Problem BehaviorNCT05918393
Behavioral Economics and Communication
A study testing functional communication training in people with Problem Behavior, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
This project examines mechanisms to address two significant challenges present in communication-based behavioral interventions for individuals with autism and comorbid severe destructive behavior (SDB): (a) inflexible communication responding and (b) reemergence of severe destructive behavior when challenges to… Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Problem Behavior
- What is being tested?
- functional communication training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2019to 7 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- between 5 and 13 years of age
- documented diagnosis of autism spectrum disorder (ASD) or a diagnosis confirmed based on the relevant cutoff score of the Autism Diagnostic Observation Scale (ADOS-2)
- referred for clinical assessment and treatment of severe destructive behavior (SDB; e.g., SIB, aggression) that (a) poses a serious danger to self, others, or the environment, and (b) interferes with the child receiving an appropriate education
- children whose functional analysis results indicate that SDB is maintained by social-negative or social-positive reinforcement will be admitted to this investigation.
Who cannot join
- severity of their SDB prohibits exposure to baseline conditions
- undergoing changes in their medication regimen
- results of the functional analyses indicate that their SDB is maintained by automatic reinforcement
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: A Behavioral Economic Approach to Improving Communication Variability and Treatment Efficacy
This project examines mechanisms to address two significant challenges present in communication-based behavioral interventions for individuals with autism and comorbid severe destructive behavior (SDB): (a) inflexible communication responding and (b) reemergence of severe destructive behavior when challenges to treatment integrity occur. Achieving the proposed aims will advance clinical practice related to the treatment of SDB and generalization of treatment effects to mitigate against the resurgence of SDB
Read the detailed description
Approximately 25% of individuals with autism spectrum disorder (ASD) are affected by co-morbid severe destructive behavior (SDB). Although there is an extensive body of literature supporting the use of behavioral interventions for decreasing the occurrence of SDB, challenges in the clinical application of these interventions still exist. The current research proposes to evaluate mechanisms for mitigating two potentially significant treatment challenges: (a) invariant responding and (b) resurgence of problem behavior. Functional Communication Training (FCT) is a common reinforcement-based treatment for SBD that involves reinforcement of a target communication response to replace SDB such that communication produces the desired behavior outcome and SDB does not. However, in typical practice only a single communication response is taught thus limiting an individual's ability to communicate if that response is not observed (e.g., touching a card) or if the device used for communication fails (e.g., iPad battery dies). Furthermore, a core deficit of ASD is engagement in restrictive patterns of behavior; thus, individuals with ASD might show a preference for only emitting one communication response among concurrently available alternatives. As noted above, if the preferred communication modality is unavailable, an individual may revert back to engaging in SDB rather than using another, more appropriate communication response - a condition generally referred to as treatment relapse. Evidence for such outcomes can be found in studies in which a FCT response is placed on extinction (i.e., the response no longer produces reinforcement) and SDB immediately increases. One potential way to mitigate against such issues is to teach multiple FCT responses. That is, teaching multiple communication responses may inoculate the individual against invariant communication responding thus reducing SDB.
Related to this, a preferred clinical practice in treating SDB with FCT is to teach the individual to tolerate delays to reinforcement following communication (e.g., waiting until the caregiver is available to interact with the child). When communication is not immediately reinforced, there exists an additional possibility of treatment relapse. Resurgence is one type of treatment relapse in which a previously reduced response re-emerges as a result of a procedural change. For example, relapse of SDB is a clinical concern often observed when delays to reinforcement are introduced. That is, when immediate reinforcement is no longer provided contingent on the target communication response, the individual might revert to engaging in SDB. Given that only one communication response is typically taught during FCT, the effects of teaching multiple communication responses on the mitigation of resurgence remains unknown.
Mitigating invariant responding and resurgence has the potential to greatly impact the lives of individuals with ASD affected by SDB by helping to ensure that positive treatment outcomes maintain across time even in the presence of challenges to treatment such as procedural integrity errors and delays to obtaining reinforcement for appropriate behavior. Thus, the proposed research seeks to strengthen the current literature base and advance current clinical practice through completion of the following aims:
Aim 1. Identify multiple functionally equivalent communication responses and assess levels of variant responding under rich schedule requirements.
Aim 2. Evaluate the effects of a behavioral economic analysis on changes in variant communication responding across multiple communication responses across progressively leaner schedule requirements.
Aim 3. This aim is exploratory in nature as we will assess the extent to which we observe resurgence of SDB following the introduction of multiple communication responses and manipulation of reinforcement schedules for the various responses.
- Conditions
- Problem Behavior
- Being tested
- functional communication training
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional communication trainingBehavioural
Also called differential reinforcement
During functional communication training, signaled intervals of reinforcement (i.e., the functional reinforcer is available contingent on communication) and extinction (i.e., the functional reinforcer is unavailable and thus both problem behavior and communication are on extinction) will be alternated within a single session. All communication responses will be reinforced every time they occur during the signaled reinforcement intervals.
| Study group | Role | What they receive |
|---|---|---|
| Functional communication training (FCT) | Other | During FCT, signaled intervals of reinforcement (i.e., the functional reinforcer is available contingent on communication) and extinction (i.e., the functional reinforcer is unavailable and thus both severe destructive behavior (SDB) and communication are on extinction) will be alternated within a single session. During the treatment-challenge evaluation, SDB will remain on extinction throughout and all communication responses will be reinforced on an FR-1 schedule during the signaled reinforcement intervals. Receives: Behavioral: functional communication training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Averge of Aappropriate Communication Responses
Appropriate communication responses for each participant will be selected based on language level as identified via the Peabody Picture Vocabulary Test, 4th edition (PPVT-4) and/or the Expressive Vocabulary Test-3rd edition (EVT-3)
Measured: Participants were seen 3-5 days/week for a 60-min visit. Second-by-second data were collected over a period of successive, 5-min (300 s) sessions conducted consecutively during the visit. The unit of analysis was mean responding during the 5-min session.
Average of Problem Behavior Responses
Individualized operational definitions of problem behavior and communication were developed for each participant. These included aggression, disruption, self-injurious behavior. Communication included card exchanges, manual signs, card touches, and augmentative device responding. These behaviors were measured via direct observation and data were analyzed by visual inspection.
Measured: Participants were seen 3-5 days/week for a 60-min visit. Second-by-second data were collected over a period of successive, 5-min (300 s) sessions conducted consecutively during the visit. The unit of analysis was mean responding during the 5-min session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start22 Apr 2019
- Primary completion20 Aug 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Problem 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
- Model description
- Single-case research design including multielement and reversal strategies
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918393
- Sponsor's protocol ID
- 941605-12
- Status last verified
- Aug 2023
- First submitted
- 2 Jun 2023
- Last updated
- 5 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Behavioral Economic Approach to Improving Communication Variability and Treatment Efficacy
- ClinicalTrials.gov ID
- NCT05918393
- Acronym / sponsor ID
- 941605-12
- Conditions
- Problem Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Posted 5 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project examines mechanisms to address two significant challenges present in communication-based behavioral interventions for individuals with autism and comorbid severe destructive behavior (SDB): (a) inflexible communication responding and (b) reemergence of severe destructive behavior when challenges to treatment integrity occur. Achieving the proposed aims will advance clinical practice related to the treatment of SDB and generalization of treatment effects to mitigate against the resurgence of SDB
Detailed description
Approximately 25% of individuals with autism spectrum disorder (ASD) are affected by co-morbid severe destructive behavior (SDB). Although there is an extensive body of literature supporting the use of behavioral interventions for decreasing the occurrence of SDB, challenges in the clinical application of these interventions still exist. The current research proposes to evaluate mechanisms for mitigating two potentially significant treatment challenges: (a) invariant responding and (b) resurgence of problem behavior. Functional Communication Training (FCT) is a common reinforcement-based treatment for SBD that involves reinforcement of a target communication response to replace SDB such that communication produces the desired behavior outcome and SDB does not. However, in typical practice only a single communication response is taught thus limiting an individual's ability to communicate if that response is not observed (e.g., touching a card) or if the device used for communication fails (e.g., iPad battery dies). Furthermore, a core deficit of ASD is engagement in restrictive patterns of behavior; thus, individuals with ASD might show a preference for only emitting one communication response among concurrently available alternatives. As noted above, if the preferred communication modality is unavailable, an individual may revert back to engaging in SDB rather than using another, more appropriate communication response - a condition generally referred to as treatment relapse. Evidence for such outcomes can be found in studies in which a FCT response is placed on extinction (i.e., the response no longer produces reinforcement) and SDB immediately increases. One potential way to mitigate against such issues is to teach multiple FCT responses. That is, teaching multiple communication responses may inoculate the individual against invariant communication responding thus reducing SDB.
Related to this, a preferred clinical practice in treating SDB with FCT is to teach the individual to tolerate delays to reinforcement following communication (e.g., waiting until the caregiver is available to interact with the child). When communication is not immediately reinforced, there exists an additional possibility of treatment relapse. Resurgence is one type of treatment relapse in which a previously reduced response re-emerges as a result of a procedural change. For example, relapse of SDB is a clinical concern often observed when delays to reinforcement are introduced. That is, when immediate reinforcement is no longer provided contingent on the target communication response, the individual might revert to engaging in SDB. Given that only one communication response is typically taught during FCT, the effects of teaching multiple communication responses on the mitigation of resurgence remains unknown.
Mitigating invariant responding and resurgence has the potential to greatly impact the lives of individuals with ASD affected by SDB by helping to ensure that positive treatment outcomes maintain across time even in the presence of challenges to treatment such as procedural integrity errors and delays to obtaining reinforcement for appropriate behavior. Thus, the proposed research seeks to strengthen the current literature base and advance current clinical practice through completion of the following aims:
Aim 1. Identify multiple functionally equivalent communication responses and assess levels of variant responding under rich schedule requirements.
Aim 2. Evaluate the effects of a behavioral economic analysis on changes in variant communication responding across multiple communication responses across progressively leaner schedule requirements.
Aim 3. This aim is exploratory in nature as we will assess the extent to which we observe resurgence of SDB following the introduction of multiple communication responses and manipulation of reinforcement schedules for the various responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-case research design including multielement and reversal strategies
| Arm | Type | Receives |
|---|---|---|
| Functional communication training (FCT) | Other | Behavioral: functional communication trainingDuring FCT, signaled intervals of reinforcement (i.e., the functional reinforcer is available contingent on communication) and extinction (i.e., the functional reinforcer is unavailable and thus both severe destructive behavior (SDB) and communication are on extinction) will be alternated within a single session. During the treatment-challenge evaluation, SDB will remain on extinction throughout and all communication responses will be reinforced on an FR-1 schedule during the signaled reinforcement intervals. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- between 5 and 13 years of age
- documented diagnosis of autism spectrum disorder (ASD) or a diagnosis confirmed based on the relevant cutoff score of the Autism Diagnostic Observation Scale (ADOS-2)
- referred for clinical assessment and treatment of severe destructive behavior (SDB; e.g., SIB, aggression) that (a) poses a serious danger to self, others, or the environment, and (b) interferes with the child receiving an appropriate education
- children whose functional analysis results indicate that SDB is maintained by social-negative or social-positive reinforcement will be admitted to this investigation.
Key exclusion criteria (3 listed)
- severity of their SDB prohibits exposure to baseline conditions
- undergoing changes in their medication regimen
- results of the functional analyses indicate that their SDB is maintained by automatic reinforcement
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 trainingAlso: differential reinforcementDuring functional communication training, signaled intervals of reinforcement (i.e., the functional reinforcer is available contingent on communication) and extinction (i.e., the functional reinforcer is unavailable and thus both problem behavior and communication are on extinction) will be alternated within a single session. All communication responses will be reinforced every time they occur during the signaled reinforcement intervals. | Behavioural | Functional communication training (FCT) |
Primary outcome
Averge of Aappropriate Communication Responses
Time frame: Participants were seen 3-5 days/week for a 60-min visit. Second-by-second data were collected over a period of successive, 5-min (300 s) sessions conducted consecutively during the visit. The unit of analysis was mean responding during the 5-min session.
Appropriate communication responses for each participant will be selected based on language level as identified via the Peabody Picture Vocabulary Test, 4th edition (PPVT-4) and/or the Expressive Vocabulary Test-3rd edition (EVT-3)
Average of Problem Behavior Responses
Time frame: Participants were seen 3-5 days/week for a 60-min visit. Second-by-second data were collected over a period of successive, 5-min (300 s) sessions conducted consecutively during the visit. The unit of analysis was mean responding during the 5-min session.
Individualized operational definitions of problem behavior and communication were developed for each participant. These included aggression, disruption, self-injurious behavior. Communication included card exchanges, manual signs, card touches, and augmentative device responding. These behaviors were measured via direct observation and data were analyzed by visual inspection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 in people with Problem Behavior, run by State University of New York - Upstate Medical University at 1 site 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?
The sponsor lists 4 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 5 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Averge of Aappropriate Communication Responses (time frame: Participants were seen 3-5 days/week for a 60-min visit. Second-by-second data were collected over a period of successive, 5-min (300 s) sessions conducted consecutively during the visit. The unit of analysis was mean responding during the 5-min session.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.