Stimulant Effects on Disruptive Behavior
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age48-12
SponsorMatthew J O'Brien, PhD, BCBA-D
About this trial
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 research by establishing an effective evaluation of the impact of stimulant medication on these behaviors. Three behavior assessments for children and adolescents diagnosed with AD/HD who exhibit disruptive behavior will be conducted:
1. Preference assessments will be conducted to determine whether preference for social and nonsocial items and activities differs under medication and non-medication conditions. 2. Functional analyses will be conducted to determine whether stimulant medication has an effect on the frequency and function or purpose of disruptive behavior. 3. Choice assessments will be conducted to evaluate the impact of stimulant medication on impulse control/delay discounting.
This study will be conducted in three phases. For each of the 5 to 10 participants there will be 8 total visits. The first 4 visits will entail a preference assessment, followed by a functional analysis. On visits 1 and 3, the participant will be asked to take his/her stimulant medication as is typically done; however, on visits 2 and 4, the participant will be asked to refrain from taking the medication.
For visits 5-8, participants will continue to participate in preference assessments, but will also be presented with a choice arrangement with work and play. In the choice arrangement, participants will be given four work cards and four play cards that they can organize in any order. Work cards will be associated with a brief academic task and play cards will be associated with a brief play period using high-preferred toys/activities. On visits 5 and 7 the participant will be asked to take his or her stimulant medication as usual, while on visits 6 and 8 the participant will be asked to refrain from taking his or her medication.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Stimulant
DrugThe stimulants used must meet FDA dosage guidelines for age.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Subjects on stimulant medicationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Behavioral Function
Data will be collected and graphed on the frequency (rate per minute) of problem behavior. Visual inspection of graphs will determine differentiation across the four conditions (three test conditions and the freeplay/control condition) to identify the function(s) of the target behavior. Changes in behavioral function will be determined by comparing data week to week for the first four weeks. Behavioral function while on medication, which will occur at week one and week three will be compared to behavioral function at week two and week four. Differences between weeks one and three and weeks two and four will be considered as change in behavioral function.
Time frame
Weekly (at each visit): week 1, week 2, week 3, week 4; Change in behavioral function will be compared using data from weeks one and three (on medication) versus weeks two and four (off medication).2
Change in Item Preference
Data on change in item preference will be collected week to week for all eight weeks. We will determine preference for an item/activity based upon the duration of time engaged with an item in the therapy room during the free operant preference assessment. Data will be compared week to week, with a focus on changes from weeks one, three, five, and seven (on medication) to weeks two, four, six, and eight (off medication). Differences in item engagement will indicate difference in item preference.
Time frame
Weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8; we will compare data from weeks 1, 3, 5, and 7 (on medication) versus weeks 2, 4, 6, and 8 (off medication)3
Change in Preference for Social and Non-Social Activities
Data will be collected on the percentage of trials an activity is selected and whether it was selected with attention or without attention for each item/activity in the therapy room of the multiple stimulus without replacement assessment. Preference for social versus non-social activities will be determined by the participant's selection during the multiple stimulus without replacement assessment. The change in preference for activities with attention and activities without attention will be determined by comparing data weekly, with a focus on differences between data in weeks 1, 3, 5, and 7 (on medication) versus weeks 2, 4, 6, and 8 (off medication).
Time frame
Weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8; Changes in preference will be determined weekly, with a focus on differences between time points on medication and weeks off of medication.4
Changes in Impulsivity in Choice-Making
Data will be collected on the sequence chosen by the subject and scored based upon the degree to which work sessions were placed up front and play activities were placed at the end. Choices whereby play activities are front loaded (i.e., more play activities earlier in the schedule) will be scored as more impulsive on a point system and choices whereby work activities are front loaded (i.e., more work activities earlier in the schedule) will be scored as less impulsive. Differences in impulsivity will be determined on a week to week basis, with a focus on differences between weeks on medication (weeks 5 and 7) and weeks off of medication (weeks 6 and 8).
Time frame
Weekly (at each visit): week 5, week 6, week 7, week 8Secondary outcomes
1
Rate of Problem Behavior
Data will be collected in all assessment sessions on the rate of problem behavior and compared for sessions on medication and sessions off medication.
Time frame
Weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 82
Item Engagement
Data will be collected in all assessment sessions involving play with items/activities on item engagement and compared for sessions on medication and sessions off medication.
Time frame
Weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 83
Compliance
Data will be collected on compliance to demands for all sessions involving work. Data will be compared for sessions sessions on medication and sessions off medication.
Time frame
Weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Matthew J O'Brien, PhD, BCBA-D
Lead sponsor
University of Iowa
Sponsor institution
Source ClinicalTrials.gov