Actively Recruiting

Phase 4
Age: 48Months - 12Years
All Genders
Healthy Volunteers
NCT03420339

Stimulant Effects on Disruptive Behavior

Led by Matthew J O'Brien, PhD, BCBA-D · Updated on 2025-03-17

10

Participants Needed

1

Research Sites

460 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this study is to determine the effects of stimulant medication on disruptive behavior, function, preference and choice; however, it is primarily methodological and will add to current research by establishing an effective evaluation of the impact of stimulant medication on these behaviors. Three behavior assessments for children and adolescents diagnosed with AD/HD who exhibit disruptive behavior will be conducted: 1. Preference assessments will be conducted to determine whether preference for social and nonsocial items and activities differs under medication and non-medication conditions. 2. Functional analyses will be conducted to determine whether stimulant medication has an effect on the frequency and function or purpose of disruptive behavior. 3. Choice assessments will be conducted to evaluate the impact of stimulant medication on impulse control/delay discounting. This study will be conducted in three phases. For each of the 5 to 10 participants there will be 8 total visits. The first 4 visits will entail a preference assessment, followed by a functional analysis. On visits 1 and 3, the participant will be asked to take his/her stimulant medication as is typically done; however, on visits 2 and 4, the participant will be asked to refrain from taking the medication. For visits 5-8, participants will continue to participate in preference assessments, but will also be presented with a choice arrangement with work and play. In the choice arrangement, participants will be given four work cards and four play cards that they can organize in any order. Work cards will be associated with a brief academic task and play cards will be associated with a brief play period using high-preferred toys/activities. On visits 5 and 7 the participant will be asked to take his or her stimulant medication as usual, while on visits 6 and 8 the participant will be asked to refrain from taking his or her medication.

CONDITIONS

Official Title

Stimulant Effects on Disruptive Behavior

Who Can Participate

Age: 48Months - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child or adolescent aged between 4 years 0 months and 12 years 11 months
  • Valid diagnosis of attention deficit/hyperactivity disorder (AD/HD)
  • Exhibits disruptive behavior, including physical or verbal aggression, self-injury, destruction of property, noncompliance, tantrums, or diagnosis of disruptive behavior disorder or oppositional defiant disorder
  • Currently prescribed a stimulant medication at an age-appropriate dose
Not Eligible

You will not qualify if you...

  • Diagnosis of autism, conduct disorder, or moderate to profound intellectual disability
  • Taking a stimulant dosage outside the recommended therapeutic range

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242

Actively Recruiting

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Research Team

M

Matthew J O'Brien, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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