- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03423940
Resurgence as Choice: Basic and Clinical Studies
Basic and Clinical Studies in Reinforcing Positive Behaviors in Intellectual and Developmental Disabilities
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Jersey
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Somerset, New Jersey, United States, 08840
- Rutgers University Center for Autism Research, Education, and Services
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- males and females between the ages of 3 and 19;
- problem behavior (e.g., aggression, property destruction, self-injurious behavior) that has been the focus of outpatient behavioral and pharmacological treatment but continues to occur, on average, more than once per hour;
- problem behavior reinforced by social consequences (i.e., significantly higher and stable rates of the behavior in one or more social test conditions of a functional analysis [e.g., attention, escape] relative to the control condition [play] and the test condition for automatic reinforcement [alone or ignore]);
- IQ and adaptive behavior scores between 35 and 70 (i.e., mild to moderate intellectual disability);
- on a stable psychoactive drug regimen (or drug free) for at least 10 half-lives of each medication with no anticipated changes;
- stable educational plan and placement, with no anticipated changes during the study.
Exclusion Criteria:
- Exclusion criteria.
- children not meeting the inclusion criteria above;
- children currently receiving intensive (i.e., 15 or more hours per week), function-based, behavioral treatment for their problem behavior through the school or another program;
- DSM-V diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism);
- presence of a comorbid health condition (e.g., blindness) or major mental disorder (e.g., bipolar disorder) that would interfere with participation in the study (e.g., requiring frequent hospitalizations);
- children with self-injurious behavior who, based on the results of the risk assessment, cannot be exposed to baseline conditions without placing them at risk of serious or permanent harm (e.g., detached retinas);
- children requiring changes in drug treatment (but such children will be invited to participate after they meet the above criteria for a stable drug regimen).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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).
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Experimental: 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.
|
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Highest Response Rate
Time Frame: Through study completion, an average of 4 months.
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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.
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Through study completion, an average of 4 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Lowest Response Rate
Time Frame: Through study completion, an average of 4 months.
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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.
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Through study completion, an average of 4 months.
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Carr EG, Durand VM. Reducing behavior problems through functional communication training. J Appl Behav Anal. 1985 Summer;18(2):111-26. doi: 10.1901/jaba.1985.18-111.
- Tiger JH, Hanley GP, Bruzek J. Functional communication training: a review and practical guide. Behav Anal Pract. 2008 Spring;1(1):16-23. doi: 10.1007/BF03391716.
- Fisher WW, Kelley ME, Lomas JE. Visual aids and structured criteria for improving visual inspection and interpretation of single-case designs. J Appl Behav Anal. 2003 Fall;36(3):387-406. doi: 10.1901/jaba.2003.36-387.
- Greer BD, Fisher WW, Saini V, Owen TM, Jones JK. Functional communication training during reinforcement schedule thinning: An analysis of 25 applications. J Appl Behav Anal. 2016 Mar;49(1):105-21. doi: 10.1002/jaba.265. Epub 2015 Oct 20.
- Shahan TA, Craig AR. Resurgence as Choice. Behav Processes. 2017 Aug;141(Pt 1):100-127. doi: 10.1016/j.beproc.2016.10.006. Epub 2016 Oct 26.
- Craig AR, Shahan TA. Behavioral momentum theory fails to account for the effects of reinforcement rate on resurgence. J Exp Anal Behav. 2016 May;105(3):375-92. doi: 10.1002/jeab.207.
- Iwata BA, Dorsey MF, Slifer KJ, Bauman KE, Richman GS. Toward a functional analysis of self-injury. J Appl Behav Anal. 1994 Summer;27(2):197-209. doi: 10.1901/jaba.1994.27-197.
- Shadish WR, Hedges LV, Pustejovsky JE. Analysis and meta-analysis of single-case designs with a standardized mean difference statistic: a primer and applications. J Sch Psychol. 2014 Apr;52(2):123-47. doi: 10.1016/j.jsp.2013.11.005. Epub 2013 Dec 27.
- Hagopian LP, Boelter EW, Jarmolowicz DP. Reinforcement schedule thinning following functional communication training: review and recommendations. Behav Anal Pract. 2011 Summer;4(1):4-16. doi: 10.1007/BF03391770.
- Saini V, Miller SA, Fisher WW. Multiple schedules in practical application: Research trends and implications for future investigation. J Appl Behav Anal. 2016 Jun;49(2):421-44. doi: 10.1002/jaba.300. Epub 2016 Mar 15.
- Hyman SL, Fisher W, Mercugliano M, Cataldo MF. Children with self-injurious behavior. Pediatrics. 1990 Mar;85(3 Pt 2):437-41.
- Emerson E, Kiernan C, Alborz A, Reeves D, Mason H, Swarbrick R, Mason L, Hatton C. The prevalence of challenging behaviors: a total population study. Res Dev Disabil. 2001 Jan-Feb;22(1):77-93. doi: 10.1016/s0891-4222(00)00061-5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2019001815
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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