Resurgence as Choice: Basic and Clinical Studies

Decreasing Destructive Behavior Clinical Trial

Official title:

Basic and Clinical Studies in Reinforcing Positive Behaviors in Intellectual and Developmental Disabilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423940
• Other study ID #: Pro2019001815
• Status: Completed
• Phase: N/A
• Start date: June 28, 2018
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 subjects who exhibit severe destructive behavior.

Eligibility: Children between the ages of 3 and 18 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.

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 compare these refinements that are derived from Resurgence as Choice Theory with current clinical practice 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) reinforcement schedule thinning show included slow, small decreases in reward deliveries (smaller than those previously reported in the literature). Accordingly, our project will examine the effects of different durations of DRA on resurgence and the effects of adjusting the schedule of reinforcement for each session to include slow and small decreases to avoid resurgence. Findings from this project could have vast clinical implications in that the investigators will demonstrate that time in treatment affects relapse and that schedule thinning can be accomplished without recurrence of destructive behavior. The investigators will compare short, moderate, and extended durations of treatment with DRA to identify the optimal duration of treatment to reduce the extent of relapse of destructive behavior. The investigators will demonstrate that the degree of relapse may depend on the length of treatment with DRA.

The investigators will use measurements of destructive behavior, appropriate behavior, and reinforcer deliveries during each treatment session to inform the number of reinforcers that will be available during upcoming treatment sessions, informed by both the Resurgence as Choice (RaC) Theory and on the results of a coordinated study with nonhuman animals. The investigators will demonstrate that this schedule thinning progression is efficacious at maintaining an 85% reduction in problem behavior (i.e., relative to baseline) during each treatment session.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

1. males and females between the ages of 3 and 18;

2. 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;

3. 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]);

4. IQ and adaptive behavior scores between 35 and 70 (i.e., mild to moderate intellectual disability);

5. on a stable psychoactive drug regimen (or drug free) for at least 10 half-lives of each medication with no anticipated changes;

6. stable educational plan and placement, with no anticipated changes during the study.

Exclusion Criteria:

• Exclusion criteria.

1. children not meeting the inclusion criteria above;

2. 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;

3. DSM-V diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism);

4. 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);

5. 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);

6. 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).

Related Conditions & MeSH terms

• Analysis of Treatment Dosage
• Decreasing Destructive Behavior
• Empirically Determined Reinforcement Schedule Thinning
• Increasing Functional Communicative Behavior

Intervention

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).
• RaC-enhanced functional communication training
We will use the quantitative predictions of Resurgence as Choice (RaC) Theory to tailor a set of reinforcement-schedule thinning steps for each subject. This quantitative prediction will allow for dynamic decisions regarding how to conduct upcoming treatment sessions, as based on both the subject's recent response to treatment and the RaC equation.

Locations

Country	Name	City	State
United States	Rutgers University Center for Autism Research, Education, and Services	Somerset	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Utah State University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hyman SL, Fisher W, Mercugliano M, Cataldo MF. Children with self-injurious behavior. Pediatrics. 1990 Mar;85(3 Pt 2):437-41. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Destructive behavior (responses per minute)	The primary outcome measure is responses per minute of destructive behavior. The investigators will calculate this outcome by dividing the total number of destructive responses per session by the total number of minutes spent in session.	Through study completion, an average of 4 months.
Secondary	Destructive behavior (proportion of baseline)	The investigators will calculate the proportion of baseline destructive behavior by dividing the rates of destructive behavior (described above) observed in treatment by the rates of destructive behavior observed in baseline.	Through study completion, an average of 4 months.