NCT05925101 · RECRUITING
Basic and Applied Research on Extinction Bursts
This trial studies behavioral therapy techniques for children with severe problem behaviors like aggression and self-injury. Researchers are testing whether gradually adjusting the rate, size, or quality of rewards during treatment can reduce a known side effect called an extinction burst, which is a temporary spike in bad behavior at the start of therapy. This is a non-phase applied behavior analysis study, meaning it is research-level work, not a drug trial.
You may qualify if
- children aged 3 to 17;
- problem behavior that occurs at least 10 times a day, despite previous treatment;
- problem behavior maintained by social positive reinforcement;
- 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.
You're excluded if
- patients currently receiving 15 or more hours per week of treatment for their problem behavior;
- DSM-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 our routine clinical-risk assessment;
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-01-27