Translational Research to Inform Interventions for Challenging Behavior

Behavior and Behavior Mechanisms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04842500
• Other study ID #: IRB #202204
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: March 2024

Study information

• Verified date: April 2023
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms
• Developmental Disabilities

Intervention

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).

Locations

Country	Name	City	State
United States	Habilitative and Training Services (HATS)	Gallatin	Tennessee
United States	Easterseals Tennessee: Prospect	Lebanon	Tennessee
United States	Possibility Place	Murfreesboro	Tennessee
United States	Next Steps at Vanderbilt	Nashville	Tennessee
United States	Chrysalis	Orem	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately post-baseline extinction challenges
Primary	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.	Pre-Assessment
Primary	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.	Pre-Assessment
Primary	Pmax	This term describes the unit price that produces the highest target-response output during progressive fixed-ratio reinforcer analysis.	Pre-Assessment
Primary	Response latency	This term describes the latency from session onset to delivery of the first programmed reinforcer during progressive fixed-ratio reinforcer analysis.	Pre-Assessment
Secondary	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.	Immediately post-baseline extinction challenges
Secondary	Overall session duration	The investigators will measure the total duration of reinforcer-analysis sessions (in seconds) to establish baseline-session parameters.	Pre-assessment