Clinical trial NCT06651606: Preventing Relapse of Problem Behavior Through Behavioral Economics: A Translational Analysis
Official title: Using Behavioral Economics to Mitigate Relapse of Problem Behavior in an Intellectual and Developmental Disabilities Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Problem Behavior
Lead sponsor: Oakland University
Sponsor class: OTHER
Collaborators: name: Auburn University
First posted: 2024-10-22
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. how well does progressive ratio training mitigate response-dependent reinstatement compared to the standard of care approach?
2. 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.

Eligibility criteria: Inclusion Criteria:

* Boys and girls from ages 6 to 21
* Engage in problem behavior
* Diagnosis of some type of intellectual and developmental disability

Exclusion Criteria:

* Not meeting the inclusion criteria

Primary outcomes:
measure: Treatment Effectiveness
timeFrame: 2 years
Secondary outcomes:
measure: Proportional and Comparative Effectiveness
timeFrame: 2 years
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
city: Rochester
country: United States
facility: Oakland University
state: Michigan
Study officials:
affiliation: Oakland University
name: Michael P Kranak, PhD
role: PRINCIPAL_INVESTIGATOR
References: