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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorAuburn University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Enhanced Teaching ArmExperimental treatment 5 interventions

Trial outcomes

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

Time frame
From enrollment to the end of the intervention at 16 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Auburn University

Lead sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Collaborator