NCT05537610 · RECRUITING
Extensions of Resurgence as Choice
This trial is testing a behavioral therapy approach for children ages 3 to 17 who have persistent problem behaviors like aggression or self-injury. Researchers want to know whether alternating between sessions where a child gets what they want and sessions where they do not can reduce the tendency for problem behavior to return after treatment. This is a Phase NA study — meaning it is a behavioral intervention trial, not a drug trial, and is not yet proven or approved.
You may qualify if
- boys and girls from ages 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 who do not meet the inclusion criteria;
- 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 2025-04-04