18 and older, any sex, with Behavior and Behavior Mechanisms. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Peak Response Rate During ExtinctionPrimary· This measure was obtained throughout the primary assessment (i.e., the extinction challenge)
This term describes the highest rate of responding observed during extinction and will be depicted as a proportion of baseline. For example, assuming the mean rate of responding during the final three sessions of baseline is 3 responses per minute (i.e., \[2.8 rpm + 3.2 rpm + 3 rpm\] / 3 = 3 rpm), and the highest rate of responding during a single session of extinction is 3.4 rpm, then peak response rate for this hypothetical individual would be 1.13 (i.e., 3.4 / 3 = 1.13). This value will serve as the primary dependent variable for each participant in all between-groups comparisons in our dat
Group
Value
95% CI
"Cheap" Unit Price, Establishing Operation
1.58
± 1.77
"Cheap" Unit Price, Abolishing Operation
0.85
± 0.85
"Expensive" Unit Price, Establishing Operation
1.3
± 0.87
"Expensive" Unit Price, Abolishing Operation
0.43
± 0.41
Schedule Value at BreakpointPrimary· PRA breakpoints were obtained during pre-assessment and were used as a matching variable prior to random assignment.
The progressive-ratio reinforcer analysis (PRA) is a game of diminishing returns that is considered an assessment of reinforcer value (e.g., if a participant does not value the reinforcer, they will quit sooner than a participant that does value the reinforcer). During the assessment, we increased the "price" (i.e., the schedule value) of reinforcers each time a participant earns two reinforcers at a currently established price.
The breakpoint describes the "price" (schedule value; e.g., FR1, FR4, FR7) of the last obtained reinforcer prior to response cessation (i.e., the breakpoint is the la
Group
Value
95% CI
"Cheap" Unit Price, Establishing Operation
16.45
± 13.24
"Cheap" Unit Price, Abolishing Operation
15.14
± 10.21
"Expensive" Unit Price, Establishing Operation
16.94
± 14.53
"Expensive" Unit Price, Abolishing Operation
18.82
± 15.07
The Schedule Value Designated as PmaxPrimary· Pmax values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters.
The progressive fixed-ratio reinforcer analysis (PFRA) is an assessment of consumer demand that first establishes how much of a reinforcer a participant would consume when consumption is free of constraint (i.e., when participants can have as much of the reinforcer as they want; referred to as "bliss-point consumption").
With bliss-point consumption established, PFRA evaluates how much a participant will "spend" (respond) to maintain bliss-point consumption patterns as price (schedule value) is increased. Unlike PRA, prices in the PFRA are held constant within each session and only increase a
Group
Value
95% CI
"Cheap" Unit Price, Establishing Operation
7.6
± 4.42
"Cheap" Unit Price, Abolishing Operation
7.32
± 4.23
"Expensive" Unit Price, Establishing Operation
9
± 4.12
"Expensive" Unit Price, Abolishing Operation
7.71
± 4.44
Response LatencyPrimary· This measure was obtained throughout the primary assessment (i.e., the extinction challenge)
This term describes the latency from session onset to eventual response cessation during the extinction challenge.
Group
Value
95% CI
"Cheap" Unit Price, Establishing Operation
213.3
± 185.6
"Cheap" Unit Price, Abolishing Operation
96
± 114.4
"Expensive" Unit Price, Establishing Operation
467.4
± 607.9
"Expensive" Unit Price, Abolishing Operation
119.8
± 132.1
Number of Sessions in ExtinctionSecondary· This measure was obtained throughout the primary assessment (i.e., the extinction challenge)
In addition to between-groups differences in peak-response rate (primary dependent variable), the investigators will also compare between-groups differences in the number of sessions required to achieve response elimination during extinction.
Group
Value
95% CI
"Cheap" Unit Price, Establishing Operation
1.2
± 0.41
"Cheap" Unit Price, Abolishing Operation
1.05
± 0.23
"Expensive" Unit Price, Establishing Operation
1.89
± 1.94
"Expensive" Unit Price, Abolishing Operation
1.06
± 0.24
Overall Session DurationSecondary· Duration values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters.
The investigators will measure the total duration of PFRA sessions (in seconds) at Pmax to establish baseline-session parameters.
Group
Value
95% CI
"Cheap" Unit Price, Establishing Operation
630.87
± 462.36
"Cheap" Unit Price, Abolishing Operation
687.84
± 843.27
"Expensive" Unit Price, Establishing Operation
668.89
± 757.57
"Expensive" Unit Price, Abolishing Operation
788.88
± 930.85
Sponsor's own description
This project is meant to identify relations between the reinforcement histories of 80 adults with intellectual and developmental disabilities (IDD) and the prevalence of extinction bursts. Extinction bursts, or temporary increases in rates and intensities of behavior during extinction, often preclude the inclusion of extinction in intervention packages meant to suppress severe challenging behavior, despite the fact that extinction is often necessary to generate therapeutic outcomes. Study results will provide insight into how researchers can enhance interventions for the severe challenging behavior of individuals with IDD while mitigating the undesirable collateral effects (i.e., extinction bursts) of therapeutic action (i.e., extinction). Expanded access to study results will be made available to those who inquire after all data have been obtained and analyzed.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University
Last refreshed: 6 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04842500.