Clinical trial NCT04842500: Translational Research to Inform Interventions for Challenging Behavior
Official title: Translational Research to Inform Interventions for Severe Challenging Behavior for Individuals With Intellectual and Developmental Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior and Behavior Mechanisms
Keywords: behavioral sciences
reinforcement schedule
motivation
economics, behavioral
developmental disability
intellectual disability
problem behavior
extinction bursts
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The investigators will enroll 80 adults with developmental disabilities in a low-stakes translational investigation employing a 2x2 factorial, crossed, and randomized matched blocks design, with batched randomization logic. Procedures will include: (a) matching participants within batches according to progressive ratio reinforcer analysis results, and (b) randomly assigning participants to one of four experimental conditions to determine whether information about reinforcer value can be used to set baseline parameters that either promote or eliminate bursts during extinction.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The Goal of this project is to identify mechanisms responsible for bursts, and to facilitate strategic extensions toward discovery for treatments of challenging behavior. AIM 1: In the service of this goal, the investigators aim to evaluate the accuracy of an efficient alternative to demand-curve analysis (i.e., progressive ratio reinforcer analysis) in quantifying reinforcer value (i.e., Pmax). AIM 2: Investigators also aim to evaluate the utility of manipulating baseline reinforcement parameters for controlling bursts when those manipulations are informed by the results of demand-curve analysis.

Eligibility criteria: Inclusion Criteria:

* Participants must be older than 18.
* Participants must have a developmental disability (unconstrained to specific diagnoses).
* Participants must be able to correctly manipulate all items used in the study.
* Participants must consent (or assent, when relevant) to procedures prior to and throughout the study.

Exclusion Criteria:

* Participants younger than 18.
* Participants without disabilities.
* Participants who cannot correctly manipulate items used in the study.
* Participants who do not consent (or assent, when relevant) to participation.

Primary outcomes:
measure: Peak Response Rate During Extinction
timeFrame: This measure was obtained throughout the primary assessment (i.e., the extinction challenge)
measure: Schedule Value at Breakpoint
timeFrame: PRA breakpoints were obtained during pre-assessment and were used as a matching variable prior to random assignment.
measure: The Schedule Value Designated as Pmax
timeFrame: Pmax values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters.
measure: Response Latency
timeFrame: This measure was obtained throughout the primary assessment (i.e., the extinction challenge)
Secondary outcomes:
measure: Number of Sessions in Extinction
timeFrame: This measure was obtained throughout the primary assessment (i.e., the extinction challenge)
measure: Overall Session Duration
timeFrame: Duration values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters.
Other outcomes:
Locations:
city: Gallatin
country: United States
facility: Habilitative and Training Services (HATS)
state: Tennessee
city: Lebanon
country: United States
facility: Easterseals Tennessee: Prospect
state: Tennessee
city: Murfreesboro
country: United States
facility: Possibility Place
state: Tennessee
city: Nashville
country: United States
facility: Next Steps at Vanderbilt
state: Tennessee
city: Orem
country: United States
facility: Chrysalis
state: Utah
Study officials:
References: