Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05537610 |
| Other study ID # |
Pro2022001284 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2023 |
| Est. completion date |
January 31, 2028 |
Study information
| Verified date |
December 2023 |
| Source |
Rutgers, The State University of New Jersey |
| Contact |
Brian Greer, PhD |
| Phone |
8488008505 |
| Email |
brian.greer[@]rutgers.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Although behavioral treatments for decreasing destructive behavior, such as differential
reinforcement of alternative behavior (DRA), are effective in the clinic, problem behavior
often returns when a caregiver does not give the child their way in the natural environment
(e.g., caregiver is busy with an infant sibling). This form of treatment relapse is known as
resurgence. The goal of the current study is to evaluate whether alternating sessions in
which the child can have their way (i.e., "on" sessions) with sessions in which the child can
not have their way (i.e., "off" sessions) helps to mitigate resurgence.
Description:
Preliminary Procedures
Functional Analysis. As part of our standard clinical practice, the investigators will
conduct a functional analysis of each participant's problem behavior. Functional analyses
identify the consequences (e.g., access to attention) that maintain problem behavior. Prior
to conducting a functional analysis, the investigators 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 and described most recently by Saini et al. (2021). The
investigators 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. The
investigators will extend session duration when indicated (e.g., if it appears that problem
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 the investigators conduct within a multielement design.
The investigators 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, the investigators will include an
additional test condition (tangible) if the caregiver reports providing, or is observed to
provide, preferred tangible items following problem behavior. For some participants who do
not display problem behavior during standard test conditions, the investigators 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 problem behavior). The investigators will program a uniquely colored
surgical smock 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 problem 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. In the demand condition, the therapist will deliver non-preferred demands
(e.g., "Write your name") using sequential verbal, model, 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 their
name) and no praise, and problem behavior will produce a 20-s break from demands. 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, the investigators 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 problem 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 problem behavior. 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 problem behavior (e.g., "Nice job playing with your blocks"). The investigators
will conduct at least three sessions in each condition or until the investigators verify that
problem behavior is maintained by social positive reinforcement (e.g., access to attention or
tangible items) using the ongoing visual inspection criteria developed and validated by our
research team.
Evaluation of differential reinforcement of alternative behavior (DRA). As part of our
standard clinical practice, the investigators first teach an alternative response, called the
functional communication response (FCR), to the child and evaluate its effectiveness
following the functional analysis. The purpose of this DRA evaluation is to ensure that DRA
effectively suppresses problem behavior and increases the child's use of the FCR when each
FCR is reinforced. The investigators often teach the child an FCR modality that therapists
can physically guide, such as a card exchange or card touch because our prior research has
shown that it is critically important to minimize exposure to the establishing operation for
problem behavior during the early stages of DRA (i.e., limiting the time the child does not
have access to the functional reinforcer). Typically, the investigators 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 problem 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. The investigators typically progress through the DRA
evaluation in the following manner: (1) baseline, (2) DRA pretraining, (3) DRA, (4) baseline,
and (5) DRA to demonstrate DRA's efficacy within a reversal design.
Baseline. Baseline for the DRA evaluation is identical to the functional-analysis test
condition related to problem behavior. The therapist restricts access to the functional
reinforcer (e.g., by removing access to the iPad) until problem behavior occurs, at which
time the therapist delivers 20-s access to the functional reinforcer (e.g., 20 s of access to
the iPad). The investigators conduct at least three baseline sessions or until response rates
stabilize or increase in a countertherapeutic direction. Baseline sessions last 5 min.
DRA Pretraining. During DRA pretraining, the investigators (a) restrict access to the
functional reinforcer, (b) prompt the FCR immediately, and then immediately thereafter, (c)
deliver the previously restricted reinforcer. For example, for a tangible function related to
accessing an iPad, the therapist would (a) restrict the iPad, (b) immediately guide the child
to exchange the FCR card, and then immediately thereafter, (c) deliver the iPad to the child
for 20 s. The investigators consider this three-step progression to constitute one trial, and
the investigators conduct 10 such trials per session. Once the investigators observe two
consecutive sessions in which problem behavior does not occur, the investigators then delay
the therapist's prompt for the child to emit the FCR such that the participant can emit the
FCR independently for increasing amounts of time across sessions. The investigators
systematically increase the delay to the therapist's prompt in this manner (e.g., 2 s, 5 s,
10 s, 20 s) until the participant emits the FCR independently on 100% of trials and problem
behavior occurs on 0% of trials. During DRA pretraining and all DRA sessions that follow DRA
pretraining, problem behavior results in extinction (i.e., the therapist continues to
withhold the functional reinforcer following problem behavior). If the child frequently
engages in problem behavior just prior to or while emitting the FCR (e.g., within 3 s), the
investigators require the child to emit another FCR without co-occurring problem behavior
before the therapist provides the functional reinforcer.
DRA. Once the child demonstrates the ability to emit the FCR reliably in the presence of the
relevant establishing operation for problem behavior and will do so without co-occurring
problem behavior, the investigators then conduct a series of 5-min sessions in which the
therapist reinforces each FCR with 20-s access to the functional reinforcer. Thus, DRA is
identical to DRA pretraining, except the therapist removes all prompts for the child to emit
FCR, and sessions last 5 min. The investigators conduct at least three DRA sessions or until
problem behavior stabilizes at near-zero rates and FCRs stabilize at high rates or increase
in a therapeutic direction.
Experiment 1
Participants will begin Experiment 1 following these routine-clinical procedures. Similar to
the DRA evaluation that participants will have already experienced and regardless of group
assignment (i.e., control or contingency-discrimination training [CDT]), responses arranged
to produce the functional reinforcer will do so for each response emitted (i.e., a
fixed-ratio [FR] 1 schedule). All reinforcer deliveries will last 20 s, and all sessions will
last 5 min.
Baseline. The investigators will reinforce problem behavior according to an FR 1 schedule of
reinforcement, using the reinforcer identified in the functional analysis. For example, if
results from the functional analysis suggest that problem behavior is maintained by access to
an iPad, the investigators will provide the iPad following instances of problem behavior in
baseline. Baseline will end when (a) the standard deviation of the last five sessions is less
than 50% of its mean (e.g., M = 2, SD ≤ 0.8) and (b) the baseline trend is flat (slope ≤
|.05|) or trending upward.
Following baseline, participants will be randomized (with minimization) to either the control
or CDT group. Group assignment will occur at this point so that baseline response rates can
be one of the variables the investigators minimize between groups through randomization plus
minimization. The investigators will similarly control for severity of problem behavior
across the two groups. Severity of problem behavior for each referral topography of concern
is assessed for each patient in the Severe Behavior Program prior to intake, using a 4-point
scale that captures the permanent products of problem behavior. As one example, the Problem
Behavior Severity Scale scores aggression as a Level 1 if it results in no marks on the body
and no blows close to or contacting the eyes; a Level 2 if it produces reddening of the skin
and/or mild swelling; a Level 3 if it results in light scratches, small or shallow breaks in
the skin, and/or moderate to severe swelling; and a Level 4 if it involves blows close to or
contacting the eyes or it results in scratches that leave scars, breaks in the skin that
leave scars, and/or trauma resulting in broken bones or lasting tissue damage or
disfigurement. Each topography is operationally defined in the Problem Behavior Severity
Scale to clearly demarcate each response of concern (e.g., separating self-injury from
aggression). Thus, randomization will occur with rates and severity of problem behavior (at a
minimum) minimized across the two experimental groups.
DRA. Following baseline, the investigators will discontinue reinforcement of problem behavior
for all participants. For participants in the control group, the investigators will use the
same FR 1 schedule of reinforcement from baseline but for an alternative form of
communication (e.g., touching a card with a picture of the participant consuming the
reinforcer) that the investigators will teach to the participant prior to enrollment. These
procedures will remain in place throughout the DRA phase for the control group. For
participants in the CDT group, these procedures will be identical whenever alternative
reinforcement is available (Sessions 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29,
31); however, the investigators will discontinue alternative reinforcement during every other
session (Sessions 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 of the DRA phase).
Thus, the CDT group will experience 16 cycles of reinforcement being available and then
unavailable for the alternative response. This DRA phase will last 31 total sessions for all
participants. Following this phase, participants will begin a resurgence test starting on
session 32.
Resurgence Test. The investigators will discontinue reinforcement for the alternative
response, while problem behavior continues to go unreinforced. This condition will last 10
sessions and will mimic lapses in the integrity with which caregivers often implement
treatment in the home, school, and community settings.
Data Collection and Computation of Interobserver Agreement and Procedural Integrity
Trained observers will collect data on the frequency of participant problem behavior and
therapist implementation of the assessment and treatment protocols to assess procedural
integrity using the 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
one-half (17%) of these 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, the investigators will collect data on whether therapists
correctly implemented the planned antecedents, prompts, and consequences for each target
response. The investigators 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. The investigators 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 interobserver agreement, sessions will be
partitioned into successive, 10-s intervals (e.g., Seconds 0-9, 10-19, 20-29). In each 10-s
interval, the investigators 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 a given 10-s interval. The investigators
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.
