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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Functional Communication Training
  Functional Communication Training (FCT) focuses on teaching an appropriate functional communicative response (FCR) to access the reinforcer maintaining severe problem behavior (SPB). This procedure involves selecting an appropriate topography for the FCR (e.g., touching a card, exchanging a picture) and using a backward chaining approach. The training will progress from full physical prompts to partial prompts and eventually to independent, unprompted responses, all within a trial-based format.
• Поведенческое Extinction-Correlated Stimuli
  A distinct extinction-correlated stimulus (e.g., a laminated picture card) will be used in all treatment sessions where severe problem behavior (SPB) is subject to extinction contingencies. This stimulus will also be present during relapse challenges (described below). The selection of the stimulus will be individualized for each participant to ensure it has no prior association with treatment-related contexts, minimizing the influence of pre-existing learning histories.
• Поведенческое Caregiver Fading
  Behavioral Skills Training (BST) will be used to teach caregivers to (1) implement the behavioral intervention package (i.e., differential reinforcement of alternative behavior with extinction) in a controlled setting with confederates and (2) transition into behavioral sessions with the participant while gradually phasing out the clinical therapist. Caregivers will begin by implementing mastered intervention components alongside the therapist during sessions with the participant, where the the
• Поведенческое Structured-Probe Schedule Thinning
  Once a clinically significant decrease in severe problem behavior (SPB) is achieved (defined as an 80% reduction from the baseline mean rate), schedule thinning will be implemented. This process involves reducing the density of reinforcement by introducing a multiple schedule with alternating periods where reinforcement for the functional communication response (FCR) is available and unavailable. Schedule thinning will begin immediately at the terminal schedule, with an 80% reduction in reinfor
• Поведенческое Multiple-Context Generalization Training
  In multiple-context training, treatment will be implemented at the terminal schedule (i.e., after completing schedule thinning) in new contexts, including unique locations and with different individuals, distinct from the setting used during the initial treatment phase.

Первичные конечные точки

• Renewal and Resurgence of Challenging Behavior [Срок оценки: From enrollment to the end of the intervention at 16 weeks]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Auburn University — Auburn
• Kennedy Krieger Institute — Baltimore

Публикации

• 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. PMID 38724468

Идентификаторы

NCT: NCT06732219 · R21HD112724

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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