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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT05918393
Study groupRoleWhat they receive
Functional communication training (FCT)OtherDuring 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.

  1. 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.

  2. 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.

  1. First posted26 Jun 2023
  2. Study start22 Apr 2019
  3. Primary completion20 Aug 2021
  4. Study completion7 Dec 2021

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

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