Recruiting

Stimulant Effects

Sponsor:

Matthew J O'Brien, PhD, BCBA-D

Code:

NCT03420339

Conditions

Attention Deficit Hyperactivity Disorder

Problem Behavior

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Accepted

Interventions

Stimulant

Study Details

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. 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

Attention Deficit Hyperactivity Disorder

Problem Behavior

Study ID

NCT03420339

Start date

Oct 1, 2018

Status verified date

Mar, 2025

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 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).
2. 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.
3. Participant must exhibit disruptive behavior, defined as one or more of the following:

1. 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.
2. self-injury: Hitting self, biting self, banging head on an object/hard surface, pinching self, or scratching self with visual skin damage.
3. 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.)
4. 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.
5. 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.
6. an active diagnosis of disruptive behavior disorder or oppositional defiant disorder.
4. Participant must already be prescribed a stimulant medication for the treatment of AD/HD symptoms and at an approved dose for age.

Exclusion Criteria:

1. a diagnosis of autism, conduct disorder, or intellectual disability in the moderate, severe or profound range.
2. prescribed or taking a stimulant dosage outside of recommended therapeutic range.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Subjects on stimulant medication

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

Interventions

Stimulant

The stimulants used must meet FDA dosage guidelines for age.

Primary outcome measure

  • 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). ]
  • Change 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) ]
  • Change in Preference for Social and Non-Social Activities [ 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. ]
  • Changes in Impulsivity in Choice-Making [ Time Frame: Weekly (at each visit): week 5, week 6, week 7, week 8 ]

Central Contacts and Locations

Central contacts

Matthew J O'Brien, PhD

319.384.9827matthew-j-obrien@uiowa.edu

Locations

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Matthew J. O'Brien, PhD

319.384.9827matthew-j-obrien@uiowa.edu

Lane Strathearn, MBBS, PhD

319.356.7044lane-strathearn@uiowa.edu

More Information

Sponsor

Matthew J O'Brien, PhD, BCBA-D

Last update posted

Mar 17, 2025

Last verified

Mar, 2025

Keywords

  • stimulant medication
  • behavioral function
  • preferences
  • delay discounting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Matthew J O'Brien, PhD, BCBA-D on 2025-03-17.