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NCT03420339 · ClinicalTrials.gov registry record · Phase 4
Stimulant Effects on Disruptive Behavior
A Phase 4 study of Attention Deficit Hyperactivity Disorder and Problem Behavior, sponsored by Matthew J O'Brien, PhD, BCBA-D.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03420339 is a Phase 4 study of Attention Deficit Hyperactivity Disorder and Problem Behavior that is actively recruiting participants, run by Matthew J O'Brien, PhD, BCBA-D. The registered enrollment target is 10 participants, below the 207-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03420339, a Phase 4 study of Attention Deficit Hyperactivity Disorder and Problem Behavior, is actively recruiting participants, sponsored by Matthew J O'Brien, PhD, BCBA-D.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Conditions Studied
Interventions
- DRUG Stimulant
Study Locations (1)
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2027-08-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03420339
The ClinicalTrials.gov registry entry for NCT03420339 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (95% lower). The listed sponsor is Matthew J O'Brien, PhD, BCBA-D, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 1 intervention - of which Stimulant is the first listed.
NCT03420339 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT03420339 about?
NCT03420339 is a clinical study titled "Stimulant Effects on Disruptive Behavior". 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 behavior...
What is the current status of trial NCT03420339?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2018-10-01. Estimated completion is 2027-08-01.
What conditions does trial NCT03420339 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder, Problem Behavior.
What interventions are being tested in trial NCT03420339?
The interventions under investigation include: Stimulant (DRUG).
Who is sponsoring clinical trial NCT03420339?
This trial is sponsored by Matthew J O'Brien, PhD, BCBA-D, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03420339 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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