Status:
RECRUITING
Stimulant Effects on Disruptive Behavior
Lead Sponsor:
Matthew J O'Brien, PhD, BCBA-D
Conditions:
Attention Deficit Hyperactivity Disorder
Problem Behavior
Eligibility:
All Genders
48-12 years
Phase:
PHASE4
Brief Summary
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 rese...
Detailed Description
This study includes the consent, a pre-visit interview, and two assessment phases occurring at weekly visits. Phase I includes four visits, each lasting approximately 2 hours. Phase II includes four v...
Eligibility Criteria
Inclusion
- 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).
- 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.
- Participant must exhibit disruptive behavior, defined as one or more of the following:
- 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.
- self-injury: Hitting self, biting self, banging head on an object/hard surface, pinching self, or scratching self with visual skin damage.
- 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.)
- 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.
- 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.
- an active diagnosis of disruptive behavior disorder or oppositional defiant disorder.
- Participant must already be prescribed a stimulant medication for the treatment of AD/HD symptoms and at an approved dose for age.
Exclusion
- a diagnosis of autism, conduct disorder, or intellectual disability in the moderate, severe or profound range.
- prescribed or taking a stimulant dosage outside of recommended therapeutic range.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03420339
Start Date
October 1 2018
End Date
August 1 2027
Last Update
March 17 2025
Active Locations (1)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242