Stimulant Effects on Disruptive Behavior

Launched by MATTHEW J O'BRIEN, PHD, BCBA-D · Feb 1, 2018

Keywords

ClinConnect Summary

This clinical trial, titled "Stimulant Effects on Disruptive Behavior," is studying how stimulant medications affect disruptive behaviors in children and adolescents diagnosed with Attention Deficit Hyperactivity Disorder (AD/HD). The main aim is to see how these medications influence children's choices, preferences for activities, and the reasons behind their disruptive behavior. To participate, children must be between 4 and 12 years old, have an AD/HD diagnosis, and show specific disruptive behaviors, such as aggression, self-injury, or noncompliance.

Participants will attend a total of eight visits where they will alternate between taking their prescribed stimulant medication and not taking it. During these visits, they will engage in assessments to evaluate their preferences for activities and how well they can control their impulses. This study is an important step in understanding how stimulant medications can help manage disruptive behaviors in children with AD/HD.

Gender

ALL

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.