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Behavioral Economics and Communication

Primary Purpose

Problem Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
functional communication training
Sponsored by
State University of New York - Upstate Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Problem Behavior

Eligibility Criteria

5 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SUNY Upstate Medical University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Functional communication training (FCT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Appropriate communication
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)
Problem behavior
Individualized operational definitions of problem behavior will be developed for each participant. Examples include aggression, disruption, pica, and self-injurious behavior. These data will be determined by clinical interview and measured via direct observation. There are no formal questionnaires, rating scales, or other measures associated with this outcome.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2023
Last Updated
June 23, 2023
Sponsor
State University of New York - Upstate Medical University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05918393
Brief Title
Behavioral Economics and Communication
Official Title
A Behavioral Economic Approach to Improving Communication Variability and Treatment Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
December 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State University of New York - Upstate Medical University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Problem Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-case research design including multielement and reversal strategies
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional communication training (FCT)
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
functional communication training
Other Intervention Name(s)
differential reinforcement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Appropriate communication
Description
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)
Time Frame
3-5 days per week for approximately 12 weeks
Title
Problem behavior
Description
Individualized operational definitions of problem behavior will be developed for each participant. Examples include aggression, disruption, pica, and self-injurious behavior. These data will be determined by clinical interview and measured via direct observation. There are no formal questionnaires, rating scales, or other measures associated with this outcome.
Time Frame
3-5 days per week for approximately 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Behavioral Economics and Communication

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