NCT05790668 · Rutgers, The State University of New Jersey
Motivational Refinements for Facilitating Reinforcement Schedule Thinning
What this study is about
Destructive behavior represents a comorbid condition of developmental disability for which risk increases with intellectual disability severity, communication deficits, and co-occurring autism spectrum disorder.
View original scientific description
Destructive behavior represents a comorbid condition of developmental disability for which risk increases with intellectual disability severity, communication deficits, and co-occurring autism spectrum disorder. Destructive behavior, such as self-injurious behavior and aggression, causes harm to the child and others and increases the risk for institutionalization, social isolation, physical restraint, medication overuse, and abuse. Clinicians have used functional analyses to identify the variables that reinforce destructive behavior and to develop effective, function-based treatments. Functional communication training (FCT) is an empirically supported, function-based treatment that decreases destructive behavior. Using FCT, the clinician teaches the child to use a functional communication response (FCR) to request the reinforcer maintaining destructive behavior, while placing destructive behavior on extinction. For example, if functional analysis results showed that attention reinforced destructive behavior, the clinician would provide attention when the child used the FCR ("Play with me, please") and would not provide attention for destructive behavior. Two limitations of FCT are that (a) schedules of reinforcement maintaining the FCR must often be thinned gradually to levels that are practical for caregivers to implement consistently in the home and in the community, and (b) this necessary process of reinforcement schedule thinning regularly causes destructive behavior to increase following initially effective treatment, a form of treatment relapse called resurgence. The current project aims to improve these limitations of FCT by (a) hastening the process of reinforcement schedule thinning by removing unnecessary schedule-thinning steps using the results of a progressive interval assessment and (b) mitigating the resurgence of destructive behavior by providing stimuli that highly compete with the reinforcer maintaining destructive behavior. The investigators will conduct a randomized clinical trial to evaluate the extent to which these two promising refinements to FCT improve the process of reinforcement schedule thinning, and an exploratory experiment will examine the interactive effects of these two approaches. This novel project has the potential to substantially improve standards of care guiding the treatment of severe destructive behavior and to improve the long-term outcomes for children and families afflicted by these debilitating behavior disorders.
Interventions
BEHAVIORAL
Traditional Schedule Thinning
During traditional schedule thinning during functional communication training with discriminative stimuli (e.g., multiple schedules, chained schedules), practitioners correlate a unique stimulus with reinforcement (e.g., a green card) and another for extinction (e.g., a red card). When the reinforcement and extinction stimuli are presented, the child's communication responses are honored or not honored, respectively. Behavior analysts begin with a brief period of extinction (e.g., 2 s) and gradually increase that duration as the child displays low levels of destructive behavior and high levels of discriminated communication responses (i.e., communication requests during reinforcement components only) until the child reaches a terminal schedule informed by caregiver/child preference (e.g., 2.5-min reinforcement, 10-min extinction). Typically, the starting extinction period is brief and arbitrarily selected and there are no competing stimuli programmed.
BEHAVIORAL
PIA-Informed Schedule Thinning
This intervention involves the same general components as Traditional Schedule Thinning. However, rather than starting with an arbitrary duration of the extinction component (e.g., 2 s), the behavior analyst empirically derives the starting point based on a progressive-interval assessment (PIA). The PIA involves rapidly increasing the duration of the extinction component within a single session to determine the leanest schedule of reinforcement that does not produce untoward effects. Behavior analysts will progress through the following extinction durations within a single session: 3 s, 11 s , 21 s, 34 s, 50 s, 70 s, 95 s, 126 s, 164 s, 213 s, and 270 s. For example, if the participant displays destructive behavior at 164 s consistently, but not at 126 s, the experimenters will start schedule thinning with a 126-s extinction component. There will be no competing stimuli programmed in this intervention.
BEHAVIORAL
PIA-Informed Schedule Thinning with Competing Stimuli
This intervention is identical to PIA-Informed Schedule Thinning except that behavior analysts will program competing activities (e.g., alternative activities like toys or therapist attention) during extinction components. The competing stimuli will be derived from a competing stimulus assessment in which destructive behavior is analyzed across various conditions in which only the activity is manipulated during the extinction period (e.g., a session with action figures during extinction, a session with tablet during extinction). The items that produce the highest levels of child engagement and lowest levels of destructive behavior are known as highly competing items.
Primary outcome measures
Destructive behavior (responses per minute)
Time frame: Through study completion, an average of 4 weeks.
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.
Discriminated functional communication responses (percentage)
Time frame: Through study completion, an average of 4 weeks.
The investigators will calculate this outcome by dividing the number of child requests when reinforcement is signaled as available by the total number of child requests during reinforcement and extinction, then multiplying the quotient by 100 to convert it to a percentage. This indicates the level of accuracy with communication requests, with 80-100% being optimal.
Efficiency of schedule thinning
Time frame: Through study completion, an average of 4 weeks.
In addition to the above metrics, it is expect that informing schedule thinning with the PIA or competing items may result in reaching the terminal schedule (e.g., 270-s extinction) more rapidly than conditions not so informed. Thus, investigators will analyze the number of treatment sessions required for an intervention to produce destructive behavior below an 85% reduction from baseline and discriminated functional communication responses above 80% at the terminal-schedule value.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- boys and girls from ages 3 to 17
- destructive behavior that occurs at least 10 times a day, despite previous treatment
- destructive behavior reinforced by social consequences
- stable protective supports for self-injurious behavior (e.g., helmet) with no anticipated changes during enrollment
- on a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free
- stable educational plan and placement with no anticipated changes during the child's treatment
Exclusion criteria
- patients who do not meet the inclusion criteria
- patients currently receiving 15 or more hours per week of treatment for their destructive behavior
- Diagnostic and Statistical Manual-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism)
- a comorbid health condition or major mental disorder that would interfere with study participation
- occurrence of self-injury during study assessments that presents a risk of serious or permanent harm (e.g., detached retinas) based on routine clinical-risk assessment
- patients requiring changes to protective supports for self-injury or drug treatment, but investigators will invite these patients to participate when protective supports and drug regimen are stable
Where
- New Brunswick, New Jersey
- Somerset, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2025 · Source of record for eligibility and locations