NCT04045600 · RECRUITING
Refinements of Functional Communication Training
This trial is testing three versions of a behavioral therapy called Functional Communication Training, or FCT, which teaches children with severe problem behaviors like aggression or self-injury to communicate their needs instead of acting out. The study wants to know which version of FCT holds up best when treatment conditions change, such as moving from a clinic to a home setting. This is a Phase NA study, meaning it is a behavioral research study, not a drug trial.
You may qualify if
- 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 like attention (FCT is not appropriate for automatically reinforced destructive behavior)
- 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 destructive 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 SIB 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 drug-treatment changes, but the experimenters will invite these patients to participate if they meet inclusion criteria after drug regimen is 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 2026-06-17