Challenging BehaviorNCT06732219
A Single-Arm Pilot Trial for Mitigating Relapse of Severe Problem Behavior
A study testing Functional Communication Training, Extinction-Correlated Stimuli and Caregiver Fading in people with Challenging Behavior, run by Auburn University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Challenging Behavior
- What is being tested?
- Functional Communication Training, Extinction-Correlated Stimuli and Caregiver Fading
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Nov 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Auburn University
Auburn, Alabama, 36830
John M Falligant, PhD, 205-807-2371, jmf0031@auburn.edu
Madeline Levin, M.S., 334-844-4412, mjl0083@auburn.edu
- Not yet recruiting
Kennedy Krieger Institute
Baltimore, Maryland, 21231
Patricia Kurtz, PhD, 443-923-2894, kurtz@kennedykrieger.org
Patricia Kurtz, PhD
About this study
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:
Read more
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.
Read the 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.
- Conditions
- Challenging Behavior
- Being tested
- Functional Communication Training, Extinction-Correlated Stimuli, Caregiver Fading, Structured-Probe Schedule Thinning, Multiple-Context Generalization Training
- Keywords
- neurodevelopmental disorders, autism, challenging behavior
- Medical subject headings
- Neurodevelopmental Disorders, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Communication TrainingBehavioural
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 StimuliBehavioural
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 FadingBehavioural
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 ThinningBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Functional Communication Training; Behavioral: Extinction-Correlated Stimuli; Behavioral: Caregiver Fading; Behavioral: Structured-Probe Schedule Thinning; Behavioral: Multiple-Context Generalization Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of the intervention at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start14 Nov 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Challenging BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Responsible party
- Principal investigator, John Michael Falligant, Auburn University
- Investigators
- John Falligant, PhD, Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732219
- Sponsor's protocol ID
- R21HD112724
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38724468
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Pilot Trial for Mitigating Relapse of Severe Problem Behavior
- ClinicalTrials.gov ID
- NCT06732219
- Acronym / sponsor ID
- R21HD112724
- Conditions
- Challenging Behavior
- Keywords
- neurodevelopmental disorders, autism, challenging behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced Teaching Arm | Experimental | Behavioral: Functional Communication Training, Behavioral: Extinction-Correlated Stimuli, Behavioral: Caregiver Fading, Behavioral: Structured-Probe Schedule Thinning, Behavioral: Multiple-Context Generalization TrainingParticipants 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Communication TrainingFunctional 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. | Behavioural | Enhanced Teaching Arm |
| Extinction-Correlated StimuliA 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. | Behavioural | Enhanced Teaching Arm |
| Caregiver FadingBehavioral 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. | Behavioural | Enhanced Teaching Arm |
| Structured-Probe Schedule ThinningOnce 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. | Behavioural | Enhanced Teaching Arm |
| Multiple-Context Generalization TrainingIn 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. | Behavioural | Enhanced Teaching Arm |
Primary outcome
Renewal and Resurgence of Challenging Behavior
Time frame: From enrollment to the end of the intervention at 16 weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Background: PubMed 38724468Strohmeier 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Falligant, PhD principal investigator
Auburn University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Communication Training, Extinction-Correlated Stimuli and Caregiver Fading in people with Challenging Behavior, run by Auburn University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John M Falligant, PhD (334-844-4412, jmf0031@auburn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renewal and Resurgence of Challenging Behavior (time frame: From enrollment to the end of the intervention at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06732219, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.