NCT05925101 Basic and Applied Research on Extinction Bursts
| NCT ID | NCT05925101 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Problem Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-07-07 |
| Primary Completion | 2028-03-01 |
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 40 participants in total. It began in 2023-07-07 with a primary completion date of 2028-03-01.
⚠ 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
Although highly effective, treatments like FCT include extinction, which can have adverse side effects. The extinction burst, an increase in the frequency or intensity of destructive behavior at the start of treatment, is the most common side effect of extinction, and can increase the risk of harm to the patient and others. The goal of the current study is to evaluate the prevalence of extinction bursts when various parameters of reinforcement (i.e., rate, magnitude, quality) are manipulated.
Eligibility Criteria
Inclusion Criteria: 1. children aged 3 to 17; 2. problem behavior that occurs at least 10 times a day, despite previous treatment; 3. problem behavior maintained by social positive reinforcement; 4. stable protective supports for self-injurious behavior (e.g., helmet) with no anticipated changes during enrollment; 5. on a stable psychoactive drug regimen for at least 10 half-lives per drug or drug free; 6. stable educational plan and placement with no anticipated changes during the child's treatment. Exclusion Criteria: 1. patients currently receiving 15 or more hours per week of treatment for their problem behavior; 2. DSM-5 diagnosis of Rett syndrome or other degenerative conditions (e.g., inborn error of metabolism); 3. a comorbid health condition or major mental disorder that would interfere with study participation; 4. occurrence of self-injury during study assessments that presents a risk of serious or permanent harm (e.g., detached retinas) based on our routine clinical-risk assessment; 5. patients requiring changes to protective supports for self-injury or drug treatment, but we will invite these patients to participate when protective supports and drug regimen are stable.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05925101 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 17 Years, studying Problem Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05925101 currently recruiting?
Yes, NCT05925101 is actively recruiting participants. Contact the research team at wayne.fisher@rutgers.edu for enrollment information.
Where is the NCT05925101 trial being conducted?
This trial is being conducted at Somerset, United States.
Who is sponsoring the NCT05925101 clinical trial?
NCT05925101 is sponsored by Rutgers, The State University of New Jersey. The trial plans to enroll 40 participants.