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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: Recruiting Phase 4 study of Attention Deficit Hyperactivity Disorder and Problem Behavior, sponsored by Matthew J O'Brien, PhD, BCBA-D.

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 217-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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

Interventions

  • DRUG Stimulant

Study Locations (1)

Iowa

  • University of Iowa Hospitals and Clinics - Iowa City

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2018-10-01
Est. Completion 2027-08-01
Phase Phase 4
Matthew J O'Brien, PhD, BCBA-D

2 total trials

What NCT03420339 shows while recruiting

NCT03420339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 217-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (95% lower).

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 a single indexed study location in 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.

Similar trials for Attention Deficit Hyperactivity Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03420339's enrollment target sits among peer trials

10 102nd of 102 higher than 1 of 102 other Attention Deficit Hyperactivity Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03420339, the US trial registry maintained by the National Library of Medicine. NCT03420339 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.