Preventing Relapse of Problem Behavior Through Behavioral Economics: A Translational Analysis

Not Applicable

Recruiting

• Conditions: Problem Behavior

• Registration Number: NCT06651606
• Lead Sponsor: Oakland University

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.

Study Timeline

• Study Start: 2024-09-30
• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-18
• Study First Posted: 2024-10-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-03-10
• Study Completion: 2026-09-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment Effectiveness	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).

Secondary Outcome Measures

Name	Time	Method
Proportional and Comparative Effectiveness	2 years	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.

Trial Locations

Locations (2)

Auburn University; 🇺🇸 Auburn, Alabama, United States

Oakland University; 🇺🇸 Rochester, Michigan, United States