Actively Recruiting

Phase 4
Age: 48Months - 12Years
All Genders
Healthy Volunteers
ID03420339

The Effects of Stimulant Medication on Disruptive Behavior, Choice, and Preference in Children and Adolescents Exhibiting Disruptive Behavior

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

10

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of stimulant medication on disruptive behavior, function, preference, and choice in children and adolescents diagnosed with attention deficit hyperactivity disorder (AD/HD) who exhibit disruptive behavior. The study aims to improve methods for assessing how stimulant medication influences these behaviors by conducting three types of behavior assessments: preference assessments, functional analyses, and choice assessments. This trial is primarily methodological and involves a small group of 5 to 10 participants. The study is divided into three phases with a total of eight visits. During visits 1 to 4, participants undergo preference assessments and functional analyses, alternating between taking their prescribed stimulant medication and refraining from it. Visits 5 to 8 continue with preference assessments and introduce a choice arrangement where participants organize work and play activities using picture cards. Medication is taken on visits 1, 3, 5, and 7, and withheld on visits 2, 4, 6, and 8. Each visit includes specific tasks such as academic work, play periods, and behavioral observations. Participants will be involved in assessments lasting 1 to 2 hours per visit over eight weekly visits. Data collected include engagement with items and activities, frequency and function of disruptive behavior, choice-making, compliance, and impulsivity. Researchers will use computer software to record and analyze behavior during therapy room sessions. Outcome measures focus on changes in behavioral function, item preference, social and nonsocial activity preferences, and impulsivity, comparing periods on and off medication. The study also monitors problem behavior rates and task compliance throughout the visits.

CONDITIONS

Brief Title

Stimulant Effects on Disruptive Behavior

Who Can Participate

Age: 48Months - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant must be a child or adolescent between 4 years, 0 months and 12 years, 11 months old.
  • Participant must have a valid diagnosis of attention deficit/hyperactivity disorder (AD/HD).
  • Participant must show disruptive behavior such as physical or verbal aggression, self-injury, destruction, noncompliance, tantrums, or have a diagnosis of disruptive behavior disorder or oppositional defiant disorder.
  • Participant must be prescribed stimulant medication at an age-appropriate dose for AD/HD treatment.
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for consent and eligibility review; interview may occur at consent or separately

Treatment

Duration - 8 weeks

Participants undergo two phases of assessments involving stimulant medication and withholding medication on alternating visits to evaluate behavior, preferences, and impulsivity.

Eight weekly visits; visits 1, 3, 5, and 7 with medication, visits 2, 4, 6, and 8 without medication

Trial Site Locations

Total: 1 location

1

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242

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Research Team

M

Matthew J O'Brien, PhD

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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