Stimulant Effects on Disruptive Behavior

This study includes the consent, a pre-visit interview, and two assessment phases occurring
at weekly visits. Phase I includes four visits, each lasting approximately 2 hours. Phase II
includes four visits, each lasting approximately 1 hour. The following are the description of
the consent, pre-visit, and Phases I and II:

Consenting:

A research team member will review eligibility criteria and study procedures with a
prospective subject prior to requesting consent. Following consent, an interview will occur
by phone or in person. If the caregiver desires, the interview may take place on the same
visit as the consent (but following obtaining consent). In relation to the medication,
withholding the medication will not occur until the second assessment visit (following the
initial review and consent visit and also the interview).

Pre-Visit Interview:

If the interview is not conducted at the time of consent, it will be conducted either (a) at
the first assessment visit, (b) by phone prior to the first visit or (c) in person prior to
the first visit. The interview is standardized and gathers information on the subject's
demographics, diagnosis/es, medications and stimulant medication history, disruptive
behaviors and contexts, preferred items/activities, and common demands.

Phase I (visits 1, 2, 3,& 4):

Phase I of the study includes four visits total. Each visit will be conducted in the same
manner and include three stages: (1) a free operant preference assessment, (2) a multiple
stimulus without replacement preference assessment, and (3) three sessions of each test
condition in a functional analysis. On visits 1 and 3 the subject will take his or her
stimulant medication as expected before beginning the assessment procedures. Medications
expected to have a delayed onset of action (e.g., Daytrana patch) will require the subject to
take the medication greater than 60 minutes before the start of the assessments. On visits 2
and 4, the subject will withhold medication for the period he or she is completing the three
stages. All data collection will be done using DataPal computer scoring software in the
observation area of the therapy room. Each of these assessments is described next:

Stage 1: Free Operant Preference Assessment Upon arrival, the subject will enter the therapy
room with a research team member, referred to as "researcher" henceforth. The therapy room
will have no more than 10 items/activities, including up to 6 items/activities identified by
the caregiver as "preferred", up to 2 items/activities selected by the researcher as
potentially preferred, and up to 2 items/activities identified by the caregivers as neutral
or "non preferred". The researcher will inform the subject that he or she may play with any
of the items/activities within the therapy room. The researcher will make available his or
her attention for the entirety of this portion of the assessment. No demands will be given to
the subject and no consequences will be given for disruptive behavior. Data will be collected
on the duration of item/activity engagement by the subject for each item/activity in the
therapy room. This assessment will last 10 minutes. Items/activities with the greatest
duration of engagement will be considered the highest preferred.

Stage 2: Multiple Stimulus Without Replacement within a Concurrent Operants Design Following
the free operant preference assessment, 6 items/activities will be selected for another
preference assessment. These items/activities will be available with and without attention.
This preference assessment will be conducted in the same therapy room by the same researcher
as the previous preference assessment. The assessment will begin by asking the subject to
choose his or her most preferred item/activity to play with and with or without attention.
The subject will be allowed 2 minutes with the item/activity and then it will be removed from
the array. The subject will choose the next preferred item/activity with or without attention
for another 2 minutes before removing that item/activity. This will continue until all
items/activities have been selected (approximately 15 minutes). Data will be collected on the
order of selection, attention or no attention, and engagement during the 2 minutes of access
to each respective item/activity.

Stage 3: Functional Analysis of Problem Behavior

Following the preference assessments in Stages 1 and 2, a functional analysis of problem
behavior will be conducted to determine the function(s) of the subject's problem behaviors.
Disruptive behaviors will be deemed "target behaviors" for the functional analysis. All
sessions of the functional analysis will be conducted by the researcher in the same therapy
room as the previous two phases. Each session will last 5 minutes total, with 3 sessions for
each test condition and 3 free play sessions. This results in a total of 12, 5-minute
sessions, which may last between 75 to 90 minutes total. The order of conditions will be
randomized for each round (i.e., one test of each condition and a free play session), with a
newly randomized order for each round. The conditions include Escape, Tangible, Attention,
and Free Play and are described below:

Free Play:

This condition serves as a control condition. Toys and activities will be available, as well
as the researcher's attention. No work materials will be present. The researcher will begin
the session by informing the subject that he/she may play with any toys/activities in the
therapy room and that attention is available (e.g., "John, you can play with any of the toys
in the room. I'll play with you if you like."). If a target behavior occurs (as well as any
other "problem" behavior), the researcher will continue with attention and avoid commenting
on the behavior.

Escape:

In this condition the subject will asked to complete demands. The demands will be (a) within
the subject's skill range and (b) known to be aversive. This could be an academic task or a
domestic task. The researcher will begin the session by presenting the demand to the subject
using clear instructions (e.g., "John, it is time to do some math problems."). The researcher
will provide praise as he/she is actively working. Attention will never be diverted. Tasks
will continue to be presented unless a target problem behavior is observed. If a target
behavior is emitted the researcher will provide a 30-second break from the work task. Once
the 30-second break has ended the researcher will return to work using a prompt similar to
that when the session started. For any subsequent occurrence of the target behavior there
will be another break for 30 seconds. All non-target problem behaviors are ignored.

Tangible:

In this condition an item/activity identified as "high-preferred" and an item/activity
identified as "low preferred" will be used. Just prior to the start of this condition, the
subject is allowed access to the high-preferred item/activity. Once the session begins, the
high-preferred item/activity will be restricted by the researcher and the low-preferred
item/activity will be presented for play. Attention is not restricted during this condition.
If the subject emits a target behavior the high-preferred item/activity is returned to the
subject for 30 seconds and subsequently restricted again. If no target behavior occurs then
the low-preferred item/activity will be the only play option for the entire five minutes.

Attention:

In this condition the subject has access to preferred items and activities and no demands are
presented. At the beginning of the session the researcher will inform the subject that he or
she should play with the toys available but that the attention will be unavailable. The
researcher will leave the play area, go to the other side of the therapy room and begin
reading a book or magazine. If a target behavior is emitted the researcher will approach the
subject and provide a brief statement of disapproval and reiterate the expectation to
behavior appropriately, followed by a return to ignoring the subject. All appropriate
behavior, including requests for attention, will be ignored for the entirety of the session.

For the functional analysis, 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.

Phase II (visits 5, 6, 7, & 8):

Following completion of the first three stages (visits 1-4), four additional visits will be
required (visits 5-8). These additional visits will consist of three stages: (1) free operant
preference assessment; (2) multiple stimulus without replacement preference assessment in a
concurrent operants design; and (3) work-break schedule with choice. Stages 1 and 2 will be
conducted the same as Phase I. On visits 5 and 7 the subject will take his or her stimulant
medication as expected before beginning and on visits 6 and 8, the subject will be asked to
withhold medication for the period he or she is completing the three stages. All data
collection will be done using DataPal computer scoring software that is installed on
computers in the observation area of the therapy room.

Stage 1: Free Operant Preference Assessment This assessment will be conducted just as
described for Phase I of the study.

Stage 2: Multiple Stimulus Preference Assessment within a Concurrent Operants Design This
assessment will be conducted just as described for Phase I of the study.

Stage 3: Work-Play Schedule with Choice The purpose of this assessment is to evaluate delayed
discounting and impulse control in choice making. In this stage, 8 picture cards and a
schedule board (a plastic board with 8 Velcro placeholders for the picture cards) will be
presented to the subject. Four of the picture cards will show a picture of a child working
and the text "work". Four picture cards will depict a child playing and the text "play". Each
"work" card will represent an academic work task. The worksheet(s) will take an estimated 5
minutes to complete Each "play" card will represent 3 minutes of play time with the
high-preferred item/activity identified through the preference assessments in Stages 1 and 2.
Attention will not be available during work or play; however, the subject may request help
with the work if needed. Completion of the schedule will take approximately 32 minutes.

At the outset, the subject will be asked to organize the schedule in any sequence desired.
There are many sequences the subject could choose (e.g., work(w)-play(p)-w-p-w-p-w-p;
wwwwpppp, wwppwwpp, ppppwwww) and there will be no restriction on the sequence as long as all
of the work and play cards are used in the sequence. Once the schedule is set by the subject
the researcher will ask the subject to respond "final".

Following the sequencing of the schedule, the researcher direct and remind the subject of all
transitions from one activity to the next. Each completed activity will result in the removal
of the picture card from the schedule until all picture cards have been removed. The
researcher will check the worksheets to ensure completion and will require the subject to
complete any unfinished work items and redo incorrect work items until he or she has achieved
80% accuracy or better. Problem behavior will be placed on extinction (i.e., it will be
ignored by the researcher and there will be no programmed consequences).. Data will be
collected on the sequence chosen, compliance, on-task/off-task behavior, and problem
behavior.

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.