Translational Research to Inform Interventions for Challenging Behavior

Sponsor

Vanderbilt University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04842500

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

2.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Behavior and Behavior Mechanisms	Behavioral: Demand Informed Moderator Analysis	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

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.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:

Single (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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

Peak response rate during extinction [Immediately post-baseline extinction challenges]
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 [Pre-Assessment]
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 [Pre-Assessment]
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 [Pre-Assessment]
This term describes the unit price that produces the highest target-response output during progressive fixed-ratio reinforcer analysis.
Response latency [Pre-Assessment]
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 [Immediately post-baseline extinction challenges]
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 [Pre-assessment]
The investigators will measure the total duration of reinforcer-analysis sessions (in seconds) to establish baseline-session parameters.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Best Buddies Tennessee	Brentwood	Tennessee	United States	37027
2	Habilitative and Training Services (HATS)	Gallatin	Tennessee	United States	37066
3	Down Syndrome Association of Middle Tennessee	Hermitage	Tennessee	United States	37076
4	Next Steps at Vanderbilt	Nashville	Tennessee	United States	37203
5	The Metro Parks DisABILITIES program	Nashville	Tennessee	United States	37203
6	Friends Life Community	Nashville	Tennessee	United States	37204
7	MillarRich	Nashville	Tennessee	United States	37218