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

Florida International University (FIU) logo

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

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

Trial contacts and locations

2

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Central trial contact

Gregory A Fabiano

Data sourced from clinicaltrials.gov

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