跳至主要内容
临床试验/NCT05925101
NCT05925101招募中不适用

Basic and Applied Research on Extinction Bursts

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Rate of destructive behavior

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Clinical (Human) Study on Effects of Reinforcement-Rate Drop

Experimental

Based on the TWML, we hypothesize that a large drop in reinforcement rate at the start of treatment with extinction alone or with FCT will increase the probability of an extinction burst. Preventing such drops will lessen the probability of an extinction burst. We will test the effects of eliminating reinforcement in the extinction-only condition and the effects of substantially decreasing the rate of reinforcement in the rate-drop condition. We will compare these two suboptimal treatments with one in which we ensure that the rate of reinforcement remains equal to baseline, called the rate-hold condition, which the TWML predicts will prevent an extinction burst.We will equate reinforcement magnitude (i.e., each reinforcer delivery will be 20 s) and quality (i.e., the functional reinforcer identified during the functional analysis) across the baseline and the rate-drop and rate-hold conditions (no reinforcement will be delivered in the extinction-only condition).

干预措施: Extinction-only condition (Behavioral)

Clinical (Human) Study on Effects of Reinforcement-Rate Drop

Experimental

Based on the TWML, we hypothesize that a large drop in reinforcement rate at the start of treatment with extinction alone or with FCT will increase the probability of an extinction burst. Preventing such drops will lessen the probability of an extinction burst. We will test the effects of eliminating reinforcement in the extinction-only condition and the effects of substantially decreasing the rate of reinforcement in the rate-drop condition. We will compare these two suboptimal treatments with one in which we ensure that the rate of reinforcement remains equal to baseline, called the rate-hold condition, which the TWML predicts will prevent an extinction burst.We will equate reinforcement magnitude (i.e., each reinforcer delivery will be 20 s) and quality (i.e., the functional reinforcer identified during the functional analysis) across the baseline and the rate-drop and rate-hold conditions (no reinforcement will be delivered in the extinction-only condition).

干预措施: Rate-drop condition (Behavioral)

Clinical (Human) Study on Effects of Reinforcement-Rate Drop

Experimental

Based on the TWML, we hypothesize that a large drop in reinforcement rate at the start of treatment with extinction alone or with FCT will increase the probability of an extinction burst. Preventing such drops will lessen the probability of an extinction burst. We will test the effects of eliminating reinforcement in the extinction-only condition and the effects of substantially decreasing the rate of reinforcement in the rate-drop condition. We will compare these two suboptimal treatments with one in which we ensure that the rate of reinforcement remains equal to baseline, called the rate-hold condition, which the TWML predicts will prevent an extinction burst.We will equate reinforcement magnitude (i.e., each reinforcer delivery will be 20 s) and quality (i.e., the functional reinforcer identified during the functional analysis) across the baseline and the rate-drop and rate-hold conditions (no reinforcement will be delivered in the extinction-only condition).

干预措施: Rate-hold condition (Behavioral)

Clinical (Human) Study on Effects of Reinforcement-Magnitude Drop

Experimental

Based on the TWML, we hypothesize that a large drop in reinforcement magnitude at the start of treatment will increase the probability of an extinction burst. Preventing drops will lessen the probability of an extinction burst. We will test the effects of eliminating reinforcement in the extinction-only condition and the effects of substantially decreasing the magnitude of reinforcement in the magnitude-drop condition. We will compare these two suboptimal treatments with one in which we ensure that the magnitude of reinforcement remains equal to baseline, called the magnitude-hold condition, which the TWML predicts will prevent an extinction burst. We will equate reinforcement rate (i.e., independent, VI 1.5-s schedules) and quality (i.e., the functional reinforcer identified during the functional analysis) across baseline and both FCT conditions (no reinforcement will be delivered in the extinction-only condition).

干预措施: Extinction-only condition (Behavioral)

Clinical (Human) Study on Effects of Reinforcement-Magnitude Drop

Experimental

Based on the TWML, we hypothesize that a large drop in reinforcement magnitude at the start of treatment will increase the probability of an extinction burst. Preventing drops will lessen the probability of an extinction burst. We will test the effects of eliminating reinforcement in the extinction-only condition and the effects of substantially decreasing the magnitude of reinforcement in the magnitude-drop condition. We will compare these two suboptimal treatments with one in which we ensure that the magnitude of reinforcement remains equal to baseline, called the magnitude-hold condition, which the TWML predicts will prevent an extinction burst. We will equate reinforcement rate (i.e., independent, VI 1.5-s schedules) and quality (i.e., the functional reinforcer identified during the functional analysis) across baseline and both FCT conditions (no reinforcement will be delivered in the extinction-only condition).

干预措施: Magnitude-drop condition (Behavioral)

Clinical (Human) Study on Effects of Reinforcement-Magnitude Drop

Experimental

Based on the TWML, we hypothesize that a large drop in reinforcement magnitude at the start of treatment will increase the probability of an extinction burst. Preventing drops will lessen the probability of an extinction burst. We will test the effects of eliminating reinforcement in the extinction-only condition and the effects of substantially decreasing the magnitude of reinforcement in the magnitude-drop condition. We will compare these two suboptimal treatments with one in which we ensure that the magnitude of reinforcement remains equal to baseline, called the magnitude-hold condition, which the TWML predicts will prevent an extinction burst. We will equate reinforcement rate (i.e., independent, VI 1.5-s schedules) and quality (i.e., the functional reinforcer identified during the functional analysis) across baseline and both FCT conditions (no reinforcement will be delivered in the extinction-only condition).

干预措施: Magnitude-hold condition (Behavioral)

Clinical (Human) Study on Effects of Reinforcement-Quality Drop

Experimental

Note: We will conduct Ex 3 with participants who display destructive behavior reinforced by access to tangible items so that we can vary reinforcement quality using the results of a paired-stimulus preference assessment. Based on the TWML, we hypothesize that a large drop in reinforcement quality at the start of FCT will increase the probability of an extinction burst. Preventing such drops will lessen the probability of an extinction burst. Therefore, we will program a large drop in the quality of reinforcement in our quality-drop condition and ensure that the quality of reinforcement remains equal to the quality of reinforcement in baseline in the quality-hold condition. In Experiment 3, we will equate reinforcement rate (i.e., independent, VI 1.5-s schedules) and magnitude (i.e., each reinforcer delivery will be 20 s) across baseline and both FCT conditions.

干预措施: Quality-drop condition (Behavioral)

Clinical (Human) Study on Effects of Reinforcement-Quality Drop

Experimental

Note: We will conduct Ex 3 with participants who display destructive behavior reinforced by access to tangible items so that we can vary reinforcement quality using the results of a paired-stimulus preference assessment. Based on the TWML, we hypothesize that a large drop in reinforcement quality at the start of FCT will increase the probability of an extinction burst. Preventing such drops will lessen the probability of an extinction burst. Therefore, we will program a large drop in the quality of reinforcement in our quality-drop condition and ensure that the quality of reinforcement remains equal to the quality of reinforcement in baseline in the quality-hold condition. In Experiment 3, we will equate reinforcement rate (i.e., independent, VI 1.5-s schedules) and magnitude (i.e., each reinforcer delivery will be 20 s) across baseline and both FCT conditions.

干预措施: Quality-hold condition (Behavioral)

Clinical (Human) Study on Counteracting Reinforcement-Rate Drop with Quality Increase

Experimental

Based on the TWML, we hypothesize that a large drop in reinforcement rate at the start of FCT will increase the probability of an extinction burst but that simultaneously increasing reinforcement quality will counteract the negative effects of a drop in reinforcement rate. We will program a large drop in the rate of reinforcement in the rate-drop-only condition, and in the rate-drop/quality-increase condition we will program the same drop in reinforcement rate but also program a large increase in reinforcement quality.

干预措施: Rate-drop condition (Behavioral)

Clinical (Human) Study on Counteracting Reinforcement-Rate Drop with Quality Increase

Experimental

Based on the TWML, we hypothesize that a large drop in reinforcement rate at the start of FCT will increase the probability of an extinction burst but that simultaneously increasing reinforcement quality will counteract the negative effects of a drop in reinforcement rate. We will program a large drop in the rate of reinforcement in the rate-drop-only condition, and in the rate-drop/quality-increase condition we will program the same drop in reinforcement rate but also program a large increase in reinforcement quality.

干预措施: Rate-drop/quality-increase condition (Behavioral)

结局指标

主要结局

Rate of destructive behavior

时间窗: 5 years

The investigators will collect continuous, direct-observation measures of destructive behavior throughout all phases of the study. They will compare rates of destructive behavior during the first three sessions of each treatment condition to baseline.

次要结局

  • Number of participants with extinction bursts(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wayne W. Fisher, Ph.D., BCBA-D, LP

Director of RUCARES and CSH-RUCARES/ Henry Rutgers Endowed Professor of Pediatrics

Rutgers, The State University of New Jersey

研究点 (2)

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