Problem BehaviorNCT06651606
Preventing Relapse of Problem Behavior Through Behavioral Economics: A Translational Analysis
A study testing Progressive Ratio Training (PRT) and Differential Reinforcement of Alternative (DRA) Behavior with Extinction in people with Problem Behavior, run by Oakland University at 2 sites in United States.
Trial summary
The goal of this clinical trial is to compare a novel tactic for mitigating reinstatement compared to the current standard of care approach using a translational-treatment model. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Problem Behavior
- What is being tested?
- Progressive Ratio Training (PRT) and Differential Reinforcement of Alternative (DRA) Behavior with Extinction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2024to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Boys and girls from ages 6 to 21
- Engage in problem behavior
- Diagnosis of some type of intellectual and developmental disability
Who cannot join
- Not meeting the inclusion criteria
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Auburn University
Auburn, Alabama, 36849
John M Falligant, PhD, 334-844-6483, jmf0031@auburn.edu
John M Falligant, PhD
- Recruiting
Oakland University
Rochester, Michigan, 48309
Michael P Kranak, PhD, 248-370-4251, kranak@oakland.edu
Michael P Kranak, PhD
About this study
Official title: Using Behavioral Economics to Mitigate Relapse of Problem Behavior in an Intellectual and Developmental Disabilities Population
The goal of this clinical trial is to compare a novel tactic for mitigating reinstatement compared to the current standard of care approach using a translational-treatment model. The main questions it aims to answer are:
- how well does progressive ratio training mitigate response-dependent reinstatement compared to the standard of care approach?
- how well does progressive ratio training mitigate response-independent reinstatement compared to the standard of care approach?
Read the detailed description
Behavioral treatments can be an effective means to treat problem behavior. One of the most common behavioral treatments is differential reinforcement of alternative behavior, frequently implemented as functional communication training. Most demonstrations of behavioral treatments, including functional communication training, are conducted in highly controlled settings by trained therapists. When these treatments are implemented in community settings (e.g., an individual's home) by caregivers, they will be challenged, which can lead to the recurrence and sustained relapse of problem behavior. Recurrence and relapse can be the first step in a chain that leads to treatment failure. Fortunately, some tactics have been designed to sustain treatment effectiveness and mitigate two forms of relapse (i.e., resurgence and renewal) that result from two of three primary treatment challenges. These tactics function as inoculation (i.e., make problem behavior less likely to return). However, there are no tactics designed to specifically mitigate a third form of relapse: reinstatement
This project involves a novel inoculation tactic to mitigate reinstatement and protect against the third common treatment challenge: extinction errors. The tactic in question is based on substantial conceptual and empirical evidence from behavioral economics, as well as the investigators' pilot work. The project uses an innovative translational-treatment model to better understand which of the proposed tactics (our novel tactic or the default standard-of-care approach) better inoculates against extinction errors through real-world analogues. The use of a translational-treatment model is consistent with other research examining the role of basic processes in behavioral treatment when collateral effects are unknown, and will also engender a thorough examination of the proposed tactics.
In Aim 1, investigators will establish a proxy response, apply treatment to that proxy response, and examine the effectiveness of progressive ratio training in inoculating against extinction errors and mitigating response-dependent reinstatement.
In Aim 2, investigators will establish a proxy response, apply treatment to that proxy response, and examine the effectiveness of progressive ratio training in inoculating against extinction errors and mitigating response-independent reinstatement. Outcomes of this research could improve the current standard of care for behavioral treatments to make them more effective in community application, result in the development and validation of novel inoculation tactics, and significantly improve the lives of individuals with IDD.
- Conditions
- Problem Behavior
- Being tested
- Progressive Ratio Training (PRT), Differential Reinforcement of Alternative (DRA) Behavior with Extinction
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Ratio Training (PRT)Behavioural
Progressive ratio training (PRT) is used to prevent recurrence of the proxy response when extinction errors occur. PRT involves providing a reinforcer for the proxy response on a geometric progressive ratio (PR) scale. The schedule requirement will increase for the target response each time a reinforcer is delivered. For example, once a reinforcer is delivered on the PR-2 schedule, the requirement will increase to a PR-4, then to a PR-8, -16,
-32, etc.
Differential Reinforcement of Alternative (DRA) Behavior with ExtinctionBehavioural
In DRA with extinction, the proxy for problem behavior is placed on extinction and no longer produces reinforcement. The proxy for communication behavior produces reinforcement on a fixed-ratio 1 schedule of reinforcement.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Ratio Training | Experimental | Participants in the progressive ratio training Arm will experience the novel reinstatement-mitigation tactic: Progressive Ratio Training (PRT).
Progressive ratio training (PRT) is used to prevent recurrence of the proxy response when extinction errors occur. PRT involves providing a reinforcer for the proxy response on a geometric progressive ratio (PR) scale. The schedule requirement will increase for the target response each time a reinforcer is delivered. For example, once a reinforcer is delivered on the PR-2 schedule, the requirement will increase to a PR-4, then to a PR-8, -16,
-32, etc. Receives: Behavioral: Progressive Ratio Training (PRT) |
| Standard of Care | Experimental | Participants in the standard of care Arm will receive an analogue to the standard of care approach for problem behavior: differential reinforcement of alternative behavior (DRA) with extinction.
In DRA with extinction, the proxy for problem behavior will cease to produce reinforcement while the proxy for communication behavior will produce reinforcement on a fixed-ratio 1 schedule of reinforcement. Receives: Behavioral: Differential Reinforcement of Alternative (DRA) Behavior with Extinction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Effectiveness
The number of individuals for whom treatment remains effective (either progressive ratio training or current standard-of-care), which investigators will determine by comparing the mean rate of responding in baseline and subsequent conditions (Treatment and Reinstatement Tests 1 and 2). If investigators find at least an 80% reduction in target behavior in a condition (a standard clinical target for problem behavior), they will conclude that the treatment is effective (or remains effective).
Measured: 2 years
Secondary outcomes (1)
Proportional and Comparative Effectiveness
The proportional and comparative effectiveness of the treatments, which investigators will determine from the mean rate of behavior in Phase 2 Treatment and the treatments during Phase 3 Reinstatement Tests (with progressive-ratio training and the standard-of-care approach), and determine the difference in percent reduction between treatment and the reinstatement tests. This second measure is preliminary: no pilot data speak to what may be observed. However, these data are likely to be important to future research.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start30 Sep 2024
- Primary completion10 Mar 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem BehaviorStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oakland University
- Sponsor type
- University, hospital or other
- Collaborators
- Auburn University
- Responsible party
- Sponsor
- Investigators
- Michael P Kranak, PhD, Principal investigator, Oakland University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651606
- Sponsor's protocol ID
- 1R21HD113794-01A1
- Status last verified
- Aug 2025
- First submitted
- 18 Oct 2024
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share outcome data as specified in the approved Data Management and Sharing Plan.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Behavioral Economics to Mitigate Relapse of Problem Behavior in an Intellectual and Developmental Disabilities Population
- ClinicalTrials.gov ID
- NCT06651606
- Acronym / sponsor ID
- 1R21HD113794-01A1
- Conditions
- Problem Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Oakland UniversityUniversity, hospital or other
- Collaborators
- Auburn University
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare a novel tactic for mitigating reinstatement compared to the current standard of care approach using a translational-treatment model. The main questions it aims to answer are:
- how well does progressive ratio training mitigate response-dependent reinstatement compared to the standard of care approach?
- how well does progressive ratio training mitigate response-independent reinstatement compared to the standard of care approach?
Detailed description
Behavioral treatments can be an effective means to treat problem behavior. One of the most common behavioral treatments is differential reinforcement of alternative behavior, frequently implemented as functional communication training. Most demonstrations of behavioral treatments, including functional communication training, are conducted in highly controlled settings by trained therapists. When these treatments are implemented in community settings (e.g., an individual's home) by caregivers, they will be challenged, which can lead to the recurrence and sustained relapse of problem behavior. Recurrence and relapse can be the first step in a chain that leads to treatment failure. Fortunately, some tactics have been designed to sustain treatment effectiveness and mitigate two forms of relapse (i.e., resurgence and renewal) that result from two of three primary treatment challenges. These tactics function as inoculation (i.e., make problem behavior less likely to return). However, there are no tactics designed to specifically mitigate a third form of relapse: reinstatement
This project involves a novel inoculation tactic to mitigate reinstatement and protect against the third common treatment challenge: extinction errors. The tactic in question is based on substantial conceptual and empirical evidence from behavioral economics, as well as the investigators' pilot work. The project uses an innovative translational-treatment model to better understand which of the proposed tactics (our novel tactic or the default standard-of-care approach) better inoculates against extinction errors through real-world analogues. The use of a translational-treatment model is consistent with other research examining the role of basic processes in behavioral treatment when collateral effects are unknown, and will also engender a thorough examination of the proposed tactics.
In Aim 1, investigators will establish a proxy response, apply treatment to that proxy response, and examine the effectiveness of progressive ratio training in inoculating against extinction errors and mitigating response-dependent reinstatement.
In Aim 2, investigators will establish a proxy response, apply treatment to that proxy response, and examine the effectiveness of progressive ratio training in inoculating against extinction errors and mitigating response-independent reinstatement. Outcomes of this research could improve the current standard of care for behavioral treatments to make them more effective in community application, result in the development and validation of novel inoculation tactics, and significantly improve the lives of individuals with IDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Ratio Training | Experimental | Behavioral: Progressive Ratio Training (PRT)Participants in the progressive ratio training Arm will experience the novel reinstatement-mitigation tactic: Progressive Ratio Training (PRT). Progressive ratio training (PRT) is used to prevent recurrence of the proxy response when extinction errors occur. PRT involves providing a reinforcer for the proxy response on a geometric progressive ratio (PR) scale. The schedule requirement will increase for the target response each time a reinforcer is delivered. For example, once a reinforcer is delivered on the PR-2 schedule, the requirement will increase to a PR-4, then to a PR-8, -16, -32, etc. |
| Standard of Care | Experimental | Behavioral: Differential Reinforcement of Alternative (DRA) Behavior with ExtinctionParticipants in the standard of care Arm will receive an analogue to the standard of care approach for problem behavior: differential reinforcement of alternative behavior (DRA) with extinction. In DRA with extinction, the proxy for problem behavior will cease to produce reinforcement while the proxy for communication behavior will produce reinforcement on a fixed-ratio 1 schedule of reinforcement. |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Boys and girls from ages 6 to 21
- Engage in problem behavior
- Diagnosis of some type of intellectual and developmental disability
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria
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 |
|---|---|---|
| Progressive Ratio Training (PRT)Progressive ratio training (PRT) is used to prevent recurrence of the proxy response when extinction errors occur. PRT involves providing a reinforcer for the proxy response on a geometric progressive ratio (PR) scale. The schedule requirement will increase for the target response each time a reinforcer is delivered. For example, once a reinforcer is delivered on the PR-2 schedule, the requirement will increase to a PR-4, then to a PR-8, -16, -32, etc. | Behavioural | Progressive Ratio Training |
| Differential Reinforcement of Alternative (DRA) Behavior with ExtinctionIn DRA with extinction, the proxy for problem behavior is placed on extinction and no longer produces reinforcement. The proxy for communication behavior produces reinforcement on a fixed-ratio 1 schedule of reinforcement. | Behavioural | Standard of Care |
Primary outcome
Treatment Effectiveness
Time frame: 2 years
The number of individuals for whom treatment remains effective (either progressive ratio training or current standard-of-care), which investigators will determine by comparing the mean rate of responding in baseline and subsequent conditions (Treatment and Reinstatement Tests 1 and 2). If investigators find at least an 80% reduction in target behavior in a condition (a standard clinical target for problem behavior), they will conclude that the treatment is effective (or remains effective).
1 secondary outcome
Proportional and Comparative Effectiveness
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: Yes. The investigators plan to share outcome data as specified in the approved Data Management and Sharing Plan.
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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.
Michael P Kranak, PhD principal investigator
Oakland University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Ratio Training (PRT) and Differential Reinforcement of Alternative (DRA) Behavior with Extinction in people with Problem Behavior, run by Oakland University at 2 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael P Kranak, PhD (248-370-4251, kranak@oakland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Effectiveness (time frame: 2 years). 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 21 Aug 2025.