic accommodations are used during seat work and quiz

Treatment:

Behavioral: General Classroom

Drug: Placebo

Behavioral: Behavioral classroom

Drug: Methylphenidate Hydrochloride ER