Can a smarter therapy tame severe behavior problems in kids?
NCT ID NCT05790668
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial tests two refinements to functional communication training (FCT), a therapy that teaches children with developmental disabilities to replace destructive behaviors like aggression or self-injury with appropriate requests. The refinements aim to make the therapy faster and prevent relapse during the gradual reduction of reinforcement. The study will enroll 30 children aged 3 to 17 who exhibit destructive behavior at least 10 times a day despite prior treatment. The goal is to see if these improvements can reduce destructive behavior more efficiently and safely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Behavioral intervention: functional communication training with refinements (progressive interval assessment and competing stimuli)
- What this could lead to
- If successful, this could make behavioral therapy for severe destructive behavior faster and more effective, reducing harm and improving family life.
- What could go wrong
- This is a small, early-stage trial. The refinements may not work for all children, and there is a risk of temporary increases in destructive behavior during treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * patients who do not meet the inclusion criteria * patients currently receiving 15 or more hours per week of treatment for their destructive behavior * Diagnostic and Statistical Manual-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 routine clinical-risk assessment * patients requiring changes to protective supports for self-injury or drug treatment, but investigators will invite these patients to participate when protective supports and drug regimen are stable
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Douglass Developmental Disabilities Center
RECRUITINGNew Brunswick, New Jersey, 08901, United States
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Rutgers University Center for Autism Research, Education, and Services
RECRUITINGSomerset, New Jersey, 08873, United States