A Single-Arm Pilot Trial for Mitigating Relapse of Severe Problem Behavior

Not Applicable

Recruiting

• Conditions: Challenging Behavior

• Registration Number: NCT06732219
• Lead Sponsor: Auburn University

Brief Summary

The goal of this study is to improve how we teach self-control and communication skills to children and adolescents with challenging behaviors. Researchers aim to find ways to make behavior-change treatments more effective and long-lasting, even when the environment or reinforcement schedules change.

The main questions this study will answer are:

Can innovative techniques help children maintain learned skills, such as asking for attention or waiting for rewards, when faced with new people, places, or situations? How do cognitive and behavioral factors, like memory, timing, and decision-making, affect the success of treatments?

Participants in this study will:

Complete assessments to identify preferred activities and understand the causes of challenging behaviors.

Learn communication skills to replace challenging behaviors, such as tantrums or crying, with more appropriate actions like asking for attention.

Participate in activities designed to understand their individual responses to different types of rewards and delays.

Detailed Description

Purpose:

The purpose of this research is to explore experimental approaches for improving the durability and generalization of reinforcement-based behavioral interventions. While such interventions are highly effective for reducing challenging behaviors and teaching new skills, their effectiveness can diminish over time due to environmental changes, implementation inconsistencies, or reductions in reinforcement schedules. This study investigates how cognitive and behavioral factors influence treatment outcomes and tests innovative strategies to enhance the long-term success of behavior-change interventions.

Study Objectives:

Evaluate the feasibility of using innovative reinforcement-based tactics to enhance the durability of behavioral interventions.

Investigate how individual factors, such as timing perception, reward sensitivity, and decision-making, impact treatment outcomes.

Assess generalization and maintenance of newly acquired skills across various environmental contexts and with different individuals.

Methods and Procedures:

Participants will engage in a series of assessments and training sessions designed to identify and target challenging behaviors, replace them with functional communication skills, and evaluate the robustness of behavior change under varying conditions. The procedures include:

Preference Assessment:

Identifying preferred items and activities to use as reinforcers during treatment.

Competing Stimulus Assessment:

Identifying activities that engage participants during periods when high-preference items are unavailable.

Functional Behavioral Assessment:

Using interviews, direct observations, and experimental analyses to identify antecedents and consequences maintaining challenging behaviors, such as tantrums or crying.

Functional Communication Training (FCT):

Teaching participants alternative communication skills, such as requesting attention, that serve the same function as challenging behaviors.

Generalization and Maintenance Training:

Testing participants' ability to transfer learned skills to novel environments and individuals by systematically varying environmental contexts and reinforcement conditions.

Study Timeline

• Study Start: 2024-11-14
• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Renewal and Resurgence of Challenging Behavior	From enrollment to the end of the intervention at 16 weeks	The prevalence and magnitude of relapse (e.g., renewal or resurgence) in severe problem behavior (SPB). To assess relapse, we will calculate the highest single-session rate of SPB from the five most recent treatment sessions before a context change or reinforcement downshift (prechange period) and up to the first three sessions after the change (postchange period). If fewer sessions are available in either period, all available data will be used. Relapse will be identified if the maximum rate of SPB in any postchange session exceeds the maximum rate observed during all prechange sessions. The magnitude of relapse will be quantified using the log proportion rate of response, which normalizes session-by-session rates and allows for proportional comparisons across individuals. Outcome data will be collected during schedule thinning, generalization, and treatment challenges and compared to pooled relapse data from external controls to provide a benchmark for interpretation

Trial Locations

Locations (2)

Auburn University; 🇺🇸 Auburn, Alabama, United States

Kennedy Krieger Institute; 🇺🇸 Baltimore, Maryland, United States