Clinical trial NCT06732219: A Single-Arm Pilot Trial for Mitigating Relapse of Severe Problem Behavior
Official title: A Single-Arm Pilot Trial for Mitigating Relapse of Severe Problem Behavior
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Challenging Behavior
Keywords: neurodevelopmental disorders
autism
challenging behavior
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
First posted: 2024-12-13
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: We will include individuals between the ages of 6 to 17 with IDD who have at least one topography of SPB that is maintained by social positive (e.g., attention, access to preferred items) reinforcement. The age range is driven by the need to maximize the number of participants; there is no evidence to suggest that age is a relevant variable regarding relapse of SPB.

Primary outcomes:
measure: Renewal and Resurgence of Challenging Behavior
timeFrame: From enrollment to the end of the intervention at 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Auburn University
name: John Falligant, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strohmeier CW, Cengher M, Chin MD, Falligant JM. Application of a terminal schedule probe method to inform schedule thinning with multiple schedules. J Appl Behav Anal. 2024 Jul;57(3):676-694. doi: 10.1002/jaba.1081. Epub 2024 May 9.