Translational Research to Inform Interventions for Challenging Behavior

NCT04842500 | Completed Results

• 1 other identifier: IRB #202204
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 5

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.

Conditions

Behavior and Behavior Mechanisms

Keywords

behavioral sciences; reinforcement schedule; motivation; economics, behavioral; developmental disability; intellectual disability; problem behavior; extinction bursts

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Number of Sessions in Extinction

  This measure was obtained throughout the primary assessment (i.e., the extinction challenge)

• Overall Session Duration

  Duration values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters.

Study Arms (4)

"Cheap" Unit Price, Establishing Operation

EXPERIMENTAL

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

"Cheap" Unit Price, Abolishing Operation

EXPERIMENTAL

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

"Expensive" Unit Price, Establishing Operation

EXPERIMENTAL

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

"Expensive" Unit Price, Abolishing Operation

EXPERIMENTAL

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

Interventions

Demand Informed Moderator Analysis 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; "Cheap" Unit Price, Establishing Operation; "Expensive" Unit Price, Abolishing Operation; "Expensive" Unit Price, Establishing Operation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (5)

Habilitative and Training Services (HATS)

Gallatin, Tennessee, 37066, United States

Location

Easterseals Tennessee: Prospect

Lebanon, Tennessee, 37060, United States

Location

Possibility Place

Murfreesboro, Tennessee, 37133, United States

Location

Next Steps at Vanderbilt

Nashville, Tennessee, 37203, United States

Location

Chrysalis

Orem, Utah, 84057, United States

Location

MeSH Terms

Conditions

Behavior; Developmental Disabilities; Intellectual Disability; Problem Behavior

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Child Behavior

Results Point of Contact

• Title: Dr. Joseph Lambert
• Organization: Vanderbilt University

joseph.m.lambert@vanderbilt.edu

615-343-0824

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 13, 2021
• Study Start: August 1, 2021
• Primary Completion: May 24, 2023
• Study Completion: May 14, 2024
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Data and materials will be made available upon request.

Locations

US (5)