Basic and Applied Research on Extinction Bursts
1 other identifier
interventional
40
1 country
1
Brief Summary
Although highly effective, treatments like FCT include extinction, which can have adverse side effects. The extinction burst, an increase in the frequency or intensity of destructive behavior at the start of treatment, is the most common side effect of extinction, and can increase the risk of harm to the patient and others. The goal of the current study is to evaluate the prevalence of extinction bursts when various parameters of reinforcement (i.e., rate, magnitude, quality) are manipulated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2023
CompletedFirst Posted
Study publicly available on registry
June 29, 2023
CompletedStudy Start
First participant enrolled
July 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
April 29, 2026
April 1, 2026
4.7 years
June 21, 2023
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of destructive behavior
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.
5 years
Secondary Outcomes (1)
Number of participants with extinction bursts
5 years
Study Arms (4)
Clinical (Human) Study on Effects of Reinforcement-Rate Drop
EXPERIMENTALBased 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).
Clinical (Human) Study on Effects of Reinforcement-Magnitude Drop
EXPERIMENTALBased 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).
Clinical (Human) Study on Effects of Reinforcement-Quality Drop
EXPERIMENTALNote: 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.
Clinical (Human) Study on Counteracting Reinforcement-Rate Drop with Quality Increase
EXPERIMENTALBased 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.
Interventions
In this condition, therapists will place destructive behavior on extinction and deliver no reinforcement for functional communication responses (FCRs).
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 behavior in baseline.
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.
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.
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 assessment could not guarantee that the selected stimulus would be of a higher quality than the reinforcer for destructive behavior.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Specialized Hospital-Rutgers University Center for Autism Research, Education, and Services
Somerset, New Jersey, 08873, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of RUCARES and CSH-RUCARES/ Henry Rutgers Endowed Professor of Pediatrics
Study Record Dates
First Submitted
June 21, 2023
First Posted
June 29, 2023
Study Start
July 7, 2023
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
May 31, 2028
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- The informed consent form shall be available to the caregiver immediately after caregiver signature. If requested, the study protocol will be sent to the caregiver after the study is complete.
- Access Criteria
- Each caregiver of a child enrolled in the study will be eligible to receive the above documents.
The experimenters plan to make data available to participants, if requested, and submit results for publication.