NCT05928247 · RECRUITING
Manualized Assessment and Treatment Model of Challenging Behavior
This trial is testing a standardized behavioral treatment manual for children ages 3 to 17 who have serious challenging behaviors like aggression or self-injury. Researchers want to know whether this structured approach — using techniques like teaching communication as a replacement for problem behavior — works better than current patchwork methods. This is a Phase NA study, meaning it is a behavioral intervention trial, not a drug trial.
You may qualify if
- children from ages 3 to 17;
- challenging behavior that occurs at least 10 times a day, despite previous treatment;
- challenging behavior maintained by social positive or automatic 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 challenging 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 (Betz, 2011);
- patients requiring changes to protective supports for self-injury or drug treatment, but the investigators 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 2026-05-08