Clinical trial NCT05918393: Behavioral Economics and Communication
Official title: A Behavioral Economic Approach to Improving Communication Variability and Treatment Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problem Behavior
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-06-26
Enrollment: 9
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-case research design including multielement and reversal strategies
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Appropriate communication
timeFrame: 3-5 days per week for approximately 12 weeks
measure: Problem behavior
timeFrame: 3-5 days per week for approximately 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
References: