Translational Research to Inform Interventions for Challenging Behavior

Translational Research to Inform Interventions for Severe Challenging Behavior for Individuals With Intellectual and Developmental Disabilities

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.

Study Overview

• Status: Completed
• Conditions: Behavior and Behavior Mechanisms
• Intervention / Treatment: Behavioral: Demand Informed Moderator Analysis

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Gallatin, Tennessee, United States, 37066
      • Habilitative and Training Services (HATS)
    • Lebanon, Tennessee, United States, 37060
      • Easterseals Tennessee: Prospect
    • Murfreesboro, Tennessee, United States, 37133
      • Possibility Place
    • Nashville, Tennessee, United States, 37203
      • Next Steps at Vanderbilt
  • Utah
    • Orem, Utah, United States, 84057
      • Chrysalis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Cheap" Unit Price, Establishing Operation; 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.	Behavioral: Demand Informed Moderator Analysis; 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).
Experimental: "Cheap" Unit Price, Abolishing Operation; 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.	Behavioral: Demand Informed Moderator Analysis; 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).
Experimental: "Expensive" Unit Price, Establishing Operation; 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.	Behavioral: Demand Informed Moderator Analysis; 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).
Experimental: "Expensive" Unit Price, Abolishing Operation; 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.	Behavioral: Demand Informed Moderator Analysis; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This measure was obtained throughout the primary assessment (i.e., the extinction challenge)
Schedule Value at Breakpoint	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 last schedule value that supported enough responding to produce a reinforcer, before the participant quit playing the game). Higher breakpoints are interpreted as reflecting higher-value reinforcers. Lower breakpoints are interpreted as reflecting lower-value reinforcers.	PRA breakpoints were obtained during pre-assessment and were used as a matching variable prior to random assignment.
The Schedule Value Designated as Pmax	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 across sessions. Initially, participants "spend" more. Eventually, they "spend" less. The price that produces maximum "spending" (i.e., higher and lower prices yield lower response outputs) is referred to as Pmax. Pmax is one way to quantify a reinforcer's value. That is, reinforcers that produce high Pmax have more value than reinforcers that produce low Pmax.	Pmax values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters.
Response Latency	This term describes the latency from session onset to eventual response cessation during the extinction challenge.	This measure was obtained throughout the primary assessment (i.e., the extinction challenge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This measure was obtained throughout the primary assessment (i.e., the extinction challenge)
Overall Session Duration	The investigators will measure the total duration of PFRA sessions (in seconds) at Pmax to establish baseline-session parameters.	Duration values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters.

Collaborators and Investigators

• Sponsor: Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): May 24, 2023
• Study Completion (Actual): May 14, 2024

Study Registration Dates

• First Submitted: April 4, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: motivation; developmental disability; intellectual disability; problem behavior; behavioral sciences; reinforcement schedule; economics, behavioral; extinction bursts
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Developmental Disabilities
• Other Study ID Numbers: IRB #202204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No