BridgeMD
New treatment option for Aggression
Official title Refinements of Functional Communication Training
ClinicalTrials.gov ID: NCT04045600
What this study is testing
- What it's testing
- Although treatments for problem behavior, like functional communication training (FCT), can be highly effective in the clinic, changes in the way the FCT is implemented (e.g., when transferring treatment to the home, when teachers implement treatment with poor fidelity) can result in treatment relapse. The goal of this study is to evaluate whether using treatment signals and gradually introducing materials from natural contexts can help mitigate treatment relapse during context changes and poor treatment-integrity scenarios.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 17
You may be able to join 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 likely can't join 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...
- Patients requiring drug-treatment changes, but the experimenters will invite these patients to participate if they meet inclusion criteria after drug...
The study team makes the final eligibility decision.
Where it's taking place
- Somerset, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Somerset, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.