Effects of stimulant medication on disruptive behavior in children with ADHD

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

This study tests how stimulant medication affects disruptive behavior, preferences, and impulse control in children and teens with ADHD.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 48 Months to 12 Years
• Sex: All
• Sponsor: University of Iowa (Academic / other)
• Locations: 1 site (Iowa City, Iowa)
• Trial ID: NCT03420339 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 4 to 13 years with a diagnosis of ADHD who exhibit disruptive behaviors.

Not a fit: Patients who do not have a diagnosis of ADHD or do not exhibit disruptive behaviors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for managing disruptive behaviors in children with ADHD.

How similar studies have performed: Previous studies have shown that stimulant medications can effectively reduce disruptive behaviors in children with ADHD, supporting the relevance of this approach.

Eligibility criteria

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 this trial is running

Iowa City, Iowa

• 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

Conditions Attention Deficit Hyperactivity Disorder; Problem Behavior; stimulant medication; behavioral function; preferences; delay discounting