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

Sponsor

Florida International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05469386

Collaborator

(none)

288

Enrollment

Locations

Arms

50.6

Anticipated Duration (Months)

144

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
ADHD	Drug: Methylphenidate Hydrochloride ER Behavioral: Behavioral classroom Drug: Placebo Behavioral: General Classroom Behavioral: Academic Accommodations	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

288 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 13, 2022

Anticipated Primary Completion Date :

Aug 31, 2025

Anticipated Study Completion Date :

Aug 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo capsule administered in the morning	Behavioral: Behavioral classroom Enhanced positive behavior supports implemented in classroom Behavioral: General Classroom General education classroom procedures Behavioral: Academic Accommodations Accommodations are introduced to support the child's independent seat work completion and quiz scores
Experimental: Methylphenidate ER (.3 mg/kg dose) Methylphenidate ER (.3 mg/kg dose)administered in the morning	Behavioral: Behavioral classroom Enhanced positive behavior supports implemented in classroom Behavioral: General Classroom General education classroom procedures Behavioral: Academic Accommodations Accommodations are introduced to support the child's independent seat work completion and quiz scores
Active Comparator: General Classroom General classroom procedures	Drug: Methylphenidate Hydrochloride ER Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.) Drug: Placebo Placebo capsule Behavioral: Academic Accommodations Accommodations are introduced to support the child's independent seat work completion and quiz scores
Experimental: Positive Behavior Support Classroom Positive Behavior Support Classroom procedures	Drug: Methylphenidate Hydrochloride ER Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.) Drug: Placebo Placebo capsule Behavioral: Academic Accommodations Accommodations are introduced to support the child's independent seat work completion and quiz scores
Experimental: Academic accommodations Academic accommodations are used during seat work and quiz	Drug: Methylphenidate Hydrochloride ER Methylphenidate Hydrochloride ER (.3 mg/kg dose q.d.) Behavioral: Behavioral classroom Enhanced positive behavior supports implemented in classroom Drug: Placebo Placebo capsule Behavioral: General Classroom General education classroom procedures

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FIU Center for Childern and Families	Miami	Florida	United States	33199
2	Center for Children and Families	Amherst	New York	United States	14226

Sponsors and Collaborators

Florida International University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Florida International University

ClinicalTrials.gov Identifier:

NCT05469386

Other Study ID Numbers:

800013424

First Posted:

Jul 21, 2022

Last Update Posted:

Jul 21, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Methylphenidate

Study Results

No Results Posted as of Jul 21, 2022