NCT05790668 Motivational Refinements for Facilitating Reinforcement Schedule Thinning
| NCT ID | NCT05790668 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Decreasing Destructive Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-10-24 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-10-24 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Brian D Greer, Ph.D.
PRINCIPAL INVESTIGATOR
Rutgers, The State University of New Jersey
Frequently Asked Questions
Who can join the NCT05790668 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Decreasing Destructive Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05790668 currently recruiting?
Yes, NCT05790668 is actively recruiting participants. Contact the research team at brian.greer@rutgers.edu for enrollment information.
Where is the NCT05790668 trial being conducted?
This trial is being conducted at New Brunswick, United States, Somerset, United States.
Who is sponsoring the NCT05790668 clinical trial?
NCT05790668 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Brian D Greer, Ph.D. at Rutgers, The State University of New Jersey. The trial plans to enroll 30 participants.