Effects of stimulant medication on disruptive behavior in children with ADHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate how stimulant medication influences disruptive behavior, preferences, and impulse control in children and adolescents diagnosed with ADHD. It involves a series of behavioral assessments conducted over multiple visits, including preference assessments to gauge interest in activities, functional analyses to observe the effects of medication on disruptive behavior, and choice assessments to measure impulse control. The study is designed to provide a methodological framework for understanding the impact of stimulant medication on these behaviors. Participants will undergo assessments both with and without medication to compare results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant must be a child or adolescent between the ages of 4 years, 0 months, and 13 years, 0 months (participants must not be older than 12 years, 11 months).
2. Participant must have a valid diagnosis of attention deficit/hyperactivity disorder (AD/HD). No specification of type (e.g., predominately inattentive type, predominately hyperactive-impulsive type, or combined type) will be necessary.
3. Participant must exhibit disruptive behavior, defined as one or more of the following:

   1. physical or verbal aggression towards others: Hitting, kicking, biting, scratching, choking, spitting at, or throwing items at another person, and/or making insults, threats, or swearing at another person.
   2. self-injury: Hitting self, biting self, banging head on an object/hard surface, pinching self, or scratching self with visual skin damage.
   3. destruction: Damaging (or attempts to damage) personal or public property (e.g., breaking an object into two or more pieces, using an object to break other objects, ripping objects or parts of objects from walls, floors, or furniture, and denting cars, objects, or walls.)
   4. noncompliance:Regular occurrence of verbal refusal (e.g., saying "no", "I don't want to", "I won't do it" or "not now") to any academic or non-academic request, and/or any response that does not match the delivered instruction within 30 seconds from the time the instruction was delivered.
   5. tantrum:Crying (i.e., any vocalizations \[sounds or words\] accompanied by facial contraction with and without tears for any period of time) and/or screaming (occurrence of vocalizations above normal conversational volume for any period of time), with or without body flailing.
   6. an active diagnosis of disruptive behavior disorder or oppositional defiant disorder.
4. Participant must already be prescribed a stimulant medication for the treatment of AD/HD symptoms and at an approved dose for age.

Exclusion Criteria:

1. a diagnosis of autism, conduct disorder, or intellectual disability in the moderate, severe or profound range.
2. prescribed or taking a stimulant dosage outside of recommended therapeutic range.

Where it's running

• University of Iowa Hospitals and Clinics
  Iowa City, Iowa, United States Recruiting

Study contacts

• Principal investigator: Matthew J O'Brien, PhD — University of Iowa
• Study coordinator: Matthew J O'Brien, PhD
• Email: matthew-j-obrien@uiowa.edu
• Phone: 319.384.9827

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.