Behavior and Behavior MechanismsNCT04842500
Translational Research to Inform Interventions for Challenging Behavior
A study testing Demand Informed Moderator Analysis in people with Behavior and Behavior Mechanisms, run by Vanderbilt University at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior and Behavior Mechanisms
- What is being tested?
- Demand Informed Moderator Analysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Aug 2021to 14 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Habilitative and Training Services (HATS)
Gallatin, Tennessee, 37066
Easterseals Tennessee: Prospect
Lebanon, Tennessee, 37060
Possibility Place
Murfreesboro, Tennessee, 37133
Next Steps at Vanderbilt
Nashville, Tennessee, 37203
Chrysalis
Orem, Utah, 84057
About this study
Official title: Translational Research to Inform Interventions for Severe Challenging Behavior for Individuals With Intellectual and Developmental Disabilities
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.
Read the 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.
- Conditions
- Behavior and Behavior Mechanisms
- Being tested
- Demand Informed Moderator Analysis
- Keywords
- behavioral sciences, reinforcement schedule, motivation, economics, behavioral, developmental disability, intellectual disability, problem behavior, extinction bursts
- Medical subject headings
- Behavior, Developmental Disabilities, Intellectual Disability, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demand Informed Moderator AnalysisBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Demand Informed Moderator Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This measure was obtained throughout the primary assessment (i.e., the extinction challenge)
Secondary outcomes (2)
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.
Measured: This measure was obtained throughout the primary assessment (i.e., the extinction challenge)
Overall Session Duration
The investigators will measure the total duration of PFRA sessions (in seconds) at Pmax to establish baseline-session parameters.
Measured: Duration values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Aug 2021
- Primary completion24 May 2023
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Behavior and Behavior MechanismsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph M. Lambert, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842500
- Sponsor's protocol ID
- IRB #202204
- Status last verified
- Jan 2025
- First submitted
- 4 Apr 2021
- Last updated
- 6 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Peer-reviewed published empirical reports will follow CONSORT reporting guidelines, as well as other principles of rigor and transparency highlighted through the Equator network (https://www.equator-network.org/).
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Research to Inform Interventions for Severe Challenging Behavior for Individuals With Intellectual and Developmental Disabilities
- ClinicalTrials.gov ID
- NCT04842500
- Acronym / sponsor ID
- IRB #202204
- Conditions
- Behavior and Behavior Mechanisms
- Keywords
- behavioral sciences, reinforcement schedule, motivation, economics, behavioral, developmental disability, intellectual disability, problem behavior, extinction bursts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Posted 6 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| "Cheap" Unit Price, Establishing Operation | Experimental | Behavioral: Demand Informed Moderator AnalysisPre-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. |
| "Cheap" Unit Price, Abolishing Operation | Experimental | Behavioral: Demand Informed Moderator AnalysisPre-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. |
| "Expensive" Unit Price, Establishing Operation | Experimental | Behavioral: Demand Informed Moderator AnalysisPre-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. |
| "Expensive" Unit Price, Abolishing Operation | Experimental | Behavioral: Demand Informed Moderator AnalysisPre-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Demand Informed Moderator AnalysisThis 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). | Behavioural | "Cheap" Unit Price, Abolishing Operation, "Cheap" Unit Price, Establishing Operation, "Expensive" Unit Price, Abolishing Operation, "Expensive" Unit Price, Establishing Operation |
Primary outcome
Peak Response Rate During Extinction
Time frame: This 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 Breakpoint
Time frame: PRA 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 Pmax
Time frame: Pmax 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 Latency
Time frame: This 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.
2 secondary outcomes
Number of Sessions in Extinction
Time frame: This measure was obtained throughout the primary assessment (i.e., the extinction challenge)
Overall Session Duration
Time frame: Duration values were obtained during pre-assessment and were used as a scaling variable to set baseline schedule parameters.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Peer-reviewed published empirical reports will follow CONSORT reporting guidelines, as well as other principles of rigor and transparency highlighted through the Equator network (https://www.equator-network.org/).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Demand Informed Moderator Analysis in people with Behavior and Behavior Mechanisms, run by Vanderbilt University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Response Rate During Extinction (time frame: This measure was obtained throughout the primary assessment (i.e., the extinction challenge)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.