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Translational Research to Inform Interventions for Challenging Behavior

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04842500
Enrollment
86
Registered
2021-04-13
Start date
2021-08-01
Completion date
2024-05-14
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior and Behavior Mechanisms

Keywords

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

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.

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.

Interventions

BEHAVIORALDemand 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).

Sponsors

Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Peak Response Rate During ExtinctionThis measure was obtained throughout the primary assessment (i.e., the extinction challenge)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.
Schedule Value at BreakpointPRA breakpoints were obtained during pre-assessment and were used as a matching variable prior to random assignment.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.
The Schedule Value Designated as PmaxPmax values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters.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.
Response LatencyThis measure was obtained throughout the primary assessment (i.e., the extinction challenge)This term describes the latency from session onset to eventual response cessation during the extinction challenge.

Secondary

MeasureTime frameDescription
Number of Sessions in ExtinctionThis measure was obtained throughout the primary assessment (i.e., the extinction challenge)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 DurationDuration values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters.The investigators will measure the total duration of PFRA sessions (in seconds) at Pmax to establish baseline-session parameters.

Countries

United States

Participant flow

Recruitment details

Recruitment entailed flyer distribution through relevant program directors. Directors vetted interest and only passed along contact information of individuals from their organization who expressed interest in the study.

Pre-assignment details

Prior to randomization, all participants completed an assessment (i.e., the progressive-ratio analysis) that generated our matching variable (i.e., the breakpoint produced by the targeted reinforcer). Five participants dropped out during this assessment (prior to randomization). The reasons for dropping out were scheduling conflicts (x4) and a significant health concern unrelated to this study (x1).

Participants by arm

ArmCount
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. 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).
15
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. 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).
19
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. 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).
18
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. 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).
17
Total69

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyProtocol Violation1001
Overall StudyWithdrawal by Subject4123

Baseline characteristics

CharacteristicCheap Unit Price, Abolishing OperationTotalExpensive Unit Price, Abolishing OperationExpensive Unit Price, Establishing OperationCheap Unit Price, Establishing Operation
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants7 Participants1 Participants1 Participants2 Participants
Age, Categorical
Between 18 and 65 years
16 Participants62 Participants16 Participants17 Participants13 Participants
Disability
Autism Spectrum Disorder
4 Participants12 Participants4 Participants2 Participants2 Participants
Disability
Deaf-Blindness
0 Participants0 Participants0 Participants0 Participants0 Participants
Disability
Deafness
0 Participants0 Participants0 Participants0 Participants0 Participants
Disability
Emotional Disturbance
0 Participants0 Participants0 Participants0 Participants0 Participants
Disability
Hearing Impairment
0 Participants0 Participants0 Participants0 Participants0 Participants
Disability
Intellectual Disability
16 Participants59 Participants15 Participants17 Participants11 Participants
Disability
Multiple Disabilities
0 Participants0 Participants0 Participants0 Participants0 Participants
Disability
Orthopedic Impairment
1 Participants2 Participants0 Participants0 Participants1 Participants
Disability
Other Health Impairment
2 Participants9 Participants5 Participants2 Participants0 Participants
Disability
Specific Learning Disability
0 Participants0 Participants0 Participants0 Participants0 Participants
Disability
Speech or Language Impairment
1 Participants2 Participants0 Participants1 Participants0 Participants
Disability
Traumatic Brain Injury
0 Participants2 Participants0 Participants0 Participants2 Participants
Disability
Visual Impairment, Including Blindness
0 Participants2 Participants0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants0 Participants1 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants68 Participants17 Participants17 Participants15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants2 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants5 Participants1 Participants3 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
16 Participants61 Participants16 Participants15 Participants14 Participants
Region of Enrollment
United States
19 Participants69 Participants17 Participants18 Participants15 Participants
Sex: Female, Male
Female
10 Participants29 Participants6 Participants5 Participants8 Participants
Sex: Female, Male
Male
9 Participants40 Participants11 Participants13 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 190 / 180 / 17
other
Total, other adverse events
0 / 150 / 190 / 180 / 17
serious
Total, serious adverse events
0 / 150 / 190 / 180 / 17

Outcome results

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.

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

ArmMeasureValue (MEAN)Dispersion
Cheap Unit Price, Establishing OperationPeak Response Rate During Extinction1.58 Proportion of baseline (frequency)Standard Deviation 1.77
Cheap Unit Price, Abolishing OperationPeak Response Rate During Extinction0.85 Proportion of baseline (frequency)Standard Deviation 0.85
Expensive Unit Price, Establishing OperationPeak Response Rate During Extinction1.3 Proportion of baseline (frequency)Standard Deviation 0.87
Expensive Unit Price, Abolishing OperationPeak Response Rate During Extinction0.43 Proportion of baseline (frequency)Standard Deviation 0.41
Primary

Response Latency

This term describes the latency from session onset to eventual response cessation during the extinction challenge.

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

ArmMeasureValue (MEAN)Dispersion
Cheap Unit Price, Establishing OperationResponse Latency213.3 secondsStandard Deviation 185.6
Cheap Unit Price, Abolishing OperationResponse Latency96 secondsStandard Deviation 114.4
Expensive Unit Price, Establishing OperationResponse Latency467.4 secondsStandard Deviation 607.9
Expensive Unit Price, Abolishing OperationResponse Latency119.8 secondsStandard Deviation 132.1
Primary

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.

Time frame: PRA breakpoints were obtained during pre-assessment and were used as a matching variable prior to random assignment.

ArmMeasureValue (MEAN)Dispersion
Cheap Unit Price, Establishing OperationSchedule Value at Breakpoint16.45 Schedule Value at BreakpointStandard Deviation 13.24
Cheap Unit Price, Abolishing OperationSchedule Value at Breakpoint15.14 Schedule Value at BreakpointStandard Deviation 10.21
Expensive Unit Price, Establishing OperationSchedule Value at Breakpoint16.94 Schedule Value at BreakpointStandard Deviation 14.53
Expensive Unit Price, Abolishing OperationSchedule Value at Breakpoint18.82 Schedule Value at BreakpointStandard Deviation 15.07
Primary

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.

Time frame: Pmax values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters.

ArmMeasureValue (MEAN)Dispersion
Cheap Unit Price, Establishing OperationThe Schedule Value Designated as Pmax7.6 The Schedule Value Designated as PmaxStandard Deviation 4.42
Cheap Unit Price, Abolishing OperationThe Schedule Value Designated as Pmax7.32 The Schedule Value Designated as PmaxStandard Deviation 4.23
Expensive Unit Price, Establishing OperationThe Schedule Value Designated as Pmax9 The Schedule Value Designated as PmaxStandard Deviation 4.12
Expensive Unit Price, Abolishing OperationThe Schedule Value Designated as Pmax7.71 The Schedule Value Designated as PmaxStandard Deviation 4.44
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.

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

ArmMeasureValue (MEAN)Dispersion
Cheap Unit Price, Establishing OperationNumber of Sessions in Extinction1.2 Number of sessions in extinctionStandard Deviation 0.41
Cheap Unit Price, Abolishing OperationNumber of Sessions in Extinction1.05 Number of sessions in extinctionStandard Deviation 0.23
Expensive Unit Price, Establishing OperationNumber of Sessions in Extinction1.89 Number of sessions in extinctionStandard Deviation 1.94
Expensive Unit Price, Abolishing OperationNumber of Sessions in Extinction1.06 Number of sessions in extinctionStandard Deviation 0.24
Secondary

Overall Session Duration

The investigators will measure the total duration of PFRA sessions (in seconds) at Pmax to establish baseline-session parameters.

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

ArmMeasureValue (MEAN)Dispersion
Cheap Unit Price, Establishing OperationOverall Session Duration630.87 secondsStandard Deviation 462.36
Cheap Unit Price, Abolishing OperationOverall Session Duration687.84 secondsStandard Deviation 843.27
Expensive Unit Price, Establishing OperationOverall Session Duration668.89 secondsStandard Deviation 757.57
Expensive Unit Price, Abolishing OperationOverall Session Duration788.88 secondsStandard Deviation 930.85

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026