CompletedNot Applicable

Translational Research to Inform Interventions for Challenging Behavior

United States86 participantsStarted 2021-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Peak Response Rate During Extinction

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

Schedule Value at Breakpoint

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

The Schedule Value Designated as Pmax

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

Response Latency

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

Trial details

NCT IDNCT04842500

SponsorVanderbilt University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-24

Results submitted2024-05-14

View on ClinicalTrials.gov More Behavior and Behavior Mechanisms trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Peak Response Rate During Extinction

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

Schedule Value at Breakpoint

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

The Schedule Value Designated as Pmax

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

Response Latency

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