Stimulant Effects on Disruptive Behavior

NCT03420339 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 201709737
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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. 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. 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. 3.Choice assessments will be conducted to evaluate the impact of stimulant medication on impulse control/delay discounting.

Conditions

Attention Deficit Hyperactivity Disorder; Problem Behavior

Keywords

stimulant medication; behavioral function; preferences; delay discounting

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

• 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.

  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)

• 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).

  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.

• 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).

  Weekly (at each visit): week 5, week 6, week 7, week 8

Secondary Outcomes (3)

• Rate of Problem Behavior

  Weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8

• Item Engagement

  Weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8

• Compliance

  Weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8

Study Arms (1)

Subjects on stimulant medication

EXPERIMENTAL

All participants: Children and adolescents diagnosed with AD/HD, displaying disruptive behavior, and taking stimulant medication.

Drug: Stimulant

Interventions

Stimulant DRUG

The stimulants used must meet FDA dosage guidelines for age.

Also known as: Adderall, Concerta, Aptensio, Daytrana, Metadate, Quillivant, Ritalin, Focalin, Vyvanse

Subjects on stimulant medication

Eligibility Criteria

• Age: 48 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Matthew J O'Brien, PhD, BCBA-D: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Problem Behavior

Interventions

Central Nervous System Stimulants; Adderall; Methylphenidate; Dexmethylphenidate Hydrochloride; Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines

Study Officials

• Matthew J O'Brien, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew J O'Brien, PhD

CONTACT

319.384.9827; matthew-j-obrien@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: In this study all participants will participate in behavioral assessments (i.e., preference assessments, functional analysis, choice assessments) while taking a stimulant medication and without taking a stimulant medication. All participants will experience the same protocol.

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 5, 2018
• Study Start: October 1, 2018
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)