Recruiting

Observational Study

Sponsor:

Auburn University

Code:

NCT06732219

Conditions

Challenging Behavior

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Functional Communication Training

Extinction-Correlated Stimuli

Caregiver Fading

Structured-Probe Schedule Thinning

Multiple-Context Generalization Training

Study Details

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

Study ID

NCT06732219

Start date

Nov 14, 2024

Status verified date

Dec, 2024

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Enhanced Teaching Arm

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.

Interventions

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.

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.

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 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

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

John M Falligant, PhD

334-844-4412jmf0031@auburn.edu

Patricia Kurtz, PhD

443-923-2894kurtz@kennedykrieger.org

Locations

Auburn University

Recruiting

Auburn, Alabama, United States, 36830

Contacts

John M Falligant, PhD

205-807-2371jmf0031@auburn.edu

Madeline Levin, M.S.

334-844-4412mjl0083@auburn.edu

More Information

Sponsor

Auburn University

Last update posted

Dec 13, 2024

Last verified

Dec, 2024

Keywords

  • neurodevelopmental disorders
  • autism
  • challenging behavior

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Auburn University on 2024-12-13.