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Recruiting NCT05925101

Basic and Applied Research on Extinction Bursts

No phase Interventional Problem Behavior Aggression Self Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Extinction-only condition, Rate-drop condition, Rate-hold condition, Magnitude-drop condition.
Who it may be relevant to
Registry conditions: Problem Behavior, Aggression, Self Injury. Basic parameters: 3 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Although highly effective, treatments like FCT include extinction, which can have adverse side effects. The extinction burst, an increase in the frequency or intensity of destructive behavior at the start of treatment, is the most common side effect of extinction, and can increase the risk of harm to the patient and others. The goal of the current study is to evaluate the prevalence of extinction bursts when various parameters of reinforcement (i.e., rate, magnitude, quality) are manipulated.

Detailed description

PRELIMINARY PROCEDURES

Paired-Stimulus Preference Assessment As part of our standard clinical practice, the investigators will use a paired-stimulus preference assessment to evaluate each participant's preference for various leisure items. During this assessment, therapists will select an array of items informed by the Reinforcer Assessment for Individuals with Severe Disability (RAISD), which is a structured interview between the behavior analyst and the participant's caregiver to identify stimuli that may serve as reinforcers. Then, on each trial of the assessment, the therapist will place two of the items (e.g., iPad, Nintendo Switch) in front of the participant. When the participant reaches for a given item, the therapist will remove the unselected item while the data collector records which of these two items the participant approached and the participant's consumption of the selected item. After approximately 30 s, the therapist will present another pair of stimuli to the participant, with processes in place to randomize the positioning (left, right) of the stimuli and the order in which pairs are presented. This will continue until the therapist presents all potential pairs of stimuli to the participant. The data collector will then compute and graph the number of times each stimulus was selected to derive a preference hierarchy (e.g., low, moderate, high). The most selected item that the participant reliably consumes will serve as the stimulus programmed in Experiment 3's high-quality condition and the tangible reinforcer for all conditions in Experiments 1 and 2 should the participant's destructive behavior be maintained by tangible reinforcement. The least selected item with which the participant interacts will serve as the stimulus programmed in Experiment 3's low-quality condition.

Competing-Stimulus Assessment As part of our standard clinical practice, the investigators will use a competing-stimulus assessment to evaluate each participant's preference for various food and leisure items relative to the functional reinforcer for destructive behavior. During this assessment, therapists will select an array of items informed by the RAISD. Then, on each 2-min trial of the competing-stimulus assessment, the therapist will place one of the stimuli (e.g., M\&Ms) in front of the participant and allow the participant to interact with or consume that item. If at any point during the trial, the participant displays destructive behavior, the therapist will deliver the functional reinforcer (e.g., attention) for 20 s. During each trial, trained observers record the duration of engagement with each competing stimulus and each occurrence of destructive behavior. Each stimulus is assessed three times (i.e., three 2-min trials) in a quasirandom order. Then, the results are tabulated and summarized in a graph showing the duration of stimulus engagement and the rate of destructive behavior for each stimulus. The highest competing stimulus is the one with the highest duration of stimulus engagement and the lowest rates of destructive behavior. Researchers will use this selected stimulus in Experiment 4 in the rate-drop/quality increase condition to determine whether delivering a higher quality reinforcer will counteract the effects of a drop in the rate of reinforcement and prevent or mitigate an extinction burst at the start of

FCT.

Functional Analysis As part of our standard clinical practice, the investigators will conduct a functional analysis of each participant's destructive behavior. Functional analyses help identify what consequences (e.g., access to attention) maintain destructive behavior. Prior to conducting a functional analysis, researchers routinely conduct a risk assessment to ensure that it is safe to conduct a functional analysis with each patient using the procedures developed in our program. Researchers also will conduct preference assessments with each participant to determine a preference hierarchy (e.g., of toys, foods). The investigators will use this information to individualize each condition of the functional analysis for each participant. Researchers will extend session duration when indicated (e.g., if it appears that destructive behavior begins to occur near the end of a 5-min session). The functional analysis will include at least three test conditions (social attention, demand, and monitored alone/ignore) and one control condition (play) that researchers conduct within a multielement design. Researchers will interview the caregivers prior to the functional analysis to determine the relevant stimuli (e.g., types of attention, preferred items, demands) to program within each condition. In accordance with "best clinical practice," researchers will include an additional test condition (tangible) if the caregiver reports providing, or is observed to provide, preferred tangible items following destructive behavior. For some participants who do not display destructive behavior during standard test conditions, researchers may evaluate other test conditions relevant to their case to determine idiosyncratic sources of reinforcement (e.g., social control, where adult compliance with child requests functions as reinforcement for destructive behavior). Researchers will program a uniquely colored surgical smock, worn by the therapist, for each condition to facilitate discrimination between test and control conditions.

In the attention condition, the therapist will provide the participant with high-quality attention for 1 min prior to the session. Then, the therapist will withdraw attention and pretend to read a magazine while the participant has an opportunity to play with a moderately preferred toy. If the participant emits destructive behavior, the therapist will deliver 20 s of vocal (e.g., "Stop that, you'll hurt yourself") and physical (e.g., rubbing the participant's back) attention according to a fixed-ratio 1 (FR 1) schedule. In the demand condition, the therapist will deliver non-preferred demands (e.g., "Write your name") using sequential verbal, modeled, and physical prompts every 5 s. Compliance will produce praise (e.g., "Nice job writing your name!"), noncompliance will result in physical guidance (e.g., hand- over-hand prompting the participant to write his or her name) and no praise, and destructive behavior will produce a 20-s break from demands on an FR 1 schedule. In the monitored alone condition, the participant will be alone in a treatment room without any toys or materials, but a therapist will monitor the participant from behind a one-way observation window. If the participant displays aggression toward others, researchers will conduct a monitored ignore condition instead of an alone condition, during which a therapist will monitor the participant from inside the therapy room but will not interact with the participant or respond to the participant's destructive behavior. In the tangible condition, the therapist will provide the participant access to a highly preferred toy for 1 min prior to the start of the session. The therapist will then withdraw the toy at the beginning of the session and return it to the participant for 20 s following destructive behavior according to an FR 1 schedule. In the control condition (play), the therapist will provide continuous access to the participant's highly preferred toy from the tangible condition and will deliver attention every 20 s for the absence of destructive behavior (e.g., "Nice job playing with your blocks!"). Researchers will conduct at least three sessions in each condition or until researchers verify that destructive behavior is maintained by social reinforcement (e.g., access to attention or tangible items) using the ongoing visual inspection criteria developed and validated by our research team.

IN-HOME BASELINE GENERALIZATION SESSIONS

Following the functional analysis described above, the treatment team determines whether it is safe to conduct baseline sessions in the home prior to initiating treatment. If the participant caused physical harm to self, others, or the environment or if they required specialized equipment (e.g., protective equipment; a padded treatment room; emergency restraint) to prevent such harm during the functional analysis, then researchers do not conduct baseline sessions in the home, but still collect post-treatment generalization sessions in the home (described below). If it is safe to conduct baseline sessions in the home, researchers use the following procedures.

Baseline Sessions Researchers collect a series of three 5-min baseline sessions in the test condition from the functional analysis with the highest rates of destructive behavior. Prior to the first session, the therapist inspects the room in the home where the sessions will take place and removes any objects that could be dangerous to the participant or the caregivers (e.g., an object that could be used as a weapon). Next, researchers use behavioral skills training to teach the caregiver how to implement the session procedures using verbal instruction, modeling, behavioral rehearsal (i.e., role-play with a therapist), and performance feedback. Researchers train each caregiver to a mastery criterion (i.e., at least 90% accuracy across all components when implementing practice sessions with a therapist) prior to conducting baseline sessions with the participant. Additionally, prior to conducting session in the home, researchers train caregivers in our managing-challenging-behavior techniques (e.g., blocking hits and kicks, releasing bites) until the caregivers implement all techniques with 90% accuracy during role-play. If at any point the participant displays destructive behavior that poses an imminent danger to self, others, or the environment that cannot be safely blocked (e.g., eye poking, biting), the therapist terminates the session.

Data Collection During generalization sessions, our research team will monitor the sessions inconspicuously (e.g., collecting directo bservation data from a nearby hallway using specialized software; routinely checking inter-observer agreement).

General Instructions to Caregiver "We are asking for your assistance in helping us to understand and observe your child's destructive behavior. We would appreciate you help in working to replicate the challenging situations that you discussed with your primary therapist. Our goal in conducting these sessions is to help us to identify things and may trigger and reinforce your child's problem behavior in the home. The session that we would like you to conduct will be 5 minutes in length. For each 5- minute session, we would like you to follow the procedures described below as closely as possible. After you read the instructions, we will answer any questions that you have before we start the session. If at any point, you feel that you or your child are unsafe, please let a therapist know, and we will immediately assist in keeping you and your child safe. It is our goal to maintain safety throughout the assessment and treatment of your child's destructive behavior."

Condition-Specific Instructions to Caregiver The therapist will set up the materials and arrange the room and select the specific instructions to give to the caregiver from the options below based on the results of the functional analysis (e.g., for escape-reinforced destructive behavior, they will set up for a demand condition and use the instructions below labeled "Demand"). The therapist will give the caregiver a copy of the selected instructions described below, have them read it, and then answer any questions they have.

Demand. "In this session, we want you to instruct your child to complete a variety of nonpreferred tasks from the list of such tasks that you and your child's primary therapist specified during the parent interview. The session will last 5 minutes. You may use any materials in the room that you would like to complete the instructions dur

Interventions

  • Behavioral Extinction-only condition
    In this condition, therapists will place destructive behavior on extinction and deliver no reinforcement for functional communication responses (FCRs).
  • Behavioral Rate-drop condition
    In this condition,we will place destructive behavior on extinction and deliver the functional reinforcer contingent on the FCR on a VI 15-s schedule. This change from a VI 1.5-s schedule for destructive behavior in baseline to a VI 15-s schedule for the FCR during FCT will produce a large drop in reinforcement rate during FCT relative to baseline.
  • Behavioral Rate-hold condition
    In this condition, we will place destructive behavior on extinction and deliver the functional reinforcer contingent on the FCR on a yoked VI 1.5-s schedule that exactly matches the rate and timing of reinforcer deliveries for destructive behavior in baseline.
  • Behavioral Magnitude-drop condition
    In this condition, we will place destructive behavior on extinction and deliver the functional reinforcer contingent on the FCR according to a VI 1.5-s schedule, but we will deliver the reinforcer for just 6 s each time. This change from delivering 60 s of access to the functional reinforcer following destructive behavior in baseline to delivering 6 s of reinforcer access for the FCR during FCT will produce a large reduction in the magnitude of reinforcement relative to baseline.
  • Behavioral Magnitude-hold condition
    This condition will be identical to the magnitude-drop condition except that we will deliver 60 s of access to the functional reinforcer contingent on the FCR, so that the magnitude of reinforcement will equal that delivered in baseline for destructive behavior. To ensure that the magnitude of reinforcement does not drop in the magnitude-hold condition, we will yoke the rate and timing of reinforcer deliveries for the FCR during FCT to the rate and timing of reinforcer deliveries for destructive
  • Behavioral Quality-drop condition
    In this condition, we will place destructive behavior on extinction and deliver the reinforcer from the paired-choice assessment that the participant chooses approximately 1/12th as often as the highest preference stimulus from that assessment. This change from the most preferred stimulus from the paired-choice assessment to one chosen 1/12th as often will constitute a large drop in the quality of reinforcement during FCT relative to baseline.
  • Behavioral Quality-hold condition
    We will place destructive behavior on extinction and deliver the most preferred reinforcer from the paired-choice assessment on a yoked VI 1.5-s schedule that exactly matches the rate and timing of reinforcer deliveries for destructive behavior in baseline in this condition.
  • Behavioral Rate-drop/quality-increase condition
    In this condition, we will program the same large drop in reinforcement by delivering reinforcement on a VI 15-s schedule, but we also will increase reinforcement quality by simultaneously delivering the highest quality reinforcer identified during a competing stimulus assessment. We will use the competing stimulus assessment in Ex 4 because it directly assesses the quality of alternative reinforcement relative to the quality of the reinforcer for destructive behavior, whereas the paired-choice

Primary outcome measures

  • Rate of destructive behavior [Time frame: 5 years]
Secondary outcome measures (1)
  • Number of participants with extinction bursts [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • children aged 3 to 17;
  • problem behavior that occurs at least 10 times a day, despite previous treatment;
  • problem behavior maintained by social positive reinforcement;
  • stable protective supports for self-injurious behavior (e.g., helmet) with no anticipated changes during enrollment;
  • on a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free;
  • stable educational plan and placement with no anticipated changes during the child's treatment.

Exclusion criteria

  • patients currently receiving 15 or more hours per week of treatment for their problem behavior;
  • DSM-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism);
  • a comorbid health condition or major mental disorder that would interfere with study participation;
  • occurrence of self-injury during study assessments that presents a risk of serious or permanent harm (e.g., detached retinas) based on our routine clinical-risk assessment;
  • patients requiring changes to protective supports for self-injury or drug treatment, but we will invite these patients to participate when protective supports and drug regimen are stable.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Children's Specialized Hospital-Rutgers University Center for Autism Research, Education, — Somerset

Identifiers

NCT: NCT05925101 · Pro2022002044

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗