Basic and Clinical Studies in Reinforcing Positive Behaviors in Intellectual and Developmental Disabilities
Phase: NA
Conditions: Problem Behavior, Self-injury, Communication
Sponsor: Rutgers, The State University of New Jersey

Cover Page 
Official Title: Basic and Clinical Studies in Reinforcing Positive Behaviors in Intellectual and 
Developmental Disabilities 
NCT Number: NCT03423940 
Document Date: 1/23/23 
 
 

 
 
 
 
 
 
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INTERVENTIONAL 
RESEARCH PROTOCOL TEMPLATE 
(HRP-503a) 
 
 
 
 
STUDY INFORMATION 
 
▪ 
Title of Project: 
Resurgence as Choice: Basic and Clinical Studies 
 
▪ 
Principal Investigator Name 
Brian Greer, Ph.D, BCBA-D 
 
▪ 
Principal Investigator Div. & Dept. 
Rutgers Biomedical and Health Sciences / Brain Health Institute 
 
▪ 
Principal Investigator Contact Info:  
brian.greer@rutgers.edu 
888 Easton Ave, Somerset, NJ 08873 
848-800-8505 
 
▪ 
Protocol Version and Date: 
V8 01.23.2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
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1.0 Research Design 
 
1.1 Purpose/Specific Aims 
 
Destructive behavior within intellectual disability. About 4 million people in the U.S. have an intellectual 
disability, and 12.5% (½ million) display destructive behavior, such as aggression and self-injurious 
behavior (SIB).1 The risk for destructive behavior increases with intellectual-disability severity, 
communication deficits, and co-occurring autism spectrum disorder.2 Severe destructive behavior is a 
primary reason for institutionalization. In 1994, the annual costs of destructive behavior exceeded $3.5 
billion in the U.S., and the costs are considerably higher today.3 SIB produces health complications, 
including soft-tissue damage, blindness, self-amputation of body parts, fractures, brain trauma, and 
even death.4 Individuals with aggressive behavior are at increased risk for institutionalization, social 
isolation, physical restraint, over-use of medication, denial of services, and physical abuse. 
 
Functional analysis and treatment of destructive behavior. The assessment of aberrant behavior has 
traditionally been based on its structural characteristics and the extent to which certain responses co-
occur (e.g., peculiar vocal, social, and motor responses lead to the diagnosis of autism). Another 
approach to assessing aberrant behavior is by its function (i.e., the behavior's effect on the 
environment). Other fields of science have long understood the importance of analyzing both the 
structure and function of dynamic entities, and recently behavior analysts have increasingly assessed 
destructive behavior both in terms of its structural characteristics (e.g., aggression, SIB) and 
its function. For example, a boy with autism might display SIB because when he does, 
others do not approach or interact with him. In this case, the function of SIB would be to avoid or escape 
social interaction. Functional analysis, as a specific method for analyzing, understanding, and 
developing treatments for destructive behavior, began in 1982 with the publication of the seminal paper 
by Iwata and colleagues.6 This method consisted of a control condition (play) and three test conditions 
(attention, demand, and alone) designed to test the prevailing behavioral hypotheses regarding SIB 
articulated by Carr.7 These three hypotheses were that SIB was maintained by (a) positive 
reinforcement in the form of contingent attention; (b) negative reinforcement in the form of escape from 
or avoidance of nonpreferred tasks; and/or (c) automatic reinforcement (e.g., reinforced by the sensory 
stimulation automatically produced by the response). 
 
Functional analysis has become the predominant method of prescribing effective behavioral 
treatments for persons with intellectual disability who display severe destructive behavior.8 Numerous 
investigations directly comparing function- and non-function-based treatments have consistently 
produced results favoring the function-based approach.9,10 In addition, results of large-scale, meta 
analyses and epidemiological studies indicate that, across studies, behavioral treatments were more 
effective when they were based on a prior functional analysis.12,13,14 
 
Functional communication training. Perhaps the most important asset of functional-analysis methods 
has been the systematic identification of the reinforcer (i.e., reward that maintains behavior in the 
environment) for destructive behavior, which allows the behavior analyst to decrease destructive 
behavior and replace it with more prosocial behavior.15 One such treatment that is inexorably linked to 

 
 
 
 
 
 
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functional analysis is differential reinforcement of alternative behavior (DRA). DRA is often prescribed 
when a functional analysis indicates that destructive behavior is reinforced by socially mediated 
consequences.16-24 With DRA, the social consequence (e.g., attention, toys, breaks from instructions) 
that heretofore reinforced destructive behavior is delivered contingent on an appropriate 
communication response, while destructive behavior is on extinction (i.e., reinforcers are no longer 
provided). For example, if a functional analysis shows that aggression is reinforced by escape from 
demands, DRA would typically involve (a) teaching the child to access breaks from demands via a 
functional communication response (FCR; e.g., saying, "Break, please") and (b) placing destructive 
behavior on extinction (i.e., continuing with scheduled demands independent of destructive behavior). 
In large studies and reviews, investigators have cited DRA as the most commonly implemented, 
effective treatment for destructive behavior that is based on the results of a functional analysis.17-21 
 
Limitations of DRA. Although highly effective, DRA has a number of limitations17-21 that compromise its 
effectiveness when implemented by caregivers in the natural environment. In the latter stages of DRA, 
caregivers are trained to implement treatment, and it is critical that they do so with high procedural 
integrity (e.g., 90% accuracy), which is more likely if the intervention is practical and compatible with 
their daily routine. Researchers have identified two important practical limitations of DRA that can 
interfere with accurate caregiver implementation, namely that treated individuals request reinforcement 
via the FCR (a) at exceedingly high rates (e.g., request to escape every adult directive) or (b) when it 
is difficult for the caregiver to deliver reinforcement (e.g., requesting attention when a parent is changing 
an infant sibling). Our research team and others have used reinforcer-schedule thinning procedures to 
address these limitations and improve the practicality of DRA.21,23 Reinforcer schedule thinning involves 
progressively and systematically reducing the amount of reinforcers available during treatment 
sessions. This process is conducted in order to prepare the treatment to be practically used when 
reinforcers cannot always be feasibly delivered. Unfortunately, in the first large study on reinforcer-
schedule thinning, we found that DRA was ineffective in 14 of 25 applications when schedule thinning 
reached a practical endpoint.21 In most cases, it was necessary to add a more restrictive and intrusive 
punishment component to DRA in order to thin the schedule and also maintain low rates of destructive 
behavior. A recent replication of this large study reported somewhat more favorable outcomes, but DRA 
plus schedule thinning still only maintained a 90% reduction from baseline in 11 of 23 applications 
(48%).23 In addition, other recent studies have found that when participants treated with DRA were 
subsequently exposed to extinction of the FCR (or thin reinforcement schedules), treatment relapse 
often occurred in the form of resurgence of destructive behavior.24-26 Similarly, in the first large scale 
study examining the prevalence of resurgence during schedule thinning, we found that resurgence 
occurred in 19 out of 25 applications or 76%.27 Collectively, the limitations stated above are evidence 
for continued refinement to DRA procedures to increase efficacy. In the same way, it is imperative that 
we develop more durable procedures that will reduce the likelihood of resurgence (i.e., relapse of 
destructive behavior). These limitations of DRA are actually predicted by a quantitative model derived 
from behavioral momentum theory. Behavioral momentum theory is a quantitative theory that predicts 
that DRA, as it is typically implemented, actually promotes resurgence and resistance to extinction for 
destructive behavior when the FCR is exposed to extinction or thin reinforcement schedules. More 
importantly, behavioral momentum theory provides clear quantitative guidance on how DRA 
procedures might be altered in order to mitigate or prevent treatment relapse.28 Several lines of 
research have used behavioral momentum theory as a guide to develop more efficacious DRA 
procedures. Unfortunately, recent developments suggest that behavioral momentum theory may not 

 
 
 
 
 
 
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accurately predict resurgence, and the core concepts may be flawed.31,32Accordingly, Resurgence as 
Choice Theory provides an alternative avenue as a quantitative model that provides more accurate 
predictions of resurgence during extinction challenges (i.e., reinforcers are no longer provided for 
appropriate behavior) and reinforcement schedule thinning (i.e., fewer reinforcers are available for 
appropriate behavior).31,32 
 
The following specific aims relate to only those clinical studies that will be conducted at Children’s 
Specialized Hospital–Rutgers University Center for Autism Research and Services (CSH–RUCARES) 
and at the Douglas Developmental Disabilities Center (DDDC), both of which are Rutgers University 
research and training sites owned by Rutgers University. Other specific aims from the grant application 
pertain to studies involving nonhuman animal subjects, which will be conducted solely at Utah State 
University. 
 
Specific Aim 1: Identify the optimal duration of treatment with DRA. We will compare short, moderate, 
and extended durations of treatment with DRA to identify the optimal duration of treatment to reduce 
the extent of relapse of destructive behavior. We will demonstrate that the degree of relapse may 
depend on the length of treatment with DRA. 
 
Specific Aim 2: Demonstrate the benefits of DRA treatments with empirically informed schedule thinning 
progressions. We will use measurements of destructive behavior, appropriate behavior, and reinforcer 
deliveries during each treatment session to inform the number of reinforcers that will be available during 
upcoming treatment sessions, informed by both the Resurgence as Choice (RaC) Theory and on the 
results of a coordinated study with nonhuman animals. We will demonstrate that this schedule thinning 
progression is efficacious at maintaining an 85% reduction in problem behavior (i.e., relative 
to baseline) during each treatment session. 
 
 
A.  Objectives  
Severe problem behavior (e.g., self-injurious behavior, aggression) of children with intellectual 
disabilities is prevalent, potentially dangerous, and negatively impacts social integration and quality of 
life.33, 34 Function-based differential reinforcement of alternative behavior (DRA) interventions reduce 
such behavior effectively,21,35,36 but treatment relapse often occurs when a caregiver does not deliver 
reinforcement for the alternative behavior (e.g., caregiver is busy with an infant sibling). Such relapse 
is known as resurgence. Resurgence is typically studied in a three-phase experiment: (a) reinforcement 
is delivered exclusively for the target response in the Phase 1 baseline; (b) reinforcement is delivered 
exclusively for an appropriate alternative response in the Phase 2 treatment; and (c) all reinforcer 
deliveries cease in the Phase 3 extinction challenge, which serves as the resurgence test and simulates 
a lapse in treatment implementation by caregivers. Resurgence as Choice (RaC) is a quantitative theory 
of resurgence built from two fundamental and well-established principles of reinforcement: (a) 
individuals allocate proportionally more responding to responses that produce proportionally more 
reinforcement (i.e., the matching law); and (b) the value of reinforcement decreases over time, typically 
by a hyperbolic-decay function (e.g., delay discounting). Nevin et al 37 attempted to apply the matching 
law early on to the phenomenon of response persistence, which is related closely to resurgence, but 
failed largely because the matching law typically applies to multiple, concurrently available reinforcers. 
Researchers typically evaluate response persistence and resurgence when reinforcers are unavailable 

 
 
 
 
 
 
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(e.g., during extinction). Nevin developed behavioral momentum theory (BMT) as a result, which 
accounts for response persistence and resurgence in some situations but not in others.31,32 Our 
preliminary data suggest that RaC better describes resurgence by adding the principle of 
reinforcement-value decay using a mathematical formula to account for reinforcement history. 
Reinforcement-value decay quantitatively accounts for dynamically changing reinforcement conditions, 
including when all reinforcement ceases during the resurgence test. RaC combines these two well-
established principles into a mathematical model that appears to account for resurgence in situations 
in which BMT has failed. Moreover, RaC is a more general model of resurgence that makes predictions 
about variables not accounted for by BMT (e.g., response effort; reinforcer quality). In addition, it does 
so more parsimoniously, with fewer free parameters. Our overarching hypothesis is that RaC-informed 
differential reinforcement treatments, relative to BMT, will be less susceptible to resurgence of problem 
behavior: (a) during periods when reinforcers are unavailable during the resurgence test; (b) when 
reinforcer availability diminishes during reinforcement schedule thinning; and (c) when other response 
or reinforcement parameters change, such as increases in response effort. 
1.2 Research Significance 
Resurgence as Choice theory is based on two well-developed concepts: (a) Individuals allocate 
proportionally more behavior towards responses that proportionally produce more reinforcement, and 
(b) the value of different experiences with reinforcers decreases over time. The theory is relatively more 
parsimonious than behavioral momentum theory and provides more general predictions than 
behavioral momentum theory.32 In essence, the theory is grounded in the notion that relapse of behavior 
is governed by the same processes that underlie choice behavior (e.g., destructive behavior and 
appropriate communicative responses).32The two predictions that are most relevant to our project are 
(a) resurgence of destructive behavior will decrease with increased DRA treatment duration, and (b) 
reinforcement schedule thinning show included slow, small decreases in reward deliveries (smaller 
than those previously reported in the literature). Accordingly, our project will examine the effects of 
different durations of DRA on resurgence and the effects of adjusting the schedule of reinforcement for 
each session to include slow and small decreases to avoid resurgence. Findings from this project could 
have vast clinical implications in that we will demonstrate that time in treatment affects relapse and that 
schedule thinning can be accomplished without recurrence of destructive behavior.  
 
1.3 Research Design and Methods 
 
A. Research Procedures 
 
General methods common to Experiments 1 and 2. Potential subjects will receive treatment 3 to 6 
hours a day, 5 days a week for about 8-16 weeks depending on the subject's availability. If 
Experiment 1 is successful at reducing destructive behavior to a desirable level with DRA at a 
dense schedule, we may conduct Experiment 2 with the same subjects. However, each experiment 
tof the project is independent of the other experiment, and no experiment is required before 
conducting the other experiment. We may assign subjects to experiments of the project via 
randomization procedures. Assessment and treatment will be conducted initially in treatment rooms 
with adjacent observation windows to allow unobtrusive measurement of behavior. Some treatment 
rooms will have padded walls and floors, which will be used, when necessary, to maintain patient 
and staff safety. Therapists will conduct multiple sessions daily with each child. We will use 
controlled, single-case experimental designs (e.g., multielement, reversal) to conduct analyses and 

 
 
 
 
 
 
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test clinical hypotheses for each child in which subjects serve as his/her own control. We will 
interpret assessment and treatment results for each child using structured, visual inspection criteria 
developed and refined by our research team, which have demonstrated reliability, validity, and 
power to detect differences between test and control conditions with individual children 
(within-subject; each child serves as his/her own control).38,39 A large amount of our methodology 
will be performed as our standard-of-care procedures in a severe behavior program.  
 
Children referred to the Severe Behavior program engage in severe destructive behavior such as 
aggression, property destruction, or self-injurious behavior for several different reasons. That is, 
their destructive behavior may be evoked (or triggered) by commonly occurring situations such as 
having a preferred toy or snack removed, being asked to do schoolwork or chores or having a 
caregiver too busy to pay attention to them at the moment. The research activities will not introduce 
any new triggers other than those that maintain destructive behavior in the natural environment. 
For example, in the course of the research, we may determine (using functional analysis methods) 
that a child’s aggression is maintained by escape from non-preferred tasks, and we will present 
these work tasks throughout the study. We will present these tasks in order to teach the child to 
ask for a break instead of engaging in aggression, and in order to determine whether the use of a 
multiple schedule (signals for periods in which the child will be given a break if (s)he asks and 
periods when (s)he needs to do her work) will mitigate relapse of aggression during common 
treatment challenges. While none of the research procedures will expose children to evocative 
situations that do not occur in their natural (home or school) environment, there is still the likelihood 
that we will see temporary increases in destructive behavior during (a) assessment (i.e., functional 
analysis), (b) when increasing the amount of time that the child needs to wait or work without getting 
his or her way (i.e., schedule thinning), and (c) during treatment challenges (i.e., tests for 
resurgence). The following procedures are in place to minimize risk to subjects. All therapists 
participating in the study will receive formal training on how to appropriately and safely block 
problem behavior in a manner that minimizes risks of harm. For example, if a child engages in self-
injurious behavior in the form of hand-to-head hitting, therapists working with the child will stay 
within arms reach of the child at all times and carry small pads which can be used to reduce the 
impact of the self-injurious behavior. If the child’s problem behavior appears to escalate to unsafe 
levels, the session will be ended and clinically-approved measures will be taken to ensure the 
safety of the child. 
 
Experiment 1: Clinical study on treatment duration.  
 
Our preliminary data40 suggest that DRA treatments for destructive behavior like those described 
below consistently produce at least 85% reduction in baseline rates of destructive behavior after 1-
4 DRA sessions. Based on these results, we will set the length of our short-duration condition to 
approximately 4 sessions. RaC predicts that this short duration of DRA will produce high 
magnitudes of resurgence during a resurgence test but less resurgence than predicted by BMT. 
We will compare this short-duration condition with a moderate-duration condition (i.e., 
approximately 8 sessions of DRA) and an extended-duration condition (i.e., approximately 32 
sessions of DRA). RaC predicts that, relative to the short-duration condition, the moderate-duration 
condition will reduce resurgence only slightly, but the extended-duration condition will reduce 
resurgence considerably. Each of three durations of DRA (i.e., short, moderate, and extended) will 

 
 
 
 
 
 
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consist of three phases, a baseline phase, a treatment phase (i.e., DRA), and an extinction phase 
(i.e., resurgence test). We will conduct this progression of phases three times per participant (i.e., 
one progression for each duration of DRA), with each progression occurring in a novel stimulus 
context (i.e., three contexts per participant assigned to conditions 
randomly), to minimize carryover effects. 
 
Baseline- and DRA-progressive-interval assessment. We will conduct a brief, progressive-interval 
assessment (PIA) to identify a sufficiently dense schedule of reinforcement for use in subsequent 
baseline and DRA sessions. The assessment will be identical to the functional-analysis condition 
with the highest rates of destructive behavior (e.g., the attention condition of the functional analysis 
for attention-reinforced destructive behavior) with the following exceptions: (a) initially, destructive 
behavior will be reinforced on a dense schedule of reinforcement, (b) periods of nonreinforcement 
will begin and increase after every two reinforcer deliveries, and (c) the assessment will end after 
two reinforcement deliveries corresponding to a nonreinforcement period of 180 s or if untoward 
effects are observed (i.e., a burst of destructive behavior or negative emotional responding). We 
will use the results of the PIA to select a dense schedule of reinforcement that does not produce 
bursts of destructive behavior nor negative vocalizations for use in the baseline and DRA phases. 
 
Stimulus contexts. Reinforcement effects tend to be specific to the stimulus context in which 
reinforcement is delivered.41 Therefore, we will compare the effects of different durations of DRA 
(i.e., short, moderate, and extended) in equivalent but distinct stimulus contexts. We will correlate 
each stimulus context with a color, counterbalanced across participants and DRA durations. For 
example, we will use a blue overhead light, blue alternative communication card, and blue therapist 
clothing in one progression (e.g., short-DRA duration). We will correlate another progression (e.g., 
moderate-DRA duration) with yellow, and the final progression (e.g., extended-DRA duration) with 
red. 
Baseline. The baselines will be identical to the functional-analysis condition associated with the 
highest levels of destructive behavior (e.g., the attention condition for attention-reinforced 
destructive behavior), except that we will reinforce problem behavior according to a dense, 
intermittent schedule of reinforcement, using the schedule identified from the PIA. To obtain stable 
rates of destructive behavior across the baseline conditions, data collection will continue for at least 
five sessions in each condition once the data in each condition meet the following stability criteria: 
(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. 
 
DRA Training. Once the above stability criteria have been met, DRA training will begin in a separate 
stimulus context (e.g., in a room without an overhead light, with a white alternative communication 
card and white therapist clothing). In most cases, exchanging a card with a picture of the child 
consuming the reinforcer (e.g., attention) will be used as the functional (alternative) communication 
response (FCR) because it can be effectively prompted using gentle physical guidance regardless 
of the child's functioning level (but other response options, such as card touches or vocal 
responses, may be used). Reinforcers for the alternative behavior are those functional reinforcers 
identified in the functional analysis (i.e., the consequence that maintains problem behavior in the 
natural environment, and the same reinforcer used in baseline). For example, the reinforcer for a 
child with escape-maintained problem behavior would be a break from academic, pre-academic, 

 
 
 
 
 
 
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household, or daily living tasks, whereas the reinforcer for a child with attention-maintained problem 
behavior would be access to attention (e.g., playing, chatting) from an adult, and the reinforcer for 
a child with problem behavior maintained by access to tangibles will be a specific toy or food. DRA 
training will be identical to baseline, except that the therapist will (a) not provide reinforcement for 
destructive behavior (extinction) and (b) use gentle physical guidance to prompt the FCR, 
increasing the delay to physical guidance as the child learns the FCR while displaying little or no 
destructive behavior. 
 
Training will vary across participants depending on the functional reinforcer identified in the 
functional analysis assessment that precedes all research procedures. The appropriate functional 
communication response for a participant will be determined by the doctoral-level case manager 
based on functioning level and existing communication repertoire. For participants for whom the 
functional reinforcer (that is, the consequence that maintains problem behavior in the home or 
school) is identified as attention, pretraining will involve the following steps. First, the therapist will 
provide approximately 1 minute of high-quality attention (e.g., chatting, playing, tickles). Second, 
the therapist will briefly remove attention (i.e., pretend to read a book or magazine or do some 
work). Third, a second therapist will prompt the functional communication response. The prompt 
might be hand-over-hand guidance if the child is being taught to use a card exchange as a 
functional communication response for attention. The prompt might be a point prompt (pointing to 
the card) if the child is being taught to use a card touch as the functional communication response 
for attention. The prompt might be a vocal model prompt (e.g., “say ‘play with me’) if the child is 
being taught to use a vocal functional communication response for attention. Fourth, as soon as 
the participant responds to the prompt by emitting the functional communication response, the 
therapist will again provide high-quality attention. In initial sessions (a session consists of ten trials 
in which attention is removed, a prompt is given, and attention is returned), the child will be 
prompted immediately after attention is removed (i.e., a 0-second prompt delay). The prompt delay 
will be increased systematically across sessions (i.e., from 0-s delay to 2-s delay after 2 consecutive 
sessions with 80% or above prompted or independent responding) according to the following 
progression: 0-s, 2-s, 5-s, 10-s. Training will continue until the participant is responding 
independently (i.e., without a prompt) for 80% of trials in two consecutive sessions. 
 
For participants for whom the functional reinforcer (that is, the consequence that maintains problem 
behavior in the home or school) is identified as tangible, pretraining will involve the following steps. 
First, the therapist will provide approximately 1 minute of access to the specific toy or food. Second, 
the therapist will briefly remove the toy or food. Third, a second therapist will prompt the functional 
communication response. The prompt might be hand-over-hand guidance if the child is being 
taught to use a card exchange as a functional communication response for the toy or food. The 
prompt might be a point prompt (pointing to the card) if the child is being taught to use a card touch 
as the functional communication response for the toy or food. The prompt might be a vocal model 
prompt (e.g., “say ‘toy please’”) if the child is being taught to use a vocal functional communication 
response for the toy or food. Fourth, as soon as the participant responds to the prompt by emitting 
the functional communication response, the therapist will again provide the toy or food for the child 
to play with or consume. In initial sessions (a session consists of ten trials in which the toy or food 
is removed, a prompt is given, and the toy or food is returned), the child will be prompted 
immediately after the toy or food is removed (i.e., a 0-second prompt delay). The prompt delay will 

 
 
 
 
 
 
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be increased systematically across sessions (i.e., from 0-s delay to 2-s delay after 2 consecutive 
sessions with 80% or above prompted or independent responding) according to the following 
progression: 0-s, 2-s, 5-s, 10-s. Training will continue until the participant is responding 
independently (i.e., without a prompt) for 80% of trials in two consecutive sessions. 
 
For participants for whom the functional reinforcer (that is, the consequence that maintains problem 
behavior in the home or school) is identified as escape, pretraining will involve the following steps. 
First, the therapist will provide approximately 1 minute of break time (i.e., the child is not required 
to do schoolwork, housework, pre-academic tasks, activities of daily living, etc. Second, the 
therapist will briefly present instructions to do tasks using a tell-show-do procedure (i.e., giving an 
instruction, modeling completion of the task, and prompting the child to complete the task). Third, 
a second therapist will prompt the functional communication response. The prompt might be hand-
over-hand guidance if the child is being taught to use a card exchange as a functional 
communication response for escape from demands. The prompt might be a point prompt (pointing 
to the card) if the child is being taught to use a card touch as the functional communication response 
for escape from demands. The prompt might be a vocal model prompt (e.g., “say ‘break please’”) 
if the child is being taught to use a vocal functional communication response for escape from 
demands. Fourth, as soon as the participant responds to the prompt by emitting the functional 
communication response, the therapist will remove all instructions and demand materials. In initial 
sessions (a session consists of ten trials in which the toy or food is removed, a prompt is given, 
and escape from demands is provided), the child will be prompted immediately the therapist begins 
delivering instructions (i.e., a 0-second prompt delay). The prompt delay will be increased 
systematically across sessions (e.g., from 0-s delay to 2-s delay after 2 consecutive sessions with 
80% or above prompted or independent responding) according to the following progression: 0-s, 
2-s, 5-s, 10-s. Training will continue until the participant is responding independently (i.e., without 
a prompt) for 80% of trials in two consecutive sessions. 
 
DRA. During DRA, each therapist will (a) discontinue reinforcement for destructive behavior 
(extinction) and (b) use a dense, intermittent schedule of reinforcement for independent (not 
guided) FCRs. The number of DRA sessions will depend on the current DRA-duration condition 
(i.e., short = approximately 4, 10-min sessions, moderate = approximately 8, 10-min sessions, or 
extended = approximately 32, 10-min sessions). Following each duration of DRA, participants will 
begin the resurgence test. 
 
Resurgence Test. Next, we will discontinue reinforcement (i.e., program extinction) for the 
alternative response (i.e., the FCR), while problem behavior continues to go unreinforced. This 
condition will mimic lapses in the integrity with which caregivers often implement treatment in the 
home, school, or community settings. This phase will continue until the rate of destructive behavior 
is approximately 90% lower than its baseline mean for two consecutive sessions. We expect large 
differences in resurgence of destructive behavior between the extended-DRA condition and the 
short-DRA condition and a small-to-nonsignificant effect for the other paired comparisons (i.e., 
short vs. moderate and moderate vs. extended). 
 
Experiment 2: Clinical study on schedule thinning. 
 

 
 
 
 
 
 
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We will develop and then assess an alternative schedule-thinning progression for use with children 
receiving DRA for destructive behavior that we predict to greatly reduce or prevent resurgence of 
destructive behavior during schedule thinning. One advantage of RaC over BMT is that with RaC 
we can update our prediction model dynamically after each session during schedule thinning. The 
prediction of RaC regarding how many reinforcers should be programmed for the next session 
would change as a result of this recent episode of responding (or lack thereof). We will use this 
feature of RaC to guide schedule thinning in our test group. The control group will be based on 
typical responding during reinforcer-schedule thinning observed in the published literature, much 
of which is based on research from our own clinic (see below). Thus, we do not intend to enroll 
participants prospectively into the control group. Baseline, DRA training, DRA, and stimulus 
context. Baseline, DRA training, and DRA procedures will be identical to those conducted in 
Experiment 1 except that destructive behavior and the alternative response (i.e., the FCR) will be 
reinforced on a continuous (or near-continuous) schedule in baseline and DRA sessions, 
respectively. DRA training will be conducted in a manner identical to the procedures used in 
Experiment 1. The baseline and DRA sessions will continue until the stability criteria specified for 
Experiment 1 are met. All sessions will be conducted within one stimulus context, as described 
above. 
 
DRA schedule thinning. Following an initial demonstration of the efficacy of DRA in which the 
participant is taught the FCR to access the reinforcer maintaining problem behavior, we will initiate 
DRA schedule thinning by introducing and then systematically lengthening periods of time in which 
that reinforcer is unavailable. Periods in which the reinforcer is available and unavailable will be 
signaled using strategies most relevant to the child's treatment and skill-level, such as different 
colored stimuli (e.g., green and red wristbands), the presentation and absence of work materials, 
or the presentation and absence of the communication materials. For schedule-thinning steps, we 
will use the quantitative models of RaC Theory and the results of a corresponding study with 
nonhuman animals to dynamically adjust each upcoming schedule-thinning step. We will use 
additional teaching procedures (e.g., prompting, blocking) as necessary to facilitate schedule 
thinning, as we would clinically. DRA schedule thinning will continue until the stability criteria 
specified for Experiment 1 are met under terminal schedules that are similar to those found within 
our control group. We will then compare these data to a control group consisting of the published 
data depicted in Briggs et al.27 and reviewed by Saini et al.42 We will compare our results from the 
test group in the current study to the published data to determine whether RaC-informed schedule 
thinning substantially reduced resurgence compared to traditional schedule-thinning methods 
published in the literature. 
 
 
B. Data Points 
Dependent variables and measurement. The primary dependent measure will be the rate of 
destructive behavior (aggression, property destruction, self-injurious behavior) assessed via direct 
observation. Aggression will be defined as forceful pushing or striking others with body parts (e.g., 
pushing, hitting, kicking, head-butting), hitting others with objects or throwing objects at others, 
pinching, scratching, or biting. Property destruction will be defined as forceful banging, throwing, 
overturning, tearing or climbing on objects not made for that purpose. Self-Injurious Behavior will 
be defined as forceful striking, scratching, rubbing, poking or biting ones own body parts such that 

 
 
 
 
 
 
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repetition of the behavior has or will cause bodily injury (e.g., head punching or banging, eye-
poking). Observation, blinding, reliability, and validity of dependent and procedural-integrity 
measures. Trained observers will collect data on child destructive behavior and therapist   
implementation of the assessment and treatment protocols to assess procedural integrity using 
BDataPro®42, 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 research questions and hypotheses for one half (17%) of these sessions. For at least one 
third of sessions, observers will collect procedural-integrity data to determine whether the 
assessment and treatment protocols are implemented as planned. That is, we will collect data on 
whether therapists correctly implemented the planned antecedents, prompts, and consequences 
for each target response. We 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. (reliability).  
 
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, we 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. We 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% on any dependent measure for 3 consecutive 
sessions. We recently completed the first calibration study to determine the accuracy of continuous 
recording of direct-observation measures of behavior.43 In this study, five novice and five 
experienced observers recorded response samples on laptop computers with a priori determined 
response rates ranging from 0 to 8 responses per minute, which covered the range of 90% of the 
data sets published in the Journal of Applied Behavior Analysis, the flagship journal of applied 
behavior analysis. Results showed that the experienced observers recorded rates that were 
accurate to within ± 0.2 responses per minute (M = ± 0.12). Observers for this project will be 
comparably experienced and accurate. In addition to its accuracy, direct-observation measures 
have several advantages over other assessments (e.g., rating scales) in terms of validity. Because 
target behaviors are directly measured, issues related to construct and predictive validity are not 
relevant (i.e., no need to predict or estimate a criterion variable when it is measured directly). 
Instead, direct-observation measures are judged primarily in terms of their face validity (e.g., Does 
the operational definition of aggression match the everyday meaning of the term?) and content 
validity (e.g., Do the topographies of destructive behavior measured in this project adequately cover 
the ones included in prior investigations?).44 We developed the current definitions of destructive 
behavior based on recommendations of an NIH consensus conference45 and subsequent reviews 
of the literature.15 
C. Study Duration 
We will conduct routine-clinical and study-specific procedures with each participant approximately 
3 to 6 hours per day for approximately 5 days per week for about 8-16 weeks. We expect the study-
specific procedures to last approximately 3 weeks during each participant’s clinical admission. 
Therapists will conduct approximately 15 to 30 sessions daily per participant. 
D. Endpoints 

 
 
 
 
 
 
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The primary endpoint for Study 1 will be a rate of destructive behavior that is approximately 90% 
lower than the baseline mean for two consecutive sessions. The primary endpoint for Study 2 will 
be stable responding (standard deviation not exceeding 50% of the mean), under a terminal 
schedule that is similar to those found within our control group. 
1.4 Preliminary Data 
 
Our preliminary data40 suggest that DRA treatments for problem behavior like those described below 
consistently produce at least an 85% reduction in baseline rates of problem behavior after 1 to 4 DRA 
sessions. Based on these results, we will set the length of our short-duration condition to 4 sessions. RaC 
predicts that this short duration of DRA will produce high magnitudes of resurgence during a resurgence 
test, but less resurgence than predicted by BMT. We will compare this short-duration condition with a 
moderate duration condition (i.e., 8 sessions of DRA), and an extended-duration condition (i.e., 32 sessions 
of DRA). RaC predicts that, relative to the short-duration condition, the moderate-duration condition will 
reduce resurgence only slightly, but the extended-duration condition will reduce resurgence considerably. 
 
1.5 Sample Size Justification 
 
With a minimum expected reduction in the per-case prevalence of 50% across 12 participants, we 
estimate a power of 0.89 with alpha=0.05. In addition, on a per-schedule-step basis, the power increases 
to 0.98 with alpha=0.05. We will assess the adequacy of RaC and BMT in describing the data.  
 
1.6 Study Variables 
 
A.   Independent Variables, Interventions, or Predictor Variables  
 
Study 1. 
 
Extended DRA. This intervention involves conducting DRA treatment for approximately 32 sessions.  
 
Moderate DRA. This intervention involves conducting DRA treatment for approximately 8 sessions. 
 
Short DRA. This intervention involves conducting DRA treatment for approximately 4 sessions. 
 
Study 2. 
RaC-Informed Schedule Thinning. For schedule-thinning steps, we will use the quantitative models of 
RaC Theory and the results of a corresponding study with nonhuman animals to dynamically adjust 
each upcoming schedule-thinning step. We will use additional teaching procedures (e.g., prompting, 
blocking) as necessary to facilitate schedule thinning, as we would clinically. 
 
Traditional Schedule Thinning. We will look to the published literature to identify studies in which 
schedule-thinning was conducted arbitrarily (i.e., not in accordance with the predictions of RaC). 
 
B.  Dependent Variables or Outcome Measures  
 

 
 
 
 
 
 
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Study 1. 
 
Rate of destructive behavior during the Resurgence Test following Extended DRA. We will collect 
continuous, direct-observation measures of destructive behavior throughout all phases of the study.  
 
Rate of destructive behavior during the Resurgence Test following Moderate DRA. We will collect 
continuous, direct-observation measures of destructive behavior throughout all phases of the study.  
 
Rate of destructive behavior during the Resurgence Test following Short DRA. We will collect 
continuous, direct-observation measures of destructive behavior throughout all phases of the study.  
 
Study 2. 
 
Rate of destructive behavior during RaC-informed Schedule Thinning. We will collect continuous, 
direct-observation measures of destructive behavior throughout all phases of the study. 
 
Rate of destructive behavior during Traditional Schedule Thinning. We will collect continuous, direct-
observation measures of destructive behavior throughout all phases of the study. 
 
 
1.7 Drugs/Devices/Biologics  
Not Applicable 
  
A. Drug/Device Accountability and Storage Methods 
Not Applicable 
 
1.8 Specimen Collection 
 
A. Primary Specimen Collection 
Not Applicable 
▪ 
Types of Specimens: Not Applicable 
▪ 
Annotation: Not Applicable 
▪ 
Transport: Not Applicable 
▪ 
Processing: Not Applicable 
▪ 
Storage: Not Applicable 
▪ 
Disposition: Not Applicable 
 
B. Secondary Specimen Collection 
Not Applicable 
▪ 
Types of Specimens: Not Applicable 
▪ 
Annotation: Not Applicable 
▪ 
Transport: Not Applicable 
▪ 
Storage: Not Applicable 
▪ 
Disposition: Not Applicable 
 

 
 
 
 
 
 
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1.9 Data Collection 
 
A. Primary Data Collection 
▪ 
Location: We will conduct the study within the Severe Behavior Program at CSH–RUCARES. 
We will conduct initial assessment and treatment in rooms with an adjacent observation 
window for unobtrusive measurement of behavior. We plan for almost all rooms to contain 
padded walls and floors to maintain patient and staff safety.  
 
We will also conduct the study within research rooms of the DDDC. We will conduct the study 
within rooms with an adjacent observation window for unobtrusive measurement of behavior. 
All research rooms contain padded walls and floors and are approximately 3 meters by 2 
meters. 
 
▪ 
Process of Data Collection: Trained observers will use laptop computers with BDataPro® 
software developed in our lab to score frequency of participant destructive behavior and 
caregiver or therapist behavior. We will define destructive behavior as pushing, pinching, 
scratching, kicking, or biting others; hitting others with body parts or objects; banging, 
throwing, overturning, or tearing objects; climbing on objects not made for that purpose; 
striking, scratching, rubbing, poking or biting self, such that repetition has or will cause injury 
(e.g., eye-poking). We will convert destructive-behavior frequency to a rate by dividing the 
number of destructive responses in a session by the session duration in minutes. We will 
assess procedural integrity by scoring whether therapists correctly implemented the planned 
antecedents, prompts, and consequences for target responses. We will convert correct 
antecedents, prompts, and consequences to a percentage after dividing the number of correct 
responses by the number of correct-response opportunities. 
▪ 
Timing and Frequency: We will collect data continuously during 5- or 10-min sessions during 
the majority of each participant’s appointment (e.g., spending 2.75 hr of a 3-hr appointment in-
session). 
▪ 
Procedures for Audio/Visual Recording: We will video-record most sessions of the 
research for later data collection (e.g., collecting reliability or treatment-integrity data). 
▪ 
Study Instruments: Our study does not use formal research instruments (e.g., 
questionnaires) but instead relies on observational data collection. See below for more 
information. 
▪ 
Ethnographic Studies, Interviews, Or Observation: Trained observers will collect data 
using a specialized data-collection program developed and recently validated by our research 
group 42 A second independent observer will score at least one third of sessions to assess 
data accuracy (i.e., reliability). For at least half of sessions in which reliability data are 
collected (17%), the second data collector will be blind to the experimental conditions and 
study hypotheses. The reliability of direct-observation measures is typically established by 
measuring interobserver agreement, which involves comparing the exact number of target 
behaviors scored in each 10-s observation interval and dividing the number of exact 
agreement intervals by the total number of intervals and multiplying by 100 to determine a 
percentage. We will then use structured visual inspection to analyze each caregiver’s single-
case data sets for both experiments. Members of our research group developed these visual-
inspection procedures, which have been validated and are highly reliable. 38,39 

 
 
 
 
 
 
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▪ 
Subject Identifiers: When recording observational data with BDataPro, the program will 
record the patient’s name and the date/time of data collection. When depicting these data in 
graphical form or in presentation/publication, we will assign the subject a pseudonym. We will 
retain this pseudonym key on a secure network drive within a password-protected 
spreadsheet available only to the study personnel. 
 
B. Secondary Data Collection  
Not Applicable 
▪ 
Type of Records: Not Applicable 
▪ 
Location: Not Applicable 
▪ 
Inclusion/Exclusion: Not Applicable   
▪ 
Data Abstraction Form(s): Not Applicable 
 
1.10 Timetable/Schedule of Events 
Dr. Shahan (Utah State University) will coordinate the project and meet with the clinical team (Greer and 
Fisher) via teleconference monthly and in person twice yearly. Such meetings will ensure the methods and 
analyses of the clinical studies are informed by incoming results from the animal studies and that the animal 
studies remain clinically relevant based on incoming clinical data. We will adjust studies in both domains 
as needed to meet these goals. 
 
If the first animal experiment conducted at Utah State University (Experiment 1 in the grant and figure 
below) shows that cycles of on/off DRA reduce resurgence in animals, we will examine this procedure in 
the clinic in a subsequent project period. Should Study 2 of the present application (Exp. 4 in the grant and 
figure below) find that the RaC-informed, schedule-thinning procedure is more effective than the standard 
procedure in the clinic, a new R01 will propose a randomized clinical trial. If differences in response effort 
or reinforcer quality in Exp. 6 and 8 (animal studies conducted at Utah State) impact resurgence in animals 
as predicted, later experiments will examine such effects in the clinic. If increases in alternative-response 
effort produce resurgence as predicted in Exp. 7, we will later conduct an experiment (akin to Study 2 / Exp. 
4) in the clinic in which a RaC-informed effort increasing procedure is developed to minimize resurgence. 
Future animal studies could examine how other factors common with DRA in the clinic impact resurgence. 
RaC makes specific predictions about how punishment, changes in motivating operations, and training of 
multiple alternative responses affect resurgence. Finally, should RaC poorly describe the data from the 
present project, we will work to refine the theory. We are confident a matching-law based approach to DRA 
and resurgence has considerable merit, but RaC is currently based on specific assumptions about how 
changing reinforcement conditions affect the value of the target and alternative behaviors (e.g., hyperbolic 
decay via the temporal weighting rule). Although these assumptions work well with existing data, data from 
this project will be critical for assessing these assumptions further and, if needed, refining them to improve 
predictions about how to reduce resurgence in the clinic. 
 

 
 
 
 
 
 
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2.0 Project Management 
 
2.1 Research Staff and Qualifications 
 
Dr. Greer is the director of the Severe Behavior Program at CSH–RUCARES, assistant director of 
RUCARES, and an assistant professor of Pediatrics at Rutgers. Previously, Dr. Greer was the associate 
director of the Severe Behavior Program in the Center for Autism Spectrum Disorders and an assistant 
professor at the UNMC. Dr. Greer received his Ph.D. in behavioral psychology from the University of 
Kansas in 2013. He later completed a postdoctoral fellowship at the UNMC’s Munroe-Meyer Institute 
under the direction of Dr. Wayne Fisher. He has served on the Board of Editors for the Journal of 
Applied Behavior Analysis and currently serves as an associate editor for Behavioral Development. Dr. 
Greer is the 2013 recipient of the Baer, Wolf, and Risley Outstanding Graduate Student Award, and he 
received the National Institutes of Health’s Loan Repayment Program Award in 2016. 
 
Dr. Fisher is the Henry Rutgers Endowed Professor of Pediatrics, RWJMS and the director of Rutgers 
Center for Autism Research, Education and Services (RUCARES). He is a board-certified behavior 
analyst at the doctoral level, and a licensed psychologist. Previously, Dr. Fisher was the H.B. Munroe 
professor of behavioral research in the UNMC’s Munroe-Meyer Institute and the Department of 
Pediatrics. During this time he was also is the director of the Center for Autism Spectrum Disorders at 
the Munroe-Meyer Institute. Prior to his time at the Munroe-Meyer Institute, he was a professor of 
psychiatry at Johns Hopkins University School of Medicine and served as executive director of the 
Neurobehavioral Programs at the Kennedy Krieger Institute and the Marcus Behavior Center at the 
Marcus Institute, where he built clinical-research programs in autism and developmental disabilities 
with national reputations for excellence. Dr. Fisher’s methodologically sophisticated research has 
focused on several intersecting lines including preference, choice, and the assessment and treatment 
of autism and severe behavior disorders. His research has been notable for the creative use of 
concurrent schedules of reinforcement, which have become commonplace in clinical research primarily 

 
 
 
 
 
 
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due to his influence. He has published over 180 peer-reviewed papers in over 35 different behavioral 
and medical journals, including: Journal of Applied Behavior Analysis, Psychological Reports, American 
Journal on Developmental and Developmental Disabilities, Pediatrics, Journal of Developmental and 
Behavioral Pediatrics, and The Lancet. Dr. Fisher has had near-continuous federal grant support for 
his research for 19 years. He is a past Editor-in-Chief and past Associate Editor of the Journal of Applied 
Behavior Analysis, a past president of the Society for the Experimental Analysis of Behavior, a fellow 
in the Association for Behavior Analysis International (ABAI) and a recipient of the Bush Leadership 
Award, the American Psychological Association’s (APA; Division 25) Award for Outstanding 
Contributions to Applied Behavioral Research, the UNMC Distinguished Scientist Award, the University 
of Nebraska system-wide Award for Outstanding Research and Creative Activity, and the Society for 
the Experimental Analysis of Behavior’s Don Hake Translational Research Award. 
 
 
2.2 Research Staff Training 
 
The principal investigator, secondary investigator, and key personnel will meet with research staff at 
least 2 hours per week to review research data and protocols. Postdoctoral personnel will train and 
supervise research assistants and monitor data collection and protocol implementation. Postdoctoral 
personnel will meet daily with the clinical-research team and observe protocol implementation daily 
for 1 hour per participant.  
 
The investigators will train all staff to implement assaultive-behavior-management procedures to 
criterion and maintain criterion levels of clinical performance. Staff will receive periodic retraining and 
investigators will collect data on participant and team physical status and behavior during all 
procedures to monitor for safety and treatment fidelity. The principal investigator and coinvestigators 
will approve, oversee, and monitor the assaultive-behavior-management procedures and 
accompanying participant and team data and problem solve about participants or situations that are 
associated with increased injury or that teams report are more problematic than usual. The principal 
investigator and co-investigators will be on-call throughout the day to provide support in difficult 
situations. 
 
Examples of components that the principal investigator and co-investigators will monitor are correct 
context and color, scheduling and implementing the DRA components in the correct order and 
duration, ensuring that participant responding meets the stability criterion before a phase change, and 
implementing schedule thinning procedure correctly. In our routine clinical practice, one full-time 
psychologist or doctoral-level behavior analyst will supervise the treatment of three to five children 
with severe destructive behavior simultaneously. Supervisors will maintain this small caseload 
because patients will typically receive treatment for 3 to 6 hours per day, 5 days per week and will 
have severe and complex destructive behavior. For the current project, the principal investigator and 
co-investigators will maintain a similar caseload to provide the level of supervision necessary to 
ensure that the clinical-research team manages the participants using appropriate and safe 
assaultive-behavior-management procedures; follows research protocols with high procedural 
integrity; collects reliable data; and accurately analyzes, graphs, and interprets the data. As indicated 
above, the research team will meet daily to review participant data. Based on our clinical experience, 

 
 
 
 
 
 
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the principal investigator and co-investigators often review data, observe sessions, and problem solve 
with the team multiple times per day. 
 
2.3 Resources Available 
 
CSH–RUCARES includes an indoor playroom, multiple self-contained therapy rooms, some of which 
are equipped with one-way observation windows and padded floors and walls. The clinic is fully 
equipped with furniture, office equipment, computers, digital audio-visual recording equipment, and 
support staff. The clinic has multiple faculty members, administrative staff, and enough therapists to 
maintain a staff-to-client ratio equal to or greater than 2:1. Therapists have training ranging from the 
baccalaureate to postdoctoral level. All staff are trained in CPR and safe management of assaultive 
behavior. 
 
Children treated by the clinic spend up to 6 hours per day in behavior-therapy sessions. Based on the 
needs of each child, the child’s treatment team develops a program to increase functional 
communication, social, and daily living skills and decrease challenging behavior. The faculty in the clinic 
supervise therapy sessions and the therapeutic milieu. Therapists collect and graph direct-observation 
data on target skills and behaviors. Each faculty member and therapist has a laptop computer capable 
of analyzing and graphing data. The therapists graph session-by-session data, and the therapist and 
faculty review and analyze the data throughout the day. The treatment team uses these data to 
systematically guide assessment and evaluate and refine treatment development. The team 
systematically evaluates treatment components using single-case experimental designs; they refine or 
replace ineffective components until discharge goals are achieved. Each child’s progress receives peer 
review multiple times per week by senior behavior analysts and staff.  
 
The research will also be conducted in one or two research rooms in a self-contained area of the DDDC. 
These rooms are equipped with an adjacent observation window for unobtrusive measurement of 
behavior by caregivers/research assistants. All research rooms contain padded walls and floors and 
are approximately 3 meters by 2 meters. 
 
2.4 Research Sites 
CSH–RUCARES 
 
888 Easton Avenue 
 
Somerset, New Jersey 08873 
 
Douglass Developmental Disabilities Center 
151 Ryders Lane 
New Brunswick, New Jersey 08901-8557 
 
3.0 Multi-Center Research 
N/A 
4.0 Subject Considerations 
 
4.1 Subject Selection and Enrollment Considerations  

 
 
 
 
 
 
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A. Method to Identify Potential Subjects 
Potential subjects will be identified within the patient population of the clinic on the basis of meeting 
the inclusion criteria below. 
 
B. Recruitment Details 
The clinical team will recruit subjects from the clinical population of children receiving treatment for 
severe problem behavior. The team will approach the caregivers of children who meet the inclusion 
criteria below early on in their admission and will conduct the process of consent with caregivers 
who express interest in having their children participate in the study. 
 
C. Subject Screening 
Members of the research team involved in clinical care of the patients will evaluate each patient 
consecutively admitted to the program for participation in the research based on an 
interdisciplinary- evaluation and functional-analysis results. We will consider any patient who meets 
the inclusion criteria eligible for participation.  
 
Inclusion criteria. 
(a) males and females between the ages of 3 and 17; 
(b) problem behavior (e.g., aggression, property destruction, self-injurious behavior) that 
has been the focus of outpatient behavioral and pharmacological treatment but continues 
to occur, on average, more than once per hour; 
(c) problem behavior reinforced by social consequences (i.e., significantly higher and 
stable rates of the behavior in one or more social test conditions of a functional analysis 
[e.g., attention, escape] relative to the control condition [play] and the test condition for 
automatic reinforcement [alone or ignore]); 
(d) IQ and adaptive behavior scores between 35 and 70 (i.e., mild to moderate 
intellectual disability); 
(e) on a stable psychoactive drug regimen (or drug free) for at least 10 half-lives of each 
medication with no anticipated changes; 
(f) stable educational plan and placement, with no anticipated changes during the study. 
 
Exclusion criteria. 
(a) children not meeting the inclusion criteria above; 
(b) children currently receiving intensive (i.e., 15 or more hours per week), function-
based, behavioral treatment for their problem behavior through the school or another 
program; 
(c) DSM-V diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn 
error of metabolism); 
(d) presence of a comorbid health condition (e.g., blindness) or major mental disorder 
(e.g., bipolar disorder) that would interfere with participation in the study (e.g., requiring 
frequent hospitalizations); 
(e) children with self-injurious behavior who, based on the results of the risk assessment, 
cannot be exposed to baseline conditions without placing them at risk of serious or 
permanent harm (e.g., detached retinas); 

 
 
 
 
 
 
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(f) children requiring changes in drug treatment (but such children will be invited to 
participate after they meet the above criteria for a stable drug regimen). 
 
4.2 Secondary Subjects 
Not Applicable 
 
4.3 Number of Subjects 
 
A. Total Number of Subjects 
We conservatively estimate at least 60% of patients receiving clinical treatment in our program will 
meet the inclusion criteria. During the project, we will recruit 22 (12 for study 1 and 10 for Study 2) 
and retain 20 children with severe destructive behavior. We expect 10% attrition. 
B. Total Number of Subjects If Multicenter Study 
Not Applicable 
C. Feasibility 
We will recruit 22 and retain 20 children with severe destructive behavior from the Severe Behavior 
Program. We will recruit 12 and retain 11 children for Study 1, and we will recruit 10 and retain 9 
children for Study 2.  We conservatively estimate at least 60% of patients will meet the criteria (n = 
45 per year available; eight per year needed, maximum). The research team will communicate the 
recruitment plan to all case managers in the Severe Behavior Program so that case managers can 
recommend relevant participants. The principal investigator and research staff will meet to discuss 
recruitment status and resolve any issues related to recruitment. 
 
Additionally, the DDDC has 10 classes with a class size between 5 and 8 patients. Thus, the DDDC 
has between 50 and 80 patients at a given time. The majority of patients have a diagnosis of ASD, 
and a large minority of patients are reported to display destructive behavior. We expect that roughly 
5-10 patients will be appropriate for the study, and recruitment is deemed feasible. 
 
 
4.4 Consent Procedures 
 
A. Consent Process 
▪ 
Location of Consent Process 
The consent process will take place in a private area such as a conference room to allow the 
caregivers to reflect on their child’s participation in the study in a quiet environment. The 
consent process may also take place remotely via telephone or video conference (e.g., 
Zoom) for caregivers who do not attend appointments in person. Consent forms will be 
physically sent home to caregivers to obtain signatures if the consent process does not occur 
in person. 
▪ 
Ongoing Consent 
Not Applicable 
▪ 
Individual Roles for Researchers Involved in Consent 
Primary or secondary investigators or participating personnel who are credentialed as Board 
Certified Behavior Analysts will provide caregivers with an overview of the study and the 
consent process. These investigators will ask questions to ensure that the caregivers 

 
 
 
 
 
 
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understand the documents presented to them and will refer any of their concerns to the 
primary investigator. Providers at the DDDC who are aware of the inclusion criteria for this 
protocol will identify potential participants from their site; however, only the research team 
from CSH–RUCARES listed on this IRB will approach caregivers regarding participation and 
conduct consent with these caregivers. 
▪ 
Consent Discussion Duration 
Parents/guardians will be allowed as much time as they would like to review the research 
procedures that we plan to implement and will be encouraged to take the information home 
to make their decisions. 
▪ 
Coercion or Undue Influence 
We will provide the option for caregivers to include family, friends, an advocate, or other 
confidants.  
▪ 
Subject Understanding 
Investigators will question the caregivers about each section of the consent form to ensure 
that they understand. In addition, we will offer to read the consent to the caregivers.  
 
B. Waiver or Alteration of Consent Process  
▪ 
Waiver or Alteration Details 
We are requesting the omission of the assent portion of the consent document. Assent is 
being waived because the capability of these children (taking into account the ages, maturity, 
and psychological state of the children involved) is so limited that they cannot reasonably be 
consulted. Thus, we will not obtain assent from any subjects. A majority will be diagnosed 
with autism and/or developmental disability and all of our patients engage in high levels of 
destructive behavior (e.g., aggression, self-injury, and property destruction). Thus, the 
children are typically incapable of providing assent to participate in treatment or research 
procedures. In situations in which we have had typically developing children over the age of 7 
as patients at UNMC, it was often still the case that these children are unable to make 
informed decisions regarding the assessment and treatment of their destructive behavior. We 
will conduct the process of consent with the children's caregivers. The children's caregivers 
will be fully informed of the procedure, risks, and benefits. The caregivers have full rights to 
remove their child from the study at any time. If the child's problem behavior appears to 
escalate to unsafe levels, the session will be ended and clinically approved measures will be 
implemented to ensure the safety of the child. 
 
▪ 
Destruction of Identifiers 
We will obtain parental permission for each participant in the study. We will collect the following 
subject identifiers in association with the research data: Name, all elements of dates (except 
year) related to an individual (e.g., birth, admission, discharge, medical record numbers, and 
full-face photographic images). A unique subject identifying code will be used to link data to 
these identifiers. Subject names will be converted to initials during the subject’s participation. 
Following completion, pseudonyms will be assigned to subjects and the pseudonym identifier 
will be encrypted on the server. The justification for recording these specific subject identifiers 
is to schedule appointments and follow up with subjects. Subject identifiers will be maintained 
for a minimum of six years, at which point they will be destroyed with the help of the Rutgers 
IT department. All electronic data (e.g., session data) will be stored on the encrypted server 

 
 
 
 
 
 
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and any hard copy data will be stored in the client's long-term file located in a locked cabinet 
in a locked office. After six years, the IT department will assist with data destruction. During the 
course of the study, we may record sessions for data-collection purposes for children whose 
caregivers. These videos will be recorded through a webcam directly into an encrypted 
computer and stored on the encrypted network drive or encrypted hard drive. We will delete 
these videos six years from the collection date or earlier (if no additional data collection is 
required) 
▪ 
Use of Deception/Concealment 
Not Applicable  
a. Minimal Risk Justification 
Not Applicable 
b. Alternatives 
Not Applicable 
c. Subject Debriefing 
Not Applicable 
 
 
C. Documentation of Consent 
▪ 
Documenting Consent 
At the end of the process of consent, the study representative conducting the process of 
consent will ask the caregiver if they would like their child to participate in the study, and if so, 
they will be asked to sign the consent form. If the consent process occurs remotely, a 
physical copy of the consent form will be sent to the caregiver’s home, and they will be asked 
to return it signed if they would like their child to participate in the study. A copy of the signed 
consent form will be given to the parent or legal guardian, a copy will be scanned into the 
child’s medical record, and a copy will be kept securely (i.e., in a locked cabinet behind a 
locked door) by a primary or secondary investigator. The consent process (including people 
present, time, date, length of the consent process, questions asked, and answers provided) 
will be documented in narrative form in a progress note which is part of the child’s medical 
record. 
▪ 
Waiver of Documentation Of Consent (i.e., will not obtain subject’s signature) 
Not Applicable 
 
4.5 Special Consent/Populations 
 
A. Minors-Subjects Who Are Not Yet Adults  
▪ 
Parental Permission 
Parental permission in the form of parent/legal guardian consent will be the primary form of 
consent obtained in the study.  
▪ 
Non-Parental Permission 
Only parents and legal guardians will be authorized to provide consent for participation in the 
study. 
▪ 
Assent Process 
We will not obtain assent from any subjects. A majority will be diagnosed with autism and/or 
developmental disability and all of our patients engage in high levels of destructive behavior 

 
 
 
 
 
 
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(e.g., aggression, self-injury, and property destruction). Thus, the children are typically 
incapable of providing assent to participate in treatment or research procedures. In situations 
in which we have had typically developing children over the age of 7 as patients at UNMC, it 
was often still the case that these children are unable to make informed decisions regarding 
the assessment and treatment of their destructive behavior. We will conduct the process of 
consent with the children's caregivers. The children's caregivers will be fully informed of the 
procedure, risks, and benefits. The caregivers have full rights to remove their child from the 
study at any time. If the child's problem behavior appears to escalate to unsafe levels, the 
session will be ended and clinically approved measures will be implemented to ensure the 
safety of the child. 
• 
Documentation of Assent 
Not Applicable 
▪ 
Reaching Age of Majority During Study 
Not Applicable 
 
B. Wards of the State 
Not Applicable 
▪ 
Research Outside of NJ Involving Minors 
Not Applicable 
 
C. Non-English-Speaking Subjects 
Non-English speaking subjects will be enrolled in the study. 
▪ 
Process for Non-English-Speaking Subjects 
▪ 
If we encounter a non-English speaking family, we will request to use the short-form 
process as per the eIRB policies. We will use a qualified or certified translator to translate 
the study title into the consenting caregiver’s native language (e.g., Italian), provide the 
translator’s qualifications, and submit the materials to the IRB for review. We will then 
follow the respective short-form policies to use a qualified translator and witness during 
the consent process with the study personnel and family. Because we anticipate frequent 
opportunities to serve Spanish-speaking patients, we have submitted Spanish translation 
of the IRB long form for the IRB’s consideration. For these Spanish-speaking families, we 
will use the translated long form. For all other non-English speaking families, we will 
continue to leverage the short-form process. Additionally, we will include an interpreter to 
conduct the consent process and use such translation services to provide at least weekly 
updates on the subject's participation. Contact information for translation services will be 
made available to the caregivers such that the caregivers can ask questions or refer 
concerns at any point during the study. The caregivers will be told to take as much time 
as needed with the investigators and translator and will be asked questions about each 
section of the consent form to ensure that they understand. 
▪ 
Short Form Consent for Non-English Speakers 
Yes (see above). We anticipate frequent opportunities to serve Arabic-speaking families and 
have therefore included an Arabic short form for consent. 
 
D. Adults Unable to Consent / Cognitively Impaired Adults (for interventional studies) 
Not Applicable 

 
 
 
 
 
 
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▪ 
NJ Law-Assessment of Regaining the Capacity to Consent 
Not Applicable 
▪ 
Capacity to Consent 
Not Applicable 
a. NJ Law-Selecting A Witness  
Not Applicable 
b. Removing a Subject 
Not Applicable 
 
 
4.6 Economic Burden and/or Compensation for Subjects 
 
A. Expenses  
Many of the procedures are clinically indicated and represent the standard of care. 
Procedures that fall in this category will be billed to the participants' health insurance. 
There are no other financial obligations that the subject will incur as a result of participating in 
the study. 
B. Compensation/Incentives 
No compensation or incentives will be provided.  
C.  Compensation Documentation 
Not Applicable. 
  
4.7 Risks of Harm/Potential for Benefits to Subjects 
 
A. Description of Risks of Harm to Subjects 
▪ 
Reasonably Foreseeable Risks of Harm 
There is a potential for child and therapist injury as a result of the child's problem behavior. 
Problem behavior such as aggression, property destruction, or self-injury may be occasioned 
by presenting difficult demands, restricting access to preferred items, or activities or 
restricting access to adult attention. All therapists participating in the study will have received 
formal training on how to appropriately and safely block problem behavior in a manner that 
minimizes these risks. If the child engages in problem behavior that may result in injury to the 
therapist, the therapist will have the option to wear protective equipment during the 
assessment (e.g., arm guards, chest and shoulder pads, etc.). If the child's problem behavior 
appears to escalate to unsafe levels, the session will be ended and clinically approved 
measures will be implemented to ensure the safety of the child. There is also a risk of loss of 
confidentiality. We will minimize this risk by using only Rutgers-approved storage solutions to 
maintain protected health information. 
▪ 
Risk of Harm from an Intervention on a Subject with an Existing Condition 
Not applicable 
▪ 
Other Foreseeable Risks of Harm 
There is also a risk of loss of confidentiality. The loss of confidentiality is unlikely due to the 
use of a secured network hard drive to store all personal identifiers.  
▪ 
Observation and Sensitive Information 

 
 
 
 
 
 
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All observation procedures conducted as part of the study are identical to the observation 
procedures routinely experienced by patients, and are therefore part of the standard of care. 
B. Procedures which Risk Harm to Embryo, Fetus, and/or Pregnant Subjects 
Not applicable 
C. Risks of Harm to Non-Subjects 
Therapists participating in therapy may be exposed to the same risks of bodily harm that they 
would otherwise experience as part of participating in treatment for a child’s severe problem 
behavior. 
D. Assessment of Social Behavior Considerations 
Not Applicable 
E. Minimizing Risks of Harm 
If the child has self-injurious behavior, the initial exam includes an assessment to determine the 
potential health risks associated with this behavior. In our previous program at the Munroe-Meyer 
Institute, we excluded approximately 5% of children admitted to the Severe Behavior Program 
from research participation who had such dangerous forms of self-injurious behavior that it would 
be unsafe to allow the behavior to occur while attempting to complete a functional analysis. The 
clinical supervisors in the Severe Behavior Program will closely monitor individuals admitted to 
the program who display self-injurious behavior to ensure that the tissue damage produced 
during assessment and treatment sessions is not serious, permanent, or even significantly worse 
than what typically occurs in the natural environment. The clinical team will terminate sessions 
and block self-injurious behavior or prevent it with protective equipment if the behavior results in 
reddening, bruising, or bleeding, or if the patient directs the self-injurious behavior toward delicate 
organs (e.g., the eyes). If the clinical team observes soft-tissue symptoms, they will closely 
monitor the symptoms and document them in medical progress notes until the symptoms resolve. 
If symptoms persist or if they are serious and acute, the patient will be seen by a physician or 
taken to the Emergency Room. 
▪ 
Certificate of Confidentiality 
A Certificate of Confidentiality has been obtained from the NIH. All NIH-funded studies are 
automatically issued a Certificate of Confidentiality 
▪ 
Provisions to Protect the Privacy Interests of Subjects 
The team will collect the minimum amount of personal information required to conduct 
effective assessment and treatment of the subject, consistent with clinical practice. No more 
personal information than would be obtained as part of routine treatment for severe problem 
behavior will be obtained from subjects in this study or their caregivers. 
 
F. Potential Benefits to Subjects 
Participants may receive treatment services for their destructive behavior and be taught 
replacement behaviors based on the results of the functional analyses. A reduction in destructive 
behavior may be a result of basing treatment on the functional analyses. 
 
5.0 Special Considerations 
 
5.1 Health Insurance Portability and Accountability Act (HIPAA) 
We will be obtaining, creating, and using individually identifiable health information associated with a 
HIPAA-covered component or entity in the research  

 
 
 
 
 
 
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5.2 Family Educational Rights and Privacy Act (FERPA) 
No student records will be accessed for research purposes. 
 
5.3 NJ Access to Medical Research Act (Surrogate Consent) 
Not Applicable 
 
5.4 General Data Protection Regulation (GDPR) 
Not Applicable 
 
5.5 Code of Federal Regulations Title 45 Part 46 (Vulnerable Populations) 
 
A. Special Populations 
▪ 
Children:  
The purpose of this checklist is to provide support for IRB members or the Designated Reviewer following the WORKSHEET: 
Criteria for Approval (HRP-314) when research involves children as subjects. This checklist must be used for all reviews 
(initial, continuing, modification, review by the convened IRB, and review using the expedited procedure.) 
• 
For initial review using the expedited procedure and modifications and continuing reviews where the determinations 
relevant to this checklist made on the previous review have changed, the Designated Reviewer completes this checklist 
to document determinations required by the regulations along with protocol specific findings justifying those 
determinations. The Designated Reviewer attaches this checklist to “Submit Non-Committee Review” activity. The IRB 
Office retains this checklist in the protocol file. 
• 
For initial review using the convened IRB and for modifications and continuing reviews where the determinations relevant 
to this checklist made on the previous review have changed, one of the following two options may be used: 
1. 
The convened IRB completes the corresponding section of the meeting minutes to document determinations 
required by the regulations along with protocol specific findings justifying those determinations, in which case this 
checklist does not need to be completed or retained. 
2. 
The convened IRB completes this checklist to document determinations required by the regulations along with 
protocol specific findings justifying those determinations and the IRB Office uploads this checklist in the “Submit 
Committee Review” activity and retains this checklist in the protocol file.  
Use a separate checklist for each child determination for a study. 
1 
The research meets all of the following: (Check if “Yes”. All must be checked) 
☒ 
The research falls into one of the following categories of research involving childreni: (Check box that is true) 
☐ Section 2 Criteria 
☒ Section 3 Criteria 
☐ Section 4 Criteria 
☐ Section 5 Criteria 
☒ 
Adequate provisions are made for soliciting the permission of parents or guardiansii. (Complete Section 7) 
☒ 
Adequate provisions are made for soliciting the assent of the children. (Complete Section 12) 
☒ 
One of the following is true: (Check the one that is true) 
☒ The research falls into Section 2 or 3 or does NOT involve wards of the state or any other agency, institution, or 
entity 
☐ The research falls into Section 4 or 5 and involves wards of the state or any other agency, institution, or entity 
(Complete Section 6) 
2 
Research involving children under 21 CFR §50.51/45 CFR §46.404 (Check if “Yes”. All must be checked) 

 
 
 
 
 
 
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☐ 
No greater than Minimal Risk to children is presented. 
Provide protocol specific findings justifying this determination:       
Return to Section 1. 
3 
Research involving children under 21 CFR §50.52/45 CFR §46.405 (Check if “Yes”. All must be checked) 
☒ 
The research involves greater than Minimal Risk to subjects. 
Provide protocol specific findings justifying this determination: There is a potential for child, therapist, and 
parent/caregiver injury as a result of the child's problem behavior. Problem behavior such as aggression, 
property destruction, or self-injury may be occasioned by presenting difficult demands, restricting access to 
preferred items, or 
activities or restricting access to caregiver attention. The risks may be greater during the extinction 
challenge/relapse test. All therapists participating in the study have received formal training on how to 
appropriately and safely block problem behavior in a manner that minimizes these risks. If the child engages in 
problem behavior that may result in injury to the therapist, the therapist will have the option to wear protective 
equipment during the assessment (e.g., arm guards, chest and shoulder pads, etc.). If the child engages in 
problem behavior that may result in injury to the caregiver, the caregiver will have the option for a therapist to 
come in and assist them or to terminate the session. If the child's problem behavior appears to escalate to 
unsafe levels, the session will be ended and clinically-approved measures will be implemented to ensure the 
safety of the child. There is also a risk of loss of confidentiality. The loss of confidentiality is unlikely due to the 
use of a secured network hard drive to store all personal identifiers.     
☒ 
The research presents the prospect of direct benefit to the individual subjects. 
Provide protocol specific findings justifying this determination:    
Participants may receive treatment services for their destructive behavior and be taught replacement behaviors 
based on the results of the functional analyses. A reduction in destructive behavior may be a result of basing 
treatment on the functional analyses.    
☒ 
One of the following is true. (Check box that is true) 
☒ The risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the 
individual subject. 
☐ The risk to children is presented by a monitoring procedure that is likely to contribute to the subject’s well-being. 
Provide protocol specific findings justifying this determination: By programming for common treatment challenges 
(e.g., extinction challenge/relapse test), the clinical team will be able to identify scenarios in which children are 
likely to engage in increased problem behavior after treatment, and may be able to use this information to (a) 
provide additional treatment, (b) adjust or modify the treatment, and/or (c) provide caregiver education that 
may reduce the likelihood of problem behavior recurring at unmanageable levels in the natural environment. 
☒ 
The risk is justified by the anticipated benefit to the subjects. 
Provide protocol specific findings justifying this determination: Children participating in the study are referred for 
treatment because they engage in severe and unmanageable problem behavior. Participants in the study will 
have the functions of their behavior assessed, and have a function-based treatment (FCT) applied to reduce 
their problem behavior. Participants in the study will be taught to engage in socially appropriate 
communication to access what they want, which has been demonstrated to reduce problem behavior 
maintained by escape from demands and access to attention and tangible items.  

 
 
 
 
 
 
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☒ 
The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available 
alternative approaches. 
Provide protocol specific findings justifying this determination: Participants in the study will receive a similar 
treatment to individuals in our clinic who do not participate. That is, all the procedures of the study are 
identical to clinical practice except for the extinction challenge/relapse test, which is conducted solely for 
research purposes. Therefore, the anticipated benefit-risk ratio is similar to that presented by alternative 
approaches.  
Return to Section 1. 
4 
Research involving children under 21 CFR §50.53/45 CFR §46.406 (Check if “Yes”. All must be checked) 
☐ 
The research involves greater than Minimal Risk to children presented by an intervention or procedure that does not 
hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to 
contribute to the well-being of the subject. 
Provide protocol specific findings justifying this determination:       
☐ 
The risk represents a minor increase over Minimal Risk. (“Minor increase over Minimal Risk” means, though the risks 
are greater than minimal, they do not exceed the socially acceptable risks for children with the condition or disorder 
under study.iii) 
Provide protocol specific findings justifying this determination:       
☐ 
The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent 
in their actual or expected medical, dental, psychological, social, or educational situations. 
Provide protocol specific findings justifying this determination:       
☐ 
The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition which 
is of vital importance for the understanding or amelioration of the subjects’ disorder or condition. 
Provide protocol specific findings justifying this determination:       
Return to Section 1. 
5 
Not otherwise approvable research involving children under 21 CFR §50.54/45 CFR §46.407 (Check if “Yes”. All 
must be checked) 
☐ 
The research does not meet the requirements of Sections 2, 3, or 4 
Provide protocol specific findings justifying this determination:       
☐ 
The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious 
problem affecting the health or welfare of children. 
Provide protocol specific findings justifying this determination:       
Return to Section 1. 
6 
Research involving wards of the state or any other agency, institution, or entity under 45 CFR §46.409 (Check if 
“Yes”. All must be checked) 
☐ 
One of the following is true: (Check box that is true) 
☐ The research is related to their status as wards. 
☐ The research is conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of 
children involved as subjects are not wards. 
Provide protocol specific findings justifying this determination:       
☐ 
An advocate will be appointed for each child who is a ward, in addition to any other individual acting on behalf of the 
child as guardian or in loco parentis for research approved under §46.406 or §46.407. 
Provide protocol specific findings justifying this determination:       

 
 
 
 
 
 
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☐ 
The advocate will have the background and experience to act in, and will agree to act in, the best interests of the child 
for the duration of the child’s participation in the research. 
Provide protocol specific findings justifying this determination:       
☐ 
The advocate is not associated in any way (except in the role as advocate or member of the IRB) with the research, the 
investigator(s), or the guardian organization. 
Provide protocol specific findings justifying this determination:       
Return to Section 1. 
7 Adequate provisions for soliciting the permission of parents or guardians (Check if “Yes”. All must be checked) 
☒ One of the following is true: (Check box that is true) 
☐ Permission is to be obtained from both parents unless one parent is deceased, 
unknown, incompetent, or not reasonably available, or when only one parent has legal 
responsibility for the care and custody of the child. 
☒ Permission of one parent is sufficient even if the other parent is alive, known, 
competent, reasonably available, and shares legal responsibility for the care and 
custody of the child. (Cannot be selected for Section 4 or 5 criteria) 
☐ Parental permission is waived under criteria in Section 8 
☐ Parental permission is waived under criteria in Section 9 
☐ Parental permission is waived under criteria in Section 10 
Return to Section 1. 
8 
Waiver of Parental Permission under 45 CFR §46.408(c) (Check if “Yes”. All must be checked) 
☐ 
The research is not FDA-regulated. 
 
☐ 
The research does not involve non-viable neonates. 
 
☐ 
The research protocol is designed for conditions or for a subject population for which parental or guardian permission is 
not a reasonable requirement to protect the subjects. 
Provide protocol specific findings justifying this determination:       
☐ 
An appropriate mechanism for protecting the children who will participate as subjects in the research is substituted. 
 
Provide protocol specific findings justifying this determination:       
☐ 
The waiver is not inconsistent with Federal, State, or local law. 
Provide protocol specific findings justifying this determination:       
Return to Section 1. 
9 
Waiver of Parental Permission under 45 CFR §46.408(c)/45 CFR §46.116(d)/45 CFR §46.116(f) (Check if “Yes”. All 
must be checked) 
☐ 
The research is not FDA-regulated. 
☐ 
The research does not involve non-viable neonates. 
☐ 
The research involves no more than Minimal Risk to the subjects. 
Provide protocol specific findings justifying this determination:       
☐ 
The waiver or alteration will not adversely affect the rights and welfare of the subjects. 
Provide protocol specific findings justifying this determination:       
☐ 
The research could not practicably be carried out without the waiver or alteration 
Provide protocol specific findings justifying this determination:       

 
 
 
 
 
 
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☐ 
Whenever appropriate, the subjects will be provided with additional pertinent information after participation. 
Provide protocol specific findings justifying this determination:       
☐ 
If the research involves using identifiable private information or identifiable biospecimens, the research could NOT 
practicably be carried out without using such information or biospecimens in an identifiable format. (N/A if research is 
subject to Pre-2018 Requirements OR if research does not use identifiable private information or 
biospecimens) ☐ N/A 
Provide protocol specific findings justifying this determination:       
☐ 
Waiver of consent for the storage, maintenance, or secondary research use of the identifiable private information or 
identifiable biospecimens cannot be granted for those who refused to provide broad consent. (N/A if research is 
subject to Pre-2018 Requirements OR broad consent not used for the research) ☐ N/A 
☐ 
Alteration of the consent process can only omit or alter the basic and/or additional elements of consent1. (N/A if 
research is subject to Pre-2018 Requirements OR if waiving informed consent) ☐ N/A  
Return to Section 1. 
10 Waiver of Parental Permission under FDA Guidance “IRB Waiver or Alteration of Informed Consent for Clinical 
Investigations Involving No More Than Minimal Risk to Human Subjects”iv (Check if “Yes.” All must be checked.) 
☐ 
The research IS FDA-regulated. 
☐ 
The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k) or 56.102(i)) to the subjects. 
Provide protocol specific findings justifying this determination:       
☐ 
The waiver or alteration will not adversely affect the rights and welfare of the subjects. 
Provide protocol specific findings justifying this determination:       
☐ 
The clinical investigation could not practicably be carried out without the waiver or alteration. 
Provide protocol specific findings justifying this determination:       
☐ 
Whenever appropriate, the subjects will be provided with additional pertinent information after participation. 
Provide protocol specific findings justifying this determination:       
Return to Section 1. 
11 Waiver of Parental Permission under 45 CFR §46.408(c)/45 CFR §46.116(c) (Check if “Yes”. All must be checked) 
☐ 
The research is not FDA-regulated. 
☐ 
The research does not involve non-viable neonates. 
☐ 
The research or demonstration project is to be conducted by or subject to the approval of state or local government 
officials. 
Provide protocol specific findings justifying this determination:       
 
1 An IRB may approve a consent procedure that omits some, or alters some or all, of the elements of informed 
consent set forth in 45 CFR 46.116(b) and (c). An IRB may not omit or alter any of the requirements described in 45 
CFR 46.116(a). If a broad consent procedure is used, an IRB may not omit or alter any of the elements required 
under 45 CFR 46.116(d). 

 
 
 
 
 
 
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☐ 
The research or demonstration project is designed to study, evaluate, or otherwise examine one or more of the 
following: (Check boxes that are true) 
☐ Public benefit or service programs. 
☐ Procedures for obtaining benefits or services under those programs. 
☐ Possible changes in or alternatives to those programs or procedures. 
☐ Possible changes in methods or levels of payment for benefits or services under those programs. 
Provide protocol specific findings justifying this determination:       
      
☐ 
The research could not practicably be carried out without the waiver or alteration. 
Provide protocol specific findings justifying this determination:       
      
Return to Section 1. 
12 Adequate provisions to solicit the assent of children (Check if “Yes”. All must be checked) 
☒ 
Assent will be obtained from: (Check box that is true) 
☐ All children. (Complete Section 14) 
☒ None of the children. (Complete Section 13) 
☐ Some children. (Complete Section 13 and Section 14. The protocol needs to describe which children will not 
be asked for assent) 
Return to Section 1. 
13 Reason why assent is not necessary 45 CFR §46.408(a)/21 CFR §50.55(c) (Check if “Yes”. All must be checked) 
☒ 
One or more of the following are true. (Check all boxes that are true.) 
☒ The capability of these children (taking into account the ages, maturity, and psychological state of the children 
involved) is so limited that they cannot reasonably be consulted. 
☐ The intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the 
health or well-being of the children and is available only in the context of the research 
☐ Assent is waived under Section 15 criteria 
☐ Assent is waived under Section 16 criteria 
Return to Section 1. 
14 Documentation of assent (Check if “Yes”. All must be checked) 
☐ 
If “Yes”, specify the process for documentation: 
☐ Investigator will document assent in the consent signature block. 
☐ Other (NOTE: The protocol needs to describe the process of assent documentation) 
Return to Section 1. 
15 Waiver of child assent under 45 CFR §46.408(a)/45 CFR §46.116(c)/21 CFR §50.55(d) (Check if “Yes”. All must be 
checked) 
☐ 
The research involves no more than Minimal Risk to the subjects.  
☐ 
The waiver or alteration will not adversely affect the rights and welfare of the subjects.  
☐ 
The research could not practicably be carried out without the waiver or alteration  
☐ 
Whenever appropriate, the subjects will be provided with additional pertinent information after participation. 

 
 
 
 
 
 
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☐ 
If the research involves using identifiable private information or identifiable biospecimens, the research could NOT 
practicably be carried out without using such information or biospecimens in an identifiable format. (N/A if research is 
FDA regulated, is subject to Pre-2018 Requirements OR if does not use identifiable private information or 
biospecimens) ☐ N/A 
Return to Section 1. 
16 Waiver of Child Assent under 45 CFR §46.408(a)/45 CFR §46.116(d) (Check if “Yes”. All must be checked) 
☐ 
The research is not FDA-regulated. 
 
☐ 
The research or demonstration project is to be conducted by or subject to the approval of state or local government 
officials 
☐ 
The research or demonstration project is designed to study, evaluate, or otherwise examine one or more of the 
following: (Check all boxes that are true. At least one must be checked.) 
☐ Public benefit or service programs. 
☐ Procedures for obtaining benefits or services under those programs. 
☐ Possible changes in or alternatives to those programs or procedures. 
☐ Possible changes in methods or levels of payment for benefits or services under those programs. 
☐ 
The research could not practicably be carried out without the waiver or alteration. 
Return to Section 1. 
 
 
6.0 Data Management Plan 
 
6.1 Data Analysis 
The site PI and treatment team will meet on a daily basis to review the data and the safety of participants. 
The investigators will graph and analyze the data for all participants at least daily. 
 
6.2 Data Security 
Only members of the CSH–RUCARES research team listed on this protocol will collect and analyze 
data for this study. That is, these team members will conduct sessions with all patients, even those at 
DDDC, and collect data using BDataPro on encrypted CSH laptops. These data will be electronic. 
BDataPro data and video recordings will be saved to the encrypted C:/ drives of these laptops and then 
transferred to a secure server at Children’s Specialized Hospital or to a secure cloud server (e.g., 
OneDrive for Business, Box Enterprise). These data will then be deleted from the laptop’s C:/ drive 
following the transfer in accordance with ITS procedures. The following subject identifiers will be 
recorded in association with the research data: Name, all elements of dates (except year) related to an 
individual (e.g., birth, admission, discharge, medical record numbers, and full-face photographic 
images). A unique subject identifying code will be used to link data to these identifiers. Subject names 
will be converted to initials during the subject’s participation. Following completion, pseudonyms will be 
assigned to subjects and the pseudonym identifier will be encrypted on the server. The justification for 
recording these specific subject identifiers is to schedule appointments and follow up with subjects. 
Subject identifiers will be maintained for a minimum of six years. All electronic data (e.g., session data) 
will be stored on the encrypted server and any hard copy data will be stored in the client's long-term 
file located in a locked cabinet in a locked office. After six years, the IT department will assist with data 
destruction. During the course of the study, we may record sessions for data-collection purposes for 
children whose caregivers. These videos will be recorded through a webcam directly into an encrypted 

 
 
 
 
 
 
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computer and stored on the encrypted network drive or encrypted hard drive. We will delete these 
videos six years from the collection date or earlier (if no additional data collection is required). Research 
data that contain subject identifiers will not be disclosed to outside researchers who are uninvolved with 
the study, or to any commercial sponsor, contract research organization, or external organization or 
entity. Provisions in place to protect the subject’s privacy include ensuring that only personnel listed on 
the IRB application are present during the consent process, ensuring that the fewest number of 
individuals possible are aware of the subject’s participation in research, and ensuring that research 
activities are performed in as private a place as possible. 
 
 
6.3 Data and Safety Monitoring 
A. Data/Safety Monitoring Plan 
The investigators will ensure compliance with the current Guideline for Good Clinical Practice from the 
International Conference on Harmonization of Technical Requirements for Registration of 
Pharmaceuticals for Human Use.47 All study personnel will complete the Collaborative Institutional 
Training Initiative (CITI) Human Subjects Research and Good Clinical Practice courses offered online 
by the CITI Program. Investigators will submit annual reports to  the IRB that provide information about  
informed  consent,  accrual,  results,  withdrawals,  non-compliance,  complaints and unexpected 
problems, as well as a risk and benefit assessment. 
 
We will interview the primary caregiver(s) to determine how often and under what conditions the   
participant’s destructive behavior results in physical harm to self or others. We will use this information 
to ensure that no participant is exposed to more risk during participation in this project than in the natural 
environment. We will always block or use protective equipment (e.g., arm splints) to prevent self-
injurious behavior or aggression directed toward vulnerable organs (e.g., eye-gouging).  Potentially 
harmful effects of severe head banging (e.g., detached retinas, concussions) will be mitigated by 
conducting sessions in a well- padded therapy room or, if necessary, having the individual wear  a  
padded helmet. We will terminate sessions if self-injurious behavior results in reddening of the skin or 
frank bleeding. Further occurrences of self-injurious behavior will be blocked or prevented with 
protective equipment until the tissue has fully healed or the child has been examined by a nurse or 
physician and medically cleared to continue participation. In the Severe Behavior Program, we will 
routinely collect data on all adverse events (e.g., patient-to-patient aggression, staff or patient injuries), 
regardless of severity level. If we observe soft-tissue symptoms, they will be monitored daily and 
documented with images in medical progress notes until the symptoms resolve. If symptoms persist or 
are serious and acute, we will have a physician evaluate the child if one is immediately available, or if 
not, we will bring the child to a local emergency room. All adverse events will be reviewed during 
monthly meetings. Additionally, any unexpected or serious adverse event will be reported to the IRB, 
and we will respond to the adverse event as advised by the IRB. The emergence of unexpected or 
serious adverse events related to this study may result in removal of the participant from the study. 
 
B. Data/Safety Monitoring Board Details 
One of the postdoctoral fellows on this project will serve as the data coordinator and track the IRB 
application, and ensure that study personnel are using only the latest version of the protocol. In addition, 
this postdoctoral fellow will conduct an annual audit to ensure compliance with all IRB policies and 
procedures, including review of consent forms to make certain that consent forms are up to date and 

 
 
 
 
 
 
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are properly signed and dated. The postdoctoral fellow will report the results of the annual audit to the 
investigators. If corrective actions are required following the audit, the investigators and data 
coordinator will work with the IRB to develop correction and prevention plans. In addition, we may 
conduct audits on a more frequent basis if suggested by the IRB. 
 
6.4 Reporting Results 
 
A. Individual Subjects’ Results  
The results of the study for an individual participant will be shared with the parent/legal guardian of 
the participant at their request. The general result of all clinical procedures (i.e., not specifically 
those procedures conducted for the purposes of this research study) will be shared with parties for 
which releases of information are obtained (e.g., primary care physicians, teachers). 
B. Aggregate Results 
All informed consent documents will include a specific statement informing the participants that we 
will share the study results on ClinicalTrials.gov. We will use this website in addition to 
dissemination of our work through peer-reviewed publications and presentations at professional 
conferences.  
C. Professional Reporting 
We will present papers and posters by the end of the first year and throughout the entire five-year 
project. We will present our data at regional and national conferences hosted by organizations such 
as the Association for Behavior Analysis International, the Society for the Quantitative Analyses of 
Behavior, the Association of Professional Behavior Analysts, and the Association for Psychological 
Science. Beginning in the second year, we will begin publishing preliminary outcomes. We will 
submit papers for publication in flagship journals for behavior-analytic research, such as the Journal 
of the Experimental Analysis of Behavior and the Journal of Applied Behavior Analysis. In the fourth 
year, we will begin to summarize the findings across the larger number of accrued subjects, and 
we will submit these findings for publication.  
D. Clinical Trials Registration, Results Reporting and Consent Posting 
The research qualifies as a clinical trial that must comply with the federal requirement for public 
registration, results reporting and consent posting at its conclusion. 
 
6.5 Secondary Use of the Data    
N/A 
 
7.0 Research Repositories – Specimens and/or Data 
 
After information that could identify each participant has been removed, de-identified data collected for 
this research may be used by or distributed to investigators for other research without obtaining additional 
consent. For example, de-identified graphs of a participant’s responding during the study might be re-
analyzed as part of a secondary study evaluating different outcome variables. 
 
8.0 Approvals/Authorizations 
 

 
 
 
 
 
 
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We are uploading non-Rutgers IRB approval (University of Nebraska Medical Center) and a letter of 
approval of an exception to allow newly recruited faculty to submit IRB applications as PIs prior to their 
official start dates. 
 
9.0 Bibliography 
 
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i “Children” are persons who have not attained the legal age for consent to treatments or procedures involved in the research, 
under the applicable law of the jurisdiction in which the research will be conducted. 
ii “Guardian” means an individual who is authorized under applicable State or local law to consent on behalf of a child to general 
medical care. 
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