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

Primary Purpose

ADHD

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate Hydrochloride ER
Behavioral classroom
Placebo
General Classroom
Academic Accommodations
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • FIU Center for Childern and FamiliesRecruiting
  • Center for Children and FamiliesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Active Comparator

Experimental

Experimental

Arm Label

Placebo

Methylphenidate ER (.3 mg/kg dose)

General Classroom

Positive Behavior Support Classroom

Academic accommodations

Arm Description

Placebo capsule administered in the morning

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

General classroom procedures

Positive Behavior Support Classroom procedures

Academic accommodations are used during seat work and quiz

Outcomes

Primary Outcome Measures

Behavioral frequency count of rule violations
Behavioral frequency count of rule violations. Lower scores are better.
Seatwork completion
Percentage of assigned seat work items completed correctly. Range of scores is from 0-100%. Higher scores are better.
Quiz Scores
Percentage correct out of 10 quiz questions. Range of scores is from 0-100%. Higher scores are better.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2022
Last Updated
August 3, 2023
Sponsor
Florida International University
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1. Study Identification

Unique Protocol Identification Number
NCT05469386
Brief Title
Single and Combined Effects of Behavioral, Academic, and Medication Treatments for ADHD in the Classroom
Official Title
Single and Combined Effects of Positive Behavior Support, Medication and Academic Accommodation for Children With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule administered in the morning
Arm Title
Methylphenidate ER (.3 mg/kg dose)
Arm Type
Experimental
Arm Description
Methylphenidate ER (.3 mg/kg dose)administered in the morning
Arm Title
General Classroom
Arm Type
Active Comparator
Arm Description
General classroom procedures
Arm Title
Positive Behavior Support Classroom
Arm Type
Experimental
Arm Description
Positive Behavior Support Classroom procedures
Arm Title
Academic accommodations
Arm Type
Experimental
Arm Description
Academic accommodations are used during seat work and quiz
Intervention Type
Drug
Intervention Name(s)
Methylphenidate Hydrochloride ER
Intervention Description
Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.)
Intervention Type
Behavioral
Intervention Name(s)
Behavioral classroom
Intervention Description
Enhanced positive behavior supports implemented in classroom
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule
Intervention Type
Behavioral
Intervention Name(s)
General Classroom
Intervention Description
General education classroom procedures
Intervention Type
Behavioral
Intervention Name(s)
Academic Accommodations
Intervention Description
Accommodations are introduced to support the child's independent seat work completion and quiz scores
Primary Outcome Measure Information:
Title
Behavioral frequency count of rule violations
Description
Behavioral frequency count of rule violations. Lower scores are better.
Time Frame
Through study completion, a maximum of eight weeks
Title
Seatwork completion
Description
Percentage of assigned seat work items completed correctly. Range of scores is from 0-100%. Higher scores are better.
Time Frame
Through study completion, a maximum of eight weeks
Title
Quiz Scores
Description
Percentage correct out of 10 quiz questions. Range of scores is from 0-100%. Higher scores are better.
Time Frame
Through study completion, a maximum of eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ADHD Diagnosis IQ >= 70 Exclusion Criteria: Prior adverse reaction to methylphenidate Autism Spectrum disorder level 2/3 Child is home schooled
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory A Fabiano
Phone
716-359-7823
Email
gfabiano@fiu.edu
Facility Information:
Facility Name
FIU Center for Childern and Families
City
Miami
State/Province
Florida
ZIP/Postal Code
33199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William E Pelham, PhD
Facility Name
Center for Children and Families
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregory A Fabiano, PhD
Phone
716-359-7823
Email
gfabiano@fiu.edu
First Name & Middle Initial & Last Name & Degree
Devon Tower
Phone
716-359-7500
Email
dtower@fiu.edu

12. IPD Sharing Statement

Learn more about this trial

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

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