An interventional study of Functional communication training in Problem Behavior, Self-injury and Communication, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 3 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Treatment
Background: Functional communication training (FCT) is a commonly used intervention for teaching appropriate communication skills to children with intellectual disabilities who exhibit severe destructive behavior. Resurgence as Choice (RaC) Theory, a quantitative model of behavior, may help to explain why treatment relapse often occurs after FCT. This project will use the predictions of RaC to improve FCT treatments.
Objective: To test the predictions made by RaC with human participants who exhibit severe destructive behavior.
Eligibility: Children between the ages of 3 and 19 who display destructive behavior that is maintained by social consequences, who have IQ and adaptive behavior scores between 35 and 70, who are on a stable psychoactive drug regimen (or drug free) for at least 10 half-lives of each medication with no anticipated changes, and who have a stable educational plan and placement will be be eligible to enroll.
Children with intellectual disabilities often display severe destructive behaviors that pose significant risk to self or others and represent barriers to community integration. These destructive behaviors are often treated with behavioral interventions derived from a functional analysis (FA), which is used to identify the environmental antecedents and consequences that occasion and reinforce (i.e., reward) the target response. One such treatment is called differential reinforcement of alternative behavior (DRA), which involves extinction (i.e., removal of rewards) of destructive behavior and reinforcement of an alternative communication response with the consequence that previously reinforced destructive behavior. Results from review studies indicate that interventions based on an FA, like DRA, typically reduce problem behavior by 90% or more.
One commonly used DRA intervention is functional communication training (FCT). During FCT, clinicians withhold reinforcement for destructive behavior and teach the individual a functional communication response to access reinforcement. For instance, a clinician may teach the child to exchange communication cards to express their wants and needs. However, DRA interventions reported in the literature have typically been evaluated by experts in controlled research settings, and treatment relapse often occurs in the natural environment when a caregiver is unable reinforce the DRA response every time that the response occurs due to competing responsibilities. Accordingly, a recent investigation of 25 applications of DRA found that relapse of problem behavior occurred in 76% of cases.
Resurgence as Choice Theory helps to explain why treatment relapse occurs under these circumstances and also provides mathematical equations that can be used to predict the variables that increase and decrease the likelihood that treatment relapse will occur. In this project, the investigators have used these equations to identify refinements to DRA that are likely to decrease the probability that treatment relapse will occur when the DRA response is not reinforced. In some cases, these refinements are at odds with what is recommended in the clinical literature on DRA. Therefore, it is important to evaluate these refinements that are derived from Resurgence as Choice Theory in order to determine the best way to implement DRA, so that treatment remains effective when it is implemented with less than perfect precision by caregivers in the natural environment.
The two predictions that are most relevant to our project are (a) resurgence of destructive behavior will decrease with increased DRA treatment duration, and (b) resurgence of destructive behavior will decrease with smaller, rather than larger, decreases in the availability of alternative reinforcement during the process of reinforcement schedule thinning. Accordingly, our project will examine the effects of different durations of DRA on resurgence and evaluate the effects of differently sized decreases in the availability of reinforcement to avoid resurgence. Findings from this project could have vast clinical implications for the treatment of severe destructive behavior.
Inclusion Criteria:
Exclusion Criteria:
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.
Behavioral: Functional communication training
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.
Behavioral: Functional communication training
During functional communication training (FCT), the social consequence (e.g., attention, toys, breaks from instructions) that heretofore reinforced destructive behavior (i.e., as determined through a functional analysis) is delivered contingent on an appropriate communication response, while destructive behavior is on extinction (i.e., reinforcers are no longer provided). For example, if a functional analysis shows that aggression is reinforced by escape from demands, FCT would typically involve (a) teaching the child to access breaks from demands via a functional communication response (FCR; e.g., saying, "Break, please") and (b) placing destructive behavior on extinction (i.e., continuing with scheduled demands independent of destructive behavior).
Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Highest Response Rate
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.
Time frame: Through study completion, an average of 4 months.
Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Lowest Response Rate
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.
Time frame: Through study completion, an average of 4 months.
| Milestone | Evaluation of Treatment Dosage | Evaluation of Size of Decrease in Alternative Reinforcement |
|---|---|---|
| Started | 5 | 12 |
| Completed | 4 | 9 |
| Not completed | 1 | 3 |
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.
| Participants | Evaluation of Treatment Dosage | Evaluation of Size of Decrease in Alternative Reinforcement |
|---|---|---|
| Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Highest Response Rate | 1 | 5 |
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.
| Participants | Evaluation of Treatment Dosage | Evaluation of Size of Decrease in Alternative Reinforcement |
|---|---|---|
| Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Lowest Response Rate | 2 | 6 |
Collected over Through study completion, an average of 4 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Evaluation of Treatment Dosage | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Evaluation of Size of Decrease in Alternative Reinforcement | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(Years) | Evaluation of Treatment Dosage | Evaluation of Size of Decrease in Alternative Reinforcement | Total |
|---|---|---|---|
| Mean | 8.75 (7 to 10) | 11.45 (4 to 19) | 10.73 (4 to 19) |
| Sex: Female, Male(Participants) | Evaluation of Treatment Dosage | Evaluation of Size of Decrease in Alternative Reinforcement | Total |
|---|---|---|---|
| Female | 0 | 2 | 2 |
| Male | 4 | 9 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Evaluation of Treatment Dosage | Evaluation of Size of Decrease in Alternative Reinforcement | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 2 | 6 | 8 |
| Unknown or Not Reported | 0 | 3 | 3 |
| Race (NIH/OMB)(Participants) | Evaluation of Treatment Dosage | Evaluation of Size of Decrease in Alternative Reinforcement | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 6 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 5 | 7 |
| Responses per minute of combined destructive behavior at or above 1.0 in baseline(Participants) | Evaluation of Treatment Dosage | Evaluation of Size of Decrease in Alternative Reinforcement | Total |
|---|---|---|---|
| Count of participants | 4 | 11 | 15 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The investigators plan to share our outcome data using the National Database on Autism Research (NDAR). The investigators also plan to share our outcome data on the human participants in these two experiments who are not diagnosed with autism spectrum disorder to better understand how complex, comorbid disorders (e.g., self-injury) differ in individuals with and without autism spectrum disorder.
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Rutgers, The State University of New Jersey