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Translational Research to Inform Interventions for Challenging Behavior

Primary Purpose

Behavior and Behavior Mechanisms

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Demand Informed Moderator Analysis
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavior and Behavior Mechanisms focused on measuring behavioral sciences, reinforcement schedule, motivation, economics, behavioral, developmental disability, intellectual disability, problem behavior, extinction bursts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Habilitative and Training Services (HATS)
  • Easterseals Tennessee: Prospect
  • Possibility Place
  • Next Steps at Vanderbilt
  • Chrysalis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

"Cheap" Unit Price, Establishing Operation

"Cheap" Unit Price, Abolishing Operation

"Expensive" Unit Price, Establishing Operation

"Expensive" Unit Price, Abolishing Operation

Arm Description

Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, minus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the beginning of the relevant appointment, before within-appointment reinforcer consumption has had an opportunity to approximate demand.

Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, minus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand.

Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the beginning of the relevant appointment, before within-appointment reinforcer consumption has had an opportunity to approximate demand.

Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand.

Outcomes

Primary Outcome Measures

Peak response rate during extinction
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 data-analysis plan.
Breakpoint
Reinforcement schedule which preceded the last obtained reinforcer prior to response cessation during progressive-ratio reinforcer analysis. Often used as a proxy measure to establish reinforcer value.
Demand
This term describes the number of reinforcers obtained prior to response cessation during progress fixed-ratio reinforcer analysis. Often used as a proxy measure to establish reinforcer value.
Pmax
This term describes the unit price that produces the highest target-response output during progressive fixed-ratio reinforcer analysis.
Response latency
This term describes the latency from session onset to delivery of the first programmed reinforcer during progressive fixed-ratio reinforcer analysis.

Secondary Outcome Measures

Number of sessions in extinction
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.
Overall session duration
The investigators will measure the total duration of reinforcer-analysis sessions (in seconds) to establish baseline-session parameters.

Full Information

First Posted
April 4, 2021
Last Updated
April 6, 2023
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT04842500
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior and Behavior Mechanisms
Keywords
behavioral sciences, reinforcement schedule, motivation, economics, behavioral, developmental disability, intellectual disability, problem behavior, extinction bursts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
Participant
Masking Description
Participants will be randomized to one of four baseline reinforcement conditions. They will not be informed of which condition they have been assigned to, or why they have been assigned to it.
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Cheap" Unit Price, Establishing Operation
Arm Type
Experimental
Arm Description
Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, minus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the beginning of the relevant appointment, before within-appointment reinforcer consumption has had an opportunity to approximate demand.
Arm Title
"Cheap" Unit Price, Abolishing Operation
Arm Type
Experimental
Arm Description
Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, minus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand.
Arm Title
"Expensive" Unit Price, Establishing Operation
Arm Type
Experimental
Arm Description
Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the beginning of the relevant appointment, before within-appointment reinforcer consumption has had an opportunity to approximate demand.
Arm Title
"Expensive" Unit Price, Abolishing Operation
Arm Type
Experimental
Arm Description
Pre-extinction baseline unit price for the programmed reinforcer will be its Pmax, plus one half of the distance between its Pmax and its breakpoint. Extinction will be introduced at the end of the relevant appointment, after within-appointment reinforcer consumption has approximated demand.
Intervention Type
Behavioral
Intervention Name(s)
Demand Informed Moderator Analysis
Intervention Description
This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control).
Primary Outcome Measure Information:
Title
Peak response rate during extinction
Description
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 data-analysis plan.
Time Frame
Immediately post-baseline extinction challenges
Title
Breakpoint
Description
Reinforcement schedule which preceded the last obtained reinforcer prior to response cessation during progressive-ratio reinforcer analysis. Often used as a proxy measure to establish reinforcer value.
Time Frame
Pre-Assessment
Title
Demand
Description
This term describes the number of reinforcers obtained prior to response cessation during progress fixed-ratio reinforcer analysis. Often used as a proxy measure to establish reinforcer value.
Time Frame
Pre-Assessment
Title
Pmax
Description
This term describes the unit price that produces the highest target-response output during progressive fixed-ratio reinforcer analysis.
Time Frame
Pre-Assessment
Title
Response latency
Description
This term describes the latency from session onset to delivery of the first programmed reinforcer during progressive fixed-ratio reinforcer analysis.
Time Frame
Pre-Assessment
Secondary Outcome Measure Information:
Title
Number of sessions in extinction
Description
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.
Time Frame
Immediately post-baseline extinction challenges
Title
Overall session duration
Description
The investigators will measure the total duration of reinforcer-analysis sessions (in seconds) to establish baseline-session parameters.
Time Frame
Pre-assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Habilitative and Training Services (HATS)
City
Gallatin
State/Province
Tennessee
ZIP/Postal Code
37066
Country
United States
Facility Name
Easterseals Tennessee: Prospect
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37060
Country
United States
Facility Name
Possibility Place
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37133
Country
United States
Facility Name
Next Steps at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Chrysalis
City
Orem
State/Province
Utah
ZIP/Postal Code
84057
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Peer-reviewed published empirical reports will follow CONSORT reporting guidelines, as well as other principles of rigor and transparency highlighted through the Equator network (https://www.equator-network.org/).
IPD Sharing Time Frame
Study protocol, SAP, & ICF will be submitted within 12 months of study completion and will be made available indefinitely. Complete reports will be submitted for peer review within 12 months of study completion.
IPD Sharing Access Criteria
Data and materials will be made available upon request.

Learn more about this trial

Translational Research to Inform Interventions for Challenging Behavior

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