Trial Outcomes & Findings for Behavioral Economics and Communication (NCT NCT05918393)
NCT ID: NCT05918393
Last Updated: 2026-03-05
Results Overview
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)
COMPLETED
NA
9 participants
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.
2026-03-05
Participant Flow
Recruitment began with inception of the study 4/22/19. All participants were recruited from clinical referrals to Center for Development, Behavior, and Genetics at Upstate Medical University. Recruitment ended with the closing of the study on December 7, 2021.
There were no significant events that occurred during the study.
Participant milestones
| Measure |
Functional Communication Training (FCT)
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.
functional communication training: 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.
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|---|---|
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Overall Study
STARTED
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9
|
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Overall Study
Acquisition of Variant Responding
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9
|
|
Overall Study
COMPLETED
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9
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Behavioral Economics and Communication
Baseline characteristics by cohort
| Measure |
Functional Communication Training (FCT)
n=9 Participants
Participants who experienced training in an alternative communication response.
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|---|---|
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Age, Categorical
<=18 years
|
9 Participants
n=41 Participants
|
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=41 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=41 Participants
|
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Sex: Female, Male
Female
|
3 Participants
n=41 Participants
|
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Sex: Female, Male
Male
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6 Participants
n=41 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=41 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=41 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=41 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
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Region of Enrollment
United States
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9 participants
n=41 Participants
|
|
Rate of problem behavior
|
2.03 responses per minute
n=41 Participants
|
PRIMARY outcome
Timeframe: 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.Population: Throughout the study, data were recorded via a computer-based data collection program. Data summaries (i.e., rate, percent of session) were uploaded to an Excel spreadsheet allowing for development of a graphical presentation (i.e., scatterplot line graph) of the data. The data were evaluated using structured visual inspection criteria. A total of 510 FCT sessions were analyzed across 9 participants (range, 9 - 146).
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)
Outcome measures
| Measure |
Functional Communication Training (FCT)
n=510 direct observation of 5-min sessions
Individuals in this group were taught to emit an appropriate communication alternative to problem behavior. Response rates were calculated from the observed frequencies of all occurrences of communication and problem behavior. These data were then analyzed at the participant level for all participants to determine the extent to which each individual displayed an increase in appropriate communication and a decrease in problem behavior.
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|---|---|
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Averge of Aappropriate Communication Responses
|
3.33 direct observation of 5-min sessions
Interval 1.27 to 4.4
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PRIMARY outcome
Timeframe: 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.Population: Participants were seen 3-5 days per week for approximately 60 min per visit. Data were collected over a period of successive, 5-min observation sessions conducted consecutively during the 60-min visit. A 2-3 min break occurred between observations.
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.
Outcome measures
| Measure |
Functional Communication Training (FCT)
n=510 direct observation of 5-min sessions
Individuals in this group were taught to emit an appropriate communication alternative to problem behavior. Response rates were calculated from the observed frequencies of all occurrences of communication and problem behavior. These data were then analyzed at the participant level for all participants to determine the extent to which each individual displayed an increase in appropriate communication and a decrease in problem behavior.
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|---|---|
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Average of Problem Behavior Responses
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0.48 direct observation of 5-min sessions
Interval 0.0 to 10.4
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Adverse Events
Functional Communication Training (FCT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place