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

NCT06732219 | Recruiting DMC

• 1 other identifier: R21HD112724
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Challenging Behavior

Keywords

neurodevelopmental disorders; autism; challenging behavior

Outcome Measures

Primary Outcomes (1)

• Renewal and Resurgence of Challenging Behavior

  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

  From enrollment to the end of the intervention at 16 weeks

Study Arms (1)

Enhanced Teaching Arm

EXPERIMENTAL

Participants in this arm will receive a behavioral intervention designed to reduce challenging behaviors and improve skill acquisition. The intervention includes functional communication training (FCT) to teach appropriate communication responses, the use of extinction-correlated stimuli to signal changes in reinforcement conditions, terminal probe schedule thinning to systematically reduce the frequency of reinforcement, competing stimuli to minimize engagement in challenging behaviors during reinforcement delays, and caregiver fading to promote skill generalization and maintenance across naturalistic environments. These strategies will be tailored to individual needs and administered within structured sessions.

Behavioral: Functional Communication Training; Behavioral: Extinction-Correlated Stimuli; Behavioral: Caregiver Fading; Behavioral: Structured-Probe Schedule Thinning; Behavioral: Multiple-Context Generalization Training

Interventions

Functional Communication Training BEHAVIORAL

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.

Enhanced Teaching Arm

Extinction-Correlated Stimuli BEHAVIORAL

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.

Enhanced Teaching Arm

Caregiver Fading BEHAVIORAL

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 therapist will provide in-situ feedback. Once the caregiver demonstrates at least 80% treatment integrity across two consecutive sessions, the therapist will systematically increase their distance by 3 meters each session (maintaining at least 80% integrity) until they are fully removed from the treatment area.

Enhanced Teaching Arm

Structured-Probe Schedule Thinning BEHAVIORAL

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 reinforcer density from treatment. Specifically, the FCR will be placed on extinction for 540 seconds and reinforced for 60 seconds during each session. This schedule was selected based on prior analyses of effective reductions in reinforcer density. If the treatment effect remains strong (defined as maintaining at least an 80% reduction in SPB relative to baseline), schedule thinning will proceed at this step until three consecutive sessions show consistent results.

Enhanced Teaching Arm

Multiple-Context Generalization Training BEHAVIORAL

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.

Enhanced Teaching Arm

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Auburn University: lead
• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: collaborator

Study Sites (2)

Auburn University

Auburn, Alabama, 36830, United States

RECRUITING

Kennedy Krieger Institute

Baltimore, Maryland, 21231, United States

NOT YET RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental Disorders; Autistic Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Study Officials

• John Falligant, PhD

  Auburn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John M Falligant, PhD

CONTACT

334-844-4412; jmf0031@auburn.edu

Patricia Kurtz, PhD

CONTACT

443-923-2894; kurtz@kennedykrieger.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 13, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

US (2)