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Completed

NCT Number: NCT03423940

Resurgence as Choice: Basic and Clinical Studies

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.

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Key information

Age range

3 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University Center for Autism Research, Education, and Services

Somerset, New Jersey, 08840, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

functional communication training

Behavioral

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).

Primary outcomes

  1. Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Highest Response Rate

    Time frame: 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.

Secondary outcomes

  1. Number of Participants Showing Resurgence as Predicted by the Quantitative Model -- Lowest Response Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Utah State University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2018
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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