Trial Outcomes & Findings for Resurgence as Choice: Basic and Clinical Studies (NCT NCT03423940)
NCT ID: NCT03423940
Last Updated: 2024-09-03
Results Overview
Mean responses per minute of destructive during the resurgence test conditions are compared within-participant to determine whether response rates are highest in the test condition predicted by the model to produce the highest rate of responding.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
Through study completion, an average of 4 months.
Results posted on
2024-09-03
Participant Flow
Participant milestones
| Measure |
Evaluation of Treatment Dosage
In Arm 1, we will examine the optimal duration of treatment with functional communication training (FCT). Investigators will treat each participant's behavior using FCT in three distinct contexts which will be associated with either short, moderate, or extended treatment durations. The investigators will counterbalance the order of treatment durations (short, moderate, and extended) across participants, but each individual will receive treatment at each duration. Resurgence will be tested following each treatment duration.
|
Evaluation of Size of Decrease in Alternative Reinforcement
In Arm 2, we will evaluate whether smaller, rather than larger, decreases in the availability of alternative reinforcement decreases the magnitude of resurgence. Investigators will counterbalance the order of differently sized decreases in alternative reinforcement with half of the participants in Arm 2 to determine whether the order of such decreases also affects resurgence magnitude.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
12
|
|
Overall Study
COMPLETED
|
4
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Resurgence as Choice: Basic and Clinical Studies
Baseline characteristics by cohort
| Measure |
Evaluation of Treatment Dosage
n=4 Participants
In Arm 1, we will examine the optimal duration of treatment with functional communication training (FCT). Investigators will treat each participant's behavior using FCT in three distinct contexts which will be associated with either short, moderate, or extended treatment durations. The investigators will counterbalance the order of treatment durations (short, moderate, and extended) across participants, but each individual will receive treatment at each duration. Resurgence will be tested following each treatment duration.
|
Evaluation of Size of Decrease in Alternative Reinforcement
n=11 Participants
In Arm 2, we will evaluate whether smaller, rather than larger, decreases in the availability of alternative reinforcement decreases the magnitude of resurgence. Investigators will counterbalance the order of differently sized decreases in alternative reinforcement with half of the participants in Arm 2 to determine whether the order of such decreases also affects resurgence magnitude.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.75 Years
n=99 Participants
|
11.45 Years
n=107 Participants
|
10.73 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Responses per minute of combined destructive behavior at or above 1.0 in baseline
|
4 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 4 months.Mean responses per minute of destructive during the resurgence test conditions are compared within-participant to determine whether response rates are highest in the test condition predicted by the model to produce the highest rate of responding.
Outcome measures
| Measure |
Evaluation of Treatment Dosage
n=3 Participants
In Arm 1, we will examine the optimal duration of treatment with functional communication training (FCT). Investigators will treat each participant's behavior using FCT in three distinct contexts which will be associated with either short, moderate, or extended treatment durations. The investigators will counterbalance the order of treatment durations (short, moderate, and extended) across participants, but each individual will receive treatment at each duration. Resurgence will be tested following each treatment duration.
|
Evaluation of Size of Decrease in Alternative Reinforcement
n=9 Participants
In Arm 2, we will evaluate whether smaller, rather than larger, decreases in the availability of alternative reinforcement decreases the magnitude of resurgence. Investigators will counterbalance the order of differently sized decreases in alternative reinforcement with half of the participants in Arm 2 to determine whether the order of such decreases also affects resurgence magnitude.
|
|---|---|---|
|
Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Highest Response Rate
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 4 months.Mean responses per minute of destructive during the resurgence test conditions are compared within-participant to determine whether response rates are lowest in the test condition predicted by the model to produce the lowest rate of responding.
Outcome measures
| Measure |
Evaluation of Treatment Dosage
n=3 Participants
In Arm 1, we will examine the optimal duration of treatment with functional communication training (FCT). Investigators will treat each participant's behavior using FCT in three distinct contexts which will be associated with either short, moderate, or extended treatment durations. The investigators will counterbalance the order of treatment durations (short, moderate, and extended) across participants, but each individual will receive treatment at each duration. Resurgence will be tested following each treatment duration.
|
Evaluation of Size of Decrease in Alternative Reinforcement
n=9 Participants
In Arm 2, we will evaluate whether smaller, rather than larger, decreases in the availability of alternative reinforcement decreases the magnitude of resurgence. Investigators will counterbalance the order of differently sized decreases in alternative reinforcement with half of the participants in Arm 2 to determine whether the order of such decreases also affects resurgence magnitude.
|
|---|---|---|
|
Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Lowest Response Rate
|
2 Participants
|
6 Participants
|
Adverse Events
Evaluation of Treatment Dosage
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Evaluation of Size of Decrease in Alternative Reinforcement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian D. Greer, Ph.D., BCBA-D
Rutgers, The State University of New Jersey
Phone: 848-800-8505
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place