Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05925101 |
| Other study ID # |
Pro2022002044 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 7, 2023 |
| Est. completion date |
May 2028 |
Study information
| Verified date |
August 2023 |
| Source |
Rutgers, The State University of New Jersey |
| Contact |
Wayne Fisher, PhD |
| Phone |
8488008503 |
| Email |
wayne.fisher[@]rutgers.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Although highly effective, treatments like FCT include extinction, which can have adverse
side effects. The extinction burst, an increase in the frequency or intensity of destructive
behavior at the start of treatment, is the most common side effect of extinction, and can
increase the risk of harm to the patient and others. The goal of the current study is to
evaluate the prevalence of extinction bursts when various parameters of reinforcement (i.e.,
rate, magnitude, quality) are manipulated.
Description:
PRELIMINARY PROCEDURES
Paired-Stimulus Preference Assessment As part of our standard clinical practice, the
investigators will use a paired-stimulus preference assessment to evaluate each participant's
preference for various leisure items. During this assessment, therapists will select an array
of items informed by the Reinforcer Assessment for Individuals with Severe Disability
(RAISD), which is a structured interview between the behavior analyst and the participant's
caregiver to identify stimuli that may serve as reinforcers. Then, on each trial of the
assessment, the therapist will place two of the items (e.g., iPad, Nintendo Switch) in front
of the participant. When the participant reaches for a given item, the therapist will remove
the unselected item while the data collector records which of these two items the participant
approached and the participant's consumption of the selected item. After approximately 30 s,
the therapist will present another pair of stimuli to the participant, with processes in
place to randomize the positioning (left, right) of the stimuli and the order in which pairs
are presented. This will continue until the therapist presents all potential pairs of stimuli
to the participant. The data collector will then compute and graph the number of times each
stimulus was selected to derive a preference hierarchy (e.g., low, moderate, high). The most
selected item that the participant reliably consumes will serve as the stimulus programmed in
Experiment 3's high-quality condition and the tangible reinforcer for all conditions in
Experiments 1 and 2 should the participant's destructive behavior be maintained by tangible
reinforcement. The least selected item with which the participant interacts will serve as the
stimulus programmed in Experiment 3's low-quality condition.
Competing-Stimulus Assessment As part of our standard clinical practice, the investigators
will use a competing-stimulus assessment to evaluate each participant's preference for
various food and leisure items relative to the functional reinforcer for destructive
behavior. During this assessment, therapists will select an array of items informed by the
RAISD. Then, on each 2-min trial of the competing-stimulus assessment, the therapist will
place one of the stimuli (e.g., M&Ms) in front of the participant and allow the participant
to interact with or consume that item. If at any point during the trial, the participant
displays destructive behavior, the therapist will deliver the functional reinforcer (e.g.,
attention) for 20 s. During each trial, trained observers record the duration of engagement
with each competing stimulus and each occurrence of destructive behavior. Each stimulus is
assessed three times (i.e., three 2-min trials) in a quasirandom order. Then, the results are
tabulated and summarized in a graph showing the duration of stimulus engagement and the rate
of destructive behavior for each stimulus. The highest competing stimulus is the one with the
highest duration of stimulus engagement and the lowest rates of destructive behavior.
Researchers will use this selected stimulus in Experiment 4 in the rate-drop/quality increase
condition to determine whether delivering a higher quality reinforcer will counteract the
effects of a drop in the rate of reinforcement and prevent or mitigate an extinction burst at
the start of
FCT.
Functional Analysis As part of our standard clinical practice, the investigators will conduct
a functional analysis of each participant's destructive behavior. Functional analyses help
identify what consequences (e.g., access to attention) maintain destructive behavior. Prior
to conducting a functional analysis, researchers routinely conduct a risk assessment to
ensure that it is safe to conduct a functional analysis with each patient using the
procedures developed in our program. Researchers also will conduct preference assessments
with each participant to determine a preference hierarchy (e.g., of toys, foods). The
investigators will use this information to individualize each condition of the functional
analysis for each participant. Researchers will extend session duration when indicated (e.g.,
if it appears that destructive behavior begins to occur near the end of a 5-min session). The
functional analysis will include at least three test conditions (social attention, demand,
and monitored alone/ignore) and one control condition (play) that researchers conduct within
a multielement design. Researchers will interview the caregivers prior to the functional
analysis to determine the relevant stimuli (e.g., types of attention, preferred items,
demands) to program within each condition. In accordance with "best clinical practice,"
researchers will include an additional test condition (tangible) if the caregiver reports
providing, or is observed to provide, preferred tangible items following destructive
behavior. For some participants who do not display destructive behavior during standard test
conditions, researchers may evaluate other test conditions relevant to their case to
determine idiosyncratic sources of reinforcement (e.g., social control, where adult
compliance with child requests functions as reinforcement for destructive behavior).
Researchers will program a uniquely colored surgical smock, worn by the therapist, for each
condition to facilitate discrimination between test and control conditions.
In the attention condition, the therapist will provide the participant with high-quality
attention for 1 min prior to the session. Then, the therapist will withdraw attention and
pretend to read a magazine while the participant has an opportunity to play with a moderately
preferred toy. If the participant emits destructive behavior, the therapist will deliver 20 s
of vocal (e.g., "Stop that, you'll hurt yourself") and physical (e.g., rubbing the
participant's back) attention according to a fixed-ratio 1 (FR 1) schedule. In the demand
condition, the therapist will deliver non-preferred demands (e.g., "Write your name") using
sequential verbal, modeled, and physical prompts every 5 s. Compliance will produce praise
(e.g., "Nice job writing your name!"), noncompliance will result in physical guidance (e.g.,
hand- over-hand prompting the participant to write his or her name) and no praise, and
destructive behavior will produce a 20-s break from demands on an FR 1 schedule. In the
monitored alone condition, the participant will be alone in a treatment room without any toys
or materials, but a therapist will monitor the participant from behind a one-way observation
window. If the participant displays aggression toward others, researchers will conduct a
monitored ignore condition instead of an alone condition, during which a therapist will
monitor the participant from inside the therapy room but will not interact with the
participant or respond to the participant's destructive behavior. In the tangible condition,
the therapist will provide the participant access to a highly preferred toy for 1 min prior
to the start of the session. The therapist will then withdraw the toy at the beginning of the
session and return it to the participant for 20 s following destructive behavior according to
an FR 1 schedule. In the control condition (play), the therapist will provide continuous
access to the participant's highly preferred toy from the tangible condition and will deliver
attention every 20 s for the absence of destructive behavior (e.g., "Nice job playing with
your blocks!"). Researchers will conduct at least three sessions in each condition or until
researchers verify that destructive behavior is maintained by social reinforcement (e.g.,
access to attention or tangible items) using the ongoing visual inspection criteria developed
and validated by our research team.
IN-HOME BASELINE GENERALIZATION SESSIONS
Following the functional analysis described above, the treatment team determines whether it
is safe to conduct baseline sessions in the home prior to initiating treatment. If the
participant caused physical harm to self, others, or the environment or if they required
specialized equipment (e.g., protective equipment; a padded treatment room; emergency
restraint) to prevent such harm during the functional analysis, then researchers do not
conduct baseline sessions in the home, but still collect post-treatment generalization
sessions in the home (described below). If it is safe to conduct baseline sessions in the
home, researchers use the following procedures.
Baseline Sessions Researchers collect a series of three 5-min baseline sessions in the test
condition from the functional analysis with the highest rates of destructive behavior. Prior
to the first session, the therapist inspects the room in the home where the sessions will
take place and removes any objects that could be dangerous to the participant or the
caregivers (e.g., an object that could be used as a weapon). Next, researchers use behavioral
skills training to teach the caregiver how to implement the session procedures using verbal
instruction, modeling, behavioral rehearsal (i.e., role-play with a therapist), and
performance feedback. Researchers train each caregiver to a mastery criterion (i.e., at least
90% accuracy across all components when implementing practice sessions with a therapist)
prior to conducting baseline sessions with the participant. Additionally, prior to conducting
session in the home, researchers train caregivers in our managing-challenging-behavior
techniques (e.g., blocking hits and kicks, releasing bites) until the caregivers implement
all techniques with 90% accuracy during role-play. If at any point the participant displays
destructive behavior that poses an imminent danger to self, others, or the environment that
cannot be safely blocked (e.g., eye poking, biting), the therapist terminates the session.
Data Collection During generalization sessions, our research team will monitor the sessions
inconspicuously (e.g., collecting directo bservation data from a nearby hallway using
specialized software; routinely checking inter-observer agreement).
General Instructions to Caregiver "We are asking for your assistance in helping us to
understand and observe your child's destructive behavior. We would appreciate you help in
working to replicate the challenging situations that you discussed with your primary
therapist. Our goal in conducting these sessions is to help us to identify things and may
trigger and reinforce your child's problem behavior in the home. The session that we would
like you to conduct will be 5 minutes in length. For each 5- minute session, we would like
you to follow the procedures described below as closely as possible. After you read the
instructions, we will answer any questions that you have before we start the session. If at
any point, you feel that you or your child are unsafe, please let a therapist know, and we
will immediately assist in keeping you and your child safe. It is our goal to maintain safety
throughout the assessment and treatment of your child's destructive behavior."
Condition-Specific Instructions to Caregiver The therapist will set up the materials and
arrange the room and select the specific instructions to give to the caregiver from the
options below based on the results of the functional analysis (e.g., for escape-reinforced
destructive behavior, they will set up for a demand condition and use the instructions below
labeled "Demand"). The therapist will give the caregiver a copy of the selected instructions
described below, have them read it, and then answer any questions they have.
Demand. "In this session, we want you to instruct your child to complete a variety of
nonpreferred tasks from the list of such tasks that you and your child's primary therapist
specified during the parent interview. The session will last 5 minutes. You may use any
materials in the room that you would like to complete the instructions during this session.
Please do exactly what you normally do at home to get your child to complete such tasks. We
are interested in observing how you give instructions and how your child responds to those
instructions. When the 5-minute session is over, a therapist will give you a brief break.
Again, if at any point you feel that you or your child are not safe, please let a therapist
know, and we will immediately assist in keeping you and your child safe."
Attention. "In this session, we want to observe you and your child in a situation in which
you must manage your child's behavior while you also complete a task. In this case, the task
will be to complete this questionnaire using the pencil and clipboard we have provided to
you. While you complete the task, please interact with your child as you normally would.
After one minute, you will be signaled by a therapist to tell your child that you have some
work to do and that they should play quietly. After you tell your child this, please move
away from your child and work on the task. Please react to your child's behaviors as you
normally would but do your best to complete the task we have placed on the clipboard
throughout the 5-minute session. If you complete the task, please review it, and continue to
"work on it" until the session is complete. When the 5-minute session is over, a therapist
will give you a brief break. Again, if at any point you feel that you or your child are not
safe, please let a therapist know, and we will immediately assist in keeping you and your
child safe."
Tangible. "In this session, please give your child this toy that we have identified as one of
your child's most preferred items. After one minute, you will be signaled by a therapist to
take the toy away from your child. You should play with the toy/item for the remainder of the
session. If your child displays destructive behavior, please react to it as you normally
would. When the 5-minute session is over, a therapist will give you a brief break. Again, if
at any point you feel that you or your child are not safe, please let a therapist know, and
we will immediately assist in keeping you and your child safe."
GENERAL EXPERIMENTAL PROCEDURES
Selecting the Functional Communication Response (FCR) During functional communication
training (FCT), researchers often teach the child an FCR modality that therapists can
physically guide, such as a card exchange or card touch, because it is critically important
to minimize exposure to the establishing operation for destructive behavior during the early
stages of FCT (i.e., limiting the time the child does not have access to the functional
reinforcer). Typically, researchers create a laminated index card with a photograph of the
child consuming the reinforcer (e.g., the child playing with an iPad) and then teach the
child to either exchange or touch the FCR card to gain access to the reinforcer maintaining
destructive behavior. Caregiver input (e.g., preference for a vocal response) and
participant-specific factors (e.g., low vision) are also considered when selecting the FCR
for each patient.
Experimental Design Researchers will evaluate the effects of functional communication
training on destructive behavior using an ABAB (baseline, FCT, baseline, FCT) reversal
design. Researchers will conduct within-participant comparisons of FCT conditions using an
embedded alternating-treatments design. All sessions will last 5 min. Researchers will
conduct Experiment 3 with participants whose destructive behavior is reinforced by access to
tangible items so that researchers can vary reinforcement quality based on the
paired-stimulus preference assessment.
Data Collection and Computation of Interobserver Agreement and Procedural Integrity Trained
observers will collect data on the frequency of participant destructive behavior and
therapist (or caregiver) implementation of the assessment and treatment protocols to assess
procedural integrity using BDataPro® software developed in our lab. A second observer will
score at least one third of sessions independently to assess data accuracy (reliability). The
second data collector will be blind to the project's research questions and hypotheses for at
least 1/6th (17%) of sessions. For at least one third of sessions, observers will collect
procedural-integrity data to ensure that the assessment and treatment protocols are
implemented as planned. That is, researchers will collect data on whether therapists
correctly implemented the planned antecedents, prompts, and consequences for each target
response. Researchers will then transform the data into a percentage-correct measure by
dividing the number of correct therapist responses by the number of opportunities for a
correct response. Researchers will retrain therapists who show less than 90% implementation
accuracy for two consecutive sessions. The reliability of direct-observation measures is
typically established through measurement of interobserver agreement. To calculate
inter-observer agreement, sessions will be partitioned into successive, 10-s intervals (e.g.,
Seconds 0-9, 10-19, 20-29). In each 10-s interval, researchers will determine whether the
observers agreed or disagreed on the frequency of each target behavior. An exact agreement
will be defined as both observers recording the same frequency of a target behavior in each
10-s interval. Researchers will then calculate the percentage of exact agreements per
session. Interobserver agreement in our program averages above 90%, and observers undergo
retraining if agreement levels fall below 80% for two consecutive sessions.
EXPERIMENT-SPECIFIC PROCEDURES
Experiment 1: Effect of Reinforcement Rate Drop
Baseline. Researchers will conduct three identical baselines each in separate and distinct
contexts differing in the color of the room and the therapists' clothing (e.g., blue versus
yellow versus brown rooms and therapist clothing). Each baseline will be identical to the
condition from the functional analysis with the highest rates of destructive behavior, except
for the following modifications. Researchers will program an independent, dense
variable-interval (VI) 1.5-s schedule of reinforcement for destructive behavior in each
baseline and deliver the reinforcer for 20 s each time to make the baselines highly like
typical clinical baselines. Researchers will use independent VI schedules rather than an FR 1
schedule to better control and equate the obtained rate of reinforcement in each condition.
The investigators have used VI schedules for this purpose to good effect in multiple prior
studies on resurgence of destructive behavior, the investigators have used both VI schedules
and FR 1 schedules and produced comparable results. Researchers will equate reinforcement
magnitude (i.e., each reinforcer delivery lasting 20 s) and quality (i.e., the functional
reinforcer identified during the functional analysis) across the baseline conditions.
Stability criteria. Researchers will conduct at least five baseline sessions in each context
until the standard deviation of responding in the last five sessions of each condition is no
more than 50% of the mean of those sessions.
Treatment. The reinforcement magnitude and quality will be identical to baseline. Researchers
will randomly assign the three treatments (extinction-only, rate-drop, and rate-hold
conditions) to the color-correlated baseline contexts. In the extinction-only condition,
researchers will discontinue reinforcement for destructive behavior, but not deliver
alternative reinforcement for the FCR. In the rate-drop condition, researchers will place
destructive behavior on extinction and deliver the functional reinforcer for the FCR
according to a VI 15-s reinforcement schedule (i.e., a robust reduction in reinforcement rate
relative to baseline). In the rate-hold condition, researchers will place destructive
behavior on extinction and deliver the functional reinforcer for the FCR according to a yoked
VI 1.5-s schedule that matches the exact rate and timing of reinforcer deliveries for
destructive behavior in baseline. To teach the participant the FCR in the rate-drop and
rate-hold conditions, researchers will embed a constant prompt delay in each FCT condition.
Each time the programmed VI schedule elapses, researchers will implement a 5-s prompt delay
wherein researchers allow up to 5 s for the participant to emit the FCR independently prior
to prompting the response (e.g., physically guiding the participant to exchange the FCR
card). To minimize adventitious reinforcement of destructive behavior in the FCT conditions,
researchers will incorporate a 3-s changeover delay by withholding reinforcement for FCRs
until the response occurs without destructive behavior occurring within 3 s of the FCR.
Researchers will continue treatment sessions until researchers observe an 85% reduction in
destructive behavior relative to baseline across all three conditions for two consecutive
sessions.
Experiment 2: Effect of Reinforcement Magnitude Drop
Baseline. Baseline procedures will be identical to Ex 1 except researchers will program three
times the magnitude of reinforcement. That is, researchers will program 60 s of
reinforcement, instead of 20 s, when researchers deliver the functional reinforcer in each
baseline context. Researchers will equate reinforcement quality (i.e., the functional
reinforcer identified during the functional analysis) and rate (i.e., VI 1.5-s schedule)
across the baseline conditions. Researchers will use the stability criteria described above
for Ex 1a to determine when to end baseline and initiate treatment.
Treatment. The reinforcement rate and quality will be identical to baseline. Researchers will
randomly assign the three treatments (extinction-only, magnitude-drop, and magnitude-hold
conditions) to the color-correlated baseline contexts. In the extinction-only condition,
researchers will discontinue reinforcement for destructive behavior, but not deliver
alternative reinforcement for the FCR. In the magnitude-drop condition, researchers will
place destructive behavior on extinction and deliver the functional reinforcer for the FCR
for 6 s (i.e., a large reduction in reinforcement magnitude relative to baseline). In the
magnitude-hold condition, researchers will place destructive behavior on extinction and
deliver the functional reinforcer for the FCR for the same duration as in baseline (i.e., 60
s). To teach the participant the FCR, researchers will incorporate the prompt-delay and
changeover-delay procedures as described in Ex 1a's FCT conditions. Researchers will continue
treatment sessions until researchers observe an 85% reduction in destructive behavior
relative to baseline across all three conditions for two consecutive sessions.
Experiment 3: Effect of Reinforcement Quality Drop
Participant Selection. Researchers will conduct Ex 3 with participants who display
destructive behavior reinforced by access to tangible items so that researchers can vary
reinforcement quality using the results of a paired-stimulus preference assessment.
Baseline. Baseline procedures will be identical to Ex 1, except that researchers will conduct
two identical baselines in separate and distinct contexts (rather than three). Researchers
will use the stability criteria described above for Ex 1a to determine when to end baseline
and initiate treatment.
Treatment. The reinforcement rate and magnitude will be identical to baseline. Researchers
will randomly assign the quality-drop and quality-hold conditions to the color-correlated
baseline contexts. In the quality-drop condition, researchers will place destructive behavior
on extinction and deliver the reinforcer from the paired-choice assessment that the
participant chooses approximately 1/12th as often as the highest preferred stimulus from that
assessment contingent on the FCR (i.e., which will produce a large reduction in reinforcement
quality relative to baseline). In the quality-hold condition, researchers will place
destructive behavior on extinction and deliver the same reinforcer from baseline (i.e., the
highest quality reinforcer from the paired-stimulus preference assessment) for the FCR. To
teach the participant the FCR, researchers will incorporate the prompt-delay and
changeover-delay procedures as described in Ex 1's FCT condition. Researchers will continue
treatment sessions until researchers observe an 85% reduction in destructive behavior
relative to baseline across both conditions for two consecutive sessions.
Experiment 4: Clinical Study on Counteracting Reinforcement-Rate Drop with Quality Increase.
Baseline. Baseline procedures will be identical to Ex 1, except that researchers will conduct
two identical baselines in separate and distinct contexts (rather than three). Researchers
will use the stability criteria described above for Ex 1 to determine when to end baseline
and initiate treatment.
Treatment. The reinforcement magnitude will be identical to baseline. The investigators will
randomly assign the rate-drop-only and rate-drop/quality-increase conditions to the
color-correlated baseline contexts. In the rate-drop-only condition, researchers will place
destructive behavior on extinction and deliver the functional reinforcer for the FCR
according to a VI 15-s reinforcement schedule (i.e., a robust reduction in reinforcement rate
relative to baseline). In the rate-drop/quality-increase condition, researchers will program
the same large drop in reinforcement rate by delivering reinforcement on a VI 15-s schedule
for the FCR, but also will increase reinforcement quality by simultaneously delivering the
highest quality reinforcer identified during the competing-stimulus assessment described
above. To teach the participant the FCR, researchers will incorporate the prompt-delay and
changeover-delay procedures as described in Ex 1's FCT condition. Researchers will continue
treatment sessions until an 85% decrease in destructive behavior is observed relative to
baseline across both conditions for two consecutive sessions.
Post-Study Procedures
Researchers will continue to provide relevant treatment services following the conclusion of
the patient's participation in the experiment. After initial ABAB designs with dense
reinforcement schedules for FCRs (like those in Experiments 1, 2, 3, and 4), researchers
progress treatment with systematic evaluations of reinforcement-schedule thinning. Over the
course of several weeks, researchers incorporate discriminative stimuli (e.g., multiple or
chained schedules) and progressively thin reinforcement to a practical reinforcement schedule
selected by the caregiver. During the last two weeks of treatment, researchers transfer
treatment to relevant stakeholders (e.g., caregivers, teachers) and contexts (e.g., home,
school, community).
IN-HOME POST-TREATMENT GENERALIZATION SESSIONS
After the post-study procedures described above, caregivers will implement treatment sessions
in their home to assess for generalization of treatment effects. Researchers will use
behavioral skills training to teach the caregiver how to implement the treatment procedures
using verbal instruction, modeling, behavioral rehearsal (i.e., role-play with a therapist),
and performance feedback. Researchers will train each caregiver to a mastery criterion (i.e.,
at least 90% accuracy across all components when implementing practice sessions with a
therapist) prior to conducting treatment sessions with the participant. In addition,
researchers have the caregiver implement treatment sessions under close supervision in our
clinic setting before having them implement the treatment in the home setting. During
generalization sessions in the home, our research team will monitor the sessions
inconspicuously (e.g., collecting data from a nearby hallway) and provide the caregiver with
performance feedback as needed.
After the participants meet their behavioral goals in the clinic, caregivers will implement
the terminal mult-FCT procedures within their homes during three 5-min sessions under
conditions that parallel the in-home baseline generalization condition described above (e.g.,
If the patient displayed the highest rates of destructive behavior in the demand condition of
the functional analysis, the treatment generalization sessions will also occur in a demand
context). Researchers will use data from the generalization sessions to evaluate how our
final FCT treatment works for caregivers in a natural setting. Researchers will terminate any
session if destructive behavior increases to unsafe levels for the caregivers or
participants. Researchers will provide additional caregiver training, if necessary, until
participants exhibit low levels of destructive behavior with their caregivers, as is typical
of our routine clinical practice.
