Translational Research to Inform Interventions for Challenging Behavior

NCT ID: NCT04842500

Last Updated: 2025-02-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-05-14

Brief Summary

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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

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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.

Conditions

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Behavior and Behavior Mechanisms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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"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.

Group Type EXPERIMENTAL

Demand Informed Moderator Analysis

Intervention Type BEHAVIORAL

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).

"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.

Group Type EXPERIMENTAL

Demand Informed Moderator Analysis

Intervention Type BEHAVIORAL

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).

"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.

Group Type EXPERIMENTAL

Demand Informed Moderator Analysis

Intervention Type BEHAVIORAL

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).

"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.

Group Type EXPERIMENTAL

Demand Informed Moderator Analysis

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Joseph M. Lambert

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Habilitative and Training Services (HATS)

Gallatin, Tennessee, United States

Site Status

Easterseals Tennessee: Prospect

Lebanon, Tennessee, United States

Site Status

Possibility Place

Murfreesboro, Tennessee, United States

Site Status

Next Steps at Vanderbilt

Nashville, Tennessee, United States

Site Status

Chrysalis

Orem, Utah, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB #202204

Identifier Type: -

Identifier Source: org_study_id

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